(69 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.
When used with the v.1.5.1 MediGuide gMPS System Interface Module, the EnSite Velocity System interfaces to the MediGuide Guided Medical Positioning System II to combine and display gMPS II processed patient positioning and orientation Mapping information.
The EnSite Velocity System consists of the following:
- Display Workstation .
- Amplifier .
The provided text is a 510(k) summary for a medical device (EnSite Velocity System v.1.5.1 with MediGuide gMPS System Interface Module). It outlines the device's intended use, comparison to a predicate device, and non-clinical testing. However, it does not contain the detailed information required to describe specific acceptance criteria for performance, a comprehensive study proving those criteria, or details regarding ground truth establishment and expert involvement.
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."
- "The full software performance benchmarks which measure map and waveform display refresh rates, data rates, and time to display a frame of map and waveforms were conducted."
- "The performance of the EnSite Velocity System was observed during verification and integrated system testing to ensure performance was not severely impacted by the integration with the gMPS II (K102905)."
While these statements indicate that testing was performed to ensure the device met certain performance expectations and safety requirements, they do not provide quantitative acceptance criteria or the study data that validates them. The document primarily focuses on establishing substantial equivalence to a predicate device through modifications and integration with another system.
Therefore, I cannot populate the requested table and answer many of the questions because the necessary details are not present in the provided text.
Here's a breakdown of what can be inferred from the text and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| Inferred: Ensuring changes met design requirements and did not affect safety/effectiveness. | Inferred: Bench testing, software performance benchmarks (map/waveform refresh rates, data rates, time to display a frame), and verification/integrated system testing observed that performance was not severely impacted by integration with gMPS II. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance (country, retrospective/prospective): Not specified. The testing described is "bench testing" and "software performance benchmarks," suggesting laboratory/simulated environments rather than patient data.
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)
- Number of Experts: Not applicable/not mentioned. This type of testing appears to be functional and performance-based against specifications, not reliant on expert interpretation of ground truth in a clinical context.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not mentioned.
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
- MRMC Study: No, an MRMC study was not done or mentioned. This device is an electrophysiology mapping system, not an AI-assisted diagnostic imaging device that would typically involve human "readers" interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The described "software performance benchmarks" (map and waveform display refresh rates, data rates, and time to display a frame) represent a form of standalone performance testing for the system's core functions. However, "standalone" in the context of AI often refers to an algorithm making a diagnosis without human intervention, which is not the primary function or testing focus described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For bench testing and software benchmarks, the "ground truth" would likely be the defined design requirements and expected performance specifications derived from engineering principles and predicate device behavior.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a traditional medical device (electrophysiology mapping system) and its software integration, not a machine learning or AI algorithm that would typically involve a "training set" in the context of AI model development.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable (see point 8).
§ 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).