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LipoSaver™ is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring. LipoSaver™ is indicated for use in the following surgical specialists when the fragmentation and aspiration of soft tissue is desired:

• Plastic and Reconstruction Surgery
• Orthopedic Surgery

LS-1000/LS-2000 is an ultrasonic surgical unit which uses ultrasound frequency vibration to fragment, emulsify subcutaneous fatty tissues. The PZT ceramic crystals in handpiece of LS-1000/LS-2000 transforms electrical signal into ultrasonic vibrations, and these vibrations transmit to the probe of LS-1000/LS-2000 which performs the function of fragmenting and emulsifying the subcutaneous fatty tissues. The LS-1000/LS-2000 is able to adjust the operating features such as vibration amplitude and frequency, and provides two modes as follows:

• N mode (continuous mode)
• Z mode (pulsed mode)

This document does not describe acceptance criteria for an AI/ML device, nor does it detail a study that proves a device meets such criteria.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for a medical device called "LipoSaver™". This device is a suction lipoplasty system, which is a physical device used in surgery to fragment and emulsify subcutaneous fatty tissues. It is an ultrasonic surgical unit that uses PZT ceramic crystals to generate ultrasonic vibrations.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (electrical safety, biocompatibility) and a comparison of physical and functional characteristics. It does not involve AI/ML performance evaluation.

Therefore, the requested information regarding acceptance criteria for an AI/ML device and a study proving it meets those criteria cannot be extracted from this document.

The document details:

• Device Name: LipoSaver™
• Regulation Number/Name: 21 CFR 878.5040, Suction Lipoplasty System
• Regulatory Class: Class II
• Product Code: MUU
• Predicate Device: K190551, VASERlipo System
• Non-clinical tests performed: Biocompatibility (ISO 10993-5, -10, -11, USP 43 ), Electrical safety (IEC 60601-1), Electromagnetic Compatibility (EN 60601-1-2). These tests are typically for physical medical devices to ensure they are safe and perform as intended, not for AI/ML performance.
• Comparison of technological characteristics: Operating frequency, cannula dimensions, and primary function are compared to the predicate.

None of the information requested in points 1-9 pertains to an AI/ML device or its performance study.

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