(209 days)
FOR TOPICAL DERMATOLOGICAL USE ONLY
Description Rx Product:
Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Description OTC Product:
Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns, including sunburn.
Sinclair Wound and Skin Emulsion is a non sterile viscous emulsion / gel formulation, which is presented for both Prescription (requires physician diagnosis of disease state) and over-thecounter (OTC) use.
Here's a breakdown of the acceptance criteria and the study information for the SINCLAIR WOUND AND SKIN EMULSION™ based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Functional and performance testing has been conducted to assess the safety. All results are satisfactory. |
| Effectiveness | Functional and performance testing has been conducted to assess the effectiveness. All results are satisfactory. |
| Substantial Equivalence | The device is substantially equivalent to legally marketed predicate devices: Biafene Wound Dressing Emulsion (K964240) and Carrasyn® Hydrogel Wound Dressing (K961758) / RadiaCare Gel Hydrogel Wound Dressing. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. It mentions "Functional and performance testing," but does not detail the methodology, sample sizes, or provenance of the data (e.g., country of origin, retrospective or prospective) for these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided document does not mention or describe the use of experts to establish ground truth for any test set.
4. Adjudication Method for the Test Set
The provided document does not mention or describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices through functional and performance testing, not direct comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of an algorithm was not performed or reported in the provided document. This device is a wound and skin emulsion, not an AI algorithm. The functional and performance testing mentioned refers to the physical and chemical properties and likely biocompability of the emulsion itself.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable or discussed in this submission. The "ground truth" for this device's performance would likely be established through standardized methods for assessing biocompatibility, stability, physical properties (e.g., viscosity, pH), and potentially in-vitro or in-vivo wound healing models, though these specifics are not detailed in the document. The substantial equivalence relies on comparison to predicate devices.
8. Sample Size for the Training Set
A "training set" is relevant for machine learning algorithms. Since this device is a topical emulsion and not an AI/ML algorithm, the concept of a training set does not apply to this submission.
9. How the Ground Truth for the Training Set was Established
As the concept of a training set does not apply, how its ground truth was established is not applicable to this submission.
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