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

gel-e Flex+ gel OTC is a laboratory tested non-irritating topical chitosan-based gel designed to rapidly (within 30 to 60 seconds) promote hemostasis when in contact with a bleeding wound. Gel-e Flex+ gel OTC is a clear, convenient, and easy to apply gel that can be used with commercially available gauze.

The provided text describes a 510(k) submission for the gel-e Flex+ gel OTC device, which is indicated for the local management of bleeding wounds such as minor lacerations and minor abrasions. The submission primarily focuses on establishing substantial equivalence to a predicate device (gel-e Flex+, K182811), rather than proving the device meets a specific set of acceptance criteria through a standalone clinical study with human data or an AI algorithm.

Therefore, many of the requested details regarding acceptance criteria, AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment for large datasets are not applicable to this 510(k) summary. This submission relies heavily on comparisons to the predicate device and in vitro/in vivo (animal) studies to demonstrate performance and safety.

However, I can extract information related to the performance data provided and present it in a structured way that addresses the applicable questions.

Device Studied: gel-e Flex+ gel OTC (K192667)
Indication for Use: Local management of bleeding wounds such as minor lacerations and minor abrasions.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) context refers to demonstrating that the modified device performs comparably to or as expected, given its intended use and the performance of the predicate device. It's not presented as a set of quantified thresholds for, for example, diagnostic accuracy of an AI algorithm.

Study Details for Demonstrating Performance

Given that this is a 510(k) for a topical wound gel, not an AI/software device, the following points are addressed based on the provided information. Many questions are Not Applicable (N/A) in this context.

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

   • Animal Studies: Mentioned as "preclinical studies... in a controlled acute swine model of skin laceration." No specific number of animals ("sample size") is given. The data provenance is pre-clinical animal study.
   • Preservative Effectiveness Testing: In accordance with USP , which involves challenging the product with 5 specific microbial strains (e.g., S. aureus, P. aeruginosa, E. coli, C. albicans, A. brasiliensis). The "test set" here refers to the product samples subjected to microbial challenge. No specific sample size (N) of product units tested is provided, but it would align with standard laboratory testing protocols for USP.
   • Biocompatibility/Bench/Packaging/Stability: These involve laboratory testing on a sufficient number of representative device samples to meet the requirements of the standards (ISO 10993-1, internal stability protocols, etc.). Specific sample sizes (N) are not detailed in the summary but performed according to established protocols.
   • Data Provenance: All data appears to be from laboratory and pre-clinical animal studies, likely conducted by or for the manufacturer. No indication of retrospective or prospective human clinical data.

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

   • N/A. This device is a wound gel, and the "ground truth" for its performance (hemostasis, stability, biocompatibility) is established through standardized laboratory tests and observation in animal models, not through expert human interpretation of images or clinical outcomes in the same way an AI diagnostic device would be evaluated. Results are objective measurements (e.g., pH, viscosity, time to hemostasis, microbial counts) or adherence to pass/fail criteria of specific standards.

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

   • N/A. Not relevant for laboratory or animal efficacy 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:

   • N/A. This is not an AI/software device.

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

   • N/A. This is not an AI/software device.

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

   • For Hemostasis: The "ground truth" was the observed time to hemostasis/bleeding control in a controlled acute swine model of skin laceration, compared to expected performance and the predicate device. This is an objective physiological outcome in an animal model.
   • For Preservative Effectiveness: Meeting the quantitative acceptance criteria for reduction/maintenance of microbial challenge organisms as defined by USP .
   • For Biocompatibility: Adherence to the pass/fail criteria of ISO 10993-1 standards for various biological endpoints.
   • For Bench Testing/Stability: Measured physical and chemical properties (e.g., pH, viscosity) falling within pre-defined specifications and maintaining stability over time.

7. The sample size for the training set:

   • N/A. This refers to a manufactured medical device, not an AI model that requires a training set. The "training" in this context would be the R&D and formulation process to develop the gel, which is not quantified by a "training set size."

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

   • N/A. See point 7.

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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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gel-e Flex is indicated for the local management of bleeding such as laceration and minor bleeding.

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. Gel-e Flex (Bandage) is composed of a soft, sterile, lyophilized, palmitoyl- Nacetylglucomasine (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.

The provided text describes the gel-e Flex device, specifically focusing on its preclinical studies and performance data to demonstrate substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity for an AI-powered diagnostic).

However, I can extract the information related to the performance studies conducted for this medical device and present it in a similar structure as requested, interpreting "acceptance criteria" as the performance aspects evaluated for substantial equivalence.

Here's an analysis of the provided text based on the request:

1. Table of "Acceptance Criteria" (Interpreted as Performance Aspects for Substantial Equivalence) and Reported Device Performance

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

• Test Set Description: "In vivo preclinical studies were conducted in a controlled acute swine model of minor bleeding via skin laceration."
• Sample Size: Not specified (e.g., number of swine, number of lacerations).
• Data Provenance: Animal model (swine), preclinical study. The country of origin is not specified, but the applicant's address is College Park, MD, USA. Given it's a preclinical study, it's considered prospective in terms of data collection for this specific study.

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 hemostatic agent, not a diagnostic device requiring expert interpretation of images or data to establish ground truth or diagnosis. The "ground truth" for its performance is the direct observation of bleeding control in the animal model.

4. Adjudication method for the test set

• Not applicable. As above, this is not a diagnostic study requiring expert adjudication.

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-powered diagnostic or assistive technology for human readers. It is a medical device for topical bleeding control.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• The "ground truth" for the effectiveness of the device in controlling bleeding was the direct observation of hemostasis in the acute swine model of minor bleeding via skin laceration.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device requiring a training set. The term "training set" is not relevant to the described preclinical and bench testing.

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

• Not applicable. As above, there is no training set for this device.

Summary of what the study did prove:

The study described was a preclinical in vivo study in swine combined with various bench tests, biocompatibility tests, packaging tests, and stability tests. The primary goal was to demonstrate that the gel-e Flex device (both bandage and gel configurations) is substantially equivalent to the predicate device, Hemcon Bandage OTC, in its ability to control minor bleeding and meet relevant safety and performance standards. The critical finding was that in all instances, the gel-e Flex "functioned as intended and the control of bleeding observed was as expected," and its performance was "statistically equivalent" to the predicate device across all tested parameters.

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