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The GE Discovery ST System is intended for head and whole body attenuation of The OE Disorion Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

The Discovery ST is to be used by trained health care professionals for imaging the rne Broom of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, (frolloodial) and follow up of lesions, disease and organ function such as (but not Staging, rootaging, and ivascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.

The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

The Discovery ST 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 ST 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.

Here's a breakdown of the acceptance criteria and the study information derived from the provided text for the GE Discovery ST System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text, a 510(k) summary for a medical device (GE Discovery ST System), does not explicitly state quantitative "acceptance criteria" in the way one might see for performance metrics like sensitivity, specificity, or image resolution thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (GE Discovery LS System).

Therefore, the "acceptance criteria" are implied by the regulatory requirement for substantial equivalence, meaning the device must perform at least as well as or similarly to the predicate device for its intended uses. The "reported device performance" is framed in terms of its ability to achieve these intended uses, supported by data from the predicate device and existing scientific literature.

• Head and whole body attenuation corrected PET imaging.
• Localization of emission activity using integrated PET and CT images. | The Discovery ST shares the same intended use statement as the predicate device (GE Discovery LS System, K040172).
  Discovery LS bench and clinical data demonstrate the ability of Discovery ST to:
• Image injected radiopharmaceuticals for assessment of metabolic (molecular) and physiologic functions.
• Use integrated CT and PET images to localize metabolic activity and FDG uptake in patient anatomy. |
  | Functionality for Medical Assessment:
• Aid in evaluation, diagnosis, staging, restaging, and follow-up of lesions, disease, and organ function (e.g., cancer, cardiovascular disease, brain dysfunction).
• Assist in radiotherapy planning. | Numerous published medical and scientific articles document the use of PET and PET-CT in evaluation of cancer, cardiovascular disease, and brain dysfunction. (This supports the clinical utility of the underlying technology shared by both systems.) |
  | Stand-alone CT capabilities:
• Function as a stand-alone head and whole body multislice computed tomography diagnostic imaging system. | The Discovery ST can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. (Functionality is presented as being equivalent to a stand-alone CT system.) |
  | Overall Safety and Effectiveness: Substantially equivalent to the predicate device. | "In the opinion of General Electric Medical Systems, the Discovery ST System with the above revised intended use is substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery LS System with the same intended use, 510(k) K040172." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a distinct "test set" with a defined sample size. The submission refers to "Discovery LS bench and clinical data" as supporting evidence to demonstrate the ability of the Discovery ST. The specific number of patients or scans in this data is not provided.
• Data Provenance: The data used is from "Discovery LS bench and clinical data." This indicates that the data is likely retrospective, collected from studies performed with the predicate device (Discovery LS). The country of origin is not specified, but since GE Medical Systems is located in Milwaukee, WI, it's reasonable to infer a U.S. origin, though global data is also possible for large manufacturers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The statement "Discovery LS bench and clinical data demonstrate the ability..." implies that medical professionals were involved in interpreting the clinical data, but their number and specific qualifications are not detailed. The reliance on "Numerous published medical and scientific articles" also points to a broader consensus among the scientific and medical community.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a 510(k) summary relying on existing data and substantial equivalence, a formal adjudication process for a new test set designed specifically for the Discovery ST is not described.

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, an MRMC comparative effectiveness study was not reported for this device. The device itself is an imaging system (PET/CT scanner), not an AI-assisted diagnostic tool that would typically involve improving human reader performance.
• Effect Size of AI Assistance: Not applicable, as no AI assistance component is described or evaluated in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable in the context of an imaging device. The device (Discovery ST System) is the standalone technology; its "performance" is in generating images and providing localization of activity. It operates as an imaging system, not an algorithm providing interpretations independently of a human. The text highlights its ability to operate as a "stand-alone head and whole body multislice computed tomography diagnostic imaging system," which refers to its capability to function as a CT scanner on its own, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical utility of PET and PET-CT imaging (which the device performs) is established through:
  • Clinical Data/Outcomes: "Discovery LS bench and clinical data" implies comparisons to clinical findings or known conditions.
  • Pathology/Expert Consensus (Implied): The "evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function" (e.g., cancer) by trained healthcare professionals typically relies on correlation with pathology, surgical findings, and expert clinical judgment as ground truth for disease presence and extent.
  • Published Medical and Scientific Articles: The reliance on these articles indicates that the fundamental principles and established clinical utility of PET and PET-CT for various conditions serve as a broad scientific ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the context of this 510(k) submission. This submission is for an imaging system (hardware and associated software for image acquisition and reconstruction), not a machine learning model that undergoes explicit "training." The "bench and clinical data" from the predicate device serve as evidence of the underlying technology's capability, rather than a training set for a new algorithm.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a "training set" for a machine learning model. The underlying principles and performance characteristics of PET and CT imaging are well-established in clinical medicine and physics.

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