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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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