(211 days)
SONAFINE® Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, superficial wounds, first and second degree burns and donor sites to include:
- Radiation Dermatitis
- Various types of dermatoses
- Atopic dermatitis
- Allergic contact dermatitis
- Dry waxy skin
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
Indications for OTC use:
SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations.
SONAFINE® Wound Dressing maintains a moist wound and skin environment.
SONAFINE® Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
The provided document, K110172 for SONAFINE® Wound Dressing, does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, a study proving device performance in that context, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML.
Instead, the document details a traditional medical device (wound dressing) and outlines its non-clinical performance data based on established ISO standards.
Here's a breakdown of the available performance data, framed to address the spirit of your request where possible, but highlighting the absence of AI/ML specific information:
Non-Clinical Performance Data for SONAFINE® Wound Dressing
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (ISO Standard Tests) | Reported Device Performance |
|---|---|
| Agar Overlay (direct contact) Cytotoxicity testing (Grade ≤ 1) | Grade 0 cytotoxic grade |
| ISO Intracutaneous reactivity (Irritation) testing (Non-irritant) | Non-irritant |
| Repeat Patch Dermal Sensitization Test (Buehler Method) (Non-sensitizer) | Non-sensitizer |
| Stability over 3 months at Room Temperature & accelerated conditions (Maintain product attributes & characteristics) | Maintained product attributes and characteristics |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The non-clinical tests are standard in vitro and animal models, but the specific number of samples or subjects used for each test (e.g., how many cells for cytotoxicity, how many animals for irritation/sensitization) is not detailed. The provenance is implied to be laboratory testing in accordance with ISO standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. These are laboratory tests with objective endpoints (e.g., cell viability, visual skin reactions). No human expert "ground truth" establishment in the sense of clinical interpretation is described for these non-clinical tests.
4. Adjudication Method
Not applicable. The non-clinical tests have defined protocols for evaluation rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a non-clinical evaluation of a pharmaceutical wound dressing, not an AI/ML diagnostic or assistive device.
6. Standalone Performance (Algorithm Only)
No. This device does not involve an algorithm.
7. Type of Ground Truth Used
The "ground truth" for these non-clinical tests refers to the objective outcomes determined by the standardized test methods themselves (e.g., cell viability measurements for cytotoxicity, observation of skin reactions for irritation/sensitization, analytical measurements for stability).
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
Crucially, the document explicitly states:
"SONAFINE® Wound Dressing has not been studied in a clinical setting."
This further confirms that no clinical studies, which would be essential for evaluating an AI/ML device's performance, were conducted for this product at the time of this submission.
N/A