(723 days)
The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: Pressure sores, Diabetic ulcers, Leg ulcers, Donor sites and graft sites, Surgical wounds, Skin abrasions and lacerations, 1st and 2nd degree burns, Trauma wounds. Over-the-counter use: The Maxiocel Chitosan Wound Dressing is indicated for the management of Minor cuts, Minor scalds and 1st-degree burns, Abrasions, Lacerations and to provide a barrier against bacterial penetration.
The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes. 18" x 18" (45 cm x 45 cm), 8"x 12" (20 cm x 30cm), 6" x 6" (15 cm x 15 cm), 4" x 4" (10 cm x 10 cm), 2" x 4" (5 cm x 10 cm), 2"x 2" (5 cm x 5cm), 1"x2" (2.5 cm x 5cm), 1"x1" (2.5 cm x 2.5 cm), 1" x 12" (2.5 cm x 30 cm).
The provided text describes information about the Maxiocel Chitosan Wound Dressing, but does not contain information related to acceptance criteria, device performance in terms of specific metrics like sensitivity or specificity, or the methodology of a study proving such performance against acceptance criteria.
The document is a 510(k) summary for an FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria using metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or AUC).
Therefore, I cannot fulfill the request as it asks for information not present in the provided text, specifically:
- A table of acceptance criteria and the reported device performance: No such table or metrics are provided. The "performance data" section details bench tests, biocompatibility tests, and bacterial barrier tests, but these are not presented as acceptance criteria with numerical performance results against them.
- Sample sized used for the test set and the data provenance: Not mentioned, as it's not an AI/algorithm performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned for this type of device submission.
- Adjudication method: Not applicable/not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical wound dressing, not an algorithm.
- The type of ground truth used: Not applicable/not mentioned in the context of AI/algorithm performance. The ground truth for the non-clinical tests is the established scientific methods and standards used for those specific tests.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm.
The document primarily focuses on:
- Biocompatibility testing: Passed, indicating non-cytotoxic, non-sensitizer, non-irritant, non-toxic, and compliant with bacterial endotoxin limits.
- Heavy metal testing: Met USP-232 limits.
- Bench performance testing: Mentioned tests like Appearance, Moisture Content, Absorbency, pH, Dispersion Test, Fluid Retention Test, and Tensile Strength. No specific numerical results or acceptance criteria are given for these, only that the "Subject Device performs as intended."
- Bacterial Barrier Testing: Demonstrated capacity to act as a barrier to bacterial penetration by showing "No bacterial growth was observed in the plates containing the Maxiocel Chitosan Wound Dressing" compared to control plates with cotton gauze that showed bacterial growth. The sample size was n=3 for test samples and n=3 for control samples.
- Sterilization and Packaging validation: Gamma radiation per ISO 11137-2, sterility assurance level (SAL) of 10^-6, and validated 3-year shelf life through real-time stability studies including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests.
In summary, the provided document does not contain the specific information requested about acceptance criteria and study details for an AI/algorithm-based device. It details non-clinical safety and performance testing for a wound dressing.
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