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EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment.

EchoNavigator R4.0 is a tool that assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance. EchoNavigator can be used with compatible Echo-probes and Echo units in combination with compatible Philips interventional X-ray systems.

The provided text does not contain specific acceptance criteria or an analytical study comparing the device's performance against such criteria. Instead, it describes a substantial equivalence determination for the EchoNavigator R4.0 device, comparing it to a predicate device (EchoNavigator R3.0.3, K200713).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. Also, many of the requested details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present.

However, based on the information provided, here's what can be extracted regarding the device's demonstration of substantial equivalence:

Summary of Device Evaluation for Substantial Equivalence:

The document states that the EchoNavigator R4.0 is substantially equivalent to its predicate device (EchoNavigator R3.0.3, K200713). This determination is based on:

• Indications for Use: The subject device has the same indications for use as the predicate device.
• Technological Characteristics: The subject device has the same fundamental scientific technology as the predicate device. Minor modifications (new user interface location, automated alignment functionality, minor 3D heart model updates, and updated rendering modes) were assessed and deemed not to affect safety or effectiveness.
• Non-Clinical Performance Testing: This testing was performed to demonstrate compliance with recognized consensus standards and guidance documents, as well as to verify and validate software requirements and intended use.

Here's a breakdown of the available information, noting the absence of details for many of your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Not explicitly provided as a set of quantified performance metrics (e.g., sensitivity, specificity) against defined acceptance criteria.
   • The document states that "Non-clinical verification and validation test results demonstrate that the subject device, EchoNavigator R4.0: Complies with the aforementioned FDA recognized consensus standards and guidance documents [and] Meets the acceptance criteria and is adequate for its intended use." However, the specific acceptance criteria and their corresponding results are not detailed.

2. Sample Size Used for the Test Set and Data Provenance:

   • Not specified. The document mentions "software verification testing" and "non-clinical in-house simulated use design validation testing" but does not give sample sizes for these tests or the nature of the "test set" (e.g., number of cases, type of data). There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not specified. The evaluation appears to be based on non-clinical testing and comparison to a predicate device, rather than a study requiring expert-established ground truth on patient cases.

4. Adjudication Method for the Test Set:

   • Not applicable/specified. Since no clinical study with expert ground truth is described, there is no mention of an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. The document explicitly states: "The subject device, EchoNavigator R4.0 did not require clinical study since substantial equivalence to the predicate device (EchoNavigator R3.0.3, K200713) was demonstrated in terms of the indication for use; technological characteristics; non-clinical performance testing; and safety and effectiveness." Therefore, an MRMC study and its effect size are not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

   • Not explicitly detailed in terms of reported performance metrics. The software verification testing and design validation testing would implicitly evaluate the algorithm's functionality. The mention of "automatic annotations" and "AutoViews" suggests automated algorithmic functions, but their standalone performance against specific metrics is not reported in this summary.

7. The Type of Ground Truth Used:

   • For the non-clinical verification and validation, the "ground truth" would be established by the specified system requirements, intended use, and consensus standards. There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as no clinical study was performed.

8. The Sample Size for the Training Set:

   • Not applicable/specified. This document describes a substantial equivalence submission for an existing product (EchoNavigator R4.0, an update to R3.0.3). There is no mention of machine learning model training or associated training set sizes. The device's "core algorithm for probe (transducer) detection is fundamentally unchanged" and "automatic annotations functionality is fundamentally unchanged," suggesting an established technology rather than a newly trained AI system.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable/specified, as there is no mention of a training set for machine learning models.

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