(267 days)
Next Science™ Wound Gel is indicated for the management of skin abrasions, minor irritations, cuts, exit sites and intact skin.
The Next Science™ Wound Gel is a white, virtually odorless hydrogel. The Wound Gel provides management of skin abrasions, lacerations, minor irritations, cuts, exit sites, and intact skin by maintaining a moist wound environment that is conducive to wound healing while inhibiting the growth of microorganisms in the hydrogel. The Wound Gel is applied directly to the wound and then covered with an appropriate dressing. The use of the hydrogel on a wound creates a moist environment that is conducive to wound healing. The Wound Gel will be supplied in both 1 ounce and 4-ounce low-density polyethylene tubes with a screw-top opening. Lot number and expiration dating will be embossed on the printed tube.
The provided document is a 510(k) summary for the Next Science™ Wound Gel. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods for an AI/CAD/software device as requested in the prompt. The "performance testing" mentioned is chemical/biological for a wound gel, not algorithm performance.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993 requirements) | Compliant with ISO 10993 |
| Wound Management Effectiveness | Demonstrated by a full thickness wound study |
| Preservative Efficacy (USP and ) | Demonstrated; will not introduce bacteria to application site |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the document. The studies mentioned are a "full thickness wound study" and "USP Antimicrobial Effectiveness Testing prototypes/samples."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This relates to diagnostic interpretation, which is not the function of this wound gel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This relates to diagnostic interpretation.
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:
- No. This is a wound gel, not an AI/CAD device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a wound gel, not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Adherence to ISO standards, implying laboratory testing against specific metrics.
- For wound management: Results from a "full thickness wound study," which would likely involve direct observation of healing, possibly histological assessment, or other direct biological measurements.
- For preservative efficacy: Results against USP and standards, which are laboratory microbiological tests.
8. The sample size for the training set:
- Not applicable/Not specified. This product is a wound gel, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. This product is a wound gel, not a machine learning model.
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