(87 days)
HeartNavigator Release 1 is a tool which assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance for structural heart disease procedures.
HeartNavigator Release 1 uses cardiac 3D image data of the patient as a source for procedure planning.
In the procedure planning phase, the tool supports the user to:
- Identify and Visualize relevant anatomical structures in the 3D image data.
- Determine and store the X-ray system viewing angles to be used during the procedure.
- Evaluate device placement for the current treatment.
During the procedure the tool allows the user to:
- Visualize the relevant anatomical structures in the 3D image data.
- Recall stored viewing angles and assists the user to move to these angles.
- Register the 3D image data to the X-ray system.
- See an overlay image of the 3D image data and the live fluoroscopy on a separate monitor in addition to the normal monitor showing the conventional live X-ray without alteration.
The provided text from the 510(k) summary for the Philips HeartNavigator Release 1 states that a "Clinical evaluation was performed to show safety and effectiveness of HeartNavigator Release 1 in the intended clinical environment." However, the summary does not provide any specific acceptance criteria or detailed results of this clinical evaluation. It also does not explicitly detail a study design that would allow for a comprehensive answer to all the requested points.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The general statement is that "HeartNavigator Release 1 complies with standards as detailed in this premarket submission. Clinical evaluation was performed to show safety and effectiveness of HeartNavigator Release 1 in the intended clinical environment."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device is described as "assists the user with procedure planning and provides live image guidance in addition to conventional live fluoroscopy guidance," implying an assistive role.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as a "tool which assists the user," implying it's not designed for standalone performance. The document does not describe any standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of available information regarding the clinical study:
The document states:
- "Clinical evaluation was performed to show safety and effectiveness of HeartNavigator Release 1 in the intended clinical environment." (page 2)
- It also mentions "Corresponding clinical evaluation report and test results are included in this submission." (page 2) - This implies the detailed information exists but is not part of this summary document.
- The conclusion made by Philips is that the device "does not introduce new technology" and "does not raise new issues of safety and effectiveness" compared to legally marketed devices. This suggests that the clinical evaluation likely aimed to demonstrate non-inferiority or equivalence to predicate devices, rather than establishing specific performance metrics against a novel ground truth.
In conclusion, while a clinical evaluation was performed, the provided 510(k) summary document lacks the specific details required to answer most of your questions regarding acceptance criteria and the study that proves the device meets them. The summary explicitly states that the detailed clinical evaluation report and test results were included in the full submission, but not in this public summary.
§ 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).