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Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 200 degree burns, including sunburns, and radiation dermatitis.

Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a prescription medication, requiring a physician's diagnosis of disease state prior to use. This product is formulated as an oil-in-water emulsion containing moisturizing ingredients to keep the area moist. The oil composition of Tropazone CR is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.

This document describes the premarket notification (510(k)) for Tropazone CR, a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in this document are based on demonstrating substantial equivalence to predicate devices, focusing on technological characteristics and safety. The performance is assessed through specific tests to show the device is non-irritating and non-sensitizing, and that it meets cytotoxicity standards.

2. Sample Size Used for the Test Set and Data Provenance

• Human Subjects (Biocompatibility - Irritation/Sensitization):
  • Sample Size: 50 human subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study.
• L929 Agar Overlay Cytotoxicity Study:
  • Sample Size: Not applicable in the same way as human subjects. This is an in vitro test using L929 cells.
  • Data Provenance: In vitro laboratory study.

The document does not specify geographical origin but indicates these are studies conducted to support the 510(k) submission, implying they were performed for this purpose (prospective relative to the submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• For human patch testing: The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., assessing the skin reactions). Typically, board-certified dermatologists or allergists would conduct and interpret such studies.
• For cytotoxicity testing: Similarly, the document does not specify experts. These are standardized laboratory tests, where "ground truth" is established by adherence to ISO and USP protocols and interpretation by qualified laboratory personnel.

4. Adjudication Method

Not applicable. These studies are clinical (human patch test) and lab-based (cytotoxicity) tests that follow established protocols, not typically requiring adjudication in the context of expert review of images or diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an imaging or diagnostic device that would typically involve human readers interpreting data with and without AI assistance. The studies performed are focused on biocompatibility and physicochemical equivalence.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No, a standalone (algorithm only) performance study was not conducted. This is a medical device (a wound dressing), not an algorithm or AI system.

7. Type of Ground Truth Used

• For human patch testing: The ground truth is generally considered to be the observed physiological reaction of the human skin (e.g., erythema, edema) as assessed by a trained professional following a standardized scoring system.
• For cytotoxicity testing: The ground truth is the in vitro cellular response to the device extract, measured against established criteria within the ISO 10993-5 and USP 23 standards.

8. Sample Size for the Training Set

Not applicable. This device is a wound dressing, not an algorithm that requires a training set. The studies performed are for safety and performance testing, not for training AI models.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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Tropazone Lotion 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. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Tropazone Lotion 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 polyacrylic acid polymer as the thickening agent. The oil composition of Tropazone lotion is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.

This device, Tropazone Lotion, is a hydrogel wound dressing. The provided text outlines its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a dedicated study.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a Class I unclassified device (hydrogel wound dressing), the "acceptance criteria" are primarily established by demonstrating equivalency to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics to these predicates.

2. Sample Size Used for the Test Set and Data Provenance

The submission does not describe a test set or clinical study in the traditional sense for evaluating the novel performance of Tropazone Lotion. Instead, it relies on:

• Human Safety Test: "Tropazone when tested under occlusion may be considered a non-primary irritant and a non-primary sensitizer to skin." The sample size for this test is not specified. The data provenance is also not specified, but given it's for a US regulatory submission, it's presumably from a study conducted to relevant safety standards. It does not specify if it was retrospective or prospective.
• In-vitro Test: "In a L929 Agar overlay cytotoxicity study using Tropazone, the cells exhibited a mild/moderate reaction." The sample size for this in-vitro test is not specified. Data provenance is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no specific "ground truth" derived from expert consensus for a test set in the context of device performance evaluation. The safety and biocompatibility assessments would typically rely on established dermatological and toxicological endpoints, interpreted by qualified personnel, but the number and qualifications of such experts are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. No clinical or performance test set requiring adjudication 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 lotion, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a topical lotion, not an algorithm.

7. The Type of Ground Truth Used

For the safety data:

• The biocompatibility/irritation/sensitization ground truth would be based on established dermatological endpoints in human or animal models (e.g., skin reactions scored according to a toxicity scale).
• The cytotoxicity ground truth would be based on cellular viability and morphology in an in-vitro assay, compared to controls.

For the substantial equivalence claim:

• The "ground truth" is the established performance and safety profile of the predicate devices (K041342, K073246, and K964240), based on their prior clearances.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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