(90 days)
The Cordis Webster deflectable braided-tip electrode catheter is indicated for electrophysiological mapping of cardiac structures; i.e., endocardial stimulation and recording within the right side of the heart.
The Cordis Webster deflectable braided-tip electrode catheter has been designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque shaft with an internal stainless steel braid and a tip section containing platinum electrodes that can easily be seen under fluoroscopy. The tip section also employs an internal braid to provide additional lateral stability during mapping procedures.
A piston in the handpiece is attached to an internal puller which changes the radius of curvature of the tip section. When the piston is pushed forward, the radius of curvature of the tip section is reduced; when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to its original state. The high-torque shaft allows the tip section to be maneuvered in order to facilitate accurate positioning within the heart.
This 510(k) summary describes a medical device, a deflectable braided-tip electrode catheter, and its substantial equivalence to predicate devices. It focuses on the physical and technological characteristics and non-clinical performance, rather than a study involving acceptance criteria and device performance as typically understood for AI/software devices. Therefore, a direct response to your specific questions about acceptance criteria, sample sizes, ground truth, and human reader studies is not fully applicable.
However, I can extract the relevant information from the provided text that describes the performance assessment conducted for this non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a non-AI physical device, the "acceptance criteria" are not explicitly quantitative thresholds like sensitivity or specificity. Instead, they are implied by the comparison to predicate devices and adherence to guidance documents.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Basic electrical characteristics comparable to predicate devices | Comparable to predicate devices. |
| Basic mechanical characteristics comparable to predicate devices | Comparable to predicate devices. |
| Tip stiffness no greater than currently marketed devices | No greater than other currently marketed devices. |
| Side load capability comparable to/improved over predicate devices | Greater than that of the standard deflectable catheter. |
| Adherence to "Electrode Recording Catheter Preliminary Guidance" | Applicable tests were performed in accordance with this guidance. |
| Sterilization and packaging identical to predicate devices | Identical to Cordis Webster standard deflectable and fixed curve catheters. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "non-clinical performance testing." This typically involves laboratory testing on physical samples of the device.
- Sample Size: Not explicitly stated. The phrase "the braided-tip electrode catheter" and "predicate devices" implies testing of multiple units, but a specific number is not provided.
- Data Provenance: Not applicable in the context of human data. The "data" comes from engineering and laboratory performance tests of the physical catheter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Experts: Not applicable. For a physical medical device, "ground truth" is established through standardized engineering tests, measurements, and comparisons to established device specifications or performance of predicate devices. There wouldn't be human experts establishing "ground truth" in the way it's done for diagnostic image analysis.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is for resolving disagreements in human expert labeling or interpretation, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. This type of study assesses human reader performance with and without AI assistance, which is not relevant for a physical electrophysiology catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance: No. This question pertains to AI algorithms. The described device is a physical catheter.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For this physical device, the "ground truth" is established by:
- Engineering Specifications: Performance against pre-defined engineering standards for electrical and mechanical properties.
- Comparative Performance Data: Direct comparison of the device's measured electrical, mechanical, and physical properties (e.g., tip stiffness, side load capability) against those of the identified predicate devices.
- Regulatory Guidance: Adherence to "Electrode Recording Catheter Preliminary Guidance."
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device does not involve machine learning or an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
In summary: The provided text describes a non-clinical performance study of a physical medical device (catheter) to demonstrate substantial equivalence to predicate devices based on engineering characteristics and adherence to regulatory guidance, rather than a clinical study or an AI/software performance study. Therefore, many of your questions, which are framed for AI/software evaluations, are not directly applicable.
§ 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).