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OTC Indications and Usage: BIAFINE Topical Cream is indicated for management of superficial wounds such as minor cuts, minor scrapes, minor irritations, minor blisters, 1st degree burns including sunburns, minor skin irritations following post non-ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE Topical Cream may also be used for relief of itch, pain and burning from minor skin irritations, lacerations, abrasions and minor burns.

BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients include Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.

This document is a 510(k) premarket notification for BIAFINE Topical Cream, seeking a determination of substantial equivalence to a previously cleared predicate device (K173549). It focuses on asserting equivalence rather than presenting novel acceptance criteria or a study to prove new performance.

Therefore, the requested information elements related to distinct acceptance criteria, an independent study, sample sizes for test and training sets, expert involvement, and ground truth establishment are largely not applicable (N/A) in the context of this specific regulatory submission.

The essence of this submission is that:

• The subject device (K190342) is identical in formulation, intended use, technology, and performance to its predicate device (K173549).
• The only difference explicitly mentioned and requiring additional testing is related to extending the use-life of the product.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission asserts substantial equivalence based on identical characteristics to a predicate, there are no new distinct acceptance criteria or performance metrics reported for the subject device (K190342) in comparison to the predicate, except for the use-life extension.

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

The document does not describe a separate "test set" in the context of a comparative performance study against a ground truth for the subject device (K190342), as it's asserting equivalence.

• Sample size for test set: N/A (not a new performance study vs. ground truth)
• Data provenance: "Previously submitted non-clinical testing, including biocompatibility and (closed tube) shelf life data, continue to support BIAFINE Topical Cream." This refers to data supporting the predicate device (K173549). "Additional stability testing was conducted to extend the use-life and support multi-use labeling." This implies prospective laboratory testing for the use-life extension.

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

N/A. This type of regulatory submission (510(k) for substantial equivalence of a topical cream) typically does not involve expert adjudication or ground truth establishment in the way it would for diagnostic software or image analysis. The "ground truth" for the predicate device's efficacy would have been established through clinical trials or accepted scientific principles, but that is not detailed here for a new study.

4. Adjudication Method

N/A. Not relevant for this type of submission.

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

N/A. An MRMC study is relevant for assessing human reader performance, particularly with AI assistance in diagnostic tasks. This device is a topical cream.

6. Standalone (Algorithm Only) Performance Study

N/A. This is a topical cream, not an algorithm.

7. Type of Ground Truth Used

For the claims about the topical cream's efficacy (e.g., maintaining a moist wound environment, relief of pain), the "ground truth" is based on accepted scientific principles for wound care and potentially clinical data submitted for the predicate device. For the use-life extension, the ground truth is established by stability testing results which would demonstrate that the product remains stable and effective over the extended 12-month use period after opening. The specific details of these stability testing results are not provided in this summary.

8. Sample Size for the Training Set

N/A. Not relevant for this type of medical device (topical cream). The product's characteristics are determined by its formulation and manufacturing process, not trained on data.

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

N/A. Not relevant.

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OTC Indications and Usage: BIAFINE is indicated for management of superficial wounds such as minor scrapes, minor irritations, minor abrasions, minor blisters, 1st degree burns, minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns. RX Indications and Usage: BIAFINE is indicated for management of full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers, radiation dermatitis, donor sites and 2nd degree burns. BIAFINE may also be used for relief of itch, pain and burning from minor skin irritations, abrasions and minor burns.

BIAFINE Topical Cream is a white oil-in-water cream and is supplied in lined aluminum tubes with a screw-top closure. Ingredients: Purified water, liquid paraffin, ethylene glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalane, avocado oil, trolamine/sodium alginate, triethanolamine, cetyl palmitate, methylparaben (sodium salt), sorbic acid (as potassium salt), propyl paraben (sodium salt), and fragrance.

The provided document is a 510(k) summary for the device BIAFINE Topical Cream. It aims to demonstrate substantial equivalence to predicate devices for expanded indications, particularly for Over-The-Counter (OTC) use. The document doesn't present a traditional acceptance criteria table with reported device performance in a numerical format often seen in AI/ML device studies. Instead, it relies on demonstrating equivalence through comparison of technological characteristics and supported by existing clinical literature.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence by comparing the technological characteristics of the subject device (BIAFINE Topical Cream) with predicate devices and by citing existing literature supporting the expanded indications. The "reported device performance" is essentially a qualitative claim of effectiveness and safety based on prior knowledge and published studies.

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

The document does not describe a single "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it leverages "multiple independent clinical studies" and "published literature" as evidence. These studies would have their own sample sizes and data provenance, but those details are not provided in this 510(k) summary. The clinical evidence is retrospective, drawing from previously published research and existing data on BIAFINE and similar products. The countries of origin of the data are not explicitly stated, but clinical studies are cited from various journals, and some references indicate locations such as Marseille, France.

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

N/A. This information is not applicable in the context presented. The review relies on published clinical studies and expert consensus inherent in the existing medical literature, rather than establishing new ground truth for a discrete test set. The individual studies cited would have involved medical professionals, but their specific roles in "establishing ground truth" for a single test set are not detailed in this summary.

4. Adjudication Method for the Test Set

N/A. This information is not applicable as there is no mention of a defined "test set" with a need for adjudication in the traditional sense for this 510(k) submission. Evidence is drawn from published literature.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

N/A. An MRMC study is not mentioned. The document describes clinical studies that compared BIAFINE to a placebo or another product (like petrolatum ointment) in specific conditions, but not in the format of an MRMC study designed to evaluate human readers' improvement with AI assistance. This device is a topical cream, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

N/A. This question is not applicable. The device is a topical cream, not an algorithm, so "standalone performance" in this context is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the claims made in this submission is derived from:

• Clinical outcomes and observations from numerous published independent clinical studies.
• Expert consensus inherent in the medical literature and clinical practice regarding wound healing and the management of skin conditions.
• Physiological measurements (e.g., reduction in erythema, edema) and patient-reported outcomes (e.g., relief of itch, pain, burning) from the cited studies.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.

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

N/A. The concept of a "training set" is not applicable here as the submission is for a medical device (topical cream), not an AI/ML algorithm.

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BIAFINE™ is intended to be used as a wound dressing for the following indications:

• superficial wounds
• minor abrasions
• leg ulcers
• donor sites
• 1st and 2nd degree burns, including sunburns
• radiation dermatitis
• for dermal ulcers, including full thickness wounds and pressure sores, consult a plysician

BIAFINE® Wound Dressing Emulsion

This document is a 510(k) clearance letter from the FDA for BIAFINE® Wound Dressing Emulsion. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria through a new study.

Therefore, I cannot provide the requested information from this document.

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