(15 days)
The Integris 3D-RA release 4.2 is intended to assist the physicians when analyzing 2-Dimensional, DSA X-ray images by creating 3-Dimensional views from sets of 2-Dimensional images created during rotational angiographic runs.
The Integris 3D-RA release 4.2 device allows the user to obtain a three dimensional impression of vasculature with a single contrast injection. This 3D impression is acquired by rotating the C-arm isocentrically around the region of interest. Exposures are made as the arteries in the region of interest are being filled. The set of 2-Dimensional images form the rotational angiographic examination and is transferred via DICOM connection to the 3D-RA workstation. A 3-Dimensional image is constructed from the delivered image information resulting in an object which can be viewed from almost any angle.
The provided text is a 510(k) summary for the Philips Integris 3D-RA, release 4.2. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness compliance based on existing standards. It does not contain information about studies proving the device meets specific acceptance criteria based on performance metrics.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Here's what I can extract from the provided text regarding general safety and effectiveness:
General Safety and Effectiveness Criteria (Compliance-based, not performance-based):
| Acceptance Criteria (Compliance) | Reported Device Performance (Compliance) |
|---|---|
| Compliance with federal performance standards for radiological health (21 CFR, Title 21, subchapter J – Radiological Health, parts 1020.10 and 1040.10). | "The device and its labeling will comply with the applicable requirements of the federal performance standards (Code of Federal Regulations, Title 21, subchapter J – Radiological Health, parts 1020.10 and 1040.10)." |
| Compliance with ACR/NEMA DICOM digital imaging communication standard. | "Additionally the Integris 3D-RA release 4.2 complies with the ACR/NEMA DICOM digital imaging communication standard." |
| Compliance with Underwriters Laboratories Standard for Safety UL 60950. | "The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 60950. All required documents and reports have been or will be supplied to the appropriate oversight agency to establish compliance with the applicable requirements." |
| Device does not introduce new indications for use. | "The Philips 3D-RA, release 4.2 does not introduce new indications for use..." |
| Device does not result in any new potential hazard. | "...nor does the use of the device result in any new potential hazard." |
| Substantial equivalence to the predicate device (Integris 3D-RA release 1, FDA ref. K983877). | "The Integris 3D-RA release 4.2 device is substantially equivalent to the Integris 3D-RA release 1 (FDA ref. K983877)." and "Philips Medical Systems considers the Philips 3D-RA release 4.2 substantially equivalent with the predicate device." This was affirmed by the FDA's letter stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". |
Regarding the specific questions you asked, this document provides no information on the following:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device's indication for use is "to assist physicians", implying a human-in-the-loop scenario, but no performance study is described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
This 510(k) summary is a declaration of compliance with regulatory standards and substantial equivalence, not a detailed report of a device performance study with specific acceptance criteria beyond regulatory compliance.
§ 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).