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Under the supervision of a healthcare professional, Hylamix Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylamix Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Hylamix Cream is indicated for use in:
Atopic Dermatitis Allergic Contact Dermatitis Radiation Dermatitis

Non-sterile, white, fragrance free, topical cream. Hylamix forms a physical barrier which maintains a moist wound and skin environment, and will be marketed in a 100 g tube, and 450 g jar as a prescription device.

The provided text describes the 510(k) summary for Hylamix Cream, a medical device. It focuses on demonstrating substantial equivalence to a predicate device (Hylatopic Plus™ Cream) rather than establishing performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding a study proving device performance against acceptance criteria, particularly for an AI/algorithm-based device, is not present.

However, I can extract information related to the non-clinical and clinical performance studies conducted to confirm the safety and effectiveness of the Hylamix Cream.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria with corresponding performance metrics in a table format. Instead, it reports the results of safety tests.

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

• Animal Studies:
  • Guinea Pig Sensitization: Sample size not specified.
  • Primary Dermal Irritation Tests in rabbits: Sample size not specified.
• Human Studies:
  • 48 hours Patch Test on humans: Sample size not specified.
  • Repeated Insult Patch Test (RIPT) on humans: Sample size not specified.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, these studies would have been conducted by or for IGI Laboratories, Inc. The Declaration of Helsinki and 21 CFR parts 50 & 56 (related to human subject protection) are mentioned for the human studies, confirming ethical conduct requirements were followed. Whether these were retrospective or prospective is not specified, but typically pre-market studies are 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 information is not applicable as the studies described are for a topical cream, focusing on safety (cytotoxicity, sensitization, irritation) and stability, not diagnostic performance or image interpretation that would require expert ground truth.

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

This information is not applicable for the type of animal and human safety studies described.

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. The 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:

This information is not applicable. The device is a topical cream, not an algorithm.

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

• For cytotoxicity, sensitization, and irritation tests: The "ground truth" would be the observed biological reactions (or lack thereof) in testing models, evaluated against established scientific and regulatory guidelines (e.g., ISO standards).
• For stability studies: The "ground truth" would be the measured chemical and microbiological properties over time, compared to pre-defined specifications.
• For human patch tests: The "ground truth" would be the clinical assessment of skin reactions by qualified personnel, adhering to ethical and scientific standards (Declaration of Helsinki, 21 CFR 50 & 56, ICH guideline E6).

8. The sample size for the training set:

This information is not applicable. The device is a topical cream; there is no "training set" in the context of an AI/algorithm-based device.

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

This information is not applicable. As above, there is no training set for this type of device.

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

Dermiseb Cream in indicated for use in:

• Seborrhea
• Seborrheic Dermatitis

Non-sterile, off-white to slight pale-yellow colored, low odor, steroid-free, fragrance free, topical cream. Dermiseb Cream forms a physical barrier to relieve dry waxy skin by maintaining a moist wound and skin environment, and will be marketed in a 30 g tube as a prescription device.

The provided document is a 510(k) summary for a medical device called Dermiseb Cream. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical performance study for an AI/ML medical device would.

The document primarily focuses on establishing substantial equivalence to an already cleared predicate device (Promiseb® Topical Cream). This means that the device is considered safe and effective because it is similar to a legally marketed device, not necessarily because it has met specific, quantifiable performance metrics in a new clinical study.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text, as this type of information is typically part of a clinical trial or performance study, which is not detailed here for this specific 510(k) submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not available. The document states that "Non-clinical testing was conducted to confirm the safe and effective performance of Dermiseb Cream," but it does not provide specific acceptance criteria or performance metrics. The basis for clearance is substantial equivalence to a predicate device.

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

• Not available. No specific clinical test set or study data are presented.

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)

• Not available. No ground truth establishment is described as there is no detailed clinical study presented.

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

• Not available. No adjudication method is described.

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/ML diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This is a topical cream, not an algorithm.

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

• Not available. No ground truth is described.

8. The sample size for the training set

• Not applicable. This is a topical cream, not an AI/ML model that requires a training set.

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

• Not applicable.

In summary: The provided document is a regulatory submission for a medical device (topical cream) seeking clearance based on substantial equivalence. It does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment that would be associated with the development and validation of an AI/ML diagnostic device.

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