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The GE Optima NM/CT 640 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in 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 and restaging of turnors, planning, guiding, and monitoring therapy.

The GE Optima NM/CT 640 system is a Nuclear Medicine (NM) system, which is intended to yield 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 modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging-enhancement features include an assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

The GE Optima NM/CT 640 system includes an integrated CT, which is intended specifically for attenuation correction and anatomical localization purposes only, a processing and review. workstation, and may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

Utilizing the associated CT portion and post processing, the device can produce attenuation corrected SPECT images using CT-based attenuation maps, as well as functional and anatomical mapping images registered with the SPECT images for purposes of localization and fusion.

The device does not support stand-alone CT operation.

The Optima NM/CT 640 system is a combination of the Discovery NM630 gamma camera (K111445), the certified table from the Discovery NM/CT 670 (K093514) and a 4 slice CT subsystem containing previously certified components. It consists of two back-to-back gantries, a single table, a single power distribution unit, a console with single acquisition system and associated accessories (e.g. ECG gating. Table Extender. Head Holder, etc.). The system is delivered with a processing and review workstation (currently Xeleris 3-K093982). The system is intended to be in clinics or hospitals having normal HVAC controls.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the GE Optima NM/CT 640 system, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies against acceptance criteria.

The document states: "The Optima NM/CT 640 does not require clinical studies to support substantial equivalence." This indicates that no clinical performance study, as you've described, was conducted or presented in this filing for the purpose of demonstrating performance against acceptance criteria.

Therefore, I cannot provide the requested information.

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The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in 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 and restaging of tumors, planning, guiding, and monitoring therapy.

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.

The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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 main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table. Remote Control Unit and NM operation console. The Discovery NM 630 is a subsystem of its predicate device Discovery NM/CT 670 (K093514).

The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield 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 modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multiisotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.

The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This submission states that no clinical studies were required as the device is deemed substantially equivalent to a predicate device. Therefore, there is no performance data or acceptance criteria related to clinical efficacy. The substantial equivalence is based on the device being a "stand-alone nuclear medicine functionality/components of its predicate device," meaning it does not introduce new safety risks or intended uses and performs comparably to similar devices already on the market.

Here's a breakdown of the requested information, adapted to reflect that no clinical study was performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set was used to establish performance.
• Data Provenance: Not applicable. No clinical data was used for a test set.

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

• Not applicable. No ground truth was established by experts for a test set, as no clinical studies were performed.

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

• Not applicable. No adjudication methods were mentioned as no clinical studies were performed.

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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a SPECT imaging system, not an AI-enabled diagnostic tool requiring human-in-the-loop performance evaluation.

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

• No. The device is a SPECT imaging system, not an algorithm, so a standalone performance study in the context of an algorithm's diagnostic accuracy was not performed. The "standalone functionality" mentioned refers to the device being a complete nuclear medicine system in itself, distinct from a CT component.

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

• Not applicable. No clinical ground truth was established, as no clinical studies were performed. The "ground truth" for this submission focuses on demonstrating substantial equivalence to a predicate device through technical and functional comparisons, not clinical performance metrics.

8. The sample size for the training set

• Not applicable. The device is a SPECT imaging system, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable. The device is a SPECT imaging system, not an AI/ML algorithm that requires a training set with established ground truth.

Summary of the Study (or lack thereof):

The GE Discovery NM 630 did not require clinical studies to support substantial equivalence. The argument for substantial equivalence is based on the device being a subset of its predicate device (Discovery NM/CT 670, K093514), specifically encompassing the "stand-alone nuclear medicine functionality/components." The primary reasoning is that the Discovery NM 630 employs the "same fundamental scientific technology" as the NM subsystem of the predicate device. Therefore, it is asserted that the device does not introduce new safety risks or intended uses and performs as well as or better than similar devices already on the market. Non-clinical tests were conducted which included risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, final acceptance testing, performance testing, and safety testing, all in accordance with GE's Quality System and voluntary standards. No clinical data, patient samples, or expert evaluations for diagnostic accuracy were used as part of this 510(k) submission to demonstrate performance, as it relied on technological equivalence to a legally marketed predicate.

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