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510(k) Data Aggregation
(123 days)
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.
The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.
Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.
The provided document, a 510(k) Summary for the Gymform® TOTAL ABS, Model: WB-245, describes the device's technical specifications and claims substantial equivalence to predicate devices. However, it does not detail specific acceptance criteria for a study proving the device meets those criteria in clinical performance metrics. Instead, the document focuses on demonstrating safety and performance through compliance with recognized standards and a usability study, and by comparing its technical specifications to legally marketed predicate devices.
Here's an analysis of the provided information, structured around your request, with an emphasis on what is available and what is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices, which generally implies that if the predicate device is safe and effective, and the new device is sufficiently similar and meets safety standards, it is also safe and effective.
The performance data summarized focuses on technical benchmarks and compliance:
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 |
| EMC | Compliance with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Non cytotoxic, No skin sensitization, No skin irritation |
| Software Integrity | Compliance with FDA Guidance for Software in Medical Devices (Moderate concern) | Software verification and validation testing conducted and documented |
| Waveform Parameters | Verified to demonstrate substantial equivalence to predicate devices | Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density verified |
| Usability (OTC) | Lay user can: 1) Self-select, 2) Apply safely, 3) Understand indications/contraindications/warnings | Usability testing completed in 24 subjects; tests demonstrate device meets requirements |
| Max Output Voltage | Comparable to predicate devices, within safe limits | 81.6V @ 500Ω, 96V @ 2kΩ, 99.2V @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices. |
| Max Output Current | Comparable to predicate devices, within safe limits | 163mA @ 500Ω, 48mA @ 2kΩ, 9.92mA @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices. |
| Frequency Range | Comparable to predicate devices, within safe limits | 50, 60, 70 Hz. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance. |
| Pulse Width Range | Comparable to predicate devices, within safe limits | 200 us. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance. |
| Max Current Density | Compliance with IEC 60601-2-10 and FDA guidance | 0.041 mA/cm² @ 500Ω. Compliant with standards. |
| Max Power Density | Compliance with IEC 60601-2-10 and FDA guidance, below 0.25 W/cm² | 28.81 µW/cm². Compliant with standards and below 0.25 W/cm². |
2. Sample Size for the Test Set and Data Provenance
- Usability Study Test Set: 24 subjects
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "Usability testing (OTC Study)," which is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for a usability study. The "ground truth" for a usability study is typically the direct observation of user interaction and self-reported comprehension, not expert consensus on a medical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. Usability studies do not typically involve adjudication in the same way clinical diagnostic studies do. The assessment is usually based on predefined tasks and criteria for successful completion and comprehension by the "lay user."
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 mentioned. This device is a muscle stimulator, not an AI-powered diagnostic tool for interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is not an algorithm for diagnosis. Its performance is inherent in its electrical stimulation output and how users interact with it. The stated performance evaluations (electrical, EMC, biocompatibility, waveform, usability) are effectively "standalone" in that they assess the device itself without requiring a human medical expert to interpret its output for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Biocompatibility: Laboratory testing results based on established ISO standards.
- For Electrical Safety/EMC/Waveform: Measurement against recognized engineering standards (IEC, FDA guidance).
- For Usability: User performance and comprehension against specified usability objectives for "lay users." There isn't a "ground truth" in the diagnostic sense, but rather a determination of whether users can operate the device safely and effectively according to instructions.
8. The sample size for the training set
Not applicable. This document pertains to the evaluation of a physical medical device (muscle stimulator) rather than an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm was used.
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