(283 days)
The Buttock Muscle Stimulator, model WL-2413E, is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation(EMS) through skin contact electrode for the purpose of improvement of muscle tone of the buttocks muscles.
The Buttock Muscle Stimulator, model WL-2413E, is a two channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscle. The device comprises mainly the electronic stimulator module which generates the required stimulation signals. The Buttock Muscle Stimulator, model WL-2413E, comprises a short with silicon pad electrodes which connect the signals from the stimulator to the skin. The electrodes are placed on the inner surface of the accessories. The product is supplied with a 510(K) cleared conductive gel, a user's manual, 3AAA batteries, 2 lead wires and a storage bag. The required power of the device is derived from 3 batteries located in a compartment protected by a removable battery cover. The electrodes are in the inner surface of the shorts which is worn as shown on the picture of user manual. There is no current passed from side to side. The user cannot access the wiring or connectors within the shorts.
The provided 510(k) summary for the Buttock Muscle Stimulator, model WL-2413E, does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, particularly in the context of typical AI/medical imaging device submissions.
This submission is for a medical device that applies transcutaneous electrical muscle stimulation (EMS) and is seeking substantial equivalence to a predicate device. The "study" referenced in this document is a comparison of technical characteristics to demonstrate substantial equivalence, rather than a clinical trial or performance study with acceptance criteria often seen in AI device submissions.
Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of device and regulatory submission.
However, I can provide what is available regarding the comparison to the predicate device, which serves as the basis for its clearance.
1. Table of "Acceptance Criteria" (Comparison of Performance/Characteristics to Predicate) and Reported Device Performance
Instead of formal "acceptance criteria" and "reported device performance" in the sense of a clinical outcome study, this document focuses on demonstrating that the new device's technical characteristics are "substantially equivalent" to a legally marketed predicate device. The performance is indirectly compared by showing that critical parameters are either identical or within acceptable ranges when compared to the predicate.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device: WL-2413E) |
|---|---|---|
| General Features | ||
| Prescription or OTC | OTC | Same (OTC) |
| Indication for use | Purpose of improvement of muscle tone of the buttocks muscles | Same |
| FDA product code | NGX | Same (NGX) |
| Manufacturer | SPORT-ELECT | Well-Life |
| Unit Characteristics & Output | ||
| Waveform | Biphasic | Biphasic |
| Shape | Rectangular | Rectangular |
| Max Output Voltage @500Ω | 31.2V | 40.8V |
| Max Output Voltage @2KΩ | 66.0V | 70.0V |
| Max Output Voltage @10KΩ | 66.0V | 106.0V |
| Max Output Current @500Ω | 62.4mA | 81.6mA |
| Max Output Current @2KΩ | 33.0mA | 35.0mA |
| Max Output Current @10KΩ | 6.6mA | 10.6mA |
| Duration of primary phase (usec) | 200 Max | 300 Max |
| Pulse Duration (usec) | 540 Max | 720 Max |
| Frequency (Hz) | 70 Max | 70 Max |
| Symmetrical phases? | Yes | Yes |
| Power Source | 1.5Vx3 (AAA Size) | 1.5Vx3 (AAA Size) |
| Patient Leakage Current | Under 0.1 uA (Normal), Under 0.5 uA (Single Fault) | Under 0.1 uA (Normal), Under 0.5 uA (Single Fault) |
| Number of Output Modes | 4 | 4 |
| Number of Output Channels | Synchronous, Output Coil | Synchronous, Output Coil |
| Regulated Current or Voltage? | Voltage | Voltage |
| Software/Firmware/Microprocessor | Yes | Yes |
| Automatic Overload Trip? | No | No |
| Automatic No-Load Trip? | Yes | Yes |
| Automatic Shut Off? | Yes | Yes |
| User Override control? | No | No |
| Timer Range (Minutes) | 20-40 | 20-40 |
| Compliance with Voluntary Stds? | IEC 60601-2-10 | IEC 60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Yes |
| Weight (g) | 171.6 | 80 |
| Dimensions (mm.) [W x H x D] | 87×43×69 | 64×90×20 |
| Housing Materials | ABS | ABS |
| Net charge | 0 | 0 |
| Max. phase charge | 14 uc | 24 uc |
| Max. current Density | 0.0784 mA/cm² | 0.0997 mA/cm² |
| Max. Average current @500Ω | 38.43mA | 38.644mA |
| Max. Average current @2KΩ | 14.892mA | 16.907 mA |
| Max. Average current @10KΩ | 4.996mA | 5.120 mA |
| Max. Power Density | 0.00274 Watts/cm² | 0.00399 Watts/cm² |
| Burst Mode | Yes | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on comparing technical specifications and safety standards, not a clinical test set with human subjects.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the technical specifications of the predicate device (from its 510(k) K092142) and the technical specifications of the new device derived from engineering tests and calculations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" and no "ground truth" in the clinical sense in this document. The determination of "substantial equivalence" is made by the FDA based on the presented technical comparisons and compliance with relevant standards.
4. Adjudication method for the test set:
- Not applicable. No clinical test set with adjudicated results was used.
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. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used:
- Not applicable in a clinical sense. The "ground truth" for this submission is the established technical characteristics and safety profile of the legally marketed predicate device and the adherence to relevant international standards (e.g., IEC 60601-2-10).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).