(337 days)
The MC1 is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms, 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.
The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.
Here's a summary of the acceptance criteria and study information for the General Project MC1, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Conforms with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conforms with IEC 60601-1-2 |
| Electrical Safety in Ultrasonic Physiotherapy Equipment | Conforms with IEC 60601-2-5 |
| Tissue Heating for Ultrasonic Diathermy (Required for therapeutic effect, specifically for tissue temperature to reach at least 40° C) | The MC1 increases tissue temperature as required for ultrasonic diathermy; "The two 1 MHz ultrasound transducers can be considered equivalent to the MED Sculpt in terms of heating tissue temperature to at least 40° C." Results were similar to the predicate device (MED Sculpt). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of patient or image data for evaluating clinical performance. The performance testing described focuses on engineering and physical performance (electrical safety, EMC, tissue heating).
- Sample Size: Not applicable in the traditional sense of a clinical test set. The evaluation compared the MC1's physical performance to a predicate device, the MED Sculpt.
- Data Provenance: Not applicable. The "data" refers to measurements from the device itself during controlled testing, not data derived from human subjects or retrospective/prospective studies on patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth for clinical performance was not established by experts in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No human readers or adjudicators were involved in evaluating the device's technical performance against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The submission describes technical and performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? This question is generally relevant for AI/software devices. For this physical medical device (ultrasound and massager), a "standalone" study in the AI sense is not applicable. The performance testing was of the device operating on its own.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the device's physical performance was based on established engineering standards (IEC) for safety and electromagnetic compatibility, and a specific temperature threshold (at least 40° C) for tissue heating as a measure of therapeutic efficacy for ultrasonic diathermy. This could be considered measured physical properties and engineering standards. It was not pathology, expert consensus on clinical cases, or outcomes data.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not use an "AI" or "machine learning" algorithm that requires a training set. The device's function is mechanical and ultrasonic.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable, as there is no training set for an AI algorithm.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.