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Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.

Contraindicated use on injured or otherwise impaired muscles

Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Body Control System "4M" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals. Body Control System "4M" comprises 4 electrodes, which connects the signals from the stimulator to the skin. The product is supplied with a User's Guide and a carry case.

The provided text is a 510(k) summary for the SPORT-ELEC Body Control System "4M," a muscle stimulator. It details predicate devices, general device description, intended use, and states that testing was performed to assure compliance with electrical safety and electromagnetic compatibility standards. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria related to its intended use (muscle firming, toning, strengthening).

Therefore, I cannot provide the requested information in the table format because the data is absent from the provided document.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: The document states that performance data "were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." However, it does not specify what those performance requirements (acceptance criteria) were for muscle tone, firmness, or strengthening, nor does it present any reported device performance data against such criteria. The "Performance data" section only lists compliance with electrical safety, electromagnetic compatibility, and software standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No performance study data is presented, so sample size and provenance are not mentioned.

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): Not applicable as no performance study is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no performance study is described.

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 device is a muscle stimulator, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a muscle stimulator, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no performance study is described.

8. The sample size for the training set: Not applicable as no performance study or machine learning algorithm is described.

9. How the ground truth for the training set was established: Not applicable as no performance study or machine learning algorithm is described.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with general safety standards, rather than presenting clinical or performance data for the specific indications of use (muscle toning, firming, strengthening).

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Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.

Contraindicated use on injured or otherwise impaired muscles

Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Body Control System "BS" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.

Body Control System "BS" comprises a short with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories. The product is supplied with the cream VC 57B/53 - 148, a User's Guide and a carry case.

This document outlines the acceptance criteria and supporting study for the "Body Control System 'BS'" muscle stimulator.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify a separate "test set" in the context of clinical performance testing. The reported "performance data" refers to compliance with various electrical safety, EMC, software, and risk management standards. These typically involve testing conducted on the device itself and its components, rather than human subjects or a clinical test set in the traditional sense of evaluating diagnostic or therapeutic accuracy.

Therefore, information on:

• Sample size used for the test set: Not applicable/not provided in the context of clinical outcomes.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/not provided. The performance data is based on compliance testing to international standards, which is generally conducted by accredited labs.

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

This information is not applicable/not provided as the "performance data" focuses on engineering and regulatory compliance (electrical safety, EMC, software) rather than a clinical performance study requiring a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the reasons stated above.

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

An MRMC comparative effectiveness study was not done. The device is an electro-muscle stimulator, not an AI-powered diagnostic or assistive technology for human readers.

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

A standalone performance study in the context of an algorithm's performance was not done. The "performance data" refers to the device's compliance with safety and technical standards for a physical medical device.

7. The type of ground truth used

The "ground truth" for the reported performance data is the established international standards (IEC 60601-1, -2-10, -1-2, -1-4) and regulatory guidance (FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices) themselves. Compliance is assessed against the requirements and specifications outlined in these standards.

8. The sample size for the training set

This information is not applicable/not provided. The device is not an AI/machine learning model that requires a "training set."

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

This information is not applicable/not provided for the same reason as above.

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Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs muscles.

Contraindicated use on injured or otherwise impaired muscles

Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Body Control System is a 2 channel battery operated muscle stimulation system specifically designed to exercise the arms and thighs muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.

Body Control System comprises accessories with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories.

The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.

This 510(k) submission describes the SPORT-ELEC Body Control System, a muscle stimulator intended for improving muscle tone and strengthening arm and thigh muscles in healthy individuals. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving specific performance metrics through clinical trials. As such, the information you've requested regarding detailed performance criteria and study results in the context of typical AI/diagnostic device evaluations is largely not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

This 510(k) submission does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, effect size on muscle strength). Instead, it focuses on demonstrating compliance with recognized safety and regulatory standards, and substantial equivalence to predicate devices.

• IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
• IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
  |
  | Electromagnetic Compatibility (EMC) Compliance | Testing was carried out to assure compliance with:
• IEC 60601-1-2 (Collateral Standard: Electromagnetic disturbances - Requirements and tests) |
  | Software Life-Cycle Process Compliance | Testing was carried out to assure compliance with:
• IEC 60601-1-4 (Collateral Standard: Programmable electrical medical systems) - Note: The document also mentions ISO 14971, which is for risk management, but primarily refers to IEC 60601-1-4 for software. |
  | FDA Guidance for Premarket Submissions and Software Compliance | Performance data were verified "versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." |
  | Substantial Equivalence (Technological Characteristics) | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control System Arms and Thighs device are substantially equivalent to the predicate devices (SPORT-ELEC Body Control System REF BCS K 081026, Slendertone System-Arms K 072553, Slendertone flex bottom and thighs toning system K022855). The accessories use the same stimulation signal delivery and have similar parameter settings, with electrode positioning integrated into the garment. The differences existing between the devices "do not raise new issues of safety or effectiveness." |

Study Details (as inferable from the document)

Given that this is a 510(k) submission primarily based on substantial equivalence and compliance with engineering standards, traditional clinical study details are not provided.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical performance test set for this 510(k). The "testing" mentioned refers to engineering and regulatory compliance rather than clinical efficacy/performance and thus wouldn't involve a 'test set' of patient data in the typical sense. The provenance of any data used for engineering tests is not specified, but it would have been conducted by the manufacturer (SPORT-ELEC S.A., France).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a clinical test set as part of this submission.

