(30 days)
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.
Jupiter is a computer workstation used for the display, processing, filming, and communication of Emission Tomography images (data) and hybrid imaging. It also includes capabilities to perform image corrections based on Attenuation Tomography and to provide registration of anatomical and physiological images. It consists of a Microsoft Windows 2000 based PC workstation (high resolution color monitor, keyboard, mouse, and RW-CD for archiving), an Ethernet network connection and system software. Optional DVD and optical disk archive devices are also available. The system conforms to the following mandatory and voluntary standards: CISPR 11; IEC 801, UL 2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J
The provided document is a 510(k) Premarket Notification for the GE Medical Systems Jupiter Processing and Review Workstation. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria for specific performance metrics in the way a traditional clinical trial might.
Therefore, the document does not contain the specific information requested in most of the categories (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth information for training/testing).
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| General Equivalence to Predicate Device: The Jupiter Workstation is expected to have the same technological characteristics, comparable key safety and effectiveness features, the same basic design, construction, and materials, and the same intended use as the predicate device (GE eNTEGRA Processing and Review Workstation). | The submitter concluded that the Jupiter Processing and Review Workstation is substantially equivalent to the currently cleared eNTEGRA Processing and Review Workstation, based on the documented design and development process, conformity to quality systems (21 CFR 820, ISO 9001/EN 46001), and compliance with applicable medical device safety and performance standards. |
| Electrical, Mechanical, and Radiation Safety: Conformity to applicable medical device safety and performance standards. | The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards, including CISPR 11; IEC 801, UL 2601-1, IEC 60601-1, and applicable sections of 21 CFR Subchapter J. |
Explanation: This 510(k) primarily asserts substantial equivalence based on technical specifications and adherence to general safety and quality standards, not on specific performance metrics like accuracy, sensitivity, or specificity relative to a diagnostic task. The "acceptance criteria" here are broad regulatory and technical compliance points.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified.
Explanation: The submission describes an evaluation of electrical, mechanical, and radiation safety, and conformance to standards. It does not refer to a "test set" of patient data or images in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable / Not specified.
- Qualifications of Experts: Not applicable / Not specified.
Explanation: As there's no mention of a diagnostic performance test set, there is no discussion of experts establishing ground truth for such a set.
4. Adjudication method for the test set
- Adjudication Method: Not applicable / Not specified.
Explanation: No diagnostic performance test set is described, so no adjudication method is mentioned.
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
- MRMC Study: No.
Explanation: This device is a workstation for display, processing, and review of imaging data. It is not an AI-assisted diagnostic tool or an algorithm intended to directly aid reader performance in the sense of an MRMC study. It's a foundational platform.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No.
Explanation: This device is a workstation, not a standalone diagnostic algorithm. Its function is to facilitate human review and processing of images.
7. The type of ground truth used
- Type of Ground Truth: Not applicable / Not specified for diagnostic performance.
Explanation: The "ground truth" implicitly referred to relates to the correctness of the workstation's functionality (e.g., proper display, processing capabilities, compliance with technical standards), not to diagnostic outcomes from patient images.
8. The sample size for the training set
- Sample Size: Not applicable / Not specified.
Explanation: This device is a software/hardware system, not a machine learning algorithm that typically requires a "training set" of data in the context of diagnostic performance. Its development likely involved standard software engineering and testing, not AI model training.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable / Not specified.
Explanation: As above, this concept doesn't apply directly to the development described for this workstation.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document indicates that the acceptance criteria are met through:
- Conformance to Quality Systems: The design and development process of the manufacturer conforms to 21 CFR 820 and ISO 9001/EN 46001 quality systems.
- Safety and Performance Standards Compliance: The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards. Specifically mentioned standards include CISPR 11, IEC 801, UL 2601-1, IEC 60601-1, and applicable sections of 21 CFR Subchapter J.
- Substantial Equivalence to Predicate Device: The core of the submission is the demonstration that the Jupiter Workstation is substantially equivalent to the previously marketed GE eNTEGRA Processing and Review Workstation (K000395) in terms of technological characteristics, safety, effectiveness, design, construction, materials, and intended use. This equivalence argument is the primary "proof" provided for regulatory acceptance in this 510(k) context.
In essence, the study proving the device meets the acceptance criteria is a technical and regulatory compliance assessment, not a clinical diagnostic performance study.
§ 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).