INTRODUCTION:
performance testing is defined as performance testing, performed by either a device manufacturer
or a third-party testing facility (e.g., a test laboratory), which encompasses all bench testing and
will be dependent upon the specifics of the actual device or device type. It covers mechanical and
biological engineering performance such as fatigue, wear, tensile strength, etc….
PERFORMANCE TEST:
Bench testing will contain most of the design verification and validation testing. It should be
included in the final submission if bench-test results are used to support substantial
equivalence.
1. List of specific bench tests conducted
2. Describe each test protocol
Objective of the test
Test article used in the test
Test method and procedures (including any specific test condition)
Study endpoint (the specific parameters measured)
Predefined acceptance or pass/fail criteria
3. summarize the results
4. Describe your analysis
- clear and concise, table
5. Discuss your conclusions
-comparison testing with the predicate in terms of SE
ELEMENTS FOR BENCH:
ASTM testing methods
Simulated use experiments
Validation tool {known input data for hardware/ software devices}
Finite element analysis
Cadaveric studies
Animal testing is not obligatory but can be used to support substantial equivalence. The
submission should include:
1. Specific animal tests
2. Description of test protocol:
the objective of the test,
test articles used,
test methods and procedures,
study endpoint,
the specific parameter measured,
pre-defined acceptance or pass/fail criteria
3. Summary of results
4. Analysis and conclusions
ELEMENTS OF ANIMAL STUDY:
Rationales for reduction of sample no. to spare the lives of animals
Another 510(K)submission that specifies no.
Test more than once per animal
Small vs. large and duration
Clinical testing is also not obligatory, and FDA will consider alternatives to clinical studies
given that those proposed alternatives are supported by an adequate scientific rationale. The
submission should include:
10-15%of submission
Objective of the test
Test methods and procedures (including any specific test conditions)
Study endpoints (safety and effectiveness)
Statistical methodology used
Study results and analysis performed (including statistical, as appropriate)
Conclusions-comparison testing with predicate device in terms of SE
Study is considered a significant risk, conducted under the IDE regulation 21 CFR
part812if it is conducted in the us
If, however, the study is considered -a significant risk the study is subjected to the
abbreviated requirement of 21 CFR part 812.2(b)only.
In all cases, sponsors of a clinical trial must comply with regulations governing
institutional review boards 21 CFR part 56 and informed consent 21CFR part 50.
LINKS:
https://www.medtechdive.com/news/fda-publishes-guidance-on-device-performance-
bench-tests/553523/
https://www.fda.gov/media/113230/download
https://www.fda.gov/media/93963/download
AGINA
