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BTL-899MS is indicated to be used for:

· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.

• · Strenathening, toning and firming of buttocks, thighs and calves.
• · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL-899MS device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899MS device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• · Relaxation of muscle spasms
• · Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• · Muscle re-education
• · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• · Maintaining or increasing range of motion

The BTL-899MS is a non-invasive therapeutic device. The device is comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying tissue accompanied by a pleasant feeling of warming in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.

The BTL-899MS is equipped with a large color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

Based on the provided FDA 510(k) summary for the BTL-899MS device (K240234), here is an analysis of its acceptance criteria and the study proving it meets them:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed clinical study results for a novel device. Therefore, the information regarding acceptance criteria, specific performance metrics, and detailed study methodologies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for novel AI/software devices) is limited or absent. This document primarily outlines compliance with safety and performance standards relevant to a medical device's physical and electrical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are primarily related to meeting established electrical safety, electromagnetic compatibility, usability, risk management, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices in terms of technological characteristics and intended use. There isn't a table of quantitative performance metrics for disease detection or diagnostic accuracy in this submission because it's a physical therapy device, not an AI diagnostic tool.

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

The document explicitly states "Clinical Testing: Not applicable" on page 6. This indicates that a clinical study with real patient data (test set) for performance evaluation, as would be expected for an AI/software device, was not conducted or deemed necessary for this 510(k) submission. The evaluation was based on non-clinical testing (bench testing) and comparison to predicate devices, focusing on the device's physical and electrical characteristics and mechanism of action.

Therefore, questions regarding sample size, data provenance (country, retrospective/prospective), experts, and adjudication methods for a test set are not applicable in this context.

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

Not applicable, as no clinical test set for performance evaluation was conducted.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no clinical test set for performance evaluation was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a powered muscle stimulator, not an AI diagnostic device intended to assist human readers (e.g., radiologists interpreting images).

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

Not applicable. This is a physical device, not an algorithm, and its functionality is not standalone in the sense of an AI model's performance.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's acceptance is based on:

• Compliance with established international and national technical standards (e.g., IEC 60601-1, ISO 14971) for safety, EMC, usability, and biocompatibility.
• Demonstrated substantial equivalence to previously cleared predicate devices, meaning its intended use and technological characteristics are similar enough that it does not raise new questions of safety or effectiveness. The "ground truth" for this equivalence often relies on the established safety and efficacy of the predicate devices themselves, backed by their own clearances or long-standing market presence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a training set of data.

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

Not applicable, as there is no training set for this device.

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The BTL-899M device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The BTL-899M device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

The BTL-899M is a non-invasive therapeutic device. The device is comprised of a main unit and an applicator that deliver electromagnetic energy to the targeted tissue. The device's output enables handsfree treatment.

The application of electromagnetic energy to the patient's feeling of magnetic stimulation of underlying muscles, joints and connective tissue accompanied by a pleasant feeling of warming sensation in the application area, which may contribute to increased local blood circulation and help the patient to relax and make the treatment more comfortable.

The BTL-899M is equipped with a large color touch-screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy, the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

This document (K232937) is a 510(k) premarket notification for a medical device called BTL-899M, a Powered Muscle Stimulator. The key takeaway from this document is that the FDA has determined the BTL-899M device is substantially equivalent to a legally marketed predicate device (HPM-6000, K160992).

Therefore, the primary method of proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device by satisfying safety and performance standards for the device type, rather than conducting a separate clinical study with specific acceptance criteria as one might for a novel AI device with new claims.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a traditional medical device (Powered Muscle Stimulator) and not an AI/ML diagnostic tool, the "acceptance criteria" are primarily related to safety, electrical performance, and functional equivalence to the predicate device, demonstrated through non-clinical testing and comparison. There are no specific "performance metrics" in the sense of accuracy, sensitivity, or specificity as there would be for an AI-driven diagnostic.

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

The document explicitly states "Clinical Testing: Not applicable" (page 7). This means there was no clinical test set or associated data provenance (e.g., country, retrospective/prospective) in the traditional sense for evaluating device performance against a diagnostic or therapeutic outcome. The testing was primarily non-clinical (bench testing) to ensure safety and functional equivalence.

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)

Since there was no clinical testing or a "test set" in the context of diagnostic performance, there were no experts used to establish ground truth in this manner. The ground truth, in a regulatory context, for this type of device, is established by its compliance with recognized safety and performance standards and its comparison to an already cleared device.

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

Not applicable, as no clinical test set requiring adjudication was performed.

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 powered muscle stimulator, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance in interpretation.

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

Not applicable. This is not an AI/algorithm-driven device.

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

The "ground truth" for this submission is compliance with recognized standards for electrical safety, software safety, risk management, biocompatibility, and functional equivalence to the legally marketed predicate device. There is no "ground truth" related to disease diagnosis or treatment outcomes in the way one would describe it for an AI/diagnostic device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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