(98 days)
The EnSite 3000® System is indicated for patients for whom electrophysiology studies are indicated.
- When used with the EnSite® Catheter, the EnSite 3000® 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 3000® System is intended to display the position of conventional electrophysiology catheters in the heart.
The EnSite 3000® 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 Catheter does not require direct contact with the endocardium for the detection of intracardiac electrograms. The EnSite 3000® 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 3000® 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 is a 510(k) Summary for the EnSite 3000® System. It describes the device, its intended use, and a general statement about non-clinical performance data. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a comprehensive analysis of the device's performance against defined criteria.
Therefore, I cannot fully complete the requested table and answer all questions. Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states that "Device validation testing was conducted in accordance with in-house procedures," but does not detail the specific criteria for success. | "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." |
2. Sample size used for the test set and the data provenance
The document mentions "a battery of bench and user tests" for non-clinical performance data. However, no specific sample size for a test set (e.g., number of patients or cases) is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). The tests appear to be internal validation steps rather than a formal clinical study with a specified test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the document. There is no mention of experts establishing ground truth for any test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present in the document. No adjudication method is mentioned, as there's no described test set with ground truth established by experts.
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 information is not present in the document. The EnSite 3000® System is described as a "computerized storage and display system" that aids electrophysiologists. It facilitates mapping and visualization but isn't explicitly described as an AI system that improves human reader performance in the context of an MRMC study. No MRMC study or effect size data is provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as assisting human operators ("electrophysiologist can identify the arrhythmia source and can navigate to the defined area for therapy"). There is no mention of a standalone algorithm-only performance study. The system is intended to be used with human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not present in the document. There is no detailed description of ground truth establishment for any performance evaluation.
8. The sample size for the training set
The document describes "bench and user tests" for non-clinical performance data but does not mention a training set or its sample size. This suggests that if machine learning was involved (which isn't explicitly stated but could be inferred from "computerized system"), the details of its development and validation are not included in this summary.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not present in the document.
Summary of what the document does state regarding performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Endocardial Solutions EnSite 3000® System, K012926). The non-clinical performance data mentioned refers to "a battery of bench and user tests" conducted internally ("in-house procedures"). The conclusion states that the device is "as safe and effective as the previously marketed device" and "does not raise any new issues of safety and effectiveness." This indicates that the performance evaluation was likely focused on verifying that the changes made did not negatively impact the established performance of the predicate device, rather than establishing new, quantitative performance metrics against specific acceptance criteria.
§ 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).