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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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The Dermapose Refresh is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The Dermapose Refresh is a sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 um filter for screening the tissue particle size to allow for easier injection through small, 18-21G injection cannulas. For optimum performance, Dermapose™ Refresh should be used in conjunction with the Dermapose™ Refresh Stand, which is a reusable, autoclavable component designed to hold the syringe securely during use.

The Dermapose™ Refresh is comprised of the following:

1. 50 mL polycarbonate harvesting and processing syringe unit preassembled with a 30 mL polycarbonate output syringe
2. Two 30 mL syringes
3. Three luer caps
4. Luer-to-luer adapter

The Dermapose™ Refresh is also intended to be used with Lactated Ringer's solution, injection syringes (1 or 3 mL recommended), injection cannulas (18-21G recommended), and luer-lock harvest cannula (14G recommended) which are provided by the user. Dermapose™ Refresh should be used in conjunction with the 510(k)-exempt Dermapose TM Refresh Stand.

The provided text describes a 510(k) premarket notification for the Dermapose Refresh device. It indicates that performance and biocompatibility testing were conducted, but it does not provide detailed acceptance criteria, reported performance values, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) for the performance testing.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document states: "The Dermapose™ Refresh was tested in accordance with established protocols and met the acceptance criteria for all tests performed." However, it does not explicitly list the acceptance criteria or the specific reported device performance values for the tests mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not provided. The document lists types of performance tests (Nucleated Cell Viability, Tissue Composition, System Leak, Mechanical Test), but does not specify the number of samples or runs for any of these tests.
• Data Provenance: Not provided. The document does not specify the origin of the data (e.g., country) or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the described tests (cell viability, tissue composition, leak, mechanical) are objective laboratory or engineering tests, not studies requiring expert interpretation of images or patient data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as there were no subjective assessments requiring adjudication described in the provided text.

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:

This information is not applicable. The device, Dermapose Refresh, is a medical device for processing adipose tissue, not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the described performance tests:

• Nucleated Cell Viability: The ground truth would be established by the measurements from the Luna-Stem Automated Fluorescence Cell Counter.
• Tissue Composition: The ground truth would be established by analytical methods for assessing adipose tissue layers.
• System Leak: The ground truth would be established by quantitative measurements of vacuum retention.
• Mechanical Test: The ground truth would be established by engineering specifications and measurements of mechanical connections.

These are objective measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set:

This information is not applicable. The Dermapose Refresh is a physical medical device, not an AI/machine learning model that requires a training set.

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

This information is not applicable due to the nature of the device as explained in point 8.

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