(28 days)
The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.
The GE Vision Nuclear Medicine Workstation is a nuclear medicine image display and processing workstation. It consists of a personal computer (PC) or UNIX workstation, monitor, keyboard, mouse, modem, and network interface.
The provided documents for the GE Vision Nuclear Medicine Workstation (K012568) do not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Vision POWERstation Nuclear Medicine Workstation, K912573) based on similar technological characteristics, safety features, design, and intended uses.
Here's an analysis of the information provided, framed around your requested points, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria for performance are listed in the document. The submission focuses on substantial equivalence to a predicate device. | The device has the "same technological characteristics," is "comparable in key safety and effectiveness features," "uses the same basic design," and has the "same intended uses as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission explicitly states: "Clinical Tests: None required." The assessment of the device is based on its similarity to a predicate device and adherence to safety standards, not on clinical performance testing with a specific test set.
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)
- Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned, as clinical performance testing was not required for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned, so no adjudication method was used.
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. A MRMC comparative effectiveness study was not done. The device is a "nuclear medicine image display and processing workstation," not an AI-powered diagnostic tool, and the submission predates widespread AI in medical imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. A standalone performance study was not done. The device's function is explicit: "intended for use in the display and analysis of planar and tomographic nuclear medicine images," implying a human-in-the-loop system. Performance testing for an algorithm-only component is not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. As no clinical testing was performed, no ground truth was established for performance evaluation.
8. The sample size for the training set
- Not applicable / Not provided. No training set is mentioned as this is a workstation for display and analysis, not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Given that no training set is mentioned, the method for establishing its ground truth is also not applicable.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" that proves the device meets "acceptance criteria" (which are generally defined as substantial equivalence to the predicate device and adherence to safety standards) is a documentary review and comparison rather than a clinical performance study.
The core of the submission (K012568) is a 510(k) Special Premarket Notification by GE Medical Systems. The "study" essentially consists of the following components:
- Comparison to a Predicate Device: The primary basis for clearance is demonstrating that the GE Vision Nuclear Medicine Workstation is "of a comparable type and substantially equivalent" to the previously marketed GE Vision POWERstation Nuclear Medicine Workstation (K912573). This comparison argues for equivalence in:
- Technological characteristics
- Key safety and effectiveness features
- Basic design
- Intended uses (display and analysis of planar and tomographic nuclear medicine images).
- Safety and Standards Conformance: The device was evaluated for electrical and radiation safety and deemed to conform with applicable medical device safety standards.
- Quality System Compliance: The design and development process of GE Medical Systems conforms with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
Conclusion stated by GE Medical Systems: "The the opinion of GE Medical Systems that the GE Vision Nuclear Medicine is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market."
FDA's finding: "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... for the indications for use stated in the enclosure."
In essence, for this specific submission, the "proof" is a successful demonstration of substantial equivalence to an existing legally marketed device, supported by adherence to safety standards and quality management systems, rather than a clinical performance study with defined acceptance criteria and a test set.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.