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A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

CytoFlex™ is a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches. The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices.

The provided document is a 510(k) summary for the Unicare Biomedical CytoFlex™ ePTFE barrier membrane, which is a medical device. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with acceptance criteria for an AI/algorithm-based device.

Therefore, most of the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not available in the provided text, as it describes a physical barrier membrane, not an algorithmic or AI device.

Let's break down what can be extracted and what cannot:

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

• Not Applicable. The document describes a physical medical device (ePTFE barrier membrane) and its substantial equivalence to predicate devices, not an AI or algorithmic device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here would be meeting the requirements for substantial equivalence to predicates, which is a regulatory assessment, not a device performance metric.

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

• Not Available. This information would be relevant for a study evaluating an AI/algorithmic device. The 510(k) summary for a physical device does not typically include "test datasets" in this context.

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)

• Not Applicable. Ground truth for data is not relevant for a physical barrier membrane in this type of submission.

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

• Not Applicable. See point 3.

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 is a physical product, 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 is a physical product, not an algorithm.

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

• Not Applicable. Ground truth, in the context of AI/algorithmic devices, is not a concept applied to this type of physical medical device submission.

8. The sample size for the training set

• Not Applicable. No training set exists for this physical device.

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

• Not Applicable. No training set or ground truth for a training set exists for this physical device.

Summary of Relevant Information from the Document:

• Device Name: CytoFlex™ ePTFE barrier membrane
• Device Description: "a non-resorbable barrier membrane that is composed of microporous ePTFE material. The sterile membrane has a nominal thickness of 250 microns and is supplied in a variety of shapes and sizes in sealed pouches."
• Indication for Use: "A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects."
• Proof of Meeting Regulatory Requirements (not "acceptance criteria" in the AI sense): The device was found to be "substantially equivalent" to legally marketed predicate devices (Imtec BioBarrier membrane, Osteogenics Cytoplast GBR, Gore-tex Regenerative Material, TefGen-FD). "The biocompatibility of ePTFE has been established through a long history of use in a variety of implant applications. CytoFlex™ membrane is tested, evaluated and found to be substantially equivalent to legally marketed predicate devices."

The 510(k) process for a Class II device like this primarily relies on demonstrating substantial equivalence to existing devices rather than new clinical trials with predefined performance metrics and acceptance criteria as would be expected for a novel AI algorithm.

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