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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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BTL-899F is indicated to be used for:

• Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen.
• Non-invasive lipolysis (breakdown of fat) of the thighs.
• Reduction in circumference of the thighs.
• BTL-899F is intended for use with skin types I VI.
• Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I IV.
• Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

The BTL-899F is a non-invasive therapeutic device.
BTL-899F consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.

The provided text describes a 510(k) premarket notification for the BTL-899F device, a non-invasive therapeutic device intended for lipolysis and circumference reduction in various body areas. The submission aims to demonstrate substantial equivalence to a predicate device (BTL-899A).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 55 subjects were enrolled in the study. 51 participants attended the final 3-month follow-up. The performance metrics are based on these 51 participants.
• Data Provenance: The document does not explicitly state the country of origin for the data. It is a clinical investigation conducted by BTL Industries Inc., a company with a Marlborough, Massachusetts address. The study design is described as single-arm, open-label, and interventional, indicating it was a prospective study.

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

• Number of Experts: Three independent blinded evaluators were used to assess the pre- and post-treatment images.
• Qualifications of Experts: The document does not specify the qualifications (e.g., radiologist with years of experience) of the evaluators. They are simply referred to as "independent blinded evaluators."

4. Adjudication Method for the Test Set

• The acceptance criterion for image identification was "at least two of three independent blinded evaluators." This implies a 2 out of 3 consensus or similar majority-based adjudication method for image recognition. The exact adjudication method for other observations (e.g., fat thickness measurement, side effect assessment) is not explicitly detailed, but the fat thickness reduction seems to be a measured outcome, not subjected to expert adjudication in the same way.

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 involving human readers assisting with or without AI was not conducted. This study's primary focus was on the device's direct effect on fat thickness and subjective patient outcomes, with independent evaluators assessing before/after images. The device itself is a therapeutic device, not an AI diagnostic tool.

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

• This device is a therapeutic device (electrosurgical cutting and coagulation device) that performs non-invasive lipolysis. It is not an AI algorithm in the context of image analysis or diagnostic support. Therefore, a "standalone algorithm performance" evaluation as typically understood for AI software was not applicable and not performed. The device's performance is driven by its physical application and effect.

7. The Type of Ground Truth Used

• The ground truth for the primary objective (fat thickness reduction) was based on objective measurements (ultrasound).
• For the secondary objectives:
  • Safety was assessed through clinical observation and patient reporting of adverse events.
  • Image evaluation involved a form of expert consensus (at least 2 out of 3 independent blinded evaluators).
  • Patient satisfaction and comfort were based on patient-reported outcomes.

8. The Sample Size for the Training Set

• The document does not describe a separate "training set" in the context of an AI model. The clinical investigation appears to be a single study evaluating the device's performance. The device is a physical therapeutic device, not a software algorithm that would typically undergo a separate training phase with a distinct dataset.

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

• As there is no mention of a separate training set for an AI model, this question is not applicable based on the provided document. The device's validation is based on the clinical investigation described for its performance.

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BTL-899A is indicated to be used for:

Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

The BTL-899A is a non-invasive therapeutic device.

BTL-899A consists of a main unit and applicators. The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the BTL-899A device:

Device: BTL-899A (Non-invasive lipolysis device)

Study Purpose: To demonstrate the effectiveness and safety of the BTL-899A device for non-invasive lipolysis of the upper arms.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size (Test Set/Clinical Study): Forty (40) participants.
• Data Provenance: Not explicitly stated, but the study was conducted by BTL Industries who are based in Marlborough, MA, USA, and the submission is for FDA clearance, implying the study was conducted in a manner acceptable for US regulatory review. The text does not specify if it was retrospective or prospective, but the description of "clinical investigation" with "follow-up intervals" and "participants received treatments" strongly suggests a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) independent blinded evaluators.
• Qualifications of Experts: Not specified. (e.g., "Radiologist with X years of experience" is not provided).

4. Adjudication Method for the Test Set

• Adjudication Method: "Correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators had to be reported." This indicates a 2-out-of-3 majority vote method for image recognition.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done?: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not conducted or described. This device is a therapeutic device (non-invasive lipolysis), not an AI-powered diagnostic tool assisting human readers. The clinical study evaluated the direct effect of the device on patients.

6. Standalone Performance

• Standalone Performance Done?: Not applicable in the context of this device. This is a therapeutic device, not an AI algorithm whose standalone diagnostic performance would be measured. The primary efficacy endpoint refers to human evaluators assessing the outcome of the device treatment.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the primary efficacy endpoint was established by the consensus of three independent blinded human evaluators (at least 2 out of 3 agreeing) on pre-treatment and 3-month follow-up images, as a proxy for the device's ability to induce lipolysis.
  • For the secondary endpoint of fat thickness reduction, it implies some form of objective measurement (e.g., ultrasound, caliper measurements, or other imaging) that would be considered the ground truth, though the specific method is not detailed.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This document describes the clinical validation study of a physical therapeutic device, not the development or validation of an AI algorithm which typically involves training sets.

