(16 days)
The D-Stat Rad-Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The D-Stat Rad-Band consists of a gauze pad secured to a release tab and retainer pad on a polycarbonate retainer at the end of an adjustable copolymer retention strap. Two foam pads included on the strap can be adjusted (or removed) for patient comfort. The D-Stat Rad-Band has a lyophilized non-woven gauze pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride to facilitate hemostasis. By pulling the release tab between the gauze pad and the retainer after hemostasis is achieved, the retention strap/retainer can be removed from the patient, leaving the gauze pad behind on the access site. The D-Stat Rad-Band includes an adhesive bandage.
The provided FDA 510(k) K092612 describes a medical device called the "D-Stat® Rad-Band," which is a topical hemostat. The document is an FDA clearance letter and a 510(k) summary, not a study report. Therefore, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific study to prove the device meets those criteria.
Based on the provided text, the document states:
"Technological differences in design and materials have been qualified through biomaterial assessments and other design verification testing, the results of which did not raise any new safety or performance questions."
This statement confirms that testing was conducted to address any differences from the predicate device. However, it does not provide specific details about:
- The exact acceptance criteria that were used.
- The reported device performance in relation to those criteria.
- The sample size of any test sets.
- The data provenance.
- The number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case studies.
- Standalone algorithmic performance.
- The type of ground truth used.
- The sample size or ground truth establishment for a training set.
Therefore, I cannot provide the requested information in a table or detailed descriptions directly from the given text. The document focuses on regulatory clearance based on substantial equivalence, which often means demonstrating that the new device performs as intended and is as safe and effective as a legally marketed predicate device, rather than providing the full details of performance studies against specific acceptance criteria in the format requested.
To obtain the detailed information about acceptance criteria and study results, one would typically need to refer to the full 510(k) submission, which is not fully included here, or additional study reports that would have been conducted by the manufacturer.
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