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The AdiPrep™ Adipose Transfer System is used in medical procedures involving the harvesting and transferring of autologous adipose tissue. The AdiPrep system is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The AdiPrep™ Adipose Transfer System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
• Neurosurgery
• Gastrointestinal Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General surgery

• Orthopedic Surgery .
• . Gynecological Surgery
• Thoracic Surgery .
• Laparoscopic Surgery .
• Arthroscopic Surgery ●

The Harvest AdiPrep Adipose Transfer System consists of a disposable process pack to be utilized with the SmartPReP2 centrifuge. The process pack is a sterile (EtO) single use disposable pack used for the aspiration, harvesting, and transferring of autologous adipose tissue. It is intended for the concentration of aspirated adipose tissue for subsequent transfer during the same procedure.

Here's a breakdown of the acceptance criteria and study information for the Harvest AdiPrep™ Adipose Transfer System based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than pre-defined acceptance criteria with specific thresholds for the new device. The performance is presented as a comparison to predicate devices.

Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion here is demonstrating that the Harvest AdiPrep system performs comparably to the legally marketed predicate devices, specifically in terms of nucleated cell count and viability of the autologous adipose product. The stated results show very similar mean values for both nucleated cell count and viability between the AdiPrep system and the Viafill predicate, supporting the claim of substantial equivalence.

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

• Sample Size: Not explicitly stated as a number of patients or samples. The document mentions "Clinical testing was performed to determine substantial equivalence to the predicate device."
• Data Provenance: Not specified (e.g., country of origin). The study appears to be retrospective or prospective, as it involved clinical testing to generate data for comparison. It is likely prospective as it's directly testing the new device.

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

There is no mention of "experts" or "ground truth" in the context of human expert review. The study focuses on direct biological measures (cell count and viability) of the processed adipose tissue, which are objective laboratory measurements, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. There was no expert review or adjudication process as the study involved objective laboratory measurements of device output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The device is a medical processing system for adipose tissue, not an imaging or diagnostic device that requires human interpretation. Therefore, there is no mention of human readers or AI assistance.

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

The device itself is a standalone system for processing adipose tissue. The "clinical testing" performed evaluated the output of this standalone system (nucleated cell count and viability). There is no "algorithm" or AI component involved in this device, so the terminology of "standalone algorithm performance" does not directly apply. However, the performance reported is the standalone output of the device itself.

7. The Type of Ground Truth Used

The "ground truth" here is established through objective laboratory measurements of the processed autologous adipose tissue, specifically:

• Nucleated Cell Count
• Nucleated Cell Viability

8. The Sample Size for the Training Set

There is no mention of a "training set" in this context. The device is a mechanical/biological processing system, not an AI or machine learning algorithm that requires a training set. The clinical testing mentioned is for verification and validation, not model training.

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

Not applicable, as there is no training set for this type of device.

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