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510(k) Data Aggregation
(315 days)
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
MC0485 EMS Belt is a one channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module for signal generation, a belt for fixation, and four electrode pads for signal connection to skin. The built-in electrode pads are located on the inner surface of the belt. Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the EMS Belt. There is no current passed from side to side. The user cannot access the wiring or connectors within the belt. The stimulator sends gentle electrical current to targeted muscle area through the electrode pads placed on the skin. The parameters of the EMS Belt are controlled by the buttons on the controller and are displayed by the LCD on the controller. Its intensity level can be adjustable by user.
This document is a 510(k) Pre-market Notification for the EMS Belt (Model: MC0485). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove the device meets these criteria in the context of clinical performance or diagnostic efficacy.
Therefore, the requested information regarding acceptance criteria, reported device performance in a clinical study, sample sizes, data provenance, expert participation, adjudication methods, MRMC studies, standalone algorithm performance, and training set details for a study proving the device meets acceptance criteria cannot be extracted directly from this document. This K183103 submission is for a powered muscle stimulator and primarily relies on comparison to predicate devices and adherence to recognized standards for safety and electrical performance.
However, I can extract the information presented in the document regarding the device's technical specifications and the testing performed to demonstrate safety and performance as part of the substantial equivalence claim.
Here's a breakdown of the relevant information from the provided text, addressing the closest applicable aspects of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the typical sense of a clinical performance study (e.g., sensitivity, specificity for a diagnostic device). Instead, it demonstrates compliance with recognized standards and similarity to predicate devices' specifications. The "performance" here refers to meeting these standards and having comparable technical characteristics.
| Acceptance Criteria (Compliance/Similarity) | Reported Device Performance (EMS Belt/MC0485) |
|---|---|
| Biocompatibility: | |
| Compliance with ISO 10993-5 (In Vitro Cytotoxicity) | Passed |
| Compliance with ISO 10993-10 (Irritation and Skin Sensitization) | Passed |
| EMC and Electrical Safety: | |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Passed |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Passed |
| Compliance with IEC 60601-1-11 (Home Healthcare Environment) | Passed |
| Compliance with IEC 60601-2-10 (Nerve and muscle stimulators) | Passed |
| Software Verification and Validation: | |
| Meets software requirement specifications and mitigates hazards | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. (Documentation submitted consistent with moderate level of concern). |
| Electrode Pad Performance: | |
| Current dispersion and shelf-life verification (per FDA Guidance & ASTM F1980-07) | Verified |
| Waveform and Output Specifications: | |
| Compliance with FDA Guidance for Powered Muscle Stimulator 510(k)s | Verified (Output specifications are a "little different" from predicates but comply with IEC 60601-1, IEC 60601-2-10, and FDA Guidance, not raising new safety/effectiveness issues. Specific values are detailed in the comparison table of a previous section, but are noted as being within acceptable ranges set by standards rather than against explicit "acceptance criteria" of a study.) |
| Technical Specifications (Comparison to Predicates - highlighted differences and perceived equivalence): | |
| Product Code: NGX | NGX (Similar to prednisone's NUH, NGX. Note 1 states this is within the predicate devices' classification and does not affect intended use or normal use.) |
| Power Supply: 4.5V (3 x 1.5V Alkaline batteries) | Different from some predicates (adaptor, rechargeable battery) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Number of Output Modes: 7 | Different from predicates (10, 35/15, 25, 1) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Number of Output Channels: 1 | Different from predicates (2, 2, 2, 1) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Timer Range: 20min, 25min, 30min, 40min depending on preset program | Different from predicates (5min-30min, 5min-100min, 25min, 1min-60min) but "do not raise new questions of safety and effectiveness." (Note 2) |
| Weight/Dimensions: 310g (without batteries); 78x140x30mm (controller), 430x150x12mm (belt) | Different from predicates but "insignificant in the terms of safety or effectiveness." (Note 3) |
| Housing Materials and Construction: Controller: ABS plastic; Belt: Mutispandex; Electrode pads: TPE | "Consistent completely with the predicate devices" for enclosure. TPE electrodes consistent with K143430. All skin-contacting materials comply with ISO 10993-1, 10993-5, 10993-10. (Note 4) |
| Output Electrical Parameters: Max Output Voltage, Current, Pulse Width, Frequencym, Max Phase Charge, Max Current Density, Max Power Density | "A little different from the predicate devices" but all comply with IEC 60601-1, IEC 60601-2-10, and FDA Guidance, not raising new safety/effectiveness issues. (Note 5) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on compliance with international standards and comparison with predicate devices' specifications, not on a clinical test set with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the submission does not involve a clinical test set requiring expert-established ground truth for a diagnostic or therapeutic efficacy claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no clinical test set requiring adjudication.
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
This information is not applicable. The device is an EMS Belt, not an AI-powered diagnostic or assistive tool, and the submission does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical muscle stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" in this context is adherence to recognized international consensus standards (like ISO and IEC) for biocompatibility, electrical safety, software validation, and product performance/specifications, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
This information is not applicable. The device is not an AI algorithm that requires a training set. The term "training set" is not relevant to this 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
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