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The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration.

The NM or PET data can be coupled with registered and or fused CT or MR scans, and with physiological sigmals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scamed body tissue for clinical diagnostic purposes.

The DaTQUANT optional application enables visual evaluation and quantification of 1231-ioflupane (DaTscanTM) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscanTM) images. These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.

The Q.Lung AI application may aid physicians in:

-Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies.

-Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe, bilobectomy, or pneumonectomy.

The Q.Brain application allows the user to visualize and quantify relative changes in the brain's metabolic function or blood flow activity between a subject's images and controls, which may be resulting from brain functions in: -Epileptic seizures

-Dementia. Such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, vascular dementia, and frontotemporal dementia.

-Inflammation

-Brain death

-Cerebrovascular disease such as Acute stroke, Chronic and acute ischemia

-Traumatic Brain Injury (TBI)

When integrated with the patient's clinical and diagnostic information may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries.

The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scamers and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD).

The Exini Bone application is intended to be used with NM bone scans for the evaluation of adult male patients with bone metastases from prostate cancer. Exini Bone quantifies the selected lesions and provides a Bone Scan Index value as adjunct information related to the progression of disease.

The Q.Liver application provides processing, quantification, and multidimensional review of Liver SPECT/PET and CT images for display, segmentation, and a calculation of the SPECT 'liver to lune' shunt value and the patient's Body Surface Area (BSA) for use in calculating a therapeutic dose for Selective Internal Radiation Therapy (SIRT) treatment using a user defined formula.

The O.Thera AI application allows physicians review and monitor patient radiation doses derived from nuclear medicine imaging data, including SPECT/CT, PET/CT, and Whole-body Planar images, and from biological samples from the patient. The application provides estimates of isotope residence time, absorbed dose, and equivalent dose at the whole organ level, as well as estimates of whole-body effective dose. The output from Q.Thera AI may aid physicians in monitoring patient radiation doses.

For use with internally administered radioactive products. O.Thera AI should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing informations.

Xeleris V Processing and Review System is a Nuclear Medicine Software system that is designed for general nuclear medicine processing and review procedures for detection of radioisotope tracer uptake in the patient's body, using a variety of individual processing applications orientated to specific clinical applications. It includes all of the clinical applications and features in the current production version of the predicate Xeleris V and, introduces two clinical applications

Q.Thera AI: The Q.Thera Al application allows physicians review and monitor patient radiation doses derived from nuclear medicine imaging data, including SPECT/CT, and Whole-body Planar images, and from biological samples from the patient. The application provides estimates of isotope residence time, absorbed dose, and equivalent dose at the whole organ level, as well as estimates of whole-body effective dose. The output from Q.Thera Al may aid physicians in monitoring patient radiation doses.

Q.Thera AI is a modification to the predicate's Dosimetry Toolkit application for enhancing site's dosimetry workflow through the following updates:

• Image Pre-Processing: Q.Thera Al uses the predicate's Q.Volumetrix MI application for image preprocessing, bringing additional automated organ segmentations as well as enabling dosimetry on PET/CT imaging data.
• Dosimetry Calculations: Q.Thera Al adds calculation of radiation doses to Dosimetry Toolkit's previous determination of isotope residence time. Similar to the reference Olinda/EXM (K163687), the added calculations follow the guidelines published by the Medical Internal Radiation Dose (MIRD) committee of the Society of Nuclear Medicine (SNM) and models from publication Nº 89 of the International Commission on Radiological Protection (ICRP).

Generate Planar: The Generate Planar application produces 2D derived planar images from 3D SPECT images that are acquired using GE Healthcare's StarGuide SPECT-CT system (K210173). Generate Planar was first cleared on Xeleris 4.0 (K153355). It was also included in StarGuide's 510(k) clearance for producing derived planar images from hybrid SPECT-CT studies. Xeleris V brings the Generate Planar application from Xeleris 4.0 and expands it to also produce derived planar images from SPECT-only studies.

This document does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in a clinical study report. The document is a 510(k) summary for the Xeleris V Processing and Review System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical trial with detailed performance metrics and acceptance thresholds.

However, based on the information provided, we can infer some aspects related to the evaluation of the new applications, Q.Thera AI and Generate Planar, that are part of the Xeleris V system.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

The document does not provide a table with explicit acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) or quantitative reported device performance for the Q.Thera AI and Generate Planar applications against predefined thresholds.

Instead, the non-clinical testing sections describe the scope of testing for these new applications:

• Q.Thera AI: "Bench testing for Q.Thera AI confirmed the correctness of the resulting radiation doses across different possible combinations (e.g. models, organs, isotopes) of calculations."
• Generate Planar: "For Generate Planar, bench testing demonstrated similarity between derived planar images produced from SPECT only studies to derived planar images produced from SPECT-CT studies. Similarity was demonstrated using representative clinical datasets for a variety of factors that impact attenuation levels (e.g. body region, BMI)."

These statements highlight that the "acceptance criteria" were qualitative demonstrations of "correctness" for Q.Thera AI calculations and "similarity" for Generate Planar images. There are no numerical performance metrics or thresholds mentioned.

2. Sample size used for the test set and the data provenance:

• Q.Thera AI: The document mentions "different possible combinations (e.g. models, organs, isotopes) of calculations" for bench testing, but does not specify a sample size for the test set or the number of cases. The data provenance is also not explicitly stated (e.g., country of origin, retrospective/prospective).
• Generate Planar: "representative clinical datasets for a variety of factors that impact attenuation levels (e.g. body region, BMI)" were used. Again, the specific sample size, number of cases, and data provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The testing described is bench testing focusing on internal correctness and similarity, not necessarily involving expert-derived ground truth on a test set of patient cases for diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no external expert review or adjudication of performance on a clinical test set is 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:

No MRMC comparative effectiveness study is mentioned. The document explicitly states: "The proposed Xeleris V did not require clinical studies to support substantial equivalence." This implies that no studies comparing human reader performance with and without AI assistance were conducted as part of this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The descriptions of "bench testing" for both Q.Thera AI and Generate Planar imply standalone evaluations of the algorithms' outputs against expected "correctness" or "similarity" without human intervention for interpretation or diagnosis. However, specific standalone performance metrics (e.g., accuracy against a gold standard) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Q.Thera AI: The "correctness of the resulting radiation doses" implies a ground truth based on established dosimetric models and calculations (e.g., "MIRD committee of SNM and ICRP Publication 89"). This would be a ground truth derived from established scientific/medical formulas and guidelines rather than expert consensus on patient data or pathology.
• Generate Planar: "similarity between derived planar images" suggests a ground truth or reference for comparison were other derived planar images (from SPECT-CT studies as cleared on Xeleris 4.0), rather than a clinical ground truth like pathology.

8. The sample size for the training set:

The document does not provide information about the training set size for the AI components of Q.Thera AI or Generate Planar. Given the nature of the description (dosimetry calculations based on models and similarity of image generation), it's possible that these are more rule-based or model-based applications rather than deep learning models requiring large training datasets, but this is not explicitly stated.

9. How the ground truth for the training set was established:

This information is not provided, as details about a training set are absent.

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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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