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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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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 specialties when the aspiration of soft tissue is desired:

• Plastic and Reconstructive Surgery .
• General Surgery .
• Dermatological Surgery .
• o 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 pressures are controlled using a foot pedal control switch.

The Lipokit is a sterile, single-use, manual device consisting of a cannula, and a tissue collection container (the 50cc AFT Syringe) that relies on the centrifying 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 re-injection. 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 in various sizes ranging from 2.5 - 4.0 mm 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 throughout 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) summary for the Medi-Khan USA, Inc. Lipokit with disposable 50cc AFT Syringe. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Crucially, this document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device. Instead, it relies on demonstrating "substantial equivalence" to existing, legally marketed devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the traditional sense, nor can I provide information on sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these types of studies were not conducted or reported in this submission for the purpose of establishing efficacy or performance against defined criteria.

The submission focuses on comparing the Lipokit's design and indications for use to three predicate devices:

• Shippert Medical Tissu-Trans (K050797)
• Cytori AFT System (K072587)
• MaceneRoncel Lipoplasty System (K042261) (though later listed as Macropore Puricel Lipoplasty System (K042261))

The primary "acceptance criteria" here are implied to be that the device functions similarly to the predicate devices and meets general safety standards.

Here's a breakdown of what can be extracted from the document regarding the device's characteristics and the basis for its clearance, framed in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this document does not present acceptance criteria and performance data from a dedicated study for the Lipokit. Instead, its "performance" is demonstrated through substantial equivalence to predicate devices. The implied "acceptance criteria" revolve around the device's ability to perform the same functions as the predicates without raising new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This submission relies on a comparison to predicate devices, not on a test set from a performance study of the Lipokit itself to establish efficacy. The "mechanical testing" mentioned is general and details (like sample size) are not provided.
• Data Provenance: Not applicable in the context of a clinical test set. The data presented is descriptive of the device and comparative analysis against legally marketed devices regulated by the FDA (presumably in the USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There was no "test set" and thus no ground truth established by experts in the context of a performance study for the Lipokit's efficacy. The FDA's review process, however, involves internal experts assessing the submission for substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was conducted or described.

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 mechanical system for fat transfer, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the context of a clinical performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices and the demonstration that the Lipokit is sufficiently similar in function, safety, and intended use.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This device is a mechanical system and does not involve AI or algorithms that require a training set.

In summary, the provided document is a regulatory submission for 510(k) clearance based on substantial equivalence, not a detailed report of a clinical efficacy study with performance metrics against predefined acceptance criteria. The "study" for this device was a comparative analysis against predicate devices, focusing on design, materials, intended use, and general safety considerations (like sterility and mechanical integrity).

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