(192 days)
The Vdrive® system is intended to stabilize, navigate and remotely control:
· Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system,
· Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and
· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
Vdrive® with V-CAST™ is intended to control a compatible fixed curve transseptal sheath and catheter during diagnostic and therapeutic cardiac procedures and is comprised of four major components:
- Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
- Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
- V-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices.
- V-Loop™ Disposable Kit (K140804)
- V-Sono™ Disposable Kit (K122659)
The provided text appears to be a 510(k) summary for the Stereotaxis Vdrive, Vdrive with V-CAS, and Vdrive Duo systems. This document describes the device's intended use and performance data used to establish substantial equivalence to predicate devices, rather than a study designed to prove the device meets specific acceptance criteria in the context of an in-depth clinical performance evaluation for a high-risk device or AI/ML algorithm.
Specifically, the document outlines a premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices, often through non-clinical performance testing (bench, animal) and, if applicable, a review of existing clinical data or small, confirmatory clinical studies. The level of detail regarding acceptance criteria and ground truth establishment is much less stringent than what would be expected for a novel AI/ML device requiring robust clinical validation.
Based on the provided text, here's an attempt to answer your request, focusing on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define a table of acceptance criteria with numerical targets for device performance in the same way an AI/ML study might, such as specific sensitivity, specificity, or AUC targets. Instead, it mentions that the device "met its performance and user requirements" through various tests and that the clinical study "supported the safety and effectiveness" of the system.
The closest we get to "performance" in a measurable sense for the V-CAS component is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for controlling compatible transseptal sheaths and EP catheters. | Animal Testing: "[Vdrive™ with V-CAS™] met its performance and user requirements." |
| Clinical Testing (V-CAS™ component in Vdrive Duo™): "Analysis of safety data showed that no adverse events related to the Vdrive® system occurred. Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs using the ablation catheters controlled by the V-CAS™ disposable in the 15 subjects who underwent the ablation procedure using Vdrive Duo™ with V-CAS™." | |
| User Requirements for sheath and catheter movements. | Demonstrated in animal study. |
| Functional Equivalence to existing predicate devices. | Assessed through comparison of technological characteristics and performance data (bench, animal, clinical review) to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data for V-CAS™): For the V-CAS™ disposable used with Vdrive Duo™, data was collected from 15 subjects in the VERSATILE Study.
- Data Provenance: The VERSATILE Study was a prospective, randomized multi-center clinical trial. No specific countries of origin are mentioned, but "multi-center" implies multiple clinical sites, likely within the US given the FDA submission. The study is cited with a ClinicalTrials.gov identifier (NCT01656772).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" as typically applied to diagnostic AI/ML algorithms (e.g., expert consensus for image findings) is not directly applicable here. This device is a robotic catheter control system. Therefore, the "ground truth" or primary outcome measure in the clinical study was related to the clinical success of the procedure facilitated by the device and occurrence of adverse events.
- For the V-CAS™ disposable: The outcome was the achievement of electrical pulmonary vein (PV) isolation. This outcome would have been determined by the treating electrophysiologists using established clinical methods (e.g., electrophysiological mapping demonstrating no conduction). The study involved "investigators," who would be qualified medical professionals, most likely electrophysiologists. However, the specific number and qualifications are not detailed beyond "investigators."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth as might be done for image-based diagnostic decisions. For a procedural device, the primary "adjudication" would typically involve:
- Clinical assessment by the treating physician: The success of electrical PV isolation would be determined by the electrophysiologist performing the procedure based on real-time physiological data.
- Adverse event reporting and review: Safety outcomes would be documented and reviewed according to study protocols, likely by a clinical events committee or study monitors, but this isn't explicitly detailed as an adjudication method for defining "ground truth" in the diagnostic sense.
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, an MRMC comparative effectiveness study of human readers with vs. without AI assistance was not conducted and is not relevant to this device.
The clinical study (VERSATILE Study) was a prospective, randomized multi-center trial comparing the Vdrive® with V-Loop™ system to conventional manual methods of navigation for circular mapping catheters. This is a comparison of robotic assistance versus manual methods for catheter navigation, not an AI-assisted diagnostic task. The V-CAS™ component (the subject of this 510(k)) was evaluated for safety as part of the Vdrive Duo™ arm of this trial, but the primary comparison was for V-Loop™.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is fundamentally a "human-in-the-loop" system, as it is a remote control system for catheters operated by a physician. Therefore, a "standalone algorithm only" performance evaluation is not applicable. The device's function is to assist human control.
7. The Type of Ground Truth Used
The ground truth or primary outcome for the clinical evaluation of the V-CAS™ component (within the Vdrive Duo™ arm) was the clinical outcome of electrical PV isolation (a physiological/procedural outcome) and the occurrence of adverse events (safety outcome). This is distinct from "expert consensus," "pathology," or "outcomes data" in the sense of an independent, definitive diagnostic label. Rather, it's a measure of procedural success and safety during complex medical procedures.
8. The Sample Size for the Training Set
The document describes a 510(k) submission, which demonstrates substantial equivalence, not the development and training of an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's development would involve engineering design, bench testing, and animal studies.
9. How the Ground Truth for the Training Set Was Established
As there is no AI/ML training set, this question is not applicable. The device's functional integrity and safety were established through a combination of engineering specifications, bench testing, and animal studies.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).