(154 days)
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
| "Acceptance Criteria" / Performance Aspect | Reported Device Performance |
|---|---|
| Mechanism of Action (Hemostasis) | The gel-e Flex in both bandage and gel form "functioned as intended and the control of bleeding observed was as expected." Both the predicate and subject device operate by the same mechanism of action using the same core material, chitosan. This implies effective hemostasis. |
| Bench Testing (Bandage: pH, Moisture Content, Absorbency) | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific values not provided) |
| Bench Testing (Gel: pH, Viscosity) | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific values not provided) |
| Biocompatibility (per ISO 10993-1: Cytotoxicity, Irritation, Systemic Toxicity, Pyrogenicity) | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided, but passing these tests is implied by equivalence) |
| Packaging Testing (Burst Pressure, Dye Penetration) | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided) |
| Sterilization Validation Testing | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided) |
| Shelf-Life Stability Testing | Conducted. The performance of gel-e Flex was "statistically equivalent" to the predicate device, Hemcon Bandage OTC. (Specific results not provided) |
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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