(74 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, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
Hydrogel
This 510(k) pertains to a wound dressing, a physical medical device, not a software algorithm or AI. Therefore, most of the requested information about acceptance criteria, study types, ground truth, and sample sizes for AI/algorithm performance is not applicable.
However, I can extract the information relevant to the device's biocompatibility and safety, which are the primary "acceptance criteria" presented in this document for this type of device.
Here's the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Acute Dermal Toxicity Study | Not Considered Toxic |
| Primary Skin Irritation Test | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study | No evidence of causing delayed contact sensitization. |
| Cytotoxicity Agarose overlay | Nontoxic |
| Hemolysis Test (In Vitro) | Nonhemolytic |
| USP 23 Anti-microbial Preservatives-Effectiveness | Meets USP 23 Requirements |
| Bioburden | Pass |
| Drop Ship Test | 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given document. The document summarizes the results of the tests but does not detail the methodology, sample sizes of the test subjects (e.g., animals or human skin cells), or where these tests were conducted.
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)
This information is not applicable as the tests are laboratory-based biocompatibility studies, not clinical evaluations requiring expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3.
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
This information is not applicable as this is a physical medical device (wound dressing), not an AI or algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests:
- Acute Dermal Toxicity, Primary Skin Irritation, Delayed Contact Sensitization: These typically involve observation of physiological responses in animal models (in vivo) or possibly human volunteers, compared against established toxicity/irritation scales or norms. The "ground truth" is a biological response measured against a standard.
- Cytotoxicity Agarose overlay, Hemolysis Test: These are in vitro laboratory tests where the "ground truth" is determined by established laboratory protocols and quantitative measurements of cellular response or blood cell lysis.
- USP 23 Anti-microbial Preservatives-Effectiveness: The "ground truth" is determined by meeting the specified criteria of microbial reduction as defined in the USP standard.
- Bioburden: The "ground truth" is the absence or presence of microorganisms within acceptable limits, often determined by quantitative microbial counts.
- Drop Ship Test, Latex Gloves Product Compatibility: These are physical integrity and compatibility tests, where the "ground truth" is the absence of observable leakage/damage or material changes, respectively.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI or algorithm that requires a training set. The safety and effectiveness are established through the specific tests listed.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
N/A