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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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The Diode Laser Body Sculpture Systems 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 HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs. 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. The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.

The provided text is a 510(k) premarket notification for a medical device called the "Diode Laser Body Sculpture Systems." This document outlines the device's indications for use, its comparison to predicate devices, and the non-clinical testing performed. It explicitly states that clinical testing was not applicable. Therefore, the document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in a clinical setting.

The response to your request will reflect the absence of this information from the provided document.

Acceptance Criteria and Device Performance Study

As per the provided 510(k) summary (K201731), clinical testing for the Diode Laser Body Sculpture Systems was stated as "not applicable." Therefore, the document does not contain information regarding:

• A table of acceptance criteria and reported device performance based on clinical outcomes.
• Sample sizes used for a clinical test set.
• Data provenance (country of origin, retrospective/prospective) for a clinical test set.
• Number of experts and their qualifications used to establish ground truth for a clinical test set.
• Adjudication method for a clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance study.
• Type of ground truth used for performance evaluation (beyond non-clinical safety and performance).
• Sample size for the training set for a clinical performance study.
• How ground truth for a training set was established for clinical performance.

The non-clinical testing primarily focused on electrical safety, electromagnetic compatibility, and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy or specific acceptance criteria related to fat reduction outcomes through a clinical study.

Summary of Non-Clinical Testing (as provided):

Note: The FDA 510(k) clearance is based on substantial equivalence to predicate devices, which may or may not require new clinical studies if the technological characteristics and indications for use are sufficiently similar and safety/effectiveness can be demonstrated through non-clinical data and comparison to existing devices. In this case, the statement "It is not applicable" for clinical testing indicates that the manufacturer relied on other means (likely benchmarking against predicate devices with established clinical profiles and robust non-clinical data) to demonstrate substantial equivalence.

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