Search Results

BTL-703-2 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, thighs and calves.
• · Improvement of muscle tone and firmness, for strengthening muscles in arms.

The BTL-703-2 is a non-invasive therapeutic device is comprised of a main unit and applicators that deliver electromagnetic and radiofrequency to the targeted tissue. The device's two outputs enable hands-free simultaneous treatment by two applicators.

The BTL-703-2 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.

The provided text is a 510(k) summary for the BTL-703-2 device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use. It does not typically contain detailed acceptance criteria and studies proving the device meets those criteria in the way described in your request for a medical AI/ML device.

Here's why and what information can be extracted:

• Acceptance Criteria & Performance: The document provides a comparison of technical characteristics between the proposed device (BTL-703-2) and its predicate (BTL 799-2L), as well as a reference device (BTL-899) for the radiofrequency component. These are not performance metrics in the sense of accuracy, sensitivity, or specificity that would be found in an AI/ML study. Instead, they are specifications related to the physical operation of the device (e.g., magnetic field intensity, pulse repetition rate, RF power). The "performance" here is simply that the device operates within these specified parameters, which is implicitly proven through non-clinical testing for electrical safety and electromagnetic compatibility.
• Study Design (implicitly): The document mentions "Non-clinical Testing" for electrical safety (IEC 60601-1, IEC 60601-1-2), software lifecycle processes (IEC 62304), risk management (ISO 14971), and biological evaluation (ISO 10993-1, -5, -10). These are standards compliance tests, not clinical efficacy studies with ground truth established by experts.

Therefore, many parts of your request (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary. This document is not evaluating an AI/ML diagnostic or prognostic device.

Here's what can be extracted based on the provided text, structured as closely as possible to your request, with explanations for missing/non-applicable components:

Acceptance Criteria and Study for BTL-703-2 (Powered Muscle Stimulator)

This device, BTL-703-2, is a powered muscle stimulator cleared under a 510(k) pathway, demonstrating substantial equivalence to a predicate device. The "acceptance criteria" in this context are primarily related to safety, electrical compatibility, and performance characteristics compared to the predicate, rather than diagnostic accuracy or human performance improvement as would be relevant for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes compliance with non-clinical safety and performance standards, not clinical trials to evaluate efficacy in human subjects (e.g., patient outcomes, image interpretation accuracy). Therefore, "test set" in the context of AI/ML evaluation metrics (like diagnostic accuracy) is not applicable. The "tests" performed are engineering and laboratory tests against recognized standards. The provenance of such testing is internal to the manufacturer or conducted by accredited testing laboratories.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" here is compliance with engineering and safety standards, verified through objective measurements and standard protocols, not expert consensus on medical findings.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert interpretations.

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

Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its ability to meet the technical specifications described in the table above, which is assessed through non-clinical testing. The document states: "The BTL-703-2 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards...".

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation (for 510(k) clearance) is primarily:

• Compliance with recognized electrical safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Compliance with software development lifecycle standards (e.g., IEC 62304).
• Adherence to risk management principles (ISO 14971).
• Biocompatibility of patient-contacting materials (ISO 10993 series).
• Demonstration of technical characteristics (e.g., magnetic field intensity, pulse duration, RF power) comparable to legally marketed predicate/reference devices.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device requiring a training set.

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

Not applicable.

Ask a specific question about this device