(57 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
- Interconnects
The provided text is a 510(k) summary for the EnSite Velocity System v4.0. It describes the device, its indications for use, and its substantial equivalence to a predicate device (EnSite Velocity System v3.0). However, it does not contain any information about specific acceptance criteria, performance metrics, or details of a study that proves the device meets those criteria.
Instead, the document states:
- "Bench and animal testing was performed to confirm that the changes met design requirements and did not affect the safety or effectiveness of the product." This is a general statement and does not provide specific acceptance criteria or an evaluation of performance.
- The conclusion is based on substantial equivalence to a predicate device, meaning it has the same indications for use, intended use, and fundamental scientific technology, and all technological characteristics are substantially equivalent. This suggests that extensive new performance studies (like those with detailed acceptance criteria and expert evaluation for, e.g., image analysis algorithms) were not required for this particular submission because the changes were not significant enough to warrant them.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.
Here's what can be inferred or stated based on the text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Study Information (Based on the provided text)
- Sample size used for the test set and the data provenance: Not specified. The document mentions "bench and animal testing" but provides no details on sample sizes or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 applicable. This device is an electrophysiology mapping system, not an AI-assisted diagnostic imaging device for human readers in the typical sense of an MRMC study. The document describes it as a "diagnostic tool" in patients. There is no mention of AI or human reader improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a system involving hardware (workstation, amplifier, interconnects) and intended to be used with catheters, suggesting a physician interaction, not a standalone algorithmic performance test in the conventional sense.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- The sample size for the training set: Not applicable/Not specified. This is a medical device system update based on established technology, not a de novo AI algorithm requiring a training set in the machine learning context described.
- How the ground truth for the training set was established: Not applicable/Not specified for the reasons above.
§ 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).