(18 days)
The Merit Prelude™ Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Merit's Prelude consists of a sheath introducer with side port extension and stopcock. The sheath hub includes a hemostasis valve and a suture ring. A 3-way stopcock is affixed to the proximal end of the side port extension. The Prelude assembly includes a vessel dilator that snaps securely into the sheath introducer hub.
The provided document is a 510(k) summary for the Merit Prelude™ Sheath Introducer, submitted by Merit Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving device performance against specific acceptance criteria in the context of AI/ML or diagnostic accuracy.
Therefore, many of the requested sections regarding AI/ML study specifics (e.g., sample size for test sets and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, data provenance) are not applicable to this type of regulatory submission for a medical device like a sheath introducer.
This 510(k) summary describes bench testing to establish equivalence, not a clinical study involving human readers or AI algorithms for diagnostic purposes.
Here's the information that can be extracted or inferred from the provided text, adapted to the questions:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the way typically seen for diagnostic accuracy studies or AI/ML evaluations. Instead, it describes comparative testing to demonstrate substantial equivalence to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Radiodetectability of sheath introducer and vessel dilator: The Merit Prelude should be radiodetectable similar to the predicate device. | "Comparative testing with the predicate device performed includes radiodetectability of the sheath introducer and vessel dilator." (Implies satisfactory performance). |
| Valve leak pressure: The Merit Prelude should exhibit similar valve leak characteristics as the predicate device. | "Comparative testing... includes... valve leak pressure." (Implies satisfactory performance and comparison to predicate). |
| Tip insertion force: The Merit Prelude should have similar tip insertion force as the predicate device. | "Comparative testing... includes... tip insertion force." (Implies satisfactory performance and comparison to predicate). |
| Sheath hub/cap snap fit: The Merit Prelude's snap fit should be secure. | "Comparative testing... includes... sheath hub/cap snap fit." (Implies satisfactory performance). |
| Dilator snap fit to sheath hub: The Merit Prelude's dilator snap fit should be secure. | "Comparative testing... includes... dilator snap fit to sheath hub." (Implies satisfactory performance). |
| Guide wire compatibility: The Merit Prelude should be compatible with guide wires. | "Comparative testing... includes... guide wire compatibility." (Implies satisfactory performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The testing was "bench testing" of the physical device, not related to patient data or image sets.
- Data provenance: Not applicable. The testing was conducted in-house by Merit Medical Systems, Inc. ("Merit's in-house protocols") in the USA.
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. This device is a sheath introducer, not an AI/ML diagnostic tool. Ground truth for its performance would involve engineering specifications, physical measurements, and materials science, not expert medical opinion on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical studies. This involved bench testing of a physical medical device.
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
- No MRMC study was done. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. 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 performance of the sheath introducer was based on engineering specifications, physical measurements, and comparison to the characteristics of the legally marketed predicate device (Cordis Avanti®+ Catheter Sheath Introducer System). This is a "substantial equivalence" determination based on technical and performance characteristics of similar devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device and thus does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).