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For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Restrata Soft Tissue Reinforcement (STR) is an electrospun fiber matrix intended for implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery. Restrata Soft Tissue Reinforcement is composed of resorbable synthetic fibers engineered from biocompatible materials. The fibers comprising Restrata STR are produced from polyglactin 910 (PGLA 90:10) and polydiaxonone (PDO). Contents of the package are provided sterile. The device is intended for one-time use.

The provided text is a 510(k) clearance letter for the Restrata Soft Tissue Reinforcement (STR) device. While it states that nonclinical testing was performed, it does not provide the specific acceptance criteria, reported device performance, or details about the studies that demonstrate the device meets these criteria.

Therefore, many of the requested items cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be created. The document mentions "benchtop flexural stiffness, tensile, suture pullout, burst, and tear resistance testing, as well as a comparative animal study," but it does not specify what the acceptance criteria were for these tests or what the reported performance outcomes were.

2. Sample sized used for the test set and the data provenance

• Cannot be determined. The document mentions a "comparative animal study" but does not provide details of its design, sample size, or provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Cannot be determined. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For a physical medical device like surgical mesh, "ground truth" would be established through objective physical and biological measurements, not expert consensus on interpretations. Even for the animal study, the mechanism for establishing "ground truth" (e.g., histological analysis, clinical observation) is not detailed, nor is the involvement of "experts" in establishing it.

4. Adjudication method for the test set

• Not applicable / Cannot be determined. 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 device is a physical surgical mesh, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study is not relevant.

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

• Not applicable. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

• Cannot be determined with specific detail. For the benchtop tests, the ground truth would be the physical properties measured (e.g., force required for tear, burst pressure) against material specifications. For the animal study, the ground truth would likely involve histological analysis, physical integrity of the implant in vivo, and biocompatibility observations, but this is not explicitly stated.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for a physical device would refer to its development process, which isn't described in terms of a "training set."

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

• Not applicable. See point 8.

In summary, the provided FDA clearance letter attests to the device's substantial equivalence based on a review of provided data, but it does not contain the detailed study information (specific criteria, performance results, study design details etc.) that would typically be found in the full 510(k) submission or a peer-reviewed publication.

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The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

The provided text describes the Cerafix® Dura Substitute, a medical device for dura mater repair, and its equivalence to predicate devices, particularly focusing on expanding its indicated defect size and application method. The document, however, does not contain a detailed study proving acceptance criteria for an AI/ML device. Instead, it discusses the substantial equivalence of the Cerafix® Dura Substitute based on technological characteristics and animal studies, which is typical for a 510(k) submission for a non-AI medical device.

Therefore, many of the requested points regarding AI/ML device acceptance criteria and studies cannot be answered from this document. I will focus on the information that is present regarding the non-AI device.

Acceptance Criteria and Device Performance (Based on the non-AI device context):

The document describes "Indications for Use" and "Technological Characteristics" which serve as the de facto acceptance criteria for the expanded use of the Cerafix® Dura Substitute via a 510(k) submission. The "reported device performance" is primarily demonstrated through equivalence to a predicate device and side-by-side animal studies.

Regarding AI/ML Specific Information (points 2-9):

The provided document describes a 510(k) submission for a physical medical device (Cerafix® Dura Substitute), not an AI/ML driven software device. Therefore, the following points are not applicable to this submission based on the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as this is a physical device, not an AI/ML algorithm requiring a test set for performance evaluation in the described manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm's predictions is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. The "ground truth" for this physical device's performance is derived from biological/physiological responses in animal models and comparison to known predicate device performance.
8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant "Study" for the physical device:

• Study Type: Side-by-side animal implantation studies.
• Model: Canine duraplasty model.
• Procedure: Dural defects (18 mm x 25 mm) created. Both the subject device (Cerafix® Dura Substitute) and the predicate device were implanted without the use of suture (onlay).
• Outcome Measured: "Equivalent safety and performance" between the subject and predicate devices.
• Conclusion: This animal study supported the expanded indication for onlay application and reinforced the safety and performance for dura repair. The justification for the increased defect size (from 4.4 in² to 4.9 in²) is stated as "Data included in this submission to justify defect increase," but the specific data from that justification is not detailed in this summary.

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