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1060nm laser body slimming machine 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, flank, back, and thighs.

The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.

The provided text is a 510(k) Summary for the "1060nm laser body slimming machine" (Model: RZ-01). This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device.

It's important to understand that a 510(k) summary for a substantial equivalence determination often does not include detailed clinical study results, particularly regarding acceptance criteria for device performance in terms of patient outcomes or AI model accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a predicate device, often relying on non-clinical tests (electrical safety, EMC, laser safety, etc.) and comparisons of technical specifications and intended use.

In this specific document, there is no information about acceptance criteria or a study proving the device meets performance criteria in the context of an AI/algorithm-driven device meeting specific accuracy metrics. The device in question is a laser body slimming machine, not an AI diagnostic or assistive tool.

Therefore, I cannot provide the requested information for an AI/algorithm-based device's performance study based on the provided text. The document states:

• "No clinical study is included in this submission." (Page 7)
• The comparison is based on technical specifications (laser type, wavelength, irradiance, etc.) and adherence to international safety standards (IEC, ISO).

If the request were about the safety and technical performance of this laser device, the "acceptance criteria" would relate to its compliance with the listed IEC and ISO standards, and the "study" would be the non-clinical tests conducted to prove this compliance. However, these are not the types of performance metrics or studies typically associated with AI/algorithm validation (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment methods).

Therefore, I must state that the provided text does not contain the information requested for an AI/algorithm-driven device, as the device described is a physical laser machine, and the submission explicitly states no clinical study was included.

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