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CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.

CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.

CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.

This document is a 510(k) premarket notification for the CalgaeSeal device and primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner of a typical AI/ML device submission. Therefore, much of the requested information about acceptance criteria, study design, and ground truth for an AI/ML device is not present in this document.

However, based on the provided text, I can extract the following relevant information:

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

Since this is a 510(k) for a topical hemostasis pad and not an AI/ML device, the "acceptance criteria" here refer to the successful completion of standard biological safety tests for medical devices. The performance is reported as "Pass" and "Identical" to the predicate devices.

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

This information is not provided in the document. The document refers to "Testing by DeRoyal in 510(k) K914779," suggesting that the current submission relies on the testing performed for a predicate device. Details on the sample size or data provenance for those tests are not in this text.

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):

This information is not applicable to this type of device and submission. The "ground truth" for these tests would be the established safety standards and the results of laboratory tests, not expert consensus on interpretations.

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

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or assessments, which is not the case for these biological safety tests.

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 information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

The "ground truth" for the tests mentioned (ASTM F719, F720, F749, F750) would be the specific quantitative and qualitative criteria defined within those ASTM standards for passing or failing the biological safety assessments. These are laboratory-based standards for biomaterial safety.

8. The sample size for the training set:

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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