(29 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.
The provided text appears to be a 510(k) summary for the St. Jude Medical EnSite System (Model EE3000), along with its associated components. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria based on detailed performance studies with clinical endpoints.
Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The 510(k) process relies on demonstrating that the new device has "the same technological characteristics" and is "as safe and effective as the previously marketed device" based on a comparison to a predicate device.
Here's what can be extracted based on the provided text, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
The document states: "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." and "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 document does not provide a table of
specific, quantifiable acceptance criteria or reported device performance metrics against such criteria. The focus is on demonstrating equivalence to a predicate device.
| Acceptance Criteria (Not explicitly stated, inferred to be similar to predicate) | Reported Device Performance (Not explicitly stated, inferred to be equivalent to predicate) |
|---|---|
| Safe and Effective as predicate device | "as safe and effective as the previously marketed device" |
| No new issues of safety and effectiveness | "does not raise any new issues of safety and effectiveness" |
| Technological characteristics same as predicate | "The new device has the same technological characteristics as the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
The document mentions "a battery of bench and user tests" and "device validation testing," but does not specify the sample size, data provenance (country of origin), or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth or their qualifications. Testing appears to be primarily bench and user-based as part of internal validation.
4. Adjudication method for the test set
The document does not mention any adjudication method for the test set.
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
The document does not mention a multi-reader multi-case (MRMC) study or any comparison related to human readers improving with or without AI assistance. The EnSite system described is an electrophysiology cardiac mapping system, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for assessing reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not provide details on standalone algorithmic performance. The system is described as a "computerized storage and display system for use in electrophysiology studies" which implies human interaction.
7. The type of ground truth used
The document does not specify the type of ground truth used. Given the context of comparing to a predicate device and internal validation, the "ground truth" would likely be based on established engineering and clinical standards for electrophysiology systems or direct comparison to the predicate device's output.
8. The sample size for the training set
The document does not mention a training set sample size. This type of 510(k) submission generally does not involve machine learning "training sets" in the way that AI/ML devices do.
9. How the ground truth for the training set was established
As no training set is mentioned, there is no information on how its ground truth was established.
§ 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).