Search Results

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.

Ask a specific question about this device

Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.

Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.

CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.

CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet (510(k) # K080097) in product composition (raw materials), manufacturing processes and product performance. The device consists of a chitosan Haemostatic granules (CELOX PRO 510(k) # K093593) adhered onto a base fabric (non-woven gauze) using a hot melt adhesive.

CELOX Gauze PRO achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the CELOX Gauze PRO directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding and reduce the risk of re-bleeding.

In addition because CELOX Gauze PRO absorbs water from blood, platelets are concentrated, resulting in activation of platelets to help stop bleeding and reduce the risk of re-bleeding

CELOX Gauze PRO is an effective solution that reduces time to haemostasis, even for patients on anticoagulants such as warfarin and heparin.

The CELOX Gauze Pro is packed in a three layer laminate pouch of polyester, aluminium and LDPE. The pouch provide an integral barrier that maintains dressing sterility post irradiation yet allows easy opening and aseptic dressing removal by the end user.

The CELOX Gauze PRO is available in various sizes ranging from 1" x 1" to 3″ x 10ft.

The provided text is a 510(k) summary for the CELOX Gauze PRO device. It outlines the device description, indications for use, and a general statement of testing performed to establish substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific study designs, or quantitative results of performance studies that would allow for a complete response to the requested information.

The document focuses on demonstrating substantial equivalence based on product composition, manufacturing processes, and the general principle of hemostasis, rather than providing a detailed report of clinical or performance study outcomes against specific acceptance criteria.

Therefore, for many of the requested points, the information is not present in the provided text.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The studies mentioned are "in-vivo testing and bench testing" and "biocompatibility... in compliance with the requirements of BS EN ISO 10993-1." It does not indicate where these tests were conducted or if they were retrospective or prospective.

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)

• Not applicable/Not specified. The document refers to "in-vivo testing and bench testing" and biocompatibility testing, not studies requiring expert interpretation of results for ground truth establishment in a clinical setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. This is typically relevant for studies involving human interpretation or clinical endpoints requiring consensus, which are not detailed here.

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 device is a hemostatic gauze, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a hemostatic gauze; there is no algorithm or AI component.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the "in-vivo testing and bench testing" and biocompatibility, the ground truth would typically be established by established laboratory methods, validated assays, and adherence to international standards (e.g., ISO 10993 for biocompatibility) for measuring specific biological responses or physical/chemical properties. No specific "expert consensus" or "pathology" is mentioned in this context. Outcome data is implied through the statement of efficacy in hemostasis, but detailed metrics are absent.

8. The sample size for the training set

• Not applicable. This device is a hemostatic gauze; there is no training set in the AI/machine learning sense.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set mentioned or implied for an AI/ML device.

Ask a specific question about this device