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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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NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is intended for single use only.

NovoSorb® MTX is a fully synthetic biodegradable device that is composed of a single foam layer. The foam is a 2-6 mm thick, white, open cell degradable foam with a high degree of porosity (>90%) providing a scaffold for dermal tissue integration. NovoSorb® MTX will be supplied in sizes ranging from 4 cm2 to 800 cm2 with a maximum volume of 160 cm³.

NovoSorb® MTX is a terminally sterilized, single use device intended for deep partial and full thickness wounds. It is intended for use by qualified healthcare professionals in a hospital/clinical environment and is not intended for use at home.

Each NovoSorb® MTX is packed in a transparent polymer pouch, enclosed in an aluminized pouch. A product label is placed on the pouch. The aluminized pouch together with an instruction for use is individually packaged in a cardboard envelope and a product label is placed on the envelope.

The provided FDA 510(k) summary for NovoSorb® MTX (K242149) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device.

This submission is for a medical device that is a wound dressing, not an AI or algorithm-based diagnostic or prognostic tool. Therefore, the concepts of "acceptance criteria" related to algorithm performance (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance studies, and training set details are not applicable as described in your request.

The submission focuses on demonstrating substantial equivalence to a predicate wound dressing based on material properties, physical characteristics, mechanical strength, durability, and biocompatibility.

Here's a breakdown of why your specific questions cannot be answered from this document:

• 1. A table of acceptance criteria and the reported device performance: This document discusses performance in terms of physical characteristics, mechanical strength, durability, and a hydrolytic degradation study, as well as biocompatibility. These are typical for a physical medical product, not for an algorithm's diagnostic performance. There are no explicit "acceptance criteria" listed in a tabular format for algorithm performance.
• 2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm evaluation. The document mentions testing of the device itself (e.g., hydrolytic degradation, mechanical properties) but not a dataset for an AI.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI test set requiring expert-established ground truth.
• 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 is not an AI-assisted device.
• 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 consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable. There is no AI training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a wound dressing) and does not contain any information about an AI or algorithm-based component.

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