(72 days)
The GE Discovery LS 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 LS 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 LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
The Discovery LS is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. 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 it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery LS has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a stand-alone head and whole body multislice computed tomography diagnostic imaging system.
This 510(k) summary for the GE Discovery LS System does not provide the specific details requested regarding acceptance criteria and a structured study demonstrating the device meets those criteria.
Here's an analysis of what is and isn't provided, based on the input text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document describes the device's intended use and states that "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals..." However, it does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report specific performance values against such criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document mentions "clinical data" but gives no indication of the number of patients or images included in any test set, nor the country of origin, or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not provided. There is no mention of experts involved in establishing ground truth for any test set, their number, or their qualifications.
4. Adjudication Method for the Test Set:
- Not provided. No information is given about any adjudication methods used, such as 2+1 or 3+1 consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not provided. The document mentions "bench and clinical data" but does not describe any MRMC study comparing human readers with and without AI assistance, nor does it report any effect sizes. The Discovery LS is an imaging system, not explicitly an AI-assisted diagnostic tool in the way a CAD system would be, so an MRMC study comparing human performance with and without AI might not be directly applicable in the terms typically associated with CAD.
6. Standalone (Algorithm Only) Performance Study:
- Not provided. While the device can be used as a standalone CT or PET system, there is no mention of a standalone algorithm-only performance study demonstrating its diagnostic capabilities independent of expert interpretation. The "Discovery LS" itself is the device, not an algorithm being validated in isolation. The document focuses on the system's ability to produce images and integrate them.
7. Type of Ground Truth Used:
- Implicitly clinical assessment (but not explicitly stated for a "ground truth" test set). The document states the device assists in "evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function." This implies that the 'ground truth' for validating the clinical utility of PET/CT imaging would ultimately be based on clinical outcomes, pathology, or expert clinical diagnosis, but it doesn't specify how ground truth was established for any specific study proving the device met acceptance criteria.
8. Sample Size for the Training Set:
- Not applicable / Not provided. The Discovery LS is described as an integrated imaging system, not a device primarily based on a machine learning algorithm that requires a "training set" in the typical sense. It leverages established PET and CT technologies. Therefore, a training set sample size related to an algorithm is not a relevant concept for this device's description.
9. How Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As with point 8, the concept of a "training set" and establishing ground truth for it is not applicable to the description of the GE Discovery LS System as presented.
Summary of the Study Mentioned:
The document briefly mentions "Discovery LS bench and clinical data demonstrate the ability of Discovery LS to image injected radiopharmaceuticals for the assessment of metabolic (molecular) and physiologic functions of the body and the ability of Discovery LS to use integrated CT and PET images to localize metabolic activity and FDG uptake in the patient anatomy." It also cites "Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction."
This suggests that the FDA submission primarily relies on:
- Bench testing: To verify technical performance characteristics of the integrated system.
- Clinical data: To show that the system can produce images and integrate them as intended for clinical applications. However, no specifics on this clinical data (e.g., patient numbers, study design, endpoints, performance metrics) are provided.
- Predicate device equivalence and existing literature: The core argument for substantial equivalence appears to be that it's a modification of an already cleared device (K023988) with a revised intended use, and that the underlying technologies (PET and CT) have established clinical utility. The "summary of studies" seems to largely refer to the general body of knowledge supporting PET/CT rather than specific, detailed studies performed on this particular modified device to demonstrate new or specific acceptance criteria.
§ 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.