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The provided text describes safety criteria for an exercise device but explicitly states, "Penny and Giles Biometrics makes no claims for the effectiveness of this equipment." Therefore, it is impossible to describe acceptance criteria related to a device's effectiveness or a study proving its performance against such criteria.
The information given focuses solely on passive safety and electrical safety without any performance metrics for the device's intended therapeutic or training function.
Here's a breakdown of what can be extracted and what cannot, based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Safety) | Reported Device Performance (Safety) |
|---|---|
| Passive Safety | |
| a. Extent and duration of activity determined by therapist. | Met (Appendix 1) |
| b. Equipment provides aid, does not force activity. | Met (Appendix 1) |
| c. No energy exchange between exercise device and patient. | Met (Appendix 1) |
| d. Patient not attached other than by grip. | Met (Appendix 1) |
| Electrical Safety | |
| a. Opto isolation of data outputs to 4Kv. | Met (Appendix 6) |
| b. Isolation of low voltage DC power supply to 4Kv. | Met (Appendix 6) |
| c. Primary insulation in addition to A and B. | Met (Appendix 5) |
| Effectiveness | No claims made. |
2. Sample size used for the test set and the data provenance
- Not applicable. The provided text does not describe any effectiveness testing or a test set in the context of device performance. The safety criteria are likely assessed through engineering tests and analysis rather than a patient-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No effectiveness ground truth is mentioned or established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No effectiveness test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. No effectiveness study, MRMC study, or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. No effectiveness or algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No effectiveness ground truth is mentioned. The "ground truth" for the safety criteria would be engineering specifications and safety standards, which are implied to be met by the appendices referenced.
8. The sample size for the training set
- Not applicable. No training set is mentioned as there are no claims of effectiveness or AI/algorithmic performance.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
In summary: The provided document is a safety and regulatory submission, not a performance or effectiveness study. It explicitly disclaims any claims regarding the device's effectiveness, making it impossible to answer most of your detailed questions about performance criteria and related studies.
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.