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Under the supervision of a healthcare professional, HylatopicPlus Lotion 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. HylatopicPlus Lotion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment. A moist wound & skin environment is known to be beneficial to the healing process.

HylatopicPlus Lotion is indicated for use in:

• Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis

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

This document is a 510(k) Premarket Notification for HylatopicPlus® Lotion, seeking substantial equivalence to a previously cleared device (HylatopicPlus® Cream). It does not contain information on an AI/ML device or studies proving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these concepts are not applicable to the provided document.

The document focuses on demonstrating substantial equivalence of a topical lotion to a previously cleared cream based on their formulation, intended use, and manufacturing processes, not on performance metrics of an AI/ML system.

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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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Under the supervision of a healthcare professional, HylatopicPlus™ 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. HylatopicPlus™ Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

HylatopicPlus™ Cream is indicated for use in:

• Atopic Dermatitis
• Allergic Contact Dermatitis
• Radiation Dermatitis

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

The provided text is a 510(k) Summary for a medical device (HylatopicPlus™ Cream) that is seeking clearance based on substantial equivalence to a predicate device. This type of submission does not typically include a standalone study proving the device meets specific acceptance criteria in the way a new diagnostic or AI-driven device would. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

Therefore, many of the requested items (acceptance criteria, device performance metrics, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context because this is a substantial equivalence submission for a topical cream, not a performance study for a diagnostic or AI-based device.

Here's a breakdown of the applicable and non-applicable information based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This submission is for substantial equivalence. The "acceptance criteria" are demonstrating equivalence to a predicate device, not meeting specific performance metrics in a clinical trial designed to prove efficacy against a predefined standard. The reported performance is the "identical intended uses, operating principles, components, quantities, shelf-lives, and manufacturing procedures."

2. Sample sized used for the test set and the data provenance

• Not Applicable. There is no "test set" in the context of validating a diagnostic or AI device's performance. The submission relies on comparing the device's characteristics to a predicate, not on a clinical test set.

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

• Not Applicable. No "ground truth" was established in the sense of expert consensus on outcomes for a test set. The "truth" is the characteristics of the predicate device.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication process as described would have been used.

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 is a topical cream, not an AI or diagnostic device that involves human readers interpreting results.

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 or AI device.

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

• Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate device, which is inferred from its prior 510(k) clearance based on its intended use, formulation, and manufacturing. No new clinical "ground truth" data was generated for the standalone device.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a traditional medical device like a cream.

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

• Not Applicable. See above.

Summary of Applicable Information from the Text:

The "study" in this case is the comparison of the new device (HylatopicPlus™ Cream) to a legally marketed predicate device (Hylatopic™ Plus Emollient Foam). The acceptance criteria are implicit in the concept of "substantial equivalence" as defined by the FDA.

Table of "Acceptance Criteria" (Substantial Equivalence Pillars) and Reported Device Characteristics:

Details of the Equivalence Determination:

• Predicate Device: Hylatopic™ Plus Emollient Foam (cleared under K093051). PreCision Dermatology, Inc. acquired legal rights to this predicate.
• Key Differences (and rationale for equivalence): The proposed device (Cream) is presented as a cream in packaging and on application. The predicate device (Emollient Foam) forms a foam when dispensed, but "during application, the propellant dissipates and the device returns to a cream form as it is spread on the skin." The submission argues that both are effectively in cream form on application to the skin.
• Labeling Changes: Consisted of "removal of aerosol specific text and changes to the name and logo of the company marketing the device."

The FDA's clearance letter (K110727) confirms that based on this comparison, the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

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