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Neutrogena MD™ Cream with Glycerin is intended for use in the management of minor burns and abrasions associated with resurfacing procedures, such as dermabrasion, chemical resurfacing, or laser resurfacing, in order to provide a moist wound environment that is supportive of healing.

For external use only. Not intended for use on 3rd degree burns.

Neutrogena MD™ Cream with Glycerin is a hydrogel wound dressing composed primarily of water and glycerin.

The provided text describes the 510(k) summary for the Neutrogena MD™ Cream with Glycerin. This document focuses on demonstrating substantial equivalence to predicate devices and detailing safety studies, rather than defining specific performance acceptance criteria and a study to prove meeting those criteria in the way a diagnostic algorithm might.

Therefore, much of the requested information, such as quantitative acceptance criteria, test set sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable or not present in the provided document.

However, I can extract the information that is available and indicate what is not present based on the document's content.

Device: Neutrogena MD™ Cream with Glycerin (Type: Hydrogel wound dressing)

Intended Use: Management of minor burns and abrasions associated with resurfacing procedures (dermabrasion, chemical resurfacing, laser resurfacing) to provide a moist wound healing environment. For external use only. Not intended for use on 3rd degree burns.

Reason for lack of detailed performance criteria and study: This 510(k) submission is for a medical device (a topical hydrogel dressing), not an AI/diagnostic algorithm. The evaluation focuses on safety and substantial equivalence to existing predicate devices based on formulation, intended use, and pre-clinical/clinical safety assessments. Therefore, the types of performance metrics and study designs typically used for AI diagnostics (sensitivity, specificity, ROC curves, multi-reader studies, etc.) are not relevant or included here.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define specific quantitative "acceptance criteria" in the format of a diagnostic algorithm (e.g., target sensitivity/specificity). Instead, the "acceptance" is based on meeting safety standards and demonstrating substantial equivalence to predicate devices. The "performance" is described in terms of safety study conclusions and clinical observations.

• Formulation (primarily water and glycerin)
• Intended use (moist wound healing microenvironment)
• Packaging (plastic tube dispensers, not occlusive backing)
• Preservative systems (similar methylparaben/propylparaben)
  (Spand-Gel note about absorbent polycarbonate beads indicates a minor difference but not one that negates equivalence based on the overall assessment). |

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

• Sample Size: Not explicitly stated for either the preclinical animal studies or the clinical studies. For the "Dry skin healing" study, it's a "controlled double-blind clinical evaluation," implying human subjects, but the number is not provided. For the "integrative wound management regimen" study, it's a "preliminary results" report, again with no sample size specified.
• Data Provenance:
  • Preclinical studies (Cytotoxicity, Skin Irritation, Hypersensitivity) are laboratory-based and animal studies, not human data with country of origin.
  • The "Dry skin healing" clinical study (Appa, Y. and L. Hemingway, 1994) was conducted by "Neutrogena Corporation, Los Angeles, CA," suggesting US origin.
  • The "integrative wound management regimen" clinical study (Goldman, M. 1998) is also a clinical study, but no specific location is given beyond the researcher's name and year.

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

• Not Applicable. The "ground truth" here is established through scientific testing methods (e.g., USP standards for cytotoxicity, animal models for irritation/sensitization, clinical observation for suitability), not through expert consensus on diagnostic images or similar data. The clinical studies would have involved medical professionals, but their specific role in "establishing ground truth" in a diagnostic sense is not relevant.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretations, not for evaluating properties of a wound dressing. The "controlled double-blind clinical evaluation" suggests a methodology to minimize bias in clinical assessment, but not an adjudication of "ground truth."

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

• No. This document does not mention an MRMC comparative effectiveness study. This type of study is typically relevant for evaluating the impact of AI on human diagnostic accuracy, which is not the scope of this medical device submission.

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

• Not Applicable. This is a physical medical device (cream), not an algorithm. Its performance is inherent to its properties and application, not an independent algorithmic output.

7. Type of Ground Truth Used

• A combination of:
  • In vitro and animal study results: For safety endpoints (cytotoxicity, irritation, sensitization), the "ground truth" is determined by meeting established scientific and regulatory standards (e.g., USP requirements) and observed biological responses in tested models.
  • Clinical observation/outcome: For the clinical studies, the "ground truth" for usefulness is based on observed clinical outcomes or suitability for the intended use (e.g., providing a moist wound environment, suitability for resurfacing procedures). This aligns with "outcomes data" in a broader sense.

8. Sample Size for the Training Set

• Not Applicable. As this is not an AI/ML device, there is no "training set." The development of the cream would involve R&D and formulation testing, but this isn't structured as a training set for an algorithm.

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

• Not Applicable. Since there is no training set, this question is not relevant.

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