(60 days)
The 4 French SELECTOR™ diagnostic catheter is designed to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures.
The 4 French SELECTOR™ diagnostic catheter is manufactured in multiple lengths and with multiple distal stem configurations.
This looks like a 510(k) premarket notification for a medical device rather than a study for an AI/ML powered device. The information provided describes a diagnostic catheter and its equivalence to predicate devices, not an AI system.
Therefore, many of the requested categories are not applicable to the provided text.
Here's an analysis based on the provided text, highlighting what is present and what is absent:
-
Table of acceptance criteria and the reported device performance
Acceptance Criteria (Test Performed) Reported Device Performance Bond strength tests Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Flexural rigidity Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Bodystock force decay Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Shape recovery Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Flow rate Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Dynamic pressure Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) Output/input torque to failure testing Results indicate equivalence to the previously approved predicate device, suggesting safety for its intended use. (Specific values not provided) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The general phrasing "The following tests were performed... on the 4 French SELECTOR™ diagnostic catheter and on the predicate device" does not provide specific sample quantities for each test.
- Data Provenance: Not specified. It's a physical device P510(k) submission, so "data provenance" in the AI sense isn't directly applicable here. The tests were likely conducted by the manufacturer, Schneider (USA) Inc.
-
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 document describes performance testing of a physical medical device (a catheter) against a predicate device, not an AI/ML algorithm requiring expert-established ground truth.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this pertains to expert consensus on AI outputs, which is not relevant for this device.
-
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 a hardware device. No human-in-the-loop study with AI assistance was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device. No algorithm performs a standalone function.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this physical device, "ground truth" would refer to established engineering standards or physical properties measured in a lab, not clinical expert consensus, pathology, or outcomes data in the context of an AI model's performance. The "ground truth" for the equivalence claim is the performance of the legally marketed predicate devices.
-
The sample size for the training set
- Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.
-
How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
Summary of the Study (as described in the document):
The "study" conducted for the 4 French SELECTOR™ diagnostic catheter was a series of physical and mechanical tests designed to demonstrate its substantial equivalence to a previously approved predicate device. The technological characteristics evaluated included: bond strength tests, flexural rigidity, bodystock force decay, shape recovery, flow rate, dynamic pressure, and output/input torque to failure testing. The results of these tests indicated that the new device was equivalent to the predicate, thus deeming it safe for its intended use as a conduit for contrast medium delivery and other diagnostic/therapeutic procedures during angiography. This is a standard approach for 510(k) submissions for physical medical devices of this nature.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).