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Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate. The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use. Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.

The provided text is a 510(k) summary for the device "Moisyn Dry Mouth Oral Rinse/Mist". It describes the device, its intended use, comparison with predicate devices, and performance data. However, the information requested regarding acceptance criteria and a study proving the device meets these criteria (especially related to AI/algorithm performance, expert review, MRMC studies, etc.) is not present in this document.

This document is a regulatory submission for a medical device that relieves symptoms of dry mouth. It focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and safety aspects (biocompatibility, preservation effectiveness, shelf-life, viral inactivation).

Here's a breakdown of why the requested information cannot be extracted:

• No AI/Algorithm Component: The device described is a physical oral rinse/mist, not an AI or algorithm-driven diagnostic or medical imaging device. Therefore, concepts like acceptance criteria for AI performance (sensitivity, specificity, AUC), test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable.
• Performance Data Focus: The "Performance data" section refers to standard biocompatibility testing, preservative effectiveness, and shelf-life, which are relevant for a chemical/physical product, not an AI.
• "Clinical Study" Context: The mention of a "Clinical Study" refers to a human study evaluating the effectiveness of the oral rinse in relieving dry mouth symptoms, not the performance of an AI or diagnostic algorithm. The study cited is about symptom improvement and saliva production, not diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details about an AI-related study because the device in question is not an AI/algorithm.

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Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

Catasyn RX may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Catasyn is a clear, colorless hydrogel that is composed of hypromellose, arginine derivatized chitosan, betaine, and methylparaben to form a hydrogel dressing. The device is a non-sterile, preserved hydrogel. The gel is supplied in 0.07oz. (2mL), 0.85oz (25mL), or 3oz (88.7mL) tubes.

Catasyn is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing.

This document is a 510(k) Premarket Notification for a medical device called "Catasyn Advanced Technology Wound Hydrogel." The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Instead, it presents performance data related to the physical and biological properties of the wound hydrogel itself, to show its safety and function compared to a predicate device.

Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document is for a non-AI/ML medical device.

To directly answer your prompt, based only on the provided document, the following points are relevant, but not in the context of an AI/ML device:

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

   While not "acceptance criteria" in the sense of an AI/ML model's performance metrics (like sensitivity, specificity, AUC), the document presents a table of Biocompatibility Testing with descriptions of the tests (the "criteria" for safety) and their results (the "performance"):

   Test	Description	Result
   Cytotoxicity Direct Contact	Cytotoxicity was evaluated using ISO-10993-5, Biological evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity.	Non-toxic
   Maximization Test For Delayed Type Hypersensitivity	Delayed-type hypersensitivity was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for Irritation and skin sensitization.	No Sensitization reaction was observed in any of the test animals
   Dermal Irritation	Dermal irritation was evaluated according to ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.	No erythema or edema was observed. The Primary Irritation Index for the test article was 0.
   Acute Systemic Toxicity	Acute systemic toxicity was tested according to ISO 10993-11, Biological Evaluation of Medical Devices – Tests for Systemic Toxicity.	No Biological reactivity was observed at any time point
   Hemolysis extraction method and direct contact	Hemolysis was tested according to ASTM 756-13 for both extraction and direct contact methods.	The corrected hemolytic index was 0% for extraction and direct contact. The test article is considered non-hemolytic.

   Additionally, preservation effectiveness and shelf-life data are presented:

   • Preservation: Meets USP 51 Category 2 challenge (immediately following production and at 6-month shelf life).
   • Shelf Life: Meets specifications after 9 months of real-time aging (on a 36-month study).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   For the biocompatibility tests (e.g., Cytotoxicity, Maximization Test, Dermal Irritation, Acute Systemic Toxicity, Hemolysis), the document does not specify the sample sizes of cells, animals, or human subjects used. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These are standard in vitro or in vivo (animal) lab tests, not clinical studies on human patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as this is not an AI/ML device requiring expert adjudication for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   The "ground truth" here refers to established biological and chemical safety standards (e.g., ISO 10993 series, ASTM 756-13, USP 51) and laboratory test results demonstrating the absence of toxicity, irritation, sensitization, or hemolytic reactions.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:
   Not applicable.

In summary, the provided document is a 510(k) submission for a traditional wound care product (hydrogel) and thus does not contain the information typically required for evaluating an AI/ML medical device.

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