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TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.

TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.

The provided document is a 510(k) summary for the TRAUMAGEL® Hemostatic Gel. It primarily focuses on demonstrating substantial equivalence to a predicate device (CELOX Gauze Pro) based on design, technological characteristics, and non-clinical testing.

The document does not include the information requested regarding a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI/software performance. This is because TRAUMAGEL® is a medical device (hemostatic gel), not an AI or software-based medical device. Therefore, the questions about sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, AI assistance, training data, etc., are not applicable to this product and its regulatory submission.

The "Acceptance Criteria" described in the document relate to biocompatibility testing and performance bench testing for a physical medical device, not a software algorithm.

Here's a breakdown of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance (for biocompatibility testing):

(Note: "Physical and/or Chemical Information" acceptance criteria is listed as N/A, as it's for information gathering, not a Pass/Fail test.)

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: Not explicitly stated for each non-clinical test, but implied to be sufficient for the required ISO standards.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory and animal studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not a diagnostic AI/software device requiring human expert annotation of images/data for ground truth. The "ground truth" for the non-clinical tests is established by the standardized test methods (e.g., ISO standards for biocompatibility) and direct measurement of physical or biological responses.

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

• Not applicable for non-clinical device testing.

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 physical hemostatic product, not an AI/software.

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

• Not applicable; this is not a software algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to ISO standards and observed biological responses.
• For performance bench testing: Physical and chemical properties measured against predefined specifications.
• For non-clinical animal studies: Direct observation of hemostatic performance in a porcine model. The document states: "testing demonstrated substantially equivalent performance between the device and the predicate."

8. The sample size for the training set:

• Not applicable; there is no AI/machine learning training set for this product.

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

• Not applicable.

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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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