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The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion).

The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of racer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

The GE Discovery NM/CT 570c system is a back-to-back combination of the Ventri 1.1 SPECT scanner (K080124) and the LightSpeed 7.1 CT scanner (K061817), sharing a common LightSpeed 7.1 patient table. In addition to providing CT and SPECT standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the SPECT images and to facilitate localization of the emission activity in the patient anatomy.

The provided document describes the GE Discovery NM/CT 570c system, a combination of SPECT and CT imaging systems. However, the available text does not contain detailed acceptance criteria, specific study results in terms of numerical performance metrics, or information regarding sample sizes, data provenance, expert qualifications, or adjudication methods for studies typically associated with AI/algorithm performance claims.

The submission is for a device system (hardware and associated software), not specifically an AI-driven diagnostic device as per modern understanding. Therefore, many of the requested categories like "multi-reader multi-case comparative effectiveness study" or "standalone algorithm performance" are not applicable in this context.

Here's an attempt to fill in the table and provide information based only on the provided text, with many fields necessarily marked as "Not Applicable" or "Not Provided."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not provided. The document mentions "Data acquired with uniform phantom," indicating a phantom study was conducted. No patient sample size for a test set is mentioned.
• Data Provenance: The study was conducted with a "uniform phantom." No country of origin for data or retrospective/prospective nature is specified, although phantom studies are typically controlled laboratory experiments.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided. The evaluation appears to be based on physical phantom data and direct measurement/observation of image characteristics (uniformity, localization) rather than expert interpretation of patient images for ground truth.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The evaluation described involves a "uniform phantom" and is focused on the physical performance of the system (attenuation correction, localization) rather than a diagnostic performance study requiring expert adjudication of clinical cases.

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, not applicable. This submission predates widespread AI in medical imaging devices and does not describe any human-in-the-loop diagnostic assistance features or related studies. The device is a scanner system, not an AI diagnostic tool.
• Effect size: Not applicable.

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

• Standalone Performance: Not applicable as per the modern definition of an "algorithm only" device. The "data acquired with uniform phantom" is essentially a technical validation of the system's performance (attenuation correction, localization) in a controlled setting, which could be considered a form of standalone performance for the system as a whole, but not an AI algorithm.

7. The type of ground truth used

• Ground Truth Type: For the phantom study, the "ground truth" implicitly refers to the known physical properties and uniformity of the phantom. For clinical applications, substantial equivalence relies on the established performance of the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used for the performance evaluation detailed in the summary.

8. The sample size for the training set

• Sample Size for Training Set: Not provided. This being a conventional imaging system rather than an AI/machine learning device, the concept of a "training set" for an algorithm, as typically defined, is not directly applicable.

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

• Ground Truth for Training Set: Not applicable. As above, there is no mention of an AI algorithm training set. The device functions based on established physics and engineering principles for SPECT and CT imaging, with software for processing and fusion.

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The GE LightSpeed 7.2 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed 7.2 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The GE LightSpeed 7.2 CT Scanner System is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. It is an evolutionary modification to the LightSpeed 7.1 (K061817). It is developed from the hardware platform of the 64 slice LightSpeed 7.1 system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed 7.2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The provided text is a 510(k) summary for the GE LightSpeed 7.2 CT Scanner System. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for AI/software-based performance evaluation.

CT scanners, like the GE LightSpeed 7.2, are generally evaluated for performance through a series of technical specifications andphantom studies to ensure image quality, dose, and other physical parameters meet established standards. These standards are typically defined by regulatory bodies (like the FDA, IEC, UL) and industry best practices. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy or performance metrics for each iteration, unless there are significant changes that could impact safety or effectiveness.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This detailed performance data against specific acceptance criteria for a new AI/software feature is not present. The document focuses on regulatory compliance and substantial equivalence to existing CT scanners.
• Sample sizes used for the test set and the data provenance: No such data is provided as there isn't a "test set" in the context of an AI performance evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multicase (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document states that the GE LightSpeed 7.2 CT Scanner System undergoes:

• System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
• Adherence and certification to industry and international standards (e.g., UL 60601-1, IEC 60601-1, and associated collateral and particular standards, 21CFR Subchapter J, 21CFR1020.30 and 1020.33 for X-ray requirements).
• Risk management (hazard analysis) to identify and control potential electrical, mechanical, and radiation hazards.
• Compliance with Quality System Regulations of 21CFR820.

