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gel-e Flex+ is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

The gel-e Flex+ (Bandage) is a non-invasive topical bandage intended to control minor bleeding when in contact with a wound by adhering to the site of injury. Based on in vitro testing, the gel-e Flex+ (Bandage) provides an effective barner to bacterial penetration for up to 48 hours. Gel-e Flex+ (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl-N-acetylglucomasine (chitosan), a cellulosic polymer woven fabric pad, attached to a soft adhesive backing.

The gel-e Flex+ (Gel) is a topically applied gel intended to control minor bleeding when in contact with a wound. Gel-e Flex+ (Gel) is composed of a semitransparent gel of palmitoyl-N-acetylglucomasine (chitosan), the same cellulosic polymer as the Gel-e Flex+ (Bandage), dissolved in 0.1M lactic acid in water. The lactic acid is present to improve the solubility of chitosan. In vitro testing based on USP has demonstrated the gel-e Flex+ (Gel) remains effectively preserved for up to 28 days after opening the container.

The provided text describes the gel-e Flex+ device and its equivalence to a predicate device (Hemcon Bandage PRO OTC). However, it does not contain details about specific acceptance criteria for a quantitative study, nor does it provide performance metrics in a structured table or outline a multi-reader multi-case (MRMC) study.

The document primarily focuses on demonstrating substantial equivalence based on intended use, design, materials, and that the device operates by the same mechanism of action. The "Performance Data" section describes various tests conducted (animal studies, antibacterial barrier, antibacterial properties, biocompatibility, bench testing, packaging, sterilization, and shelf-life stability) to support this equivalence.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will extract the available information and highlight what is missing.

Here's a breakdown of the available information and the missing components based on your prompt:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance values for the gel-e Flex+ that would be presented in a table format with a "Pass/Fail" or "Met" outcome. Instead, it states that "the performance of gel-e Flex+ was statistically equivalent to the predicate device, Hemcon Bandage OTC" for bench testing. For other tests like antibacterial barrier and properties, it describes the outcomes in qualitative terms (e.g., "effective barrier," "log reduction of 4.0 or greater achieved on all of the organisms tested").

Table of Acceptance Criteria and Reported Device Performance (Based on available qualitative information):

Study Details:

Based on the provided document, the studies conducted are primarily non-clinical (animal and in vitro/bench testing) to establish substantial equivalence, rather than a clinical study involving human patients or complex AI algorithm validation.

1. Sample size used for the test set and the data provenance:

   • Animal Studies: Conducted in a "controlled acute swine model of skin laceration." The specific number of animals is not provided.
   • Antibacterial Barrier/Properties: Tested against "8 bacteria" or "all of the organisms tested." The specific number of samples for each test (e.g., how many bandages for bacterial penetration) is not provided.
   • Biocompatibility and Bench Testing: "Representative samples of the device" were used. Specific sample sizes are not provided.
   • Data Provenance: The studies appear to be pre-clinical/in vitro laboratory studies specific to the device manufacturer (gel-e, Inc.) to support their 510(k) submission. The country of origin for the data is not explicitly stated, but it can be inferred to be from the US, given the applicant's address in Maryland. The studies are by nature prospective as they were conducted specifically for this submission.

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

   • This question is most relevant for studies involving human interpretation (e.g., medical imaging). Since the provided document describes non-clinical tests (animal model performance, in vitro bacterial testing, bench testing), the concept of "experts establishing ground truth for the test set" in the context of human readers is not applicable here. The "ground truth" for these tests would be the established scientific methods and readings, such as bacterial counts in a lab, or objective measurements in bench tests.

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

   • Not applicable. This method is used for resolving discordant human interpretations of data, which is not described in these non-clinical studies.

4. 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, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance and equivalence to a predicate device, not the impact of an AI on human reader performance.

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

   • Not applicable. This device is a physical product (bandage/gel) for topical application, not an algorithm or AI.

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

   • For the animal studies, the "ground truth" was direct observation of bleeding control and function in the swine model.
   • For antibacterial testing, the ground truth was derived from established laboratory methods (e.g., AATCC Test Method 100-2004, USP ) leading to quantitative bacterial count reductions or barrier efficacy.
   • For biocompatibility and bench testing, the ground truth was based on established ISO standards, USP methods, and direct physical/chemical measurements (e.g., pH, viscosity, moisture content, absorbency, burst pressure).

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It demonstrates substantial equivalence through a series of non-clinical, laboratory, and animal-model based tests. It does not contain information about clinical trials, AI performance studies, or human reader performance, which are the typical contexts for many of your specific questions.

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