(28 days)
The D-Stat Radial Hemostatic 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 Radial Hemostatic Band consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride secured to a application device consisting of an adjustable retention strap, retainer, and attached pads. After hemostasis has been achieved, the lyophilized pad may be removed from the application device, covered with a provided adhesive bandage, and left in place for up to 24 hours.
The provided text is a 510(k) premarket notification for the D-Stat Dry Radial Hemostatic Band. It details the regulatory classification, device description, intended use, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria or a study that proves the device meets such criteria in a quantitative or statistical manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy, or clinical endpoints for 510(k) devices that are usually compared to a predicate device's established performance).
The "study" mentioned here is a Summary of Non-Clinical Testing, which is a basic assessment of the device's functional integrity.
Here's the breakdown based on the information provided:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to separate the lyophilized pad from the retainer | Demonstrated (Implied by conclusion of substantial equivalence based on non-clinical testing). |
| Biocompatibility of new materials | Demonstrated (Implied by conclusion of substantial equivalence based on non-clinical testing). |
Note: The document states "No performance standards have been developed under section 514 for this device." This means there aren't pre-defined, standardized numerical benchmarks the device must meet for efficacy or safety. The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate device.
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The summary only mentions "Tests conducted included assessment of the ability to separate the lyophilized pad from the retainer and a biocompatibility assessment of new materials." This is qualitative testing, not a statistical sample size for clinical or diagnostic performance.
- Data Provenance: Not specified, but generally, non-clinical tests would be performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc.).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is for hemostasis, and the "tests" described are non-clinical, functional and biocompatibility assessments. "Ground truth" in the diagnostic or clinical sense (e.g., for image interpretation) is not established by experts for these types of tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process is described for these non-clinical tests.
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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 is not an AI/diagnostic device; therefore, no MRMC study, human readers, or AI assistance is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests described, the "ground truth" would be established by standard engineering and chemical testing methodologies and specifications, not expert consensus, pathology, or outcomes data. For example, the separation force of the pad from the retainer would be compared against an internal engineering specification. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993 series).
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.
In summary, the provided document details a 510(k) submission for a medical device that controls bleeding. The "study" mentioned is a brief summary of non-clinical tests to assess functional aspects and biocompatibility, not a clinical trial or a diagnostic performance study. The device's clearance is based on substantial equivalence to predicate devices, focusing on indications for use and technological characteristics rather than meeting specific quantitative performance criteria through a detailed clinical study.
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