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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.

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BTL-703 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.

The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.

The acceptance criteria and study information for the BTL-703 device, based on the provided FDA 510(k) summary, are described below.

Please note: This document focuses on the regulatory submission information. For medical devices like the BTL-703 (Shortwave Diathermy), the "performance" in the context of a 510(k) submission primarily refers to meeting safety and fundamental operational requirements and demonstrating substantial equivalence to a predicate device. It typically does not involve the same kind of clinical trial efficacy metrics (sensitivity, specificity, etc.) as AI/software devices. The "acceptance criteria" here are therefore related to safety standards and the ability to achieve a therapeutic temperature range.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2: Collateral standard: Electromagnetic Disturbance – Requirements and tests (Complied)
• IEC 62304: Medical device software – Software life cycle processes (Complied)
• ISO 14971: Medical devices - Application of risk management to medical devices (Complied)
• ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (Complied)
• ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (Complied)
• ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (Complied) |
  | Ablity to achieve therapeutic temperature | The device should be able to maintain a therapeutic temperature range in vivo (in relevant body tissues). Specific target: approximately 40-45°C. | The study confirmed the ability of the BTL-703 device to maintain the temperature in the range of approx. 40-45°C in vivo. |
  | Substantial Equivalence | Demonstration that the technological characteristics and indications for use are substantially equivalent to a legally marketed predicate device (K120093, BTL Elite), raising no new safety or effectiveness questions. | Comparison table provided showing similar indications for use, principle of action, clinical use, electrical protection, user interface, firmware control, type of energy, working frequency (27.12 MHz), therapy time (1-30 min), hands-free application, stop remote control, and applicator contact monitor. Differences (e.g., no pulsed mode, negative pressure applicator fixation, thermal stabilization system) were determined not to raise new safety or effectiveness questions. |

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

• Test Set (Animal Study): The document only mentions a "study in porcine model" for demonstrating temperature maintenance. It does not provide the specific sample size (number of animals or test points) used in this model.
• Data Provenance: The animal study was conducted in a porcine model. The country of origin for the data is not specified. This was a prospective study designed to specifically evaluate the device's ability to maintain temperature in vivo.

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

Not applicable. The "ground truth" for the animal study was objective temperature measurement, not a subjective assessment by human experts.

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

Not applicable. The animal study involved direct physical measurements (temperature), not subjective interpretations requiring 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

Not applicable. The BTL-703 is a physical therapy device that applies heat, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance improvements are not relevant in this context.

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

Not applicable. The BTL-703 is a physical medical device, not a software algorithm or AI.

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

• For the animal study: The ground truth was based on objective temperature measurements within the porcine model.
• For demonstrating substantial equivalence: The ground truth was based on adherence to established medical device safety standards (e.g., IEC, ISO) and comparison of technical specifications and indications for use with the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. The non-clinical testing involved rigorous testing against established standards.

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

Not applicable (as it's not an AI/ML device with a training set). The "ground truth" for the non-clinical testing was established by internationally recognized and harmonized medical device safety and performance standards.

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