(245 days)
AVO Cream Topical Emulsion is indicated for use in:
- Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers ●
- Superficial wounds
- 1st and 2nd degree burns, including sunburns .
- Dermal donor and graft site management .
- Radiation dermatitis .
- Minor abrasions .
AVO Cream Topical Emulsion is a water-based emulsion formulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound, AVO Cream Topical Emulsion provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
The provided text is a 510(k) summary for AVO Cream Topical Emulsion, a wound dressing. It declares substantial equivalence to a predicate device and states that functional and performance testing was conducted to assess safety and efficacy with satisfactory results. However, the document does not contain explicit acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the completion of the requested table and answers to points 2 through 9.
Here's an analysis of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Explanation: The document states, "Functional and performance testing has been conducted to assess the safety and efficacy of AVO Cream Topical Emulsion and the results are satisfactory." This is a general statement and does not provide specific acceptance criteria (e.g., "wound healing time reduced by X%") or quantitative performance data to fill this table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided. The document focuses on regulatory submission and substantial equivalence rather than a detailed study protocol or results.
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)
- Not applicable/Not provided. The document does not describe studies involving expert-established ground truth for a test set. The assessment of "safety and efficacy" would typically involve clinical or pre-clinical studies, but the details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- Not applicable. This is a medical device (topical emulsion) and not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (topical emulsion) and not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given it's a wound dressing, "outcomes data" related to wound healing, safety (e.g., adverse events), and patient comfort would be expected, but the document does not specify what type of data served as "ground truth" for their internal "functional and performance testing."
8. The sample size for the training set
- Not applicable/Not provided. This document implies pre-clinical and possibly clinical testing for safety and efficacy, not a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary: The provided 510(k) summary is a regulatory document affirming substantial equivalence to an existing device (Biafine® Wound Dressing Emulsion, K964240). It states that functional and performance testing was performed with satisfactory results but does not include the detailed study information, acceptance criteria, or performance metrics requested. This level of detail is typically found in the full submission, not the summary intended for public disclosure.
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