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Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.

Xonrid® Gel is a multi-component prescription medical device product. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss. Xonrid® Gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a wellrecognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel. Xonrid® Gel provides a physical, topical barrier to the skin. The product is packaged in a 75 mL bottle equipped with an airless dispensing system and a cap. The bottle is manually operated, with each pump administering approximately 240 ul of product.

The provided text describes a 510(k) summary for Xonrid® Gel, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through specific acceptance criteria and large-scale clinical trials typically associated with drug approvals or novel high-risk devices.

Therefore, the information you're requesting regarding explicit acceptance criteria and a study dedicated to proving the device meets those criteria (in the way one would for a new drug or high-risk device) isn't present in this document. Instead, the "performance data" sections describe tests conducted to support the substantial equivalence claim.

However, I can extract the available performance data and structure it to best answer your questions based on the provided text.

Here's the breakdown of the information where it is available:

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

As mentioned, explicit, quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy (common for AI/diagnostic devices) are not provided. The performance data focuses on demonstrating safety and functional equivalence.

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

• Test Set (Clinical Study):
  • Sample Size: 21 healthy volunteer subjects (11 female, 10 male)
  • Data Provenance: Not explicitly stated, but the study was described as a "single-center" study. Country of origin not provided.
  • Timing: Prospective (an "early-stage, proof-of-concept" clinical study was conducted).

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 is not applicable as Xonrid® Gel is a topical medical device for skin conditions, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for the performance related to biocompatibility and bench tests would be the direct results of the standardized assays and measurements. For the clinical study, the "truth" would be the direct physiological measurements (erythema, hydration, TEWL, elasticity) observed by a blinded evaluator.

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

Not applicable for this type of device and study. The clinical study was "evaluator-blind," meaning the assessor of the clinical outcomes was unaware of the treatment assignments, which is a form of blinding to reduce bias.

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. Xonrid® Gel is a topical medical device, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

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

Not applicable as Xonrid® Gel is a topical medical device, not an algorithm or software device.

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

• Biocompatibility: Standardized assay results (e.g., cell viability for cytotoxicity, skin reaction scores for irritation/sensitization).
• Bench Performance: In vitro measurement results (e.g., microscopic observation of barrier formation, quantitative assessment of washability).
• Clinical Study: Direct physiological measurements (erythema, skin surface hydration, transepidermal water loss, cutaneous elasticity) observed by an evaluator.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.

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

Not applicable. This device is not an AI/machine learning product.

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