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Indicated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis

NEOCERA Advanced Cream is a fragrance-free, water-soluble dressing formulated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis. NEOCERA Cream is intended for topical application. This product is to be sold by prescription only.

The provided text describes a 510(k) premarket notification for a medical device called NEOCERA Advanced Barrier Cream. It focuses on establishing substantial equivalence to a predicate device, Neosalus cream. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate device and specific non-clinical and clinical tests. It is essential to note that this document does not describe a study comparing the device against specific, quantitative performance acceptance criteria in the way one might expect for a diagnostic or therapeutic device with measurable outcomes. Instead, it demonstrates safety and biocompatibility to support substantial equivalence.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a topical cream, the "acceptance criteria" are implied by the performance of the predicate device and the regulatory requirements for similar products, particularly for safety and biocompatibility. The "reported device performance" refers to how NEOCERA cream met these implied criteria through specific tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cytotoxicity Agar Diffusion: Not specified, but generally involves a standard number of cell cultures.
• Primary Dermal Irritation in Rabbits: Not specified, but rabbit irritation tests typically involve 3-6 rabbits.
• Guinea Pig Closed Patch Sensitization Test: Not specified, but standard guinea pig sensitization studies typically use 10-20 animals per group.
• Repeated Insult Patch Test in Humans: Not specified. These studies can range from 50 to over 200 subjects.

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though biocompatibility and human patch tests are typically prospective.

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 section is not applicable as the document describes biocompatibility and safety testing for a topical cream, not a diagnostic device requiring expert interpretation of images or clinical findings to establish a "ground truth." The results of the tests (e.g., cytotoxicity, irritation index) are objective measurements.

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

This is not applicable for the reported non-clinical and clinical (safety) tests. Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish ground truth. The tests performed are objective, laboratory-based, or involve direct observation (like irritation scores) by trained personnel according to standardized protocols.

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 is not applicable. An MRMC study is designed for evaluating diagnostic devices, particularly those involving human interpretation, and comparing performance with and without AI assistance. This document pertains to a topical cream, not an AI-enabled diagnostic device.

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

This is not applicable as the device is a topical cream, not an algorithm or AI system.

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

Given the nature of the device and tests, the "ground truth" is defined by:

• For Biocompatibility (cytotoxicity, irritation, sensitization): Standardized ISO (International Organization for Standardization) protocols and GLP (Good Laboratory Practice) standards are used to generate objective quantitative and qualitative results (e.g., cytotoxicity score, irritation index, presence/absence of sensitization).
• For Human Repeated Insult Patch Test: Direct observation and scoring of skin reactions by trained clinicians or dermatologists against a predefined scale, following Good Clinical Practice (GCP) principles as indicated by adherence to the Declaration of Helsinki, ICH E6, and 21 CFR Parts 50 and 56.

8. The sample size for the training set

This is not applicable. This document describes the testing of a cream, not an algorithm that requires a training set. The term "training set" is relevant for machine learning models.

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

This is not applicable as there is no training set for this device.

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Under the supervision of a healthcare professional, Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Loutrex Topical Cream is a non-sterile, white to off-white water based emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.

The provided 510(k) application for Loutrex Topical Cream (K120730) does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about any clinical trials or performance testing.

The document is a submission for substantial equivalence to a predicate device, which focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing detailed performance study results against pre-defined acceptance criteria.

Here's a breakdown of what is and isn't in the document, based on your requested information:

What is mentioned:

• Intended Use: "Loutrex Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling, and pain. Loutrex Topical Cream helps relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process."
• Predicate Devices: Sinclair Skin Emulsion (cleared under K050158 and K111168, distributed by Promius Pharma, LLC as Promiseb® Topical Cream).
• General Statement on Testing: "Functional and performance testing has been conducted to assess the safety and efficacy of Loutrex Topical Cream and the results are satisfactory." (This is a generic statement and does not provide any specifics about the tests, acceptance criteria, or results.)

What is NOT mentioned (and therefore cannot be provided from this document):

• 1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or provide performance data for Loutrex Topical Cream.
• 2. Sample sized used for the test set and the data provenance: No information on sample size or data origin is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set or expert-established ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This device is a topical cream, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a topical cream, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as no model or algorithm is being developed or trained.
• 9. How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device for a topical cream. It explicitly states that "Functional and performance testing has been conducted to assess the safety and efficacy... and the results are satisfactory," but it does not provide any specific details about the nature of those tests, the acceptance criteria used, or the actual performance results. For a medical device like a topical cream, the "study" demonstrating safety and efficacy would typically involve clinical trials. However, the summary provided here does not include any data from such trials.

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Under the supervision of a healthcare professional, Precision Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Precision Skin Emulsion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Precision Skin Emulsion is a non-sterile, off-white, low odor, fragrance free, topical product. The Precision Skin Emulsion forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.

I am sorry but I did not find any information about acceptance criteria or a study that proves the device meets the acceptance criteria. Thus, I cannot construct a response based on the request.

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