3. Adjudication method for the test set: Not applicable.

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 muscle stimulator, not an AI diagnostic tool, and involves no human "readers" or AI assistance in interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is the adherence to electrical safety, EMC, and software standards, which is evaluated through engineering tests and documentation. Substantial equivalence relies on comparing the device's technical specifications and intended use to legally marketed predicate devices.

7. The sample size for the training set: Not applicable. There is no mention or indication of a "training set" in the context of machine learning or AI algorithm development.

8. How the ground truth for the training set was established: Not applicable.

Summary:

The SPORT-ELEC Body Control System's 510(k) clearance (K091865) relies on demonstrating substantial equivalence to existing predicate devices and compliance with recognized electrical safety and software standards. It is not a submission that presents clinical performance data from a prospective study with a test set, ground truth established by experts, or AI performance metrics. The "acceptance criteria" are regulatory and engineering compliance, rather than clinical efficacy metrics.

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Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.

Contraindicated use on injured or otherwise impaired muscles

Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Body Control is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals.

Body Control is comprised of a belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belts. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.

Here's a breakdown of the acceptance criteria and the study information for the Body Control device, based on the provided text:

Preamble:

It's important to note that the provided document is a 510(k) Premarket Notification summary for a traditional submission, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission often relies on a comparison to existing devices and adherence to recognized standards rather than extensive clinical efficacy studies with specific acceptance criteria related to a novel clinical endpoint. The "performance data" described here primarily refers to electrical safety and electromagnetic compatibility, which are foundational for any medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a specific clinical "test set" in the context of efficacy or clinical performance for the Body Control device. The testing mentioned relates to adherence to electrical safety, EMC, and software standards. These types of tests are typically conducted on a representative sample of the devices themselves, rather than a human "test set" for clinical outcomes.

• Sample Size for Test Set: Not applicable in the context of clinical efficacy; refers to device samples for engineering standards testing.
• Data Provenance: Not applicable in the context of clinical efficacy; testing against standards is typically done in controlled lab environments.

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

This information is not provided in the document as it pertains to clinical performance evaluation, which was not the primary focus of this 510(k) submission. The "ground truth" here is the adherence to engineering standards.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-centric "test set" requiring adjudication for clinical outcomes.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret data, often with and without AI assistance. The Body Control device is a powered muscle stimulator, and its approval relies on electrical safety, EMC, software compliance, and substantial equivalence to a predicate device, not on interpreting diagnostic images.

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

Not Applicable. The Body Control device is a physical muscle stimulator, not an algorithm or AI system for standalone performance evaluation in the typical sense of AI/ML devices. Its "performance" relates to its physical function and electrical characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this submission is primarily:

• Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-10).
• Compliance with electromagnetic compatibility standards (IEC 60601-1-2).
• Compliance with software standards (IEC 60601-1-4).
• Demonstrated substantial equivalence to a previously cleared predicate device (SPORT-ELEC ABDOMINAL Training System, K061914) in terms of technological characteristics, features, specifications, materials, mode of operation, and intended use.

8. The Sample Size for the Training Set

Not Applicable. The document describes a physical medical device (muscle stimulator), not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As no AI/ML algorithm training set is mentioned, the method for establishing its ground truth is not relevant.

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CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen

CT5 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises namely an electronic stimulator module which generates the required stimulation signals.

CT5 comprises belt with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the belt, which take the place of the lead wires.

The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.

The provided text describes the SPORT-ELEC CT5 muscle stimulator and its premarket notification to the FDA. The information focuses on its substantial equivalence to a predicate device and compliance with safety standards, rather than a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for muscle improvement.

Here's a breakdown based on your request, highlighting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not mentioned. The document describes compliance with electrical and software standards, but no clinical study with a test set of participants for evaluating muscle improvement is detailed.
• Data Provenance: Not applicable for a clinical test set from the provided text, as no such study is described. The device is manufactured by SPORT-ELEC S.A. based in France.

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

• Not Applicable: No clinical study or test set requiring expert ground truth establishment for muscle improvement is described in the provided text. The document focuses on regulatory compliance and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

• Not Applicable: No clinical study or test set requiring adjudication is described.

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

• No: The provided text does not mention an MRMC comparative effectiveness study, or any clinical study comparing human readers (or users) with and without AI assistance for muscle improvement.

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

• Not Applicable: This device is a muscle stimulator, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device requires human application and use.

7. The Type of Ground Truth Used

• Not Applicable: For the claims of "improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen," no clinical ground truth (e.g., physiological measurements, expert assessment, outcomes data) is described in the provided document. The regulatory pathway here relies on substantial equivalence to a previously cleared device for the stated indications, rather than new clinical efficacy data for these specific claims.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that would typically have a "training set." The engineering and safety testing performed would not involve such a concept.

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

• Not Applicable: As above, this device does not utilize a training set in the context of AI/ML.

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