(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.
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MAR 1 4 1996
Digital Conductance Meter - The Jayms Company
K9243/3
- SUMMARY OF SAFETY AND EFFECTIVENESS DATA FOR THE I. 510 (k) Digital Conductance Meter (Revised 7 November 1995)
Commercially available biofeedback devices measure the resistance of the skin and are used for relaxation training. These devices operate with a direct current to measure the resistance or an alternating current to measure impedance. Several biofeedback devices were marketed prior to 28 May 1976; and other substantially equivalent devices have been marketed since 1976, pursuant to the FDA's 510 (k) process.
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 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.
Like predicate devices, the DCM uses ohmmeter, audio and video hardware that conveys information about the skin conductance value during biofeedback. Predicate devices include the AT64 Skin Conductance Response (SCR) by Autogenic Systems Inc. (620 Wheat Lane, Wood Dale, IL, 60191) and the Biofeedback System/3 by Davicon (755 Billerica, MA). Those biofeedback devices were Middlesex, marketed prior to 1976. The DCM is also equivalent to the bioteedback functions of the Feedback Electrodermal Response Model EDR-100 (K770790) by Bio-Feedback Systems, (2736 47th Street, Boulder, CO, Inc. 80301) .
In design, the Digital Conductance Meter, the AT64 SCR and the Davicon Biofeedback System/3 use a personal computer. The DCM and the System/3 use the computer to display print and store conductance data. The System/3 and the DCM also allow a description of a protocol to be entered and saved for later recall. The AT64 SCR uses a personal computer to print data.
The materials of the DCM are equivalent to the materials used by other biofeedback. The materials form the ohmmeter circuit, display circuit and audio circuit. The DCM ohmmeter circuit can be selected for direct current (DC)
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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. The DCM has audio and video feedback signals which are substantially equivalent to the tones and the displays of the pre-1976 and predicate devices.
The use of the Digital Conductance Meter is equivalent to the use of the pre-1976 and predicate biofeedback devices. The biofeedback process is noninvasive and uses a low voltage to measure skin resistance. The pre-1976 and predicate biofeedback devices on the market have shown biofeedback to be safe and effective for relaxation training.
ﺮ :
§ 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.