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510(k) Data Aggregation
(95 days)
Dr.MUSIC 3s (Model: DM-VME03S) is intended to be used by adults for temporary relief of pain associated with sore/ aching muscles in the shoulder, waist, upper extremities(arm) and lower extremities(leg) due to strain from exercise or normal household work activities and suitable for home use.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive pain relief method. TENS treatment passes electrical pulses across the intact surface of the skin to activate the underlying nerves. The device uses a rechargeable battery to generate pulses. These pulses are applied onto the contact skin through self-adhesive reusable hydrogel electrodes.
Dr.MUSIC 3s (Model: DM-VME03S) is an over-the-counter, home-use TENS device that consists of the following components: a main unit, which consists of the control unit and the battery unit; two electrodes; an electrode case; and a mobile app. The control unit contains the power/mode button and battery indicator, and is used to control the treatment mode and intensity level. The control unit connects to the battery unit via a Micro USB adaptor. The two re-usable adhesive hydrogel electrodes (which connect to the back of each the control unit and the battery unit using a snap button connector) deliver a low frequency pulse to the body by attaching on to the skin. The user can choose from three treatment output modes (music, tapping, or massaging) and various intensity levels.
The treatment modes and intensities can be controlled via the control unit or via a mobile app. The app allows the user to control and display the output intensity of the stimulation, change the operation mode, and display the time of use, among other features.
The mobile app can be downloaded to an iOS or Android mobile device and utilizes an icon touch-based user interface. The mobile devices must run on an operating system consisting of iOS 7.0 or later version: or Android 4.3 or later version. The mobile app and the unit communicate via Bluetooth technology.
The device components are not supplied sterile and do not require sterilization or processing prior to use.
This document is a 510(k) Summary of Safety and Effectiveness for the Dr.MUSIC 3s (Model: DM-VME03S) Transcutaneous Electrical Nerve Stimulator (TENS) device. This device is seeking substantial equivalence to predicate devices (PulseRelief, K151035, and Tanyx, K123866).
Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, new performance acceptance criteria for a novel AI/software device. The "acceptance criteria" here are largely defined by compliance with established medical device standards and demonstrating similar technological characteristics to the predicate devices.
| Acceptance Criterion (Standard or Characteristic Comparison) | Reported Device Performance (Dr.MUSIC 3s) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1, IEC 6001-2-10, IEC 60601-1-11 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| RF Wireless Capabilities | Evaluated per international standards; uses Bluetooth technology for mobile app communication. |
| Usability | Complies with IEC 62366. Usability testing conducted to assess and mitigate risks related to correct use and user errors. Results demonstrate product is reasonably safe and effective. |
| Risk Management | Assessed according to ISO 14971. All identified hazards reduced to acceptable levels. |
| Biocompatibility | Complies with ISO 10993-5 and ISO 10993-10 for patient-contacting surfaces (electrodes). Evaluated for cytotoxicity, skin irritation, and skin sensitization. Met standards. |
| Software Validation & Verification | Conducted pursuant to IEC 62304. Found acceptable. Documentation provided per FDA Guidance. |
| Cybersecurity Management | Activities conducted and found acceptable. |
| Intended Use/Indications for Use (Comparison to Predicates) | Same intended use: temporary relief of pain associated with sore/aching muscles in shoulder, waist, back, neck, upper/lower extremities due to strain from exercise/normal household work, suitable for home use. |
| Treatment Mode(s) | TENS (vs. TENS and EMS for one predicate, TENS for another). |
| Number of output modes | 3 (TENS pulse) |
| Number of output channels | 1 (same as predicates) |
| Waveform | Biphasic (differs from one predicate's monophasic) |
| Shape | Rectangular (same as predicates) |
| Maximum output Current | @500Ω: 10.4mA± 10% (differs from predicates, e.g., 60mA and 95.2mA) |
| Maximum output Voltage | 38Vpk (differs from predicates, e.g., 60V and 47.6Vpp) |
| Software/Firmware/Microprocessor control? | Yes (same as predicates) |
| Patient Override Control | Yes (Power on/off in device and mobile app, intensity) (similar to predicates) |
| Timer range | 5~30 min (Preset app.: 20min) (differs from predicates, e.g., 1-59min and continuous, or none set) |
| Frequency range | 1~100Hz (similar to one predicate, differs from another's 55Hz) |
| Pulse Width (duration) | 50-150μs (differs from predicates, e.g., 60-350μs and 80μs) |
| Electrode | Hydrogel, Attaches to skin (similar to predicates) |
| Power | Internally powered Equipment: 3.7V(Li-Poly Type), 400mAh (rechargeable) (similar rechargeable battery approach to one predicate, different from disposable battery of another) |
| App on mobile device | Yes (iOS and Android platforms) (similar to one predicate, not present on another) |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not detail specific sample sizes for particular tests (e.g., in usability testing, biocompatibility). It generally states that "tests conducted" and "verification and validation activities" were performed.
- Data Provenance: Not specified in terms of country of origin. The studies are described as "non-clinical performance data" conducted for this premarket notification. These appear to be laboratory compliance tests and engineering assessments.
- Retrospective/Prospective: Not explicitly stated, but typically, these types of compliance tests are prospective for the device being submitted.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a TENS stimulator, not an AI/imaging diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is defined by compliance with engineering, safety, and biocompatibility standards.
4. Adjudication Method:
Not applicable, as this is not a study requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, typically in medical imaging. The Dr.MUSIC 3s is a therapeutic TENS device, and its submission focuses on demonstrating safety and effectiveness through compliance with standards and technological equivalence, not by comparing human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
This concept is not directly applicable in the same way it would be for a diagnostic AI algorithm. However, the device itself (Dr.MUSIC 3s) has specific performance characteristics (e.g., electrical output parameters, timer ranges, modes) that were tested in a standalone manner to ensure compliance with the referenced standards. The mobile app portion is a user interface and control mechanism, not a standalone diagnostic algorithm.
7. Type of Ground Truth Used:
For the non-clinical performance data, the "ground truth" is established by:
- Applicable international and national medical device standards (e.g., IEC 60601-1, IEC 62366, ISO 14971, ISO 10993-5, ISO 10993-10, IEC 62304).
- Engineering specifications and design requirements of the device that are tested for compliance.
These are objective, measurable criteria and standards, not subjective expert consensus, pathology, or outcomes data typically associated with diagnostic device ground truth.
8. Sample Size for the Training Set:
Not applicable. This device is a hardware medical device with associated software for control. There is no mention of a machine learning or AI algorithm that requires a "training set" in the context of typical AI/ML development. The software capabilities are for user interface, control, and display, which are typically developed through traditional software engineering methods, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" in the context of machine learning for this device.
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