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Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip.

Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.

This document, a 510(k) Premarket Notification for the Celox Rapid X-Ray Gauze, describes the device and its claimed substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human reader performance study.

The provided document is for a hemostatic gauze, not an AI-powered medical device or software. Therefore, many of your questions, such as those related to AI model performance, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this document. The "Performance Data" section in the document refers to in-vitro and in-vivo (animal) testing related to the physical and biological performance of the gauze itself, not the performance of an AI algorithm.

Based on the provided document, here's what can be extracted, acknowledging the limitations:

Acceptance Criteria and Device Performance (as covered by this document)

The document focuses on demonstrating that the new device, Celox Rapid X-Ray Gauze, is substantially equivalent to existing predicate devices, particularly the Celox Rapid Gauze (K110386), with the key difference being the addition of an X-ray detectable strip. The acceptance criteria, in this context, are primarily related to confirming that this modification does not negatively impact the device's hemostatic function and that it remains safe and effective for its intended use.

Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Hemostatic Gauze)

Given this is a physical medical device (hemostatic gauze), not an AI, the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or AUC. Instead, they are about functional performance and safety.

Regarding the other points in your request:

2. Sample sizes used for the test set and the data provenance:

   • Non-Clinical Performance Data (In-vitro): "All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. Comparison testing was performed on the secondary predicate device to support the devices being comparable." The specific sample sizes for these in-vitro tests (e.g., number of pH measurements, tensile tests) are not detailed in this summary.
   • In-vivo Animal Studies: "In-vivo studies included within this submission confirm that Celox Rapid X-ray Gauze... demonstrates efficacy in achieving hemostasis in various swine wound models with varying severities of bleeds." The exact number of swine, the number of wounds, or the specific types of wound models are not detailed in this summary.
   • Data Provenance: The studies were conducted as part of the manufacturer's (Medtrade Products Ltd, United Kingdom) design control process. The document does not specify the country of origin for the animal studies or in-vitro tests beyond the company's location. These are retrospective tests conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable. This document is for a hemostatic gauze. It does not involve human reading of medical images or data where expert ground truth establishment would be relevant for performance evaluation. The "ground truth" here is the physical and biological performance of the gauze itself, measured through laboratory and animal models.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This question is not applicable as there were no human readers or subjective interpretations requiring adjudication as part of the performance testing described.

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 question is not applicable. No MRMC study was performed as this is a hemostatic gauze, not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable. This is not an algorithm-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For this device, the "ground truth" for performance evaluation was based on:

   • Direct measurements from in-vitro (laboratory) tests (e.g., pH, tensile strength, absorbency).
   • Observed hemostatic efficacy in predefined animal models (swine wound models).
   • Standardized biocompatibility test results against established ISO and USP standards.

8. The sample size for the training set:
   This question is not applicable. This is a physical, non-AI medical device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
   This question is not applicable as there is no training set for an AI model.

In summary: The provided document is about a conventionally regulated hemostatic gauze. Your detailed questions about AI model performance, expert readers, MRMC studies, and training/test sets are relevant to AI/software as a medical device (SaMD) but not to the product described in this 510(k) summary. The "acceptance criteria" here are aligned with the physical, chemical, and biological performance of the gauze itself.

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