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Minor burns
Superficial lacerations, cuts and abrasions (partial thickness wounds) and skin tears
Under the direction of a healthcare professional, SoloSite® Gel Conformable Dressing is used to create a moist wound environment for the management of:
Venous ulcers (leg ulcers)
Surgical incisions
Diabetic foot ulcers
Pressure ulcers (including stage IV).
Additionally, SoloSite® Gel Conformable Dressing, creates a moist wound environment which assists in autolytic debridement of wounds covered with necrotic tissue.

Device Description

SoloSite® Gel Conformable Dressing is a non woven (70/30 rayon polyester blend) dressing impregnated with SoloSite® wound gel contained in a heat sealable, peal apart metalized/polyethylene pouch.
The product is applied in such a manner to completely cover the wound surface with the dressing and secured in place with an appropriate secondary dressing.
Gel conformable dressings are indicated to provide covering of the wound bed as well as creating a moist wound healing environment.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called SoloSite® Gel Conformable Dressing. It focuses on demonstrating substantial equivalence to previously marketed devices and biocompatibility testing, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a comparative effectiveness study is not present in this document.

However, I can extract the information that is available and clarify what is not.

Acceptance Criteria and Study Information for SoloSite® Gel Conformable Dressing

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

No explicit acceptance criteria with numerical targets for clinical performance are presented in this 510(k) summary. The document primarily focuses on demonstrating the device's biocompatibility and substantial equivalence to predicate devices. The "performance" reported relates to the results of biocompatibility tests, indicating the device meets safety standards.

Acceptance Criteria (Implied from testing)	Reported Device Performance
Biocompatibility:
In vitro cytotoxicity (ISO 10993-5) – No significant cell lysis or toxicity.	"The test article showed no evidence of causing cell lysis or toxicity grater then a USP grade of 2 (mild reactivity). The test article was mildly cytotoxic and passed this ISO study."
Primary skin irritation (FHSA Regulations, 16 CFR 1500) – Not a primary irritant (Irritation Index < 5.00).	"Barely perceptible irritation was observed on the skin of the rabbits. The primary irritation index was calculated to be 0.88." "The test article would not be considered a primary irritant to the skin since the empirical score was less than 5.00."
Delayed dermal contact sensitization (ISO Part 10) – No evidence of sensitization.	"The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig."
Acute systemic toxicity (ISO Part 11) – No mortality or significant systemic toxicity.	"Under the conditions of this test there was no mortality or evidence of significant systemic toxicity."
Genotoxicity (Salmonella typhimurium Reverse Mutation Study) – Not mutagenic.	"SoloSite CWD was not considered to be mutagenic to Salmonella typhimurium tester strains."
Hemolysis (In Vitro Procedure - Extract Method) – Non-hemolytic.	"The mean hemolytic index for the test article extract was 0%. The test article extract was nonhemolytic."
Functional Equivalence:
Technologically the same as predicate devices (hydrogel impregnated dressing)	"The SoloSite® Gel Conformable Dressing is technologically the same as the substantially equivalent products... in that all products are hydrogel impregnated dressings indicated to provide covering of the wound bed as well as creating a moist wound healing environment."

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:
- Biocompatibility Tests: The document refers to standard in vitro and in vivo animal tests. Specific sample sizes for each test (e.g., number of cells for cytotoxicity, number of rabbits for irritation, number of guinea pigs for sensitization, number of mice for systemic toxicity) are not explicitly stated within the provided text. These are typically defined by the referenced ISO/FHSA standards.
- Clinical Performance: No clinical test set or human subject study designed to evaluate device performance against specific outcomes is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices for its intended use claims.
Data Provenance: The biocompatibility studies appear to be laboratory studies conducted as per international standards (ISO) and U.S. federal regulations (FSHC). The country of origin for the data generation (i.e., where the labs are located) is not specified, but the submission itself is to the U.S. FDA. The biocompatibility tests are prospective in nature, meaning they were conducted specifically for this device submission.

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)

This section is not applicable as the provided document describes biocompatibility testing and a substantial equivalence review, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy. The "ground truth" for the biocompatibility tests comes from the objective, quantifiable results of the laboratory assays and animal responses as interpreted by qualified professionals performing those tests.

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

This section is not applicable. No adjudication method for a test set is mentioned because there isn't a human-reader-dependent test set for clinical performance being described. The biocompatibility results are typically based on direct measurements and observations, not a consensus or adjudication process among multiple human readers.

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 MRMC comparative effectiveness study was done. This document pertains to a medical dressing, not a diagnostic or AI-assisted device. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.

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

Not applicable. This device is a physical wound dressing, not an algorithm or AI system.

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

For the biocompatibility studies, the "ground truth" is established by:

For cytotoxicity, genotoxicity, and hemolysis: The results of in vitro laboratory assays with measurable endpoints (e.g., cell viability, mutation rates, hemolytic index).
For irritation and sensitization: Observable physiological responses in animal models, evaluated against established scoring systems.
For systemic toxicity: Observation of animal health and mortality.

There is no mention of expert consensus, pathology, or outcomes data in the context of clinical performance evaluation for this 510(k) submission.

8. The sample size for the training set

Not applicable. This document does not describe the development of an algorithm or AI model that would require a training set. The "device" is a physical product.

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

Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth establishment mentioned.

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