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The HK Liposuction Aspiration Pump is for aesthetic body contouring.

The HK Liposuction Pump is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose(Suction Lipoplasty), soft tissue, and general surgical waste.

This FDA document is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed study information typically found in a clinical trial report or a journal publication. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting and evaluating specific acceptance criteria and detailed study results from a de novo clinical study.

Therefore, the requested information components (Acceptance Criteria, Reported Device Performance, Sample Sizes, Expert Qualifications, Adjudication Methods, MRMC Studies, Standalone Performance, Ground Truth Type and Establishment for Training Set) cannot be extracted from the provided text.

The document confirms the following about the device and its regulatory clearance:

• Device Name: HK Liposuction Aspiration Pump (also referred to as HK Liposuction Aspirator, Model Ap-III & Ap230-iii)
• Intended Use: Aesthetic Body Contouring (Stated in the "Indications for Use Statement" and "510(k) Summary")
• Regulatory Class: Class II
• Regulation Number: 21 CFR 878.5040
• Regulation Name: Suction Lipoplasty System
• Product Code: MUU (later updated to QPB in 2021 as an administrative change)
• Clearance Type: 510(k) Substantial Equivalence
• Predicate Devices: Byron Medical K980392, Byron Medical K981215, Kolster Methods K895761, Wells Johnson K832274

The clearance is based on the claim that the device is "substantially equivalent ... in terms of intended use, design, operating principles, materials and performance" to the listed predicate devices. The document does not describe a clinical study with specific acceptance criteria that a new device must meet. Substantial equivalence typically relies on non-clinical performance testing and comparison to predicates, which are not detailed in this public 510(k) summary.

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