9. How Ground Truth for Training Set Was Established

• How Ground Truth Established: Not applicable, as there is no mention of a training set for an AI algorithm.

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BTL-899 FP is indicated to be used for:

• Non-invasive lipolysis (breakdown of fat) of the abdomen.
• Reduction in circumference of the abdomen.
• Non-invasive lipolysis (breakdown of fat) of the thighs.
• Reduction in circumference of the thighs.
• BTL-899 FP is intended for use with skin type I VI.

The BTL-899 FP is a non-invasive therapeutic device. BTL-899 FP consists of a main unit and applicator(s). The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with an emergency button to terminate the therapy. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators. The system combines bipolar radiofrequency with electromagnetic stimulation.

Here's a summary of the acceptance criteria and study details for the BTL-899 FP device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the BTL-899 FP device. Instead, it describes "endpoints" for its clinical studies focusing on safety and efficacy, which can be interpreted as the criteria for demonstrating the device's performance. The performance is compared to what was "previously evidenced" by a predicate device.

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

• Sample Size: 34 subjects with Fitzpatrick Skin Types (FST) IV-VI were recruited.
  • Specific breakdown: 9 subjects with skin type IV, 8 subjects with skin type V, and 8 subjects with skin type VI completed the treatments (25 subjects explicitly mentioned as completing, though 34 recruited).
• Data Provenance: Prospective, clinical investigations conducted in the United States of America.

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical endpoints (fat thickness reduction, circumference reduction, satisfaction, safety). The assessment appears to be based on direct measurements (ultrasound or MRI for fat/circumference) and patient self-reporting (Likert scale, VAS for discomfort and satisfaction). There is no mention of independent expert review of these assessments.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical study results. Measurements appear to be taken directly or reported by subjects, with no indication of a separate expert review or consensus process for conflicting interpretations.

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

No, an MRMC comparative effectiveness study was not explicitly done. The study focused on the performance of the BTL-899 FP device itself, primarily comparing it to "efficacy previously evidenced" by its predicate device (K192224), rather than comparing human readers with and without AI assistance. The BTL-899 FP is a therapeutic device, not an AI diagnostic/interpretive tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The BTL-899 FP is a physical therapeutic device with specific operational parameters, not an algorithm, AI, or software that can operate in a standalone manner without human interaction. The "algorithm" in this context refers to the device's internal firmware controlling the treatment, not an AI for interpretation or diagnosis.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through:

• Objective Measurements: Diagnostic ultrasound or magnetic resonance for fat tissue reduction, and abdominal circumference measurements.
• Patient-Reported Outcomes: 5-point Likert scale questionnaire and 10-point visual analogue scale (VAS) for therapy comfort and subjective satisfaction.
• Observation/Clinical Assessment: Monitoring for adverse reactions (inflammation, post-inflammatory hyperpigmentation, erythema, muscle soreness).

8. The Sample Size for the Training Set

The device is a physical therapeutic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device's parameters comes from pre-clinical engineering, safety testing, and potentially prior clinical studies that informed the predicate device's efficacy. The document does not describe a training set for an algorithm.

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

As stated above, this question is not applicable as the device is not an AI/ML algorithm requiring a training set with established ground truth labels. The performance of the device's internal control firmware is evaluated through engineering verification and validation against safety and performance standards (e.g., IEC 60601-1, IEC 62304) and confirmed safe and effective via a clinical study with real subjects.

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BTL-899ST is indicated to be used for:

• · Non-invasive lipolysis (breakdown of fat) of the abdomen.
• · Reduction in circumference of the abdomen.
• · Non-invasive lipolysis (breakdown of fat) of the thighs.
• · Reduction in circumference of the thighs .
• · BTL-899ST is intended for use with Skin Type I, II and III.

The BTL-899ST is a non-invasive therapeutic device.
BTL-899ST consists of a main unit and applicator(s). The main unit is equipped with a color touch screen that makes the device easy to use. The on-screen information guides the Operator through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During therapy, the screen displays information about the remaining therapy time and other therapy parameters. The device is equipped with the Total Stop Button to terminate the device. The Total Stop Button is located on the rear panel of the main unit. The two outputs (applicators) of the device enable hands-free simultaneous treatment by two applicators.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Primary Efficacy: While 75.86% of subjects responded, 81.03% of the treated thighs showed a reduction of at least 1 cm. The acceptance criteria specify "minimum of 80% of subjects...to show mean thighs circumference reduction of >= 1 cm". The provided text could be interpreted as 22 out of 29 subjects responded indicating individual subject success rather than simply thigh success. However, the subsequent sentence clarifying "Forty-seven of the total 58 thighs treated had circumference reduction of = 1 cm" in its description which is confusing and may be a typo in the provided document. Assuming it should have been ">=", the 81.03% success rate at the thigh level met the criteria. If it truly was "=1 cm criteria if the goal was a larger reduction. I will assume it's a typo in the document and should be >= 1 cm.

