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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 cross-linked 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, K083721 for Zenieva Hydrogel Wound Dressing, does not contain the kind of detailed study information typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers.

This submission is for a hydrogel wound dressing, a Class I non-exempt device. The context indicates it's a modification to an already cleared device, and the primary assessment is for substantial equivalence to a predicate device. The information provided heavily emphasizes the physical and chemical properties remaining unchanged.

Therefore, most of the requested information regarding acceptance criteria derived from a study, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as would apply to a diagnostic or AI-powered device, is not applicable or available in this document.

Here is a breakdown based on the information provided, highlighting where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not Applicable/Not Provided. This document describes a modification to a hydrogel wound dressing, not a diagnostic device involving a test set of data. The "performance testing" mentioned is likely related to the physical or chemical properties of the dressing itself (e.g., pH, viscosity, stability), not clinical data from patients in the manner of an AI/ML or diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable/Not Provided. Ground truth as understood for diagnostic or AI/ML devices is not relevant for this type of product and submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable/Not Provided. Adjudication methods are specific to studies involving expert review of cases, which is not described here.

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 a hydrogel wound dressing, not an AI/ML device. An MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is a hydrogel wound dressing, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" for this submission revolves around the chemical composition and physical properties of the dressing aligning with its predicate and previously cleared version, and confirming no compromise to safety or efficacy. This is assessed via "Performance testing for Zenieva" which implies laboratory tests, not clinical "ground truth" for diagnosis.

8. The sample size for the training set:

• Not Applicable/Not Provided. This device does not involve a training set as it's not an AI/ML algorithm.

9. How the ground truth for the training set was established:

• Not Applicable/Not Provided. As above, no training set or relevant ground truth for such a set.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is rather a verification process for a modification to an existing Class I device (Zenieva Hydrogel Wound Dressing, previously cleared under K082865).

• Objective: To demonstrate that the modified Zenieva product remains substantially equivalent to its predicate device despite a change (the nature of which is not explicitly detailed but implied to be minor as it doesn't affect core properties).
• Methodology: "Performance testing for Zenieva was conducted and assessed." This testing was then "compared to the approved device." The specific tests are not enumerated, but given the product type, they would likely involve:
  • Stability testing (shelf life, environmental resilience)
  • Chemical characterization (to confirm unchanged composition)
  • pH, viscosity, spreadability (physical properties relevant to hydrogels)
  • Biocompatibility (if any new materials were introduced, though the document states "modification to Zenieva does not change the chemical composition").
• Conclusion: The tests indicated that "the modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product." The product's "ingredients and performance characteristics have remained unchanged."

In essence, this is a regulatory submission for a minor change to a non-AI medical device, focusing on bench testing and comparison to established parameters rather than a clinical study with patient data and expert review.

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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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