(272 days)
Rx: Bioshield Silicone Film is intended to cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions.
OTC: Bioshield Silicone Film is intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions.
Rochal Bioshield Silicone Film is a polymeric solution which forms a protective, polymer film (silicone) when applied to skin. The product is biocompatible and non-stinging. The formed silicone film is colorless, transparent, water-proof barrier, which is breathable, possessing good oxygen and moisture vapor permeability.
Rochal® Bioshield Silicone Film will be supplied in a High-Density Polyethylene (HDPE), 28 mL bottles with pump spray cap.
The provided text describes a 510(k) premarket notification for the Rochal Bioshield Silicone Film. This document is a submission for medical device clearance, not a study report for an AI/ML powered device. Therefore, the information requested about acceptance criteria, specific study design for device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
The document primarily focuses on demonstrating the substantial equivalence of the Rochal Bioshield Silicone Film to legally marketed predicate devices through comparisons of indications for use, product film appearance, and functions, as well as general performance testing related to biocompatibility and sterility.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison table between the subject device (Rochal Bioshield Silicone Film), a predicate device (KeriCure Advanced Liquid Bandage), and a reference device (No Sting Barrier Film). While it lists features being compared, it does not outline specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML device.
| Feature Being Compared | SUBJECT DEVICE K182733 Rochal® Bioshield Silicone Film | PREDICATE DEVICE K131384 KeriCureTM Advanced Liquid Bandage | REFERENCE DEVICE K955103 No Sting Barrier Film |
|---|---|---|---|
| Indications for Use (Rx) | Intended to cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. | Intended to cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions, as well as closed surgical incisions and excisions. | Not applicable (OTC only for reference device) |
| Indications for Use (OTC) | Intended to help cover and protect skin from infection in minor cuts, scrapes, burns, irritations and abrasions. | Intended to help cover and protect the skin from infection in minor cuts, scrapes, burns, irritations and abrasions. | As a film-forming product, that upon application to intact or damaged skin forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction and shear. Intended as a primary barrier against irritation from body fluids. |
| Product Film Appearance | Transparent film barrier | Transparent film barrier | Transparent film barrier |
| Functions | Non-stinging, breathable, water-proof barrier | Breathable, barrier | Non-stinging, water-proof barrier |
Reported Performance (General):
- Biocompatibility: Passed ISO 10993 studies (cytotoxicity, sensitization, irritation, pyrogenicity, implantation, chemical analysis, and toxicological risk assessment).
- Sterility: Gamma sterility verified using USP 71, Sterility Tests.
- Shelf life: Real-time aging study indicates the product is stable and effective for the proposed shelf life.
Missing Information (due to the nature of the document):
- Specific quantitative acceptance criteria for each 'feature being compared'.
- Detailed quantitative performance benchmarks or statistical results from the device's operation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "biocompatibility studies" and a "real-time aging study," but no details on sample sizes or data provenance are given for these tests. This is not an AI/ML device, so there is no "test set" in that context.
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):
This information is not applicable and not provided. The device is a physical product (liquid bandage), not an AI/ML system that requires expert-established ground truth for performance evaluation in the context of diagnostic or prognostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided for the same reasons as point 3.
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:
This information is not applicable and not provided. This is not an AI-assisted device, therefore no MRMC study with human readers assisting with AI would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable and not provided. As a physical product, the "ground truth" for its performance would typically be based on established scientific methods for measuring physical and chemical properties (e.g., film formation, permeability, biological response in specific tests) rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
This information is not applicable and not provided. The device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided. The device is not an AI/ML system.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.