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Spyrosorb Foam Island Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of partial and full thickness wounds.

The following indications for use are for Prescription Use or under the direction of a health care professional:
Venous stasis ulcers
Diabctic ulcers
Pressure sores
Donor sites
Burus, Minor and Chemical
Abrasions and laccrations
Incisions

The following indications for use are for Over The Counter Use:
Superficial Abrasions, Scrapes, Cuts, and Laccrations
Minor Burns

Spyrosorb Foam Island Wound Dressings are sterile, absorplive dressings.

Spyrosorb combines the moist wound environment properties of film dressings with the absorptive qualities of traditional therapies in a structure which is both adhesive and conformable.

The wound contact surface of Spyrosorb is an absorptive foam island dressing. A second layer consisting of a microporous polyurethane self adhesive membrane facilitates the case of application to the wound site. The outcrmost layer acts as a barner to exogenous moisture and bacteria while allowing permeability to moisture vapor and oxygen.

This document is a 510(k) summary for the Spyrosorb® Foam Island Wound Dressing, an unclassified medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment typically found in comprehensive pre-market approval studies for novel devices or software.

Therefore, much of the requested information regarding acceptance criteria and study details cannot be extracted from the provided text. The submission primarily emphasizes the device's characteristics and intended use, comparing them to already marketed dressings.

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

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy that would require such a table. It states:

• "Spyrosorb Foam Island Wound Dressings have been shown in laboratory tests to be nontoxic, nonirritating, and nonsensitizing."

This is a general statement about safety testing, not performance against specific clinical or technical acceptance criteria for wound healing efficacy or absorption rates, for example.

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

The document does not detail any specific clinical test sets, sample sizes, or data provenance for performance evaluation. The "laboratory tests" mentioned are general safety tests.

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. The submission does not describe a study involving expert-established ground truth for device performance.

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

Not applicable. No such clinical test set is described.

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 medical dressing, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a medical dressing, not an algorithm.

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

Not applicable. The document refers to "laboratory tests" for safety (nontoxicity, nonirritation, nonsensitization), not performance requiring clinical ground truth.

8. The sample size for the training set

Not applicable. This is a medical dressing, not a device requiring a training set in the context of machine learning.

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

Not applicable. See point 8.

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