(286 days)
GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.
GYMFORM® ABS&CORE is a two channels battery operated muscle stimulation system specifically designed to stimulation the muscles.
The 2-area belt is intended for use on the muscles in abdomen or lower back separately.
Mini belt is intended for use on the muscles in arms, legs, thighs and buttocks areas separately.
It is comprised of a console for signal generation, two belts (2-area belt and mini belt) for fixation, and electrode pads for signal connection to skin. The electrode pads are replaceable.
Power is derived from 2 "AAA" batteries located in a compartment protected by a removable battery cover. 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 group through the electrodes placed on the skin. The parameters of the device are controlled by the buttons. Its intensity level can be adjustable by user.
The provided text describes the 510(k) submission for the GYMFORM® ABS&CORE, Model: VDPGYCSET0042, a powered muscle stimulator. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. It does not typically involve detailed studies proving novel device performance against specific clinical acceptance criteria in the way a new drug or advanced diagnostic AI might.
Instead, the "acceptance criteria" here are compliance with recognized safety and performance standards, and the "study" is a series of laboratory bench tests comparing the new device's specifications and performance against these standards and the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GYMFORM® ABS&CORE are largely based on compliance with international standards for medical electrical equipment and a comparison to predicate devices, demonstrating substantial equivalence in terms of safety and effectiveness.
| Acceptance Criterion (Standard/Comparison) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (General) | Substantially Equivalent to predicate devices (K130074, K111476) |
| Electrical Safety (IEC 60601-1 and IEC 60601-2-10 standards) | Complies with IEC 60601-1 and IEC 60601-2-10 |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2 standard) | Complies with IEC 60601-1-2 |
| Software Verification and Validation (FDA Guidance for Pre-Market Submissions and for Software Contained in Medical Devices) | Verified and Validated |
| Waveform Output Specifications (IEC 60601-2-10 and Guidance for Powered Muscle Stimulator) | Verified specifications within acceptable ranges compared to predicates |
| - Maximum Output Voltage (Vpeak-to-peak) | 132V @ 500Ω; 138V @ 2kΩ; 140V @ 10kΩ (vs. 108-126V for predicates) |
| - Maximum Current Density (Ipeak-to-peak) | 264mA @ 500Ω; 69mA @ 2kΩ; 14mA @ 10kΩ (vs. 216-12.6mA for predicates) |
| - Frequency range | 2 Hz, 10 Hz, 50 Hz, 90 Hz, 120 Hz (vs. 1-120 Hz for predicates) |
| - Pulse width range | 108μs / 124μs (vs. 100-120 μs for predicates) |
| - Pulse duration | Varies by mode, e.g., 500ms (Mode 1), 11.1ms (Mode 2) (similar to Predicate I) |
| - Net Charge | 19.2µC @ 500Ω (vs. 15.7µC for Predicate I) |
| - Maximum Phase Charge | 16.4µC @ 500Ω (vs. 13.0µC for Predicate I) |
| - Maximum Current Density (mA/cm²) | 0.082 mA/cm² @ 500Ω (vs. 0.057-0.55 mA/cm² for predicates) |
| - Maximum Power Density | 94.8 μW/cm² @ 500Ω (vs. 53.8 μW/cm² for Predicate I) |
| - ON time / OFF time | 0.5s / 0.5s (vs. 1s / 1s for Predicate I) |
| - Duty Cycle | 0.02%~1.28% (vs. 0.02%~1.19% for Predicate I) |
| Dispersion and Shelf Life (ASTM F 1980-07, Guidance: Shelf Life of Medical Device) | Tested |
| Adhesion (Section 5.4 of AAMI EC 12_2000_(R) 2010 Disposable ECG electrodes) | Tested |
| Biocompatibility (ISO10993-5 and ISO10993-10 requirements) | All user contacting materials comply |
| Functional Specifications (Power sources, leakage current, channels, modes, intensity, timer, weights, dimensions) | Compared to predicate devices; minor differences noted but compliant with IEC standards and guidance |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission, which relies primarily on bench testing and a comparison to predicate devices, not human clinical trials or retrospective/prospective medical data sets in the typical sense of AI/diagnostic device studies.
- Test Set Sample Size: Not applicable in the context of human subjects or medical images. The "test set" here refers to the device itself being subjected to various laboratory tests.
- Data Provenance: The data comes from internal laboratory bench testing conducted by the manufacturer (Well Brain International Ltd.) and comparisons against specifications of legally marketed predicate devices. The country of origin for the data is implied to be Hong Kong, China (where the manufacturer is located), though specific test labs are not detailed. It is retrospective in the sense that the new device's characteristics are compared against existing standards and predicate devices' known specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is generally not relevant for this type of 510(k) submission. "Ground truth" in this context is defined by international safety and performance standards (e.g., IEC standards, ASTM standards, AAMI standards) and the specifications of the predicate devices. Compliance with these established standards and equivalence to the predicates serves as the "ground truth" for regulatory clearance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical data (e.g., radiology reads). For a powered muscle stimulator demonstrating substantial equivalence through bench testing, the "adjudication" is essentially the determination by the manufacturer (and subsequently, the FDA) of whether the device meets the referenced standards and is substantially equivalent to the predicates.
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, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The GYMFORM® ABS&CORE is a powered muscle stimulator, and its submission focuses on electrical safety, performance, and functional equivalence, not on improving human reader performance with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done or is not applicable. The device is hardware-based with integral software/firmware for control, but it's not an "algorithm only" device in the diagnostic AI sense. Its function is direct muscle stimulation, not data analysis or diagnosis.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established through:
- Compliance with recognized international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, FDA Guidance documents (e.g., for software, powered muscle stimulators), ASTM F 1980-07, AAMI EC 12_2000_(R) 2010 electrodes, ISO10993-5, ISO10993-10.
- Specifications and performance of legally marketed predicate devices: Gymform® ABS-A-ROUND (K130074) and Contour Technology Muscle Stimulator (K111476).
The ultimate ground truth is the determination of substantial equivalence to these predicates, which implies equivalent safety and effectiveness.
8. The Sample Size for the Training Set
This information is not applicable in the context of this 510(k) submission. A "training set" refers to data used to train machine learning models. This device is a traditional medical device (powered muscle stimulator) and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set (for AI/ML) is mentioned or relevant to this device, the question of how its ground truth was established is 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).