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The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

ChitoGauzeXR is composed of polyester/rayon blend non-woven medical gauze coated with chitosan and with a radiopaque filament attached. The legally marketed ChitoGauzeXR dressing has been modified to co-package the ChitoGauzeXR hemostatic dressing with uncoated polyester/rayon blend non-woven medical gauze (also referred to as "uncoated gauze") to create the ChitoGauze FUSION Wound Packing Kit.

ChitoGauze FUSION may be produced in multiple sizes within the scope of the currently validated sizes of the ChitoGauze family of dressings. Both the ChitoGauzeXR and the uncoated gauze are Z-folded to the appropriate size and contain a radiopaque element. To visually distinguish between the two, the ChitoGauzeXR dressing contains one radiopaque yarn and the uncoated gauze contains two radiopaque yarns. The dressings are co-packaged in a pouching configuration consisting of an inner dispenser pouch and outer pouch. The inner nylon/LDPE pouch will hold both gauze components and is intended to allow controlled dispensing of the gauze dressings through a hole on top. Because there is a hole on tope, this pouch is not intended to act as a sterile barrier. The outer foil pouch is intended to provide a barrier to protect the product and maintain product sterility.

The ChitoGauze FUSION Wound Packing Kit is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 to the power of -6.

The hemostatic properties of chitosan enhance the ability of the ChitoGauzeXR to control bleeding. The uncoated gauze is intended to be used as a backing or securement dressing and to absorb excess fluid. The co-packaging of the two gauze types provides an added level of convenience to the user and facilitates ease-of-use. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria, device performance, or details of a study proving the device meets acceptance criteria. The document is a 510(k) summary for an administrative change related to a medical device's product code, and it describes the device and its intended use, but it does not contain specific acceptance criteria, detailed study results, or information about AI/ML algorithm performance.

Here's a breakdown of what the document does contain, which highlights why I cannot fulfill your request as stated:

• Device Description: It describes the ChitoGauze™ FUSION™ Wound Packing Kit, a modified version of ChitoGauze™XR, which co-packages the hemostatic dressing with uncoated gauze.
• Intended Use/Indications for Use: "The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds."
• Technological Characteristics: States that the modification (co-packaging) does not affect the fundamental scientific technological characteristics of the original ChitoGauze™XR.
• Non-Clinical Performance Data:
  • Biocompatibility: Mentions testing per ISO 10993 confirmed no effect from co-packaging.
  • In Vivo Efficacy: Describes two swine studies for hemostatic efficacy against a competitive product, showing the device controlled bleeding "at least as well." Specific quantitative results (e.g., stopping time, blood loss reduction) are not provided, nor are sample sizes for these studies.
  • Reduction of Microorganisms: Provides a table of log reduction data for various microorganisms, demonstrating antibacterial effectiveness. It explicitly states, "The clinical utility of these results is unknown."
  • Sterility: Mentions sterility validation per ISO 11137:2006 to a 10⁻⁶ SAL.
  • Radiopacity: Mentions testing per ASTM F640-07 Method C and found it equivalent to an ASTM standard.
• Clinical Performance Data: Explicitly states, "No clinical data was required for evaluation of this device."
• Conclusion: Reaffirms that the modification is not a change to intended use or fundamental technology.

Therefore, I cannot provide the requested information because:

1. Acceptance Criteria and Performance Table: The document does not specify formal acceptance criteria or present device performance in a way that allows for a direct comparison against such criteria. The non-clinical tests describe performance, but not against pre-defined thresholds for "acceptance."
2. Sample Size and Data Provenance (for test set): While two in vivo swine studies are mentioned, specific sample sizes (number of animals or injury sites) are not provided. The data provenance is "swine" (animal studies), not human. It is non-clinical.
3. Number of Experts and Qualifications: Not applicable, as no human reader studies are mentioned.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This device is a medical dressing, not an AI/ML diagnostic or assistive tool. There is no mention of human readers improving with or without AI assistance.
6. Standalone Performance: Not applicable, as this is not an AI/ML algorithm. The performance data presented (e.g., sterilization, radiopacity, antimicrobial activity) is for the physical device itself.
7. Type of Ground Truth: For the in vivo efficacy studies, the "ground truth" would implicitly be the observed bleeding control in the animal models, compared to a reference product. For the antimicrobial study, it's the measured log reduction against specified bacterial strains.
8. Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there's no "training set."
9. Ground Truth for Training Set: Not applicable.

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