(68 days)
Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.
The following indications for use are for Prescription and Over-the-Counter Use:
Dermaphylyx Skin Protectors are intended for the prevention of:
- Blisters .
- Friction Burns .
Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.
Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.
The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability
The provided text describes a 510(k) premarket notification for the "Dermaphylyx Skin Protector." This document primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a clinical study with detailed acceptance criteria and performance data as typically found for complex medical devices or AI algorithms.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they are not typically part of a 510(k) submission for a simple, unclassified device like a skin protector.
Based on the provided information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a skin protector, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is not quantified with specific metrics in the way an AI algorithm's performance would be (e.g., sensitivity, specificity).
| Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device acts as an extra layer of skin. | Dermaphylyx Skin Protectors act like an extra layer of skin. |
| Intended Use Equivalence: Prevention of blisters. | Intended for the prevention of: - Blisters. |
| Intended Use Equivalence: Prevention of friction burns. | Intended for the prevention of: - Friction Burns. |
| Material/Composition Equivalence (implied): Composed of similar materials with similar properties. | Skin contact surface: porous pressure sensitive adhesive. Second layer: polyurethane foam. (This implies it's consistent with typical skin protectors). |
2. Sample size used for the test set and the data provenance
- Not applicable. This document does not describe a clinical study with a test set of human subjects or data in the context of device performance testing for an AI algorithm. A 510(k) for a simple device like this typically relies on material characterization, biocompatibility, and functional testing, not a "test set" in the sense of evaluating diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth establishment by experts is not described as part of this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. Adjudication is not described.
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 not a diagnostic device or AI algorithm, so an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's acceptance is its substantial equivalence to a legally marketed predicate device (Spyroflex® Skin Protectors, Innovative Technologies US, Inc.), as determined by the FDA based on shared indications for use, technological characteristics (implied similarity in function and composition), and safety. There isn't a "ground truth" derived from patient outcomes or expert consensus in the typical sense of evaluating a diagnostic or AI device.
8. The sample size for the training set
- Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
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