(358 days)
The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.
A hemostasis valve is a device which is used to control the amount of blood loss or fluid flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Merit IN-LINE Hemostasis Valve:
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, the acceptance criteria and reported device performance are summarized as follows:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Provide a leak-proof seal around angioplasty catheters and guide wires. | "Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires." |
| Control amount of blood loss/fluid flow. | The device is intended to "control the amount of blood loss or fluid flow while permitting vasculature access." |
| Minimize back bleeding. | The device is "recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system." |
| Maintain a fluid-tight seal around interventional devices, catheters, and guide wires. | The device is "recommended for...maintaining a fluid-tight seal around interventional devices, catheters, and guide wires." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only states that "Products have been tested."
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)
The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation likely involved mechanical testing rather than expert-driven assessment of imaging or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method. Given the nature of a hemostasis valve, the assessment would likely be based on objective measurements (e.g., fluid leakage, pressure drop) rather than subjective expert adjudication.
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 is not applicable to the Merit IN-LINE Hemostasis Valve. This device is a mechanical medical device (hemostasis valve), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical hemostasis valve, not an algorithm. Its performance is inherent to its design and material properties, rather than an algorithm running independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance would primarily be based on objective physical measurements and engineering standards, specifically related to:
- Leakage/Seal integrity: Quantifying any fluid leakage under specified pressures when a catheter/guidewire is inserted.
- Flow control: Measuring the ability to control blood/fluid flow.
- Back bleeding prevention: Demonstrating the ability to prevent or minimize back bleeding.
This would be assessed through bench testing and compliance with relevant industry standards for medical devices of this type. It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense for determining basic functional performance.
8. The sample size for the training set
This is not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning or AI. Performance is evaluated through physical testing.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above (not an AI/ML device).
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).