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Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.

Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.

The provided FDA 510(k) summary for Synvaza and Synvaza II describes non-clinical and clinical performance testing but does not explicitly state formal acceptance criteria or directly report device performance against such criteria in a table format as requested. Therefore, the information has been extracted and presented as closely as possible to the request based on the available text.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As formal acceptance criteria are not explicitly defined in the document, I will infer what the acceptance criteria were based on the reported "Results" of the non-clinical tests. For the clinical study, the acceptance criteria are not quantifiable in the provided text.

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

• Non-clinical Testing: The sample sizes for the biocompatibility and preservation tests are not specified in the document.
• Clinical Performance Testing: The sample size is described as "preselected study subjects," but the exact number is not provided. The document does not specify the country of origin of the data, but the context of an FDA submission suggests it would be relevant to U.S. regulatory standards. The study was "open label, single arm," and involved using the device for 72 hours, which indicates it was a prospective study.

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

This information is not provided in the document. The clinical study describes self-reported pain relief by subjects, not a judgment by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the clinical study did not involve multiple readers or experts evaluating outcomes requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not mentioned or discussed in the provided document. The clinical study was a single-arm study evaluating the device's performance, not a comparison to human readers with or without AI assistance.

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

• Not applicable. The device is a physical wound rinse, not an algorithm or AI.

7. Type of Ground Truth Used

• Non-clinical Testing: The ground truth for biocompatibility and preservation tests would have been established through standard laboratory assays and compliance with specified standards (e.g., USP ).
• Clinical Performance Testing: The ground truth for pain relief was based on subjective self-reported experience of pain relief by the study participants.

8. Sample Size for the Training Set

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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

• This information is not applicable as the device is a medical product (oral wound rinse), not an AI/ML algorithm that requires a training set.

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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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SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.

The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.

This document is a 510(k) premarket notification for a medical device (SynePure Wound Cleanser). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results typical for a completely novel device or an AI/software as a medical device (SaMD).

Therefore, much of the requested information regarding acceptance criteria, study design for ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details for AI/SaMD is not applicable to this document. This document describes a relatively simple wound cleanser, not an AI-powered diagnostic or predictive tool.

Here's a breakdown of the available information based on your request:

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

Based on the document, two performance data points are mentioned, which could be interpreted as meeting certain criteria. However, explicit numerical acceptance criteria are not stated.

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

• Sample Size for Performance Data (Spray Duration, Solution Delivered): Not specified.
• Sample Size for Biocompatibility Testing: Not specified for individual tests. For acute systemic toxicity, it mentions "all animals," implying a group of animals, but the exact number is not given.
• Data Provenance: Not specified. The testing was done by Synedgen, Inc.

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

• Not Applicable. This device is a physical wound cleanser, not an AI or diagnostic tool that relies on expert interpretation for ground truth. Biocompatibility testing follows established protocols and laboratory readouts rather than expert consensus on interpretations of images or data.

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

• Not Applicable. See point 3.

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. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• For the physical performance tests (spray duration, solution delivery), the ground truth is likely direct measurement and observation against a defined threshold.
• For biocompatibility, the ground truth is established through standardized laboratory assays (e.g., cell cultures for cytotoxicity, animal models for sensitization and systemic toxicity) which yield objective results based on predefined biological endpoints.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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