(44 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.
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.
When used with the St. Jude Medical Contact Force hardware, the EnSite Velocity System EnSite Contact Force Module is intended to provide visualization of force information from compatible catheters.
The EnSite Velocity System consists of the following:
Display Workstation
Amplifier
The provided text describes the EnSite Velocity System EnSite Contact Force Module and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a specific study proving those criteria were met, or detailed performance metrics in the format requested.
It primarily focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through bench testing and adherence to design control activities.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided. 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 specify what those design requirements (acceptance criteria) were or the quantitative results of the bench testing.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The phrase "Bench testing" is too vague to determine sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No information regarding human experts or ground truth establishment for a test set is mentioned. The testing described is "bench testing," implying laboratory-based or simulated environments, not involving clinical data with expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. No adjudication method is mentioned as there's no described process involving human review of a 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:
- Cannot be provided. The document describes a medical device (an electrophysiology mapping system), not an AI algorithm assisting human readers. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is an "Electrophysiology Mapping System with console and catheter," designed to be used by clinicians ("human-in-the-loop"). It's not a standalone algorithm in the sense of an AI model generating diagnoses without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No ground truth type is specified, as the testing mentioned is "bench testing" to confirm meeting "design requirements," not clinical validation against a gold standard.
8. The sample size for the training set:
- Cannot be provided. The device is a hardware/software system, not a machine learning model that would typically have a "training set."
9. How the ground truth for the training set was established:
- Cannot be provided. As above, no training set is mentioned as this is not an AI/ML algorithm requiring one.
Summary of available information:
The document focuses on demonstrating substantial equivalence to a predicate device (EnSite Velocity System v.4.0, K130594) through:
- Same fundamental scientific technology.
- All technological characteristics being substantially equivalent.
- Bench testing to confirm that "changes met design requirements and did not adversely affect the device's safety and effectiveness" where operational and performance differences exist.
- Compliance with Quality System Regulation design controls (21 CFR 820.30).
Essentially, the acceptance criteria are implied to be "meeting design requirements" and "not adversely affecting safety and effectiveness" compared to the predicate, verified through bench testing. Specific quantitative criteria and results are not detailed in this public disclosure summary.
§ 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).