(21 days)
The GE Mobile Discovery ST PET Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.
The GE Mobile Discovery ST PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy. It is designed for use in a mobile van for transportability between diagnostic imaging sites.
The provided text is a 510(k) summary for the GE Mobile Discovery ST PET CT Imaging System, which is a medical device. Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | |
| Comparable to legally marketed predicate device (K022872) | "The GE Mobile Discovery ST PET CT Imaging System is of a comparable type and substantially equivalent to the currently marketed GE Discovery ST CT-PET System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses as the predicate device." |
| Conformance to applicable medical device safety standards | "The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards... The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance." |
| Intended uses consistent with traditional clinical practice & FDA guidelines | "Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination." |
| Intended uses and fundamental scientific technology similar to predicate | "Intended uses and fundamental scientific technology are the same as the legally marketed GE Discovery LS CT-PET System." |
| Conformance to Quality Systems Regulations (21 CFR 820, ISO 9001, EN 46001) | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems." |
| Device Functionality | |
| PET imaging capabilities (head & whole body, attenuation corrected) | Stated as an intended use: "intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging..." The substantial equivalence claim implies these capabilities are met as they are the same as the predicate. |
| Facilitate localization with integrated CT and PET images | Stated as an intended use: "...facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images..." The substantial equivalence claim implies this functionality is met as it is the same as the predicate. |
| Stand-alone CT imaging capabilities (head & whole body, multislice) | Stated as an intended use: "...and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging." The substantial equivalence claim implies these capabilities are met as they are the same as the predicate. |
| Transportability (mobile van integration) | A key differentiating feature from the predicate mentioned in the device description: "It is designed for use in a mobile van for transportability between diagnostic imaging sites." While not explicitly listed as an "acceptance criteria" for performance, it's a design characteristic that was assessed as part of the overall substantial equivalence determination, implying it met the design intent for mobility. |
Important Note: This document is a 510(k) Premarket Notification. For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is substantial equivalence to a predicate device. This means the new device is as safe and effective as a legally marketed device that is not subject to PMA. The "proof" is largely based on demonstrating this equivalence through comparison, rather than extensive new clinical trials for safety and effectiveness, especially for Class II devices.
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical Tests: None required." Therefore, there was no separate "test set" of patient data used in a clinical study to prove the safety and effectiveness of this specific device beyond its comparison to the predicate. The evaluation was primarily based on technical characteristics, safety standards conformance, and comparison of intended uses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical tests were performed with a dedicated test set requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable, as no clinical tests were performed with a dedicated test set requiring adjudication.
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
Not applicable. This device is an imaging system, not an AI-powered diagnostic tool for interpretation, and no clinical studies, including MRMC studies, were performed or required for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a PET/CT imaging system, not an algorithm, and its performance is evaluated as an integrated system in terms of image acquisition and processing capabilities, which were deemed substantially equivalent to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with a test set requiring ground truth were performed. The "ground truth" for demonstrating substantial equivalence relied on the established safety and effectiveness of the predicate device and the technical specifications of the new device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and operation are based on physics and engineering principles, and its performance is validated through engineering tests and comparison to a predicate device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.