(1296 days)
The intended use of the DCM is for relaxation training during the biofeedback process. The purpose of the skin conductance data is for the patient to receive visual and audio feedback and for the data to be recorded for reviewing and for monitoring. During operation of the predicate devices, the visual and audio feedback conveys information to the patient and the operator about the biofeedback response.
The Digital Conductance Meter (DCM) has the same technological features as other predicate Class II Biofeedback devices. Like the predicate devices, the DCM is functionally an ohmmeter. Like the predicate devices, the DCM is noninvasive and uses a low voltage to measure skin resistance. The DCM has the same electrical characteristics as predicate devices that are legally marketed as safe.
The provided text describes a Digital Conductance Meter (DCM) and its substantial equivalence to previously marketed biofeedback devices. However, it does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria.
Here's an analysis based on the provided text and the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "has the same technological features as other predicate Class II Biofeedback devices." |
| "is functionally an ohmmeter." | |
| "is noninvasive and uses a low voltage to measure skin resistance." | |
| "has the same electrical characteristics as predicate devices that are legally marketed as safe." | |
| "The DCM ohmmeter circuit can be selected for direct current (DC) output which is substantially equivalent to the AT64 SCR ohmmeter circuit or selected for alternating current (AC) output which is substantially equivalent to the EDR-100 and the System/3 ohmmeter circuits." | |
| "has audio and video feedback signals which are substantially equivalent to the tones and the displays of the pre-1976 and predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of data.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set or ground truth establishment is described.
4. Adjudication method for the test set
- Not applicable. No 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
- No MRMC comparative effectiveness study was done or described. The DCM is a biofeedback device, not an AI-powered diagnostic tool, and the concept of "human readers" in this context is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The DCM is a physical device measuring skin conductance, not an algorithm. Its operation inherently involves a human-in-the-loop (the patient and the operator for biofeedback).
7. The type of ground truth used
- Not applicable. The document relies on substantial equivalence to legally marketed predicate devices, implying that the "ground truth" for safety and effectiveness is established by the history and regulatory status of those predicates.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.