(248 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (established history of use of porcine-derived tissues in medical product manufacturing) | Met requirements of appropriate biocompatibility tests. |
| Substantial Equivalence to predicate devices (indications for use, materials, physical construction) | Deemed substantially equivalent to legally marketed predicate devices. |
| Sterility | Supplied sterile. |
| One-time use | Intended for one-time use. |
| Manufacturing Process Controls and Quality Assurance Program | Device will be manufactured according to specified process controls and a Quality Assurance Program. |
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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