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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.

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.

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MedTrade Products Skin Protective Barrier Wipe is a liquid intended for use 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 and adhesive products. It is intended as a primary barrier against irritation from body fluids.

MedTrade Product's Skin Protective Barrier Wipe is a polymeric solution which forms a unique film when applied to the skin. The product is dispersed in a unique non-cytotoxic, water based solution, which dries rapidly. MedTrade Products Skin Protective Barrier Wipe helps to protect intact or damaged skin from irritation from incontinence, digestive juices, wound drainage and adhesives. The film is coloriess, transparent and possesses good oxygen and moisture vapour permeability. MedTrade Products Skin Protective Barrier Wipe Wipes are supplied sterile in single use pouches. Packaging will consist of a single dressing in a paper / poly / foil tri laminate pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.

The provided text is related to a 510(k) premarket notification for a medical device called "MedTrade Products Skin Protective Barrier Wipe." This document establishes the substantial equivalence of the device to legally marketed predicate devices.

However, the provided text does not contain information about acceptance criteria, the detailed study design, or performance metrics that would allow for the completion of the requested table and subsequent sections.

The document primarily focuses on:

• Device Description: What the product is and what it's made of.
• Intended Use/Indications for Use: What the device is meant to do.
• Sterilization Method: How the product is sterilized.
• Biocompatibility Testing: Confirmation that biocompatibility testing was successfully completed.
• Predicates: Identification of substantially equivalent predicate devices (3M No-Sting Barrier Film K955103 & Smith & Nephew No-sting Skin Prep K973228).
• Regulatory Classification: Its classification as a Class I device and the relevant regulation.
• FDA Clearance: The official letter from the FDA granting clearance based on substantial equivalence.

Therefore, it is not possible to generate the requested table and study details from the provided text.

To answer your request, information on acceptance criteria and a detailed study report would be needed, which is typically found in the scientific literature, regulatory submissions (beyond the summary provided here), or internal company documentation.

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Skin barrier for protection against the detrimental effects of moisture, urine, or feces.

NUVO™ is a liquid, alcohol-free, film-forming product.

The provided document is a 510(k) summary for the NUVO™ Barrier Film, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than conducting extensive clinical studies to establish original performance criteria and statistically prove that the device meets those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's why and what the document does provide:

• Acceptance Criteria and Reported Device Performance: This document states the device "performs as least as well as other liquid bandage devices, such as the 3M™ No Sting Barrier Film." It does not define specific performance metrics or acceptance criteria for properties like skin protection efficacy, durability, or user comfort. Instead, it relies on comparison to a predicate device.
• Study That Proves the Device Meets Acceptance Criteria: The "study" mentioned is a set of biocompatibility tests:
  • acute dermal toxicity test (rabbit)
  • primary dermal irritation test (rabbit)
  • dermal sensitization test (guinea pig)
  • in vitro cytotoxicity test (USP XXIII)
    These tests establish the biocompatibility of the film, not its primary intended use performance (protection against moisture, urine, or feces) in a clinical setting with human subjects.
• Sample Size for Test Set and Data Provenance: Not applicable for a comparative performance study on human subjects in this 510(k) submission. The biocompatibility tests used animal models (rabbits, guinea pigs) for toxicity, irritation, and sensitization, and an in vitro test for cytotoxicity. The specific number of animals or in vitro replicates is not provided.
• Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. The ground truth for biocompatibility tests is based on established scientific protocols and observations of biological responses, not expert consensus on clinical images or outcomes.
• Adjudication Method: Not applicable.
• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not conducted or mentioned. This type of study is typically for diagnostic devices where human interpretation is involved.
• Standalone (algorithm-only) Performance: Not applicable. This device is a barrier film, not a software algorithm.
• Type of Ground Truth Used: For the biocompatibility claims, the ground truth is derived from the established biological responses observed in the animal and in vitro tests according to standardized protocols.
• Sample Size for Training Set: Not applicable. This is not a machine learning device.
• How Ground Truth for Training Set Was Established: Not applicable.

Summary Table of Information from the Provided Document:

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