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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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