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

• Sample Size: N=29 subjects completed follow-up for the primary efficacy and safety analysis. N=40 subjects were initially enrolled/treated. 38 subjects completed the 3-month follow-up (likely for safety).
• Data Provenance: The document does not explicitly state the country of origin. It is a clinical study. The timeframe for the study's execution (prospective or retrospective) is not explicitly stated, but the description of "enrolled/treated" and "follow-up" strongly indicates a prospective study.

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

• This information is not provided in the document. The study measures circumference reduction and patient satisfaction, which do not typically require a panel of experts to establish a "ground truth" in the way, for example, a diagnostic imaging study would. The measurements (circumference reductions) are objective, and satisfaction is self-reported by subjects.

4. Adjudication Method for the Test Set

• This information is not provided as the study design focuses on objective measurements and self-reported satisfaction, not a scenario requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This study is a clinical trial evaluating the device's performance in humans, not comparing human reader performance with and without AI assistance. The device itself is a therapeutic device, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This question is not applicable as the device is a physical therapeutic device (electrosurgical cutting and coagulation device and accessories), not an algorithm or AI system for diagnosis. The study evaluated its direct application on subjects.

7. Type of Ground Truth Used

• For efficacy: Direct measurements of thigh circumference reduction (objective, quantitative data) and self-reported patient satisfaction (subjective, qualitative data) served as the "ground truth."
• For safety: Observation and reporting of adverse events.

8. Sample Size for the Training Set

• This information is not applicable as the device is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The referenced clinical study is a validation study for establishing efficacy and safety in a human population.

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

• This information is not applicable for the same reason as above (not an AI algorithm).

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BTL-899 is indicated to be used for:

• · Non-invasive lipolysis (breakdown of fat) of the abdomen.
• · Reduction in circumference of the abdomen
• · The BTL-899 is intended for use with Skin Type I to Skin Type III.

The BTL-899 is a non-invasive therapeutic device is comprised of the main unit and applicators that deliver radiofrequency energy to the targeted tissue. The device two outputs enable hands-free simultaneous treatment by two applicators. The BTL-899 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 keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

Here's a breakdown of the acceptance criteria and the study details for the BTL-899 device, based on 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: N=42 subjects completed the clinical study out of N=44 enrolled.
• Data Provenance: The text does not explicitly state the country of origin, but it is a "Prospective open-label single-arm self-controlled study," indicating it was conducted specifically for this regulatory submission. It is a prospective study.

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

• Number of Experts: Two blinded evaluators for photograph identification.
• Qualifications: The specific qualifications of the evaluators are not mentioned, only that they were "blinded evaluators."

4. Adjudication Method for the Test Set

• The text mentions "two blinded evaluators" for photograph identification. It does not explicitly state an adjudication method (e.g., 2+1, 3+1). The criterion was "Correct identification... in at least 70% of treated subjects by two blinded evaluators," and the result states "Both evaluators correctly identified subject's photographs in 76.19% of cases." This implies consensus or agreement between the two was the standard for a correct identification for a given subject.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. This device is a treatment device, not an AI-assisted diagnostic or imaging interpretation tool.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

• This is not applicable as the BTL-899 is a medical device for treatment, not an algorithm, and its performance involves direct patient interface and effect. The clinical study evaluated the device's efficacy and safety in a human-in-the-loop context (administered by clinical staff).

7. Type of Ground Truth Used

• Clinical Measurements: Abdominal circumference reduction measured by tape.
• Imaging: Abdominal fat reduction measured by ultrasound images.
• Expert Consensus: Blinded evaluators for photograph identification.
• Histology: Biopsies from a separate study of 8 subjects confirmed fat breakdown and skin morphology.
• Patient Reported Outcomes: Subject satisfaction and discomfort questionnaires.

8. Sample Size for the Training Set

• The document describes a clinical study to evaluate the device's performance, not a training set for an AI algorithm. Therefore, there is no mention of a "training set" in this context. The N=42 subjects are the test set for its clinical efficacy and safety.

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

• As there is no mention of an AI algorithm or a training set, this question is not applicable. The device's performance was established through the clinical efficacy and safety study on the N=42 subjects and confirmed by histology data.

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