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K Number
K093942
Device Name
ENSITE VELOCITY SYSTEM V1.3
Manufacturer
ST. JUDE MEDICAL
Date Cleared
2010-02-25

(65 days)

Product Code
DQK
Regulation Number
870.1425
Type
Traditional
Panel
CV
Reference & Predicate Devices
K093942
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

The EnSite Velocity System consists of the following:

  • Display Workstation .
  • Amplifier
AI/ML Overview

The provided text is a 510(k) summary for the EnSite Velocity System. It details the device's intended use and substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond general "bench testing" to confirm design requirements.

Therefore, I cannot fulfill your request for the specific details outlined as the information is not present in the provided document.

Here's a breakdown of why I cannot answer each point based on the given text:

  1. A table of acceptance criteria and the reported device performance: This information is not 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," but no specific criteria or performance metrics are listed.
  2. Sample sized used for the test set and the data provenance: Not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  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 provided. This is a diagnostic mapping system, not specifically an AI-assisted diagnostic tool as described in the question.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
  7. The type of ground truth used: Not provided.
  8. The sample size for the training set: Not provided.
  9. How the ground truth for the training set was established: Not provided.

The document's primary focus is on establishing substantial equivalence to a predicate device based on similar indications for use, fundamental scientific technology, and the outcome of general bench testing. It does not delve into detailed performance studies with specific acceptance criteria as you've requested.

§ 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).