(85 days)
ChitoGauze™ is intended to be a hemostatic wound dressing.
Indications for Use (Rx):
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Indications for Use (OTC):
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.
The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.
The provided text is a 510(k) summary for the ChitoGauze™ device. It describes the device, its intended use, and non-clinical performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain acceptance criteria or a study that specifically proves the device meets such criteria in the format of a clinical trial or algorithm performance study with specified metrics like sensitivity, specificity, or AUC.
Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices by showing similar technological characteristics and non-clinical performance.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., stopping bleeding within X minutes for Y% of cases). The evaluations are primarily geared towards demonstrating substantial equivalence through biocompatibility, in vivo efficacy compared to other dressings, reduction of microorganisms, and sterility.
A table summarizing the performance data reported would look like this:
| Performance Metric | Acceptance Criteria (Not explicitly stated as such, but implied by comparison) | Reported Device Performance (ChitoGauze™) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 | Demonstrated per ISO 10993 |
| In Vivo Efficacy (Hemostasis) | Substantial equivalence to lap sponges, uncoated gauze, and competitive coated gauze in an extreme trauma model. | Exhibited substantially equivalent efficacy to lap sponges, uncoated gauze, and competitive coated gauze in an extreme trauma model. |
| Reduction of Microorganisms | Log reduction for various species (no explicit threshold stated for "effectiveness" but high log reductions are shown) | Demonstrated significant log reduction (typically >4.0) for 26 tested bacterial species (see full list in original document for specific values). The clinical utility of these results is unknown. |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11137:2006 | Sterility validation completed following ISO 11137:2006 requirements to demonstrate a 10⁻⁶ SAL using the VDmax® method. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Biocompatibility: Sample sizes are not specified, standard for ISO 10993.
- In Vivo Efficacy: The term "extreme trauma model" implies animal testing, but specifics of the model (e.g., animal species, number of animals) and thus sample size are not provided. The data provenance is not stated (e.g., country, retrospective/prospective).
- Reduction of Microorganisms: For each microorganism, the "Log Reduction" values are given. This is typically done through in vitro laboratory testing. Sample sizes (number of replicates) are not specified. Data provenance (country, retrospective/prospective) is not provided.
- Sterility: This is a validation process against a standard, not a data set in the traditional sense.
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 to this submission. The device is a hemostatic dressing, and its performance evaluation does not involve image interpretation or diagnostic tasks that would require human experts to establish ground truth in the way described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this submission, as there is no mention of human expert adjudication for the types of tests described (biocompatibility, in vivo efficacy, microbiology, sterility).
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
This is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and accepted biological safety profiles.
- In Vivo Efficacy: Ground truth for "efficacy" in stopping bleeding would be direct observation or objective measurement within an animal model, not expert consensus or pathology on a human.
- Reduction of Microorganisms: "Ground truth" is the quantitative measurement of bacterial survival after exposure to the device, typically through standard microbiology laboratory techniques (e.g., colony counting).
- Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ using validated methods and industry standards (ISO 11137:2006).
8. The sample size for the training set
This is not applicable, as there is no AI algorithm being developed or "trained" for this device.
9. How the ground truth for the training set was established
This is not applicable, as there is no AI algorithm being developed or "trained" for this device.
In summary:
The provided document is a 510(k) summary for a medical device (hemostatic dressing). It focuses on demonstrating substantial equivalence to existing devices through non-clinical laboratory and animal studies, rather than clinical trial data with specific acceptance criteria and detailed performance metrics characteristic of AI/diagnostic device submissions. The submission explicitly states: "No clinical data was required for evaluation of this device."
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