(164 days)
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
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When used with the EnSite Array™ 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.
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. When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
VeriSense™ Technology is intended for monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact during cardiac electrophysiology procedures via a proprietary Electrical Coupling Index (ECI).
The EnSite Velocity System consists of the following:
- Display Workstation .
- . Amplifier
Here's an analysis of the provided text, focusing on acceptance criteria and study details, though it's important to note that the document is a 510(k) summary, which often provides less granular detail than a full clinical study report.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the VeriSense System Software. Instead, it refers to a "summary of the clinical study applicable to the diagnostic portion (VeriSense Software)" from the CONTACT AFL study, which supported the PMA supplement for the hardware. The closest to stated performance is the statement that the VeriSense Technology is intended for "monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact."
Without specific numerical targets for metrics like sensitivity, specificity, or accuracy, it's impossible to create a table of "acceptance criteria" and "reported device performance." The document relies on the fact that an "ECI Validation" was performed as part of a larger study, and the results were deemed sufficient for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample size for the "test set" (referring to the data used to evaluate the VeriSense Software specifically) is not explicitly stated in this document. It mentions the "CONTACT AFL study" as a "prospective, multi-center" study, but does not break down the number of patients or data points used specifically for the VeriSense Software validation within that study. It also mentions a "summary report of the Electrical Coupling Index (ECI) Validation that was collected from the CONTACT AFL Study." This implies the data used was a subset or specific analysis from the larger CONTACT AFL study.
- Data Provenance: The CONTACT AFL study was described as a "prospective, multi-center" study. The document does not specify the country of origin of the data, but "multi-center" usually implies data from various clinical sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used, nor their qualifications, for establishing ground truth for the test set of the VeriSense System Software.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for the VeriSense System Software. The document describes the system as a "diagnostic tool" and "intended for monitoring catheter tip-to-tissue electrical coupling." This type of device focuses on providing information to the clinician, rather than directly replacing or augmenting human interpretation of complex images in a way that would typically warrant an MRMC study comparing human readers with and without AI assistance.
6. Standalone Performance Study
Yes, a form of standalone performance was implicitly done. The "ECI Validation" described as being collected from the CONTACT AFL study would represent the standalone performance of the VeriSense System Software in its function of "monitoring catheter tip-to-tissue electrical coupling." The document focuses on the software's ability to provide an Electrical Coupling Index (ECI) as an indication of contact, rather than its impact on clinician decision-making or patient outcomes directly in this 510(k) summary.
7. Type of Ground Truth Used
The document states that VeriSense Technology is intended for "monitoring catheter tip-to-tissue electrical coupling, which may be indicative of catheter tip-to-tissue contact." The "ECI Validation" would likely have involved comparing the Electrical Coupling Index (ECI) generated by the VeriSense software against a direct or established method of determining actual catheter tip-to-tissue contact during the electrophysiology procedures.
While the document doesn't explicitly state the exact ground truth used (e.g., direct visual confirmation, pressure sensors, histological confirmation, etc.), it implies a comparison against a more definitive measure of "tip-to-tissue contact." This would fall under a form of empirical validation or a gold-standard comparison related to the physical phenomenon it's designed to detect.
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. Given that this is a 510(k) summary for a "System Software Module" that is part of a larger mapping system, and the primary focus is on "substantial equivalence" to a predicate device, explicit details about AI model training (which is what a "training set" typically implies) are not provided. The term "software module" in this context might refer to an algorithmic component, but the document does not elaborate on its development methodology in terms of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since the document does not specify a training set or the use of machine learning in a way that requires explicit ground truth for training, it does not provide information on how ground truth for a training set 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).