(22 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).