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The Dermapose Access fat harvest system is intended for use in aesthetic body contouring.

The Dermapose™ Access is a pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.

The following are provided sterile with the Dermapose™ Access:

• A pre-assembled polycarbonate housing with a linear needle guidance system and a 12G x ● 51 mm lancet point needle to allow passage of a 14G cannula through the bore;
• A 14G x 150 mm Harvesting/Tumescent Cannula; and
• A silicone tube set with regulator valve, which connects to a user-provided vacuum source o

The Dermapose™ Access is also intended to be used with a user-provided vacuum pump capable of at least 18 inHg (60 kPa) of vacuum in order to lift the patient's skin into the guide cavity. The pump should have a standard barb fitting of approximately 1/4 inch. The use of a collection canister is recommended but is not necessary as fluid should not enter the tubing. To protect the pump from possible fluid ingress, the Dermapose™ Access includes a protective filter.

The provided document is a 510(k) Summary for the Dermapose™ Access device, which is a fat harvest system. It discusses the device's substantial equivalence to a predicate device, st'rim. However, the document does not contain explicit acceptance criteria or a detailed study report that proves the device meets specific performance criteria in the format typically used for AI/ML device evaluations.

Instead, it lists performance testing categories and states that the device "met the acceptance criteria for all tests performed." It does not provide the quantitative acceptance criteria themselves or the detailed results of the tests.

Therefore, I cannot directly extract the comprehensive information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies for this medical device.

What can be extracted or inferred from the document:

The performance testing mentioned are:

• Skin Puncture Test: Evaluated the ability to penetrate skin.
• Reliability Test: Evaluated the reliability of the device.
• Skin Hold and Needle Depth Analysis: Evaluated the performance of the device to hold and puncture skin.
• Cannula Analysis: Evaluated the laboratory testing of the cannula provided.
• Biocompatibility testing: Performed according to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Pyrogen Testing, Determination of Extractable Elements).
• Human Factors and Usability Engineering.
• Sterilization validation: According to ISO 11135:2014/Amd.1:2018.
• Shelf life testing: Based on accelerated aging and ISTA 2A ship testing, resulting in a 24-month expiry date.

The document states that the Dermapose™ Access "met the acceptance criteria for all tests performed" and "was found to be safe and effective for the intended users, uses, and use environments."

Limitations of the provided text for your request:

• Acceptance Criteria & Reported Performance: Not explicitly stated with quantitative values.
• Sample Sizes: Not mentioned for any of the performance tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Number/Qualifications of Experts: Not mentioned as these tests are likely laboratory or engineering tests, not expert-read image analysis.
• Adjudication Method: Not applicable for the types of tests described.
• MRMC Comparative Effectiveness Study: Not conducted or mentioned, as this is a physical medical device, not an AI/ML algorithm requiring human reader comparison.
• Standalone Performance: Not explicitly detailed, but the performance tests listed are likely for the device in isolation or as intended for use by a single operator.
• Type of Ground Truth: Not applicable in the context of AI/ML, as these are engineering and biocompatibility tests.
• Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/ML algorithm.

In summary, the provided FDA 510(k) summary confirms that performance testing was conducted for the Dermapose™ Access device and the results met the acceptance criteria. However, it does not provide the specific quantitative acceptance criteria or detailed results required to complete your requested table and study description for an AI/ML device. The device described is a physical surgical tool, not an AI/ML software.

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