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The Lipokit is used in the tumescent injection, aspiration, harvesting, filtering and transferring of autologous fat tissue.

The Lipokit is intended for use in the following surgical specialities when the aspiration of soft tissue is desired:

• Plastic and Reconstructive Surgery
• General Surgery
• Dermatological Surgery
• Obstetrician & Gynecological Surgery .
• Cosmetic Surgery

The Lipokit is indicated for use when harvesting of highly concentrated pure fatty tissues for aesthetic body and facial contouring is desired.

The Lipokit with disposable 50cc AFT Syringe is composed of one centrifuge unit with a motor for suction and positive pressure: a 50cc AFT (autologous fat transfer) syringe with weight-mesh piston, a cannula and other ancillary parts. The vacuum and positive pressure are controlled using a foot pedal control switch.

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and tissue collection container (the 50cc AFT Syringe) that relies on the centrifuge unit for its energy supply. The cannula is attached directly to the 50cc AFT Syringe which simplifies and reduces the steps needed in the collection, filtering and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until reinjection. The cannula is a hollow tube with an opening near the tip to communicate the centrifuge unit to the tissues and subsequently aspirate, harvest and filter subcutaneous fatty tissues from the patient into the collection container (the 50cc AFT Syringe).

The stainless steel cannula that contacts the patient is provided a various sizes ranging from 2.5 -- 4.0mm in diameter. The tip region of the cannula may have a single or multiple openings that range in size from 170mm to 260mm in length distributed uniformly or randomly though the end of the cannula.

The 50cc AFT Syringe is a polymeric 50cc volume luer-lock style, single-use syringe consisting of a polypropylene barrel with printed graduations and a weight-mesh piston composed of polycarbonate.

The provided document is a 510(k) submission for a medical device (Lipokit with disposable 50cc AFT Syringe). This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving specific performance criteria through a study with the level of detail requested.

Therefore, many of the requested details related to acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not available in this document. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared device, primarily by showing that the only change is the addition of a transformer to adapt to different voltage input.

Here's a breakdown of the information that can be extracted and what is not available:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and data provenance:

• Not Applicable / Not Available. This document describes a modification to an already cleared device, not a de novo device requiring a new clinical performance study with a test set of data. The "test set" here refers to device-level testing for electrical safety and EMC, not a clinical data set.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not Available. No clinical ground truth or expert review process is described in this document, as it's not a clinical performance study. The "ground truth" for the electrical safety and EMC testing would be the international standards themselves.

4. Adjudication method for the test set:

• Not Available. Not applicable for the type of testing described (electrical safety, EMC).

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:

• No. This device is a Lipokit system for fat transfer, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the electrical safety and EMC testing, the "ground truth" is adherence to the specified international standards: IEC 60601-1:1998, Am1:91, Am2:95 and IEC 60601-1-2:2007.

8. The sample size for the training set:

• Not Applicable / Not Available. There is no "training set" in the context of this device or the type of submission. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not Applicable / Not Available. As above, no training set data.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is primarily a technical assessment affirming that the modified device remains substantially equivalent to its predicate device (K083455), with the only change being an electrical transformer.

• Rationale: The submission argues that since the only modification is the addition of a transformer to change voltage input (220V to 120V) without altering the energy source or other hardware, the device's fundamental characteristics and performance remain unchanged.
• Specific Tests Conducted: The modified Lipokit was tested for:
  • Electrical safety in accordance with IEC 60601-1:1998, Am1:91, Am2:95.
  • Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2007 (Edition 3).
• Conclusion: The manufacturer concluded that the modified device is substantially equivalent to the cleared predicate device due to identical indications for use, operating principle, design, materials, shelf life, packaging, and sterilization processes, with the electrical safety and EMC tests confirming regulatory compliance for the modified electrical input. The FDA concurred with this determination, issuing the 510(k) clearance.

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