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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.

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