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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 is a Software Medical Device 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 FDA 510(k) clearance letter and summary for EchoNavigator R5.0 describes the device and its new features, particularly the AI-enabled M-TEER device detection and overlay (DeviceGuide functionality). While it states that no clinical study was required for overall substantial equivalence due to the predicate device, it details the verification and validation (V&V) study for the AI algorithm.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for primary testing: 72 unique patients
• Sample size for out-of-domain testing: 41 patients
• Total sample size for testing (unique patients): 113 unique patients
• Data Provenance: Data were sourced from a diverse mix of institutions (academic centers and community hospitals) across the U.S. and Europe. Clinical data were acquired using a range of compatible Philips X-ray and Philips ultrasound systems under routine procedural conditions. The validation dataset included at least 50% U.S. site data. The study was retrospective, as data was acquired first, and then used for algorithm testing ("testing was performed after algorithm development was completed and the algorithm was frozen").

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

The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for the test set regarding the positional and trajectory/orientation accuracy. It mentions that "algorithm outputs were compared to a reference standard ('ground truth') derived from pre-clinical high resolution imaging data." This suggests the ground truth for these quantitative metrics was established through high-resolution imaging rather than solely expert consensus on the clinical images.

However, for the "sufficiency of algorithm output" in a clinical review, five physicians assessed the algorithm output. Their specific qualifications (e.g., years of experience, subspecialty) are not provided beyond being "physicians."

4. Adjudication Method for the Test Set

The document does not explicitly specify an adjudication method like 2+1 or 3+1 for the quantitative ground truth metrics (positional and trajectory/orientation accuracy). The ground truth for these was "derived from pre-clinical high resolution imaging data."

For the clinical review where five physicians assessed sufficiency, the document does not mention an adjudication method beyond stating that five physicians assessed the algorithm output, achieving 93.1% sufficiency. It doesn't clarify if there was a consensus process or if individual assessments were averaged/aggregated.

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

No, an MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance versus without AI assistance was not conducted or reported. The study focused on the standalone performance of the AI algorithm for device detection and tracking.

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

Yes, a standalone performance study was done for the AI algorithm. The reported positional accuracy ($\leq$ 5 mm), trajectory/orientation accuracy ($\leq$ 10$^\circ$), and algorithm latency ($\leq$ 100 ms) are all measures of the algorithm's standalone performance without human input during operation. The "clinical review" by five physicians assessed the output of the standalone algorithm for sufficiency.

7. The Type of Ground Truth Used

• For Positional Accuracy and Trajectory/Orientation Accuracy: A "reference standard ('ground truth') derived from pre-clinical high resolution imaging data" was used. This suggests a highly precise, objective measurement from specialized imaging.
• For Clinical Review Assessment (sufficiency): Expert assessment by five physicians was used to determine the "sufficiency" of the algorithm's output.

8. The Sample Size for the Training Set

The document explicitly states: "Data used for development were not used for testing." However, it does not specify the sample size for the training set or development data.

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

The document states: "To ensure independence between development and testing, testing was performed after algorithm development was completed and the algorithm was frozen. Data used for development were not used for testing." However, it does not describe how the ground truth for the training set was established.

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

EchoNavigator 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 information about acceptance criteria or specific study results for the EchoNavigator R3.0.3 device.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

Here's a breakdown of what is and is not in the document regarding your request:

What is present in the document:

• Device Name: EchoNavigator R3.0.3
• Predicate Device: EchoNavigator R1 (K121781)
• Indications for Use: "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."
• Technological Characteristics Comparison: The document states that the proposed device has similar technological characteristics to the predicate. It notes the ability to display images from live X-ray and Ultrasound, and an unchanged core algorithm for probe detection. It also lists functionalities available in both devices (Synchronize Image Orientation, Multiple Views, Follow C-arm, Table Side Control, Manual Annotations, Image Capture Export). It mentions modifications like an extended "Multiple Views" functionality with a "Model View" and basic Touch Screen Module control for "Table Side Control."
• Non-Clinical Performance Data: Mentions "Software verification testing" and "Non-clinical in-house simulated use design validation testing" were performed, and all tests passed. It lists several recognized standards that the device complies with (IEC 62304, IEC 62366-1, IEC 82304-1, ISO 14971, ISO 15223-1, UL 2900-1, IEC 80001-1).
• Conclusion: States that EchoNavigator R3.0.3 is substantially equivalent to the predicate device in terms of indications for use, technological characteristics, safety, and effectiveness, without raising new safety or effectiveness concerns.

What is NOT present in the document (and therefore cannot be provided in the requested table/answers):

• Specific Acceptance Criteria: The document does not define quantitative or qualitative acceptance criteria for device performance (e.g., accuracy, precision, sensitivity, specificity, time measurements, etc.). It only states that tests were "passed."
• Reported Device Performance: No specific performance metrics or values are reported.
• Sample Size for Test Set: Not mentioned.
• Data Provenance (country, retrospective/prospective): Not mentioned.
• Number of Experts and Qualifications for Ground Truth: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned as being performed.
• Standalone Performance Study: The document refers to "Software verification testing" and "Non-clinical in-house simulated use design validation testing," which might be considered standalone, but no performance metrics are provided.
• Type of Ground Truth Used: Not mentioned for any studies.
• Sample Size for Training Set: Not mentioned (and likely not applicable since it's not described as an AI/ML device that requires a training set in the typical sense; the focus is on software verification and simulated use validation).
• Ground Truth Establishment for Training Set: Not mentioned.

In summary, the provided text does not contain the detailed performance data, acceptance criteria, study methodologies (like sample sizes, expert involvement, or adjudication), or ground truth specifics that your request asks for. The document is a regulatory submission focused on substantial equivalence based on non-clinical testing and comparison to a predicate, not a detailed performance study report.

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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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