(49 days)
The Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable electrophysiology catheter with integrated sensors. The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
Advisor VL Circular Mapping Catheter, Sensor Enabled (Advisor VL) is a variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal loop size with a diameter ranging from 15mm – 25mm with models containing both ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter has integrated sensors with two impedance-based navigational electrodes and two magnetic sensors located at the distal end of the shaft. The catheter is intended to be used with the EnSiteTM PrecisionTM Cardiac Mapping System.
The provided text describes the 510(k) premarket notification for the "Advisor™ VL Circular Mapping Catheter, Sensor Enabled™". This device is an electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies, specifically for mapping atrial regions of the heart.
Based on the document, this is not an AI/ML medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device (Advisor FL, Circular Mapping Catheter, Sensor Enabled K160335) through extensive non-clinical testing (bench and animal testing). There is no mention of an AI algorithm, a test set for AI performance, human expert readings, or any of the typical criteria associated with AI/ML device evaluations.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets those criteria, as this document does not pertain to such a device.
To directly address the specific points of your request:
- A table of acceptance criteria and the reported device performance: This document lists various non-clinical tests performed (e.g., Patient Leakage, Dielectric Strength, Biocompatibility, Functional Simulated Use, etc.) and states that the device "met the pre-determined acceptance criteria." It does not provide a detailed table with specific acceptance values and corresponding reported performance values for each test. This type of detailed data is typically found in the full 510(k) submission, not the summary.
- Sample sized used for the test set and the data provenance: Not applicable for an AI/ML device. For the non-clinical tests, sample sizes for specific bench or animal tests are not detailed in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no AI model's performance on human expert-labeled data is being evaluated.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML model's ground truth. Ground truth for this device would refer to the true physical/electrical properties measured during bench and animal testing.
- The sample size for the training set: Not applicable (no AI training involved).
- How the ground truth for the training set was established: Not applicable (no AI training involved).
In summary, the provided document details the regulatory clearance of a physical medical device (a cardiac catheter) based on a comparison to a predicate device and extensive non-clinical testing, not an AI/ML diagnostic or therapeutic device.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).