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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.

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.

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The GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.

The ABS-A-ROUND is a three-channel battery operated muscle stimulation system specifically designed to training muscles. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The stimulation of each channel is active atternately for 2 cycles with its set output intensity level and mode program in below default activation sequence: F channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then L channel is active for 180 seconds solely, stop for 10 seconds as idle interval; then R channel is active for 180 seconds solely, stop for 10 seconds as idle interval; repeat one cycle with above activation sequence. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately. It is comprised of an electronic stimulator module for signal generation, two belts for fixation, and electrodes for signal connection to skin. The electrodes are replaceable. Power is derived from 3 batteries located in a compartment protected by a removable battery cover for the Fitness Belt. There is no current passed from side to side. 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.

Here's an analysis of the provided text regarding the GYMFORM® ABS-A-ROUND device, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions primarily focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical studies that would typically define "acceptance criteria" and "device performance" in the way one might expect for a novel device or a high-risk device. The "performance" discussed here largely refers to compliance with electrical safety and EMC standards, and a comparison of technical specifications to predicate devices. There is no mention of a formal clinical performance study in the provided text that would establish typical diagnostic or therapeutic performance metrics like sensitivity, specificity, accuracy, or effect sizes for human improvement.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary, the "acceptance criteria" are primarily related to safety, electrical performance, and substantial equivalence to predicate devices, rather than clinical efficacy. The reported "performance" aligns with these compliance aspects.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No specific test set or clinical study data is mentioned for evaluating muscle performance or clinical outcomes. The "testing" mentioned refers to compliance with electrical safety and EMC standards. These are typically bench tests or simulations, not human subject studies.
   • The manufacturer is Well Brain International Ltd., located in Hong Kong SAR, China.

2. 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)

   • Not applicable. There is no mention of a study requiring expert-established ground truth for a test set in the context of clinical performance. The documentation focuses on engineering and regulatory compliance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No clinical test set or adjudication method is described.

4. 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 device is a powered muscle stimulator, not an imaging analysis or diagnostic AI device. There is no mention of an MRMC study or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is a direct-use muscle stimulator, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable in the clinical sense. The "truth" or reference used in this submission relates to established electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility standards (ISO10993-5, ISO10993-10), as well as FDA guidance for EMS devices. These are engineering and regulatory benchmarks, not clinical ground truth.

7. The sample size for the training set

   • Not applicable. This device does not use machine learning or require a training set in the conventional sense.

8. How the ground truth for the training set was established

   • Not applicable. As above, no training set or associated ground truth establishment process is mentioned.

Summary of the 510(k) Submission's Approach:

The Well Brain International Ltd. 510(k) submission for the GYMFORM® ABS-A-ROUND is a typical example of demonstrating substantial equivalence for a Class II medical device. The "acceptance criteria" are primarily regulatory and engineering compliance requirements. The "study" mentioned consists of testing the device against recognized electrical safety, EMC, and biocompatibility standards, and then demonstrating that its technical specifications and intended use are similar enough to existing, legally marketed predicate devices such that any differences do not raise new concerns about safety or effectiveness. There is no clinical performance study data presented in this summary to establish efficacy or diagnostic accuracy, which is common for devices of this type seeking a 510(k) clearance based on substantial equivalence.

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The electrical muscle stimulation (EMS) operation mode is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.

The therapeutic vibrator (Vibration) operation mode is indicated for the promotion of muscle relaxation.

The new device with its proprietary name/model number of Gymform Dual Flex Belt/WB-162 is a single device featured with two modes of operation, independent each other - the electrical muscle stimulation for abdominal muscles conditioning and the therapeutic vibrator for abdominal muscles relaxation.

Upon selected the electrical muscle stimulator (EMS) mode, the flex belt will function as an electrical muscle stimulator capable to achieve toning and firming of muscles in the abdominal region via using transcutaneous electrical muscle stimulation which is a technology for muscle conditioning by sending a stream of electric impulses to the motor nerve of muscle via the pair of single-patient/multiple-application biocompatible cutaneous electrodes on the inner surface of the flex belt, the muscle responds to each electric impulse by producing a contractile twitch, just as it would create voluntary muscle contractions during normal training & strengthening practice, and continues to contract until the electric impulse is over the muscle then returns to its relax state. The level of muscle contraction and relaxation is determined by the electric impulse intensity and the duration applied to the motor nerve of muscle, in which is user selectable via the flex belt control panel.

Upon selected the therapeutic vibrator (Vibration) mode, the Gymform Dual Flex Belt (new device) will function as a therapeutic vibrator to perform muscles relaxation. The therapeutic vibrator (Vibration) mode employs the method of electric muscle massage that simulates natural massage movement of a massage therapist, using oscillating movement of the eccentric motor that installed in the instrument casing to produce linear pulling vibrations to relaxing the abdominal muscle region of a patient.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Gymform Dual Flex Belt. It compares the device to a predicate device, the Slendertone FLEX Abdominal Training System Type 515 (K030708), to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" is compliance with safety standards and showing "same effectiveness" as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions an "effectiveness test report" but does not provide any details regarding the sample size used, the characteristics of the test participants, or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the report demonstrates "same effectiveness" as the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information about experts or ground truth establishment for an effectiveness study. The assessment of effectiveness appears to be based on an internal report that concluded similar effectiveness to the predicate device, but the methodology of that assessment is not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned or implied. The device is a direct-to-consumer electrical muscle stimulator, and comparative effectiveness studies of this nature are generally not required for 510(k) clearance in this context. The comparison is primarily against the performance characteristics of the predicate device for substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable as the device is a physical muscle stimulator, not an algorithm or AI system. Its performance is inherent in its electrical output and mechanical function.

7. The Type of Ground Truth Used

The document does not specify the type of "ground truth" used for effectiveness testing. Given the nature of a muscle stimulator, effectiveness might be assessed through metrics such as muscle contraction force, muscle circumference changes, or perceived muscle tone/firmness, but these details are not provided. The primary ground for clearance is "comparison of the electric muscles stimulation (EMS) mode" against a predicate.

8. The Sample Size for the Training Set

This question is not applicable as the Gymform Dual Flex Belt is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

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