(86 days)
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, venous stasis, and diabetic ulcers; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
Hydrogel
The provided document describes a 510(k) submission for the Woun'Dres® Collagen Hydrogel Wound Dressing, focusing on its biocompatibility and safety testing rather than an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific parameters cannot be fully addressed in the format provided in the prompt.
However, based on the document's content, here's a breakdown of the biocompatibility and safety testing results which serve as the "acceptance criteria" for this conventional medical device, alongside the "reported device performance."
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|
| Biocompatibility & Safety | |
| Acute Dermal Toxicity Study (Not Considered Toxic) | Not Considered Toxic |
| Primary Skin Irritation Test (Is not considered a primary Irritant) | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study (No evidence of causing delayed contact sensitization) | No evidence of causing delayed contact sensitization. |
| Cytotoxicity Agarose overlay (Nontoxic) | Nontoxic |
| Hemolysis Test (In Vitro) (Nonhemolytic) | Nonhemolytic |
| USP 23 Anti-microbial Preservatives-Effectiveness (Meets USP 23 Requirements) | Meets USP 23 Requirements |
| Bioburden (Pass) | Pass |
| Drop Ship Test (No leakage or damage to tubes occurred) | No leakage or damage to tubes occurred. |
| Latex Gloves Product Compatibility (No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed) | No changes imparted to Woun'Dres from the gloves and no change in strength of the gloves was observed. |
Regarding the study that proves the device meets (these) acceptance criteria:
The document states: "The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below." The table above is the summary of these substantiating tests.
For the AI/ML specific requests (2-9), the document does not provide this information as it pertains to a traditional wound dressing, not an AI/ML medical device.
Therefore, I cannot provide details on:
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
N/A