(89 days)
The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.
The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS) is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the bulbs allow blood to flow through the shunt and distal to the anastomotic site. A radiopaque tab, which identifies the outer diameter of the bulbs, is attached to the shunt by a tether to facilitate positioning and removal of the shunt.
The provided text describes a medical device, the Flo-Thru Intraluminal Shunt, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with AI/algorithm-based device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies).
The text focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than proving specific performance metrics against pre-defined acceptance criteria through detailed clinical or performance studies.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence | "Functional testing conducted on the Flo-Thru intraluminal shunt and predicate samples show the Flo-Thru performs in a manner substantially equivalent with regard to strength, and flow rate." |
| Handling Characteristics | "Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements." |
| Flexibility | "Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements." |
| Radiopacity | "Handling characteristics, flexibility, and radiopacity of the Flo-Thru device meet design requirements." |
| Kinking/Manipulation Memory | "Also, the Flo-Thru has no memory of kinking or manipulation." |
| Sterility | "The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS)..." (Implied acceptance criterion: device is sterile) |
| Single-Use | "The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS)..." (Implied acceptance criterion: device is single-use) |
| Radiopaque | "a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end." (Implied acceptance criterion: device is radiopaque) |
Missing Information (Not available in the provided text):
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The text mentions "functional testing" but provides no details on sample size or data provenance.
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. This device is a mechanical shunt, not an AI or diagnostic imaging device that typically requires expert ground truth for performance evaluation in the way described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device. Functional testing was done on the physical device. The "standalone" performance here would refer to the device itself as described in the table above.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the functional tests, the "ground truth" would be the engineering specifications and performance benchmarks of the predicate devices. For sterility, it would be lab tests proving sterility. For radiopacity, it would be observation under fluoroscopy or X-ray. The document doesn't detail the how for each test.
8. The sample size for the training set
- Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).