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Rx Indications for Use: DermaFINE Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include: Radiation Dermatitis Various types of dermatoses Atopic dermatitis Allergic contact dermatitis Dry waxy skin by maintaining a moist wound and skin environment.
OTC Indications for Use: DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment.

DermaFINE Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.

The provided text describes a 510(k) premarket notification for the DermaFINE Wound Dressing, which is seeking substantial equivalence to predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies for proof of efficacy. As such, the information you've requested regarding acceptance criteria and detailed study results typical of a de novo or PMA submission is largely not applicable in this context for proving clinical effectiveness of the device itself.

However, the document does provide information about non-clinical performance data which serves as the basis for demonstrating equivalence and safety.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally aligned with demonstrating that the new device shares the same technological characteristics and intended use as the predicate device, and that it performs safely. The provided document details the non-clinical tests performed to demonstrate this safety.

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

• Sample Size: The document does not specify the sample sizes used for the non-clinical tests (e.g., number of cells for cytotoxicity, number of animal subjects for irritation/sensitization).
• Data Provenance: The tests are described as being conducted "in accordance with Part 10-993 of the International Standard Organization (ISO)." This indicates in vitro and potentially in vivo (animal) testing common to medical device biocompatibility evaluations. The country of origin for the data is not specified beyond adherence to ISO standards. The data is implicitly prospective as it was conducted to support the 510(k) submission.

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

This information is not applicable for the non-clinical tests described. Biocompatibility tests like cytotoxicity, irritation, and sensitization follow standardized protocols where results are objectively measured and interpreted by trained laboratory personnel, rather than relying on expert consensus for "ground truth" as might be the case in an imaging or diagnostic study.

4. Adjudication method for the test set

This information is not applicable for the non-clinical tests described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. The non-clinical tests rely on validated laboratory methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "DermaFINE Wound Dressing has not been studied in a clinical setting."

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

This concept is not applicable to a wound dressing device. Standalone performance refers to the performance of an artificial intelligence algorithm or diagnostic without human intervention. This device is a physical wound dressing emulsion.

7. The type of ground truth used

For the non-clinical performance data, the "ground truth" is established by adherence to standardized ISO test methodologies and their inherent measurement criteria. For instance, in cytotoxicity, the "ground truth" is the observed cellular response according to the defined grading scale. For skin irritation, it's the absence or presence of erythema/edema as per the standard.

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train machine learning models. The DermaFINE Wound Dressing is a physical product, not an AI/ML device.

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

This information is not applicable for the same reason as point 8.

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(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)

(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.

(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.

(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.

(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome

Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.

Neutrasal® facilitates chewing and speaking; loosens tough mucus; prevents mucous membranes from sticking together; and improves adherence of dentures.

Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.

Silica gel, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.

This document is a 510(k) summary for the medical device Neutrasal®, a powder for supersaturated calcium phosphate rinse. It does not include information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested categories of information are not applicable or cannot be extracted from this document, as they pertain to a performance study that was not conducted or reported for this submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is not:

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

• Note: The document states that the performance testing "included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use." The listed bench tests (pH, dissolution, activity, content) were performed. However, specific numerical acceptance criteria for these properties are not explicitly stated in the document, nor are the specific numerical results of these tests reported. The implicit acceptance criterion is that these properties are equivalent to the predicate device, which is implied by the "Substantial Equivalence Conclusion."

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

• Not Applicable. No clinical test set data is provided in this submission for substantial equivalence. The "test set" here refers to the physical properties tested in bench studies.
• Data Provenance: Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service, as well as internal testing. No country of origin for data is specified beyond the laboratory location. The nature of these tests makes them "prospective" in the sense that they were conducted for this submission, but not on human subjects.

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)

• Not Applicable. This device is not an AI/diagnostic device that relies on expert interpretation of images or clinical data. Ground truth in this context refers to the chemical and physical properties of the formulation, established through laboratory testing.

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

• Not Applicable. Adjudication methods are typically for clinical study endpoints or diagnostic interpretations, neither of which are present in this submission.

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

• No. This is a medical device (oral rinse), not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.

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

• No. This is a physical medical device, not an algorithm.

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

• The "ground truth" for the device's performance relies on objective laboratory measurements of its physical and chemical properties (pH, dissolution, supersaturated state activity, content of active ingredients) and established regulatory frameworks for ingredient safety (GRAS listing) and manufacturing (cGMP). The ground truth for biocompatibility is its identity to a previously approved predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

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