(309 days)
The Stereotaxis Cardiodrive™ is intended for automatically advancing and retracting only the Stereotaxis Tangent™ Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive™ is intended to advance the Stereotaxis Tangent™ Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent™ Electrophysiology Catheter through the coronary vasculature nor the coronary sinus.
The Stereotaxis Cardiodrive™ is a tool that provides the physician with the ability and the choice to advance and retract catheters either standing bedside, or from a control room. The Stereotaxis Cardiodrive™ consists of an electrically powered Controller, Motor, and User Interface, plus sterile single-use Advancer Unit, Patient Mounting Bracket, Flexible Drive Shaft, and Hemostasis Introducer Adapter.
The provided text describes a 510(k) submission for the Stereotaxis Cardiodrive™, a device intended for automatically advancing and retracting a specific electrophysiology catheter in the right side of the heart.
This document is a 510(k) summary and approval letter, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results with acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, study design parameters (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for either training or test sets is not present in this document.
Here's an analysis of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of quantitative acceptance criteria. Instead, it makes a qualitative claim about performance equivalence:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Jomed Trak Back K990271 and IntraLuminal Therapeutics ILT Catheter K001992) | "Bench testing and animal testing demonstrate that the Stereotaxis Cardiodrive™ performs in an equivalent manner to the Jomed Trak Back predicate device." |
| Intended Use | "intended for automatically advancing and retracting only the Stereotaxis Tangent™ Electrophysiology Catheter (part # 001-001223-1) of 7F shaft diameter and 8F tip. The Cardiodrive™ is intended to advance the Stereotaxis Tangent™ Electrophysiology Catheter in the right side of the heart only. It is not intended to advance the Tangent™ Electrophysiology Catheter through the coronary vasculature nor the coronary sinus." |
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing and animal testing," but it does not specify the sample sizes for these tests for either the device or the predicate. The data provenance (country of origin, retrospective/prospective) is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The statement "Bench testing and animal testing" suggests engineering and animal model evaluations, not necessarily clinical studies involving expert clinicians establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a device for catheter manipulation, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC comparative effectiveness study is not applicable to this device's function, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an automated system for advancing and retracting a catheter, which inherently operates "standalone" in performing its mechanical function. The performance claim is that it "performs in an equivalent manner" to predicate devices, through "bench testing and animal testing." The document does not explicitly use the term "standalone performance" in the context of an algorithm, but the device's function is mechanistic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "bench testing," ground truth would likely be based on physical measurements (e.g., accuracy of advancement/retraction, force exerted, speed, reliability). For "animal testing," ground truth might involve direct observation of catheter movement within the heart, physiological measurements, and potentially necropsy findings, which could be considered a form of "outcomes data" or direct observation of the device's interaction with biology. However, the specific methods for establishing ground truth are not detailed.
8. The sample size for the training set
The document describes "Bench testing and animal testing" for performance evaluation, but it does not mention a "training set" in the context of machine learning or AI models. This device is a mechanical system, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI model, this question is not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).