(260 days)
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.
| Acceptance Criteria (Inferred for Hemostatic Gauze) | Reported Device Performance (Summary from Document) |
|---|---|
| Material Properties / Functional Integrity: | |
| pH compatibility | All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. |
| Wet Tensile and Elongation | All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. |
| Absorbency | All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. |
| Blood Immobilization | All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. |
| Hemostatic Efficacy: | |
| Ability to achieve hemostasis | In-vivo studies (animal models) confirm that Celox Rapid X-ray Gauze can perform as intended under anticipated conditions of use and demonstrates efficacy in achieving hemostasis in various swine wound models with varying severities of bleeds. |
| Safety and Biocompatibility: | |
| Biocompatibility (cytotoxicity, sensitization, etc.) | Evaluated per ISO 10993-1 and FDA guidance for "Surface Contact medical device that contacts breached and compromised skin, for a prolonged duration >24 hours to |
N/A