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The SIS Wound Dressing II is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

The SIS Wound Dressing II is primarily composed of porcine collagen that is supplied in sheet form in sizes ranging from 2 x 4 cm to 20 x 40 cm.

The provided text describes a 510(k) premarket notification for the SIS Wound Dressing II. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain information on acceptance criteria, a study proving device meeting acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies as one would expect for a novel device requiring extensive clinical validation.

Here's a breakdown of why this information is absent and what is provided:

1. A table of acceptance criteria and the reported device performance: This is not present. The 510(k) summary states, "The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests." It does not specify what those requirements (acceptance criteria) were, nor does it provide detailed performance results beyond a blanket "passed."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No sample sizes for any clinical performance testing are mentioned because such testing was not the primary focus of this 510(k). The tests focused on biocompatibility, which typically involves in-vitro or animal studies, not human test sets for efficacy.

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. There was no "ground truth" establishment for a clinical test set in the context of this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication 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 device is a wound dressing, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the biocompatibility tests, the ground truth would typically be established by standardized pass/fail criteria for specific biological responses (e.g., cytotoxicity, irritation, sensitization). This type of "ground truth" is inherent to the specific biological test methods, rather than expert consensus on clinical findings.

8. The sample size for the training set: Not applicable. The device is a physical wound dressing and does not involve AI or machine learning that would require a training set.

9. How the ground truth for the training set was established: Not applicable, as no training set exists for this device.

What the document does state regarding "proof" and "acceptance criteria" (implicitly):

• Acceptance Criteria Mentioned: "The SIS Wound Dressing II was subjected to a panel of tests to assess biocompatibility. The SIS Wound Dressing II passed the requirements of all tests." The specific requirements are not detailed, but the implicit acceptance criterion is "passing all biocompatibility tests."
• Study Proving Acceptance: The "study" is the unnamed "panel of tests to assess biocompatibility."
• Conclusion: "This device is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices." This is the ultimate "proof" sought in a 510(k) submission – that the device is as safe and effective as a legally marketed predicate. The biocompatibility tests are part of the data supporting this claim of substantial equivalence.

In summary, this 510(k) document is concerned with demonstrating substantial equivalence to predicate devices, primarily through materials analysis and biocompatibility testing, rather than detailed clinical performance studies with specific statistical acceptance criteria.

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The SIS Wound Dressing is intended for temporary coverage of partial-thickness skin loss injury, such as burns, abrasions, decubitus and chronic vascular ulcers, and autograft donor sites. This device is intended for one-time use.

The SIS Wound Dressing is supplied in sheet form in sizes ranging from 16 cm3 to 360 cm². The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the SIS Wound Dressing is provided by the established history of use of porcine-derived tissues in medical product manufacturing as well as meeting the requirements of the appropriate biocompatibility tests.

This is a 510(k) premarket notification for the SIS Wound Dressing, a porcine-derived wound dressing. The submission asserts substantial equivalence to predicate devices for temporary coverage of partial-thickness skin loss injuries.

Based on the provided documents, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

Important Limitations/Labeling Restrictions (effectively negative acceptance criteria):

• May not be labeled for use on third-degree burns.
• May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
• May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
• May not be labeled as a treatment or a cure for any type of wound.

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

The provided documents do not describe a specific clinical study with a test set of patient data for evaluating the performance of the SIS Wound Dressing. The substantial equivalence determination is primarily based on:

• Established history of use: Porcine-derived tissues in medical product manufacturing.
• Biocompatibility testing: The device "meeting the requirements of the appropriate biocompatibility tests." No sample size or specific provenance for this testing is provided, but it would typically be conducted on animal models or in-vitro.
• Comparison to predicate devices: The submission states the device is similar in indications for use, materials, and physical construction to already marketed devices.

Therefore, there is no information on:

• Sample size used for a clinical test set.
• Data provenance (country of origin, retrospective/prospective).

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

As there is no described clinical test set with patient data, there is no information on experts establishing ground truth for such a set.

4. Adjudication method

No clinical test set is described, so no adjudication method is provided.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study

No MRMC study is mentioned or implied. The 510(k) pathway for this device relies on substantial equivalence and biocompatibility, not comparative effectiveness against human readers.

6. Standalone (algorithm only without human-in-the-loop performance) study

This device is a physical wound dressing, not an algorithm or AI. Therefore, the concept of a standalone algorithm performance study is not applicable.

7. Type of ground truth used

For the biocompatibility claims, the "ground truth" would be the results of the specific biocompatibility tests performed, verified against established standards. For the substantial equivalence argument, the "ground truth" is the established performance and safety profile of the predicate devices.

8. Sample size for the training set

This device is a physical product, not a machine learning model. Therefore, the concept of a "training set" in an AI/algorithm context is not applicable.

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

Not applicable, as there is no training set in the context of an AI/algorithm.

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