(107 days)
The St. Jude Medical (SJM) Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.
7F Unidirectional Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen is a catheter that will enable electrical mapping and pacing from endocardial and intravascular sites. Additionally, the Reflexion Cannulator™ with lumen can provide access to the vascular system by either over the wire, or by steerable access to the vasculature for guidewire positioning and contrast media injection through the lumen. The catheter includes a hemostasis valve, Cath-Lock and sideport with a 3-way stopcock, The catheters are provided sterile, and are intended for single-use only.
The provided text is a 510(k) summary for the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen. This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with proving the device meets specific performance criteria through a study with acceptance criteria in the way one would for a diagnostic or AI-driven device.
The entire summary {0}-{4} focuses on comparing technological characteristics and intended use to a predicate device. It explicitly states: "All technological characteristics of the Reflexion Cannulator™ Steerable Electrophysiology Catheter with Lumen are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling." {1}
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of submission.
Here's a breakdown of what can be answered and why other parts cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not establish performance acceptance criteria in the typical sense for a diagnostic device, nor does it report performance against such criteria. The "performance" being demonstrated here is substantial equivalence to a predicate device based on technological characteristics and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study reporting on specific diagnostic performance with a test set. This is a comparison of product specifications.
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. No ground truth for a "test set" was established, as this is a device comparison for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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 device is a steerable electrophysiology catheter, not an AI-driven diagnostic tool or a device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for device performance in a diagnostic sense is mentioned. Substantial equivalence is based on a comparison to the predicate device's characteristics and intended use.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary: The provided text is a 510(k) summary for a medical device (a catheter) seeking substantial equivalence to a predicate device. It does not contain information about studies with acceptance criteria, test sets, ground truth establishment, or AI performance metrics as would be required for a diagnostic or AI-powered technology. The "proof" is the detailed comparison of the new device's technical specifications and intended use against a legally marketed predicate device.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).