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The GE NM/CT 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors; and planning, guiding, and monitoring therapy.

NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). Imaging modes include single photon, multi peak frame, with data stored frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

CT System: Intended specifically for attenuation correction and anatomical localization.

NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).

The GE NM/CT 850 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, and uptake quantitation. The system may be used for patients of all ages.

NM/CT 850 does not support standalone CT operation.

The GE NM/CT 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging of tumors; and planning, guiding, and monitoring therapy.

NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multipeak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different and planes, including Axial. Cine and Helical acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body and vascular X-Ray Computed Tomography applications

NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).

The GE NM/CT 860 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes., The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.

NM/CT 850 and NM/CT 860 consist of 2 back-to-back gantries (i.e. NM gantry carrying 2 nuclear detectors and a CT gantry), patient table, power distribution unit (PDU), operator console with two acquisition systems (i.e. NM and CT) and a digital processing system, interconnecting cables and associated accessories.
NM/CT 850 and NM/CT 860 generate NM images and CT-based attenuation correction and anatomical localization data for SPECT imaging. NM/CT 860 also generates diagnostic CT images. The NM images are generated through computer reconstruction of data acquired by a Nal-based dual detector NM system that uses a variety of planar and tomographic acquisition types. The CT images are generated by computer reconstruction of data acquired using the Revolution ACTs CT system.

The provided document is a 510(k) Pre-market Notification for the GE Healthcare NM/CT 850 and NM/CT 860 devices, which are SPECT/CT systems. The purpose of this document is to demonstrate "substantial equivalence" to existing predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them through a study.

Instead, the submission outlines non-clinical testing performed to demonstrate that the modifications to the predicate device (Discovery NM/CT 670) maintain equivalent functionality and performance. The modifications primarily involve replacing the CT subsystem with GE's 8-slice Revolution ACTs, incremental NM image quality enhancement, and the addition of a Smart Console.

Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove they are met in the traditional sense of a new device validation might not be directly applicable or explicitly stated as such in this 510(k) summary. The document emphasizes testing demonstrating equivalence to predicate devices, not setting new benchmarks.

However, I can extract the relevant information about the non-clinical testing conducted to support the claim of substantial equivalence, which serves a similar purpose in the context of this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of "acceptance criteria" for the entire device in the way one might expect for a novel AI device or a new product with entirely new performance claims. Instead, it describes "performance metrics/claims" that were tested to demonstrate substantial equivalence to predicate devices. The listed performance metrics from the "Summary of Additional Testing: Non-Clinical Testing" section are:

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

• Test Set Sample Size: The document refers to "a variety of test methods and phantoms" for non-clinical testing. For the lesion detectability and dose/time reduction evaluations, a phantom was used. No information about a "test set" of clinical data (patients/images) is provided, as the testing was non-clinical.
• Data Provenance: The data provenance is from non-clinical phantom testing conducted by GE Healthcare. This is not retrospective or prospective clinical data from human subjects. The country of origin of the data is not explicitly stated but is implied to be internal testing at GE Medical Systems Israel or other GE Healthcare facilities.

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

Not applicable in the context of this non-clinical phantom study. The "ground truth" for phantom studies is the known physical properties and configurations of the phantom itself. For the lesion detectability evaluation, while a model observer was correlated with "an average human observer," no specific number or qualifications of human experts establishing ground truth for a clinical test set are mentioned, as no clinical test set was used for this part of the evaluation.

4. Adjudication Method for the Test Set:

Not applicable, as the "test set" comprised phantoms with known configurations, not clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Given the above information and the type and scope of changes, particularly that the NM imaging component is identical to the predicate, and the CT component is virtually identical to the Revolution ACTs reference device, clinical testing is not needed to demonstrate substantial equivalence." This indicates that an MRMC study was not performed.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The non-clinical testing, particularly the use of the Channelized Hotelling Model Observer (CHO) for lesion detectability and dose/time reduction, represents a form of standalone (algorithm/system-only) performance evaluation using objective metrics on phantom data. The CHO model is an objective performance metric that predicts how well a human observer would perform.

7. The Type of Ground Truth Used:

For the non-clinical testing, the ground truth was based on the known physical properties and configurations of the phantoms used to simulate various imaging conditions and lesions.

8. The Sample Size for the Training Set:

Not applicable. This document describes a 510(k) submission for a SPECT/CT imaging device, not an AI algorithm that requires a "training set" in the machine learning sense. The "Smart Console" mentioned is an enhancement to workflow and accessibility, not an AI feature that would typically be trained on a large dataset for diagnostic output.

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

Not applicable, as there was no explicit "training set" for an AI algorithm described in this submission.

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