(14 days)
The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery VCT is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
The Discovery VCT is an integrated multi-slice Computed Tomography and Positron Emission Tomography System. It uses CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery VCT has capabilities for imaging all available PET tracers and of concurrently providing anatomical and functional information via an integrated graphical user interface. The Discovery VCT can also be used as a stand-alone head and whole body multislice CT diagnostic imaging system.
This 510(k) submission (K050559) for the GE Discovery VCT System is a modification of a legally marketed device, the GE Discovery ST System (K041543 and K042257). The core of the submission argues for substantial equivalence to the predicate device, rather than providing a study demonstrating specific performance metrics against pre-defined acceptance criteria for a novel device.
Therefore, the information typically found in novel device submissions regarding acceptance criteria and performance studies, such as specific accuracy, sensitivity, or specificity values, sample sizes for test sets, expert consensus details, and standalone algorithm performance, is not present within the provided text.
The acceptance criteria for a substantial equivalence submission are primarily demonstrated by showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. The "study" that proves this is the comparison to the predicate device.
Here's how the requested information maps to the provided text, and where it is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence: The Discovery VCT System must have the same intended use as the predicate Discovery ST System. | Met: "The GE Discovery VCT System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images." This matches the general scope and applications of the predicate device. "The Discovery VCT can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system." This function is also consistent with typical CT systems. The submission explicitly states, "the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System." |
| Technological Characteristics Equivalence: The Discovery VCT System must be substantially similar in design, materials, energy sources, and technology to the predicate Discovery ST System. Any differences must not raise new questions of safety or effectiveness. | Met: "The Discovery VCT PET/CT System is the same as the Discovery ST system described in 510(k)s K041543 and K042257 except that the PET system is integrated with a different CT system, the GE LightSpeed VCT system." This explicitly addresses the primary difference and implies that this change does not raise new safety or effectiveness concerns, as it's a known CT platform. |
| Safety and Effectiveness Equivalence: The Discovery VCT System must be as safe and effective as the predicate Discovery ST System. | Met: The explicit statement: "In the opinion of General Electric Medical Systems, the Discovery VCT System is substantially the same in design, materials, energy sources, and technology, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery ST System." |
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 Present: This information is typically found in studies for novel devices or significant performance claims. Since this is a substantial equivalence submission based on a modification of an existing device by integrating a different CT system, no new clinical performance study with a test set, in the traditional sense, is conducted or presented in the provided summary. The comparison is primarily based on technical specifications and established performance of the integrated components rather than a new clinical trial dataset for evaluation.
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 Present: As no specific test set clinical study is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Present: No test set or associated adjudication method is described within the provided text.
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/Not Present: This submission predates the widespread regulatory review of AI-assisted diagnostic devices (dated March 2005). The device described is a PET/CT imaging system, not an AI-enabled diagnostic tool in the sense of an MRMC study comparison.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Present: The device is an imaging system, not a standalone algorithm. Its performance is inherent to its imaging capabilities, which are considered substantially equivalent to the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Present: As no specific clinical test-set study is presented, there's no mention of the type of ground truth used. The ground truth for the equivalence claim is the established safety and effectiveness of the existing predicate device and the technical specifications of the integrated components.
8. The sample size for the training set
- Not Applicable/Not Present: This device is an imaging system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not Applicable/Not Present: As above, this information is not relevant to an imaging system that is not a machine learning algorithm.
§ 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.