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BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.

BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.

Instead, the document is a 510(k) summary for a medical device called BariRep. This summary is part of the process for seeking FDA clearance for a new medical device by demonstrating its "substantial equivalence" to a predicate device already on the market.

Here's what the document does say about the device and its assessment:

• Device Name: BariRep
• Common Name: Hydrogel wound dressing
• Intended Use: To manage minor burns, minor abrasions, minor cuts and minor lacerations.
• Predicate Device: Cleared under K083721, approved January 08, 2009.
• Technological Comparison: The device is stated to be "identical in formulation, specifications and performance characteristics" to the predicate device. The only change mentioned is that it is being presented for over-the-counter use.
• Non-Clinical Performance Data: "N/A" (Not Applicable)
• Conclusion: "The product's ingredients and performance characteristics have remained unchanged and are therefore, identical to the predicate. Tests and performance data are not applicable as the product remains safe, effective and substantially equivalent to the predicate. Over the counter use will not result in any increased risk to the patient."

Critically, this document explicitly states that "Tests and performance data are not applicable." This means no study was conducted or presented to demonstrate the device's performance against specific acceptance criteria, as its clearance was based on its substantial equivalence to an already approved device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance (since none were established or tested).
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details (since no non-clinical or clinical studies were performed for this submission).

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Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

The provided document is a 510(k) summary for a hydrogel wound dressing called "Zenieva." It details a submission for a modification to an already cleared device (K073246).

The key takeaway from the document regarding acceptance criteria and studies is that no new performance data or studies were conducted or required for this particular submission. The modification was solely a labeling change to add a contraindication. Therefore, the device is considered to meet acceptance criteria because its core composition, intended use, and technological characteristics remain unchanged from the previously cleared device.

Here's how the information requested applies to this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   No new acceptance criteria were established or evaluated. The submission is for a labeling change to an already cleared device. The product's ingredients and performance characteristics are stated to have remained unchanged from the previously cleared predicate device (K073246).	Not Applicable (N/A). No new performance data was generated or required as the device itself was not modified.

2. Sample Size Used for the Test Set and Data Provenance:

   • N/A. No new test set or performance study was conducted. The submission is for a labeling change to an already cleared device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • N/A. No new ground truth establishment was required as no new performance study was conducted.

4. Adjudication Method for the Test Set:

   • N/A. No new test set or adjudication was required.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study was not done. The device is a hydrogel wound dressing, not an AI-assisted diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study:

   • No. This is a medical device (hydrogel wound dressing), not an algorithm.

7. Type of Ground Truth Used:

   • N/A. No new ground truth was established for this specific submission as there were no new performance studies. The substantial equivalence for the original device would have been based on appropriate clinical or non-clinical data for a hydrogel wound dressing.

8. Sample Size for the Training Set:

   • N/A. This is a medical device, not a machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

   • N/A. Not applicable, as there is no training set for this type of medical device.

Summary Explanation:

The 510(k) submission K082865 for "Zenieva" is a resubmission or modification of a previously cleared device (K073246). The core of this submission is a labeling change to add a contraindication for one of the ingredients. The document explicitly states:

• "The proposed modification to Zenieva does not change the chemical composition, intended indications for use, physical properties, or claims."
• "Research has shown that a labeling change - adding a contraindication for one of the ingredients - is necessary. This is adding safety to the product."
• "The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are not applicable: research has shown that adding a contraindication statement for an ingredient is necessary. The product itself is not being modified; we are putting the appropriate measures in place to increase the product's safety."

Therefore, the device meets its acceptance criteria by demonstrating that the modification itself (labeling change) does not alter the fundamental safety and effectiveness of the device as previously established by the original clearance. No new studies were required or conducted for this specific 510(k) submission K082865 because the device's performance characteristics remain identical to the predicate device.

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Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

This submission describes Zenieva, a hydrogel wound dressing, and its substantial equivalence to the predicate device, MimyXTM cream (K041342). The provided text focuses on the device's composition, intended use, and non-clinical performance data, as well as the FDA's clearance letter.

Device Acceptance Criteria and Performance

The acceptance criteria for Zenieva are based on demonstrating substantial equivalence to the predicate device, MimyXTM cream. The study presented is a non-clinical performance evaluation, which aims to show that Zenieva performs similarly to the predicate and meets safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided summary does not detail the sample sizes for the in vitro cytotoxicity, skin sensitization, and primary skin irritation tests. It states that Zenieva was tested as a "surface device" with "limited contact duration (24 hours) on breached surfaces." The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin, but it is implied to be from testing conducted by Gorbec Pharmaceutical Services Inc. to support this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve clinical studies with human assessors establishing ground truth for performance metrics in a typical sense (e.g., image interpretation). Instead, the "ground truth" for the non-clinical tests (cytotoxicity, sensitization, irritation) would be established by the results of standardized laboratory assays, interpreted by qualified laboratory personnel and toxicologists. The specific number and qualifications of experts for interpreting these non-clinical tests are not detailed in the provided document.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests (cytotoxicity, sensitization, irritation) are typically objective laboratory assays with predefined endpoints, rather than requiring expert consensus or adjudication on subjective interpretations for a "test set" in the context of diagnostic or treatment efficacy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes a 510(k) submission for a hydrogel wound dressing, not an AI-assisted diagnostic or treatment device that would typically involve a MRMC study. Therefore, no effect size for human readers with and without AI assistance is reported.

6. Standalone Performance Study

Yes, in a sense. The non-clinical performance tests (cytotoxicity, skin sensitization, primary skin irritation) assess the intrinsic biological safety of the device (Zenieva) in isolation, without human-in-the-loop performance influencing the assay results. The device's "performance" in this context is its safety profile.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on standardized laboratory assay results and regulatory definitions for toxicity, sensitization, and irritation. For example, a "non-toxic" finding is based on the cellular response in a cytotoxicity assay meeting predefined criteria, rather than expert consensus on a clinical outcome or pathology.

8. Sample Size for the Training Set

Not applicable. This device is a medical product (hydrogel wound dressing) and not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device submission.

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