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The BTL-785S device has the following indications for use:

The BTL-785S with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.

The BTL-785S with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785S with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785S device used with tips BTL-785-4-3, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.

The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators:

BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide:

• Heating for the purpose of elevaing tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide:

• Non-invasive temporary reduction of facial wrinkles.

BTL-785-7-9 single-use applicator is intended to:

• Affect the appearance of lax tissue in the submental area.

The BTL-785S is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field.

The control unit of the system 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. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy. The energy flow's quality is indicated by the illuminated treatment tip. The BTL-785S device comes with five different types of applicators.

The BTL-785S device consists of the following main components:

• microprocessor-driven control unit
• radiofrequency generator
• user interface with 15.6" color touch screen
• applicators
• exchangeable applicator tips

The BTL-785S device, specifically with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator, was studied to support a new indication for use: "Affect the appearance of lax tissue in the submental area."

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: N=56 subjects.
• Data Provenance: The study was a "single-center single-arm, open-label, interventional design" clinical investigation. The document does not explicitly state the country of origin, but given the FDA submission, it implicitly refers to data relevant for the U.S. market. It is a prospective clinical study.

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

• Number of Experts: Three independent reviewers were used for the GAIS (Global Aesthetic Improvement Scale) evaluation.
• Qualifications of Experts: The document does not specify the qualifications of these experts (e.g., radiologist with 10 years of experience). It only states they were "independent reviewers."

4. Adjudication Method for the Test Set:

• The document states "GAIS evaluation by three independent reviewers." This implies a form of consensus or independent grading by multiple experts, but the specific adjudication method (e.g., arithmetic mean, majority vote, or whether disagreements were arbitrated) is not explicitly detailed. It does not mention "2+1" or "3+1" specifically.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study focuses on the standalone performance of the device and its effect on patients. The device is a radiofrequency device, not an AI diagnostic tool for human readers.

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

• Yes, a standalone clinical performance study was done for the device when used with the BTL-785-7 handpiece and BTL-785-7-9 single-use applicator. The study assessed the device's direct effect on patient outcomes (appearance of lax tissue, satisfaction, comfort, and safety) without human interpretation of device output in a diagnostic sense.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was established through a combination of:
  • Expert Consensus: General Aesthetic Improvement Scale (GAIS) evaluation by three independent reviewers.
  • Objective Measurement/Outcomes Data: Measurable reduction in the submental area (≥ 20 mm²).
  • Patient-Reported Outcomes/Feedback: Subject satisfaction with therapy outcomes and comfort levels.

8. The Sample Size for the Training Set:

• The document does not provide information on a "training set" as it pertains to an AI/algorithm development. This was a clinical study designed to demonstrate the safety and efficacy of the physical device for a specific indication, not to train an AI model.

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

• As mentioned in point 8, there is no information about a training set or how ground truth for a training set was established, as this was not an AI/algorithm development study.

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This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.

The provided text is a 510(k) summary for the "Diode Laser Body Sculpture Systems," a medical device intended for non-invasive lipolysis. While it details the device and its equivalence to a predicate device, it explicitly states, "Clinical Testing: It is not applicable."

Therefore, I cannot provide information on acceptance criteria or a study that proves the device meets those criteria from this document. The manufacturer has determined that clinical testing is not necessary to demonstrate substantial equivalence to the predicate device for this submission.

The document discusses non-clinical testing, including electrical safety, electromagnetic compatibility, and biocompatibility, but these do not involve proving the device meets specific performance criteria for its intended clinical effect through human trials.

To summarize, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document as clinical testing was deemed "not applicable."
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 physical laser system, not an AI diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (SculpSure K182741) based on similar indications for use, technological characteristics (laser type, wavelength, lipolysis method), and compliance with electrical safety and biocompatibility standards.

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