(191 days)
The EnSite System is indicated for patients for whom electrophysiology studies are indicated.
- When used with the EnSite Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
- OR
- When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.
The EnSite System is a computerized storage and display system for use in electrophysiology studies of the human heart. The system consists of a console workstation, patient interface unit, and an electrophysiology mapping catheter or surface electrode kit. Unlike currently available electrode recording catheters, the EnSite Array does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite System is a system that facilitates mapping and treatment of arrhythmias. When used with the EnSite catheter, the system is useful for treating patients with complex, non-sustained, or poorly tolerated arrhythmias that are difficult, if not impossible, to map with current mapping techniques. By visualizing the global activation pattern seen on the color-coded isopotential maps in the EnSite System, in conjunction with the reconstructed electrograms, the electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy. When used with NavX patches, the system is useful in treating patients with simpler arrhythmias by providing non-fluoroscopic navigation and visualization of conventional EP catheters
The provided text does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, nor does it detail a standalone or MRMC study.
Instead, the document is a 510(k) premarket notification for a modification to an existing device, the EnSite System (Model EE3000). The key statements relevant to performance are:
- "The changes made to the EnSite System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."
- "An evaluation of the device changes indicates that the device is as safe and effective as the previously marketed device to which it is being compared and does not raise any new issues of safety and effectiveness."
This indicates that the changes were validated internally against established procedures, and the conclusion is that the modified device performs comparably to the predicate device. However, no specific performance metrics, acceptance criteria, or study details (like sample size, ground truth, or expert qualifications) are provided in this document.
Therefore, I cannot populate the table or answer most of the requested questions based on the provided text.
Here's a summary of what can be inferred or directly stated from the text, with the understanding that detailed performance criteria and study results are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The modified device is "as safe and effective as the previously marketed device" (predicate device K070902). Device validation testing was conducted per in-house procedures. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "bench and user tests," implying internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
4. Adjudication method for the test set:
- Not specified.
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:
- Not mentioned. The device is an electrophysiology mapping system, not specifically an AI-driven image analysis tool, though it is a "programmable diagnostic computer." The document only refers to "user tests" without specifying their nature or comparative effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not mentioned. The document describes a "computerized storage and display system" used in conjunction with catheters and for clinicians to identify arrhythmia sources. It does not describe a standalone algorithm performance evaluation.
7. The type of ground truth used:
- Not specified. As the device is an electrophysiology mapping system, ground truth would typically relate to accurate identification of arrhythmia sources or catheter positions, likely established by electrophysiology study results, clinical outcomes, or expert consensus during the "user tests," but this is not detailed.
8. The sample size for the training set:
- Given this is a 510(k) for a modification to an existing device, and the description does not suggest a machine learning model from scratch, there is no mention of a "training set" in the context of typical AI/ML development. The "training" would have been part of the initial development of the predicate device (K070902), if applicable.
9. How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no mention of a training set for a new algorithm in this document.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).