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BTL 799-2L is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• · Strengthening, Toning and Firming of buttocks, thighs and calves.
• · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL 799-2L is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has two outputs that enable simultaneous treatment by two applicators.
The BTL 799-2L is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-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.

This is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria, such as a table of acceptance criteria and reported device performance metrics like sensitivity, specificity, or AUC, a specific sample size for a test set, expert qualifications, or adjudication methods, is not present here.

Instead, the submission focuses on non-clinical testing to ensure safety and essential performance, and a comparison of technological characteristics to predicate devices to argue for substantial equivalence.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the typical sense (e.g., sensitivity, specificity). The acceptance criteria implicitly are compliance with various medical device safety and performance standards (listed below) and having technological characteristics and intended use similar enough to predicate devices to not raise new safety or effectiveness concerns.
• Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity) are reported as this is a comparison to a predicate device, not a de novo performance study. The device's "performance" is demonstrated by its adherence to safety standards and its functional similarity to legally marketed devices.

2. Sample size used for the test set and the data provenance

• This information is not provided as this submission relies on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not through a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as there is no mention of a test set with expert-established ground truth.

4. Adjudication method for the test set

• This information is not provided as there is no mention of a test set or adjudication.

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

• This information is not provided as this device is a physical muscle stimulator, not an AI-assisted diagnostic or imaging device, and no MRMC study is mentioned.

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

• This information is not applicable/provided as this device is a physical muscle stimulator, not an algorithm.

7. The type of ground truth used

• Not applicable as no clinical study with a ground truth is described. The "ground truth" for this submission revolves around compliance with recognized medical device safety standards and the established safety and effectiveness of the predicate devices it is compared against.

8. The sample size for the training set

• This information is not provided as this is not an AI/machine learning device requiring a training set.

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

• This information is not provided as this is not an AI/machine learning device requiring a training set.

Non-clinical Testing Summary:

The BTL 799-2L device underwent thorough evaluation for electrical safety and compliance with the following applicable medical device safety standards:

• IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• IEC 60601-2-10: Medical Electrical Equipment – Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
• IEC 62304: Medical device software - Software life cycle processes
• ISO 14971: Medical devices – Application of risk management to medical devices
• ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization

The comparison table provided details the technological characteristics of the BTL 799-2L compared to its primary predicate BTL 799-2T (K182106) and secondary predicate HPM-6000 (K160992). The key argument is that any differences do not raise new types of safety or effectiveness questions, thus demonstrating substantial equivalence.

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BTL 799-2T is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.
· Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL 799-2T is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device two outputs enable simultaneous treatment by two applicators.
The BTL 799-2T is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user stepby-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.

This document is a 510(k) Summary for the BTL 799-2T device, indicating that it is a powered muscle stimulator regulated under 21 CFR 890.5850. The summary primarily establishes substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the regulatory pathway of substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing (e.g., electrical safety, electromagnetic compatibility, usability, risk management, biocompatibility) rather than a clinical performance study with specific quantitative performance metrics as would be expected for an AI/ML device.

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BTL 799-2 is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• · Strengthening, Toning and Firming of buttocks and thighs.

The BTL 799-2 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the BTL 799-2 helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The BTL 799-2 is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information quides the user stepby-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The provided document is a 510(k) premarket notification for a medical device called BTL 799-2, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (AM-100) rather than presenting a clinical study with detailed acceptance criteria and performance metrics for the BTL 799-2 itself.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of clinical performance (e.g., accuracy, sensitivity, specificity).

Instead, the document details non-clinical testing to ensure safety and compliance with medical device standards. The "acceptance criteria" in this context are compliance with these standards, not clinical performance metrics.

Here's a breakdown of why the requested information cannot be fully provided from this document:

1. Table of acceptance criteria and reported device performance: This document does not establish clinical performance acceptance criteria (e.g., specific percentages for improvement in abdominal tone) or report device performance against such criteria. Its entire purpose is to show technological and intended use equivalency to a previously cleared device.

   • Acceptance Criteria (as implied by the document for regulatory clearance): Compliance with relevant electrical safety and biocompatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10).
   • Reported Device Performance: The document states the BTL 799-2 "has been found to comply" with these standards. No specific performance metrics (e.g., current output, magnetic field intensity) are presented as "reported device performance" against explicit "acceptance criteria" related to a clinical outcome. The technical specifications (Magnetic Field Intensity, Pulse Repetition Rate, Pulse Duration, Induced Current in the Tissue) are listed as characteristics, but not as performance against a target.

2. Sample size used for the test set and data provenance: Not applicable. No clinical test set data is presented. The "test set" for this submission was the device itself, tested against engineering and safety standards.

3. Number of experts used to establish the ground truth and their qualifications: Not applicable. No clinical ground truth was established from patient data.

4. Adjudication method for the test set: Not applicable. No clinical test set required adjudication.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance, usually with imaging or diagnostic devices. The BTL 799-2 is a therapeutic muscle stimulator.

6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a therapeutic device, not an AI or diagnostic algorithm.

7. Type of ground truth used: Not applicable for clinical performance. For safety and substantial equivalence, the "ground truth" refers to recognized medical device standards and the characteristics of the predicate device.

8. Sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires training data.

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

Summary based on the provided document:

The BTL 799-2 device's "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to an already cleared predicate device (AM-100) and compliance with relevant electrical safety and biocompatibility standards.

Acceptance Criteria (Implicit for Substantial Equivalence and Safety):

1. Same Intended Use: The device must have the same indications for use as the predicate (improvement of abdominal tone, strengthening of abdominal muscles, firmer abdomen; strengthening, toning, and firming of buttocks and thighs).
2. Similar Technological Characteristics: The device must operate on similar principles (magnetic field, muscle stimulation) and have comparable technical specifications, or any differences must not raise new safety or effectiveness concerns.
3. Compliance with Safety Standards: The device must pass non-clinical testing against a suite of recognized international safety and biocompatibility standards.

Study/Evidence that Proves Meeting Acceptance Criteria:

The "study" in this context is the 510(k) submission itself, which provides a comparative analysis of the BTL 799-2 with the predicate device (AM-100) and documentation of non-clinical testing results.

This document serves as regulatory submission for substantial equivalence based on technical comparisons and adherence to relevant standards, not a clinical trial evaluating specific performance metrics against a predefined acceptance threshold.

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