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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.

The EchoNavigator Rel. 1 software medical device is a tool that assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo guidance. The EchoNavigator Rel. 1 device can be used with the currently marketed Philips EchoNavigator compatible Echo-probes, Echo units and interventional X-ray systems.

The provided text describes the EchoNavigator Rel. 1, a software medical device, but it does not contain the detailed information required to answer all parts of your request regarding acceptance criteria and a specific study proving device performance.

The text states that "Non-clinical verification and validation tests were performed with regards to the requirement specifications and risk management results, specifically including software verification and validation activities. The results of these tests demonstrate that EchoNavigator Rel. 1 met the acceptance criteria." However, it does not explicitly list the acceptance criteria or provide details about these studies.

Therefore, I cannot populate the table or provide specific details for sections 2 through 9.

Here's a breakdown of what can and cannot be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot provide. The document states that "EchoNavigator Rel. 1 met the acceptance criteria" but does not define what those criteria are or present specific performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot provide. No information about a specific test set, its size, or data provenance is present. The general statement about "non-clinical verification and validation tests" does not elaborate on these details.

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)

• Cannot provide. There is no mention of a ground truth established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot provide. No information on adjudication methods is present.

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 provide. The document describes EchoNavigator as a "tool that assists the interventionalist and surgeon," implying human-in-the-loop, but does not mention any MRMC study or comparative effectiveness data quantifying improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot provide. The device is described as an assistive tool, but no standalone performance data is presented or even implied.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot provide. No information on the type of ground truth used for any testing is present.

8. The sample size for the training set

• Cannot provide. There is no mention of a training set or its size.

9. How the ground truth for the training set was established

• Cannot provide. As no training set is mentioned, its ground truth establishment is also not discussed.

In summary, the provided 510(k) summary focuses on the device description, indications for use, technological characteristics, and concluding that it met acceptance criteria and is substantially equivalent to predicate devices. It does not delve into the specifics of the performance studies as requested.

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