(64 days)
The EnSite Velocity™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
- 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.
OR - 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.
The EnSite Velocity System consists of the following:
- Display Workstation .
- Amplifier
The provided text describes a 510(k) summary for the EnSite Velocity System, a medical device. However, it does not contain information regarding detailed acceptance criteria or a study proving that the device meets such criteria.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices. This pathway typically relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. This often involves demonstrating that any differences do not adversely affect safety or effectiveness, which might be supported by bench testing.
Here's a breakdown of what is present and what is missing from your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document states: "Bench testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." However, it does not provide specific acceptance criteria (e.g., "accuracy must be >90%") or a table of reported device performance against such criteria. The "changes" refer to modifications between version 1.3 and 2.0 of the EnSite Velocity System.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. There is no mention of a "test set" in the context of clinical data or patient samples. The testing described is "bench testing," which typically involves simulated conditions or controlled environments, not patient data in the sense of sample size and provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set is described.
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 Available. This document describes an electrophysiology mapping system, not an AI-assisted diagnostic tool for image interpretation or a system that modifies human reader performance in the way described. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. The device is an "Electrophysiology Mapping System" which is an interactive tool used by clinicians (human-in-the-loop). Standalone algorithm performance is not discussed as it's not relevant to this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The testing mentioned is bench testing. For bench testing, "ground truth" typically refers to engineering specifications, reference standards, or expected outputs based on known inputs, not clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- Not Applicable. This document describes a medical device, not an AI model that undergoes a "training set" in the machine learning sense. The development of the device followed "St. Jude Medical's Quality System requirements" and "design controls requirements," which is a different process than AI model training.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary: The provided 510(k) summary focuses entirely on demonstrating "substantial equivalence" of the EnSite Velocity System v.2.0 to its predicate device (EnSite Velocity System v.1.3) through modifications meeting design requirements and bench testing. It does not provide the kind of detailed information about acceptance criteria, clinical study designs, sample sizes, expert ground truth, or AI performance metrics that your request specifies. Such information is typically found in PMAs (Premarket Approval applications) or specific clinical trial reports, not usually in a 510(k) summary focused on substantial equivalence.
§ 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).