The conclusion is that the device is an "evolutionary modification" and "does not result in any new potential safety risks and performs as well as or better than devices currently on the market," and is considered substantially equivalent to predicate devices. This indicates that its performance is presumed to meet the same established safety and effectiveness levels as the predicate devices, which would have undergone their own technical performance evaluations at the time of their clearance.

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The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16/ LightSpeed Xtra) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed RT18 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT18/ LightSpeed Xtra) is indicated for head, whole body, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).

When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.5 seconds (at full) per rotation, and can acquire up to 16 slices of data per rotation with a maximum total coverage of 20mm in the axial direction. The system can be operated in Axial, Cine, Helical, Fluoro and Gated acquisition modes.

The GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

This 510(k) summary describes a GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System. The submission focuses on substantial equivalence to a predicate device and safety considerations rather than demonstrating performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided text.

Specifically:

• No detailed acceptance criteria with performance metrics are provided. The document outlines the device's technical specifications and intended use but does not list specific quantitative performance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) that a study would then prove the device meets.
• No specific study is described that tests the device's diagnostic performance against established acceptance criteria. The document mentions "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" and "Adherence and certification to industry and international standards." However, these refer to engineering and regulatory compliance, not a clinical study demonstrating diagnostic effectiveness.

Therefore, the following points will indicate that the information is "Not Available in the provided text" where the document does not contain the answer.

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device against such criteria. It emphasizes substantial equivalence to a predicate device and compliance with safety and regulatory standards.

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

• Sample Size: Not Available in the provided text
• Data Provenance: Not Available in the provided text

Explanation: As no study demonstrating diagnostic performance is described, information on sample size and data provenance for a test set is not provided.

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

• Number of Experts: Not Available in the provided text
• Qualifications of Experts: Not Available in the provided text

Explanation: Without a described study involving ground truth establishment, this information is not available.

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

• Adjudication Method: Not Available in the provided text

Explanation: This information is not available as no study involving expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study Done: No.
• Effect Size: Not Applicable.

Explanation: The document describes a CT scanner system, not an AI-powered diagnostic device or a system designed to assist human readers in a diagnostic task that would typically involve an MRMC study assessing AI assistance.

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

• Standalone Performance Study Done: No.

Explanation: This device is a CT scanner, an imaging modality, not an algorithm, so a standalone algorithm performance study is not applicable in the context described.

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

• Type of Ground Truth: Not Available in the provided text

Explanation: No study requiring the establishment of diagnostic ground truth is described.

8. The sample size for the training set:

• Sample Size: Not Available in the provided text

Explanation: As this is primarily a hardware submission for a CT scanner system, and not an AI/algorithm-focused submission, there is no mention of a training set.

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

• Ground Truth Establishment: Not Available in the provided text

Explanation: No training set is mentioned in the document.

Summary of the Document's Approach:

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (GE LightSpeed Xtra CT Scanner System K060052) and compliance with regulatory and safety standards for the manufacturing and operation of the CT scanner. It highlights:

• The new device is an "evolutionary modification" to an existing platform.
• It shares "virtually the same materials and identical operating principle" as the predicate.
• It has "similar indications for use."
• It complies with X-ray requirements (21CFR1020.30 and 1020.33) and safety standards (UL 60601-1, IEC 60601-1).
• Risk management and verification/validation ensure performance to specifications and user requirements.

This type of submission typically does not involve new clinical studies to establish diagnostic accuracy against specific human-interpretable acceptance criteria, but rather demonstrates that the updated device performs equivalently and safely to its predicate.

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The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed CT750 HD CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

If the spectral imaging option is included on the system, the system can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

The GE LightSpeed CT750 HD CT Scanner System (aka LightSpeed 8.0) is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The GE LightSpeed CT750 HD Scanner System is an evolutionary modification to LightSpeed 7.1 (K061817). It is developed from the hardware platform of LightSpeed 7.1 32/64 slice system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE LightSpeed CT750 HD Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

This 510(k) premarket notification is for the GE LightSpeed CT750 HD CT Scanner, which is a Computed Tomography X-ray System. The submission claims substantial equivalence to the GE LightSpeed 7.1 CT Scanner System (K061817).

1. Table of acceptance criteria and the reported device performance:

The document focuses on substantiating equivalence rather than defining and meeting specific analytical performance acceptance criteria for an AI/CAD system. The acceptance criteria for the GE LightSpeed CT750 HD are implicitly based on demonstrating that it performs as well as or better than the predicate device (GE LightSpeed 7.1) and adheres to relevant safety and regulatory standards.

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

The document does not describe a "test set" in the context of evaluating an AI or CAD algorithm. Instead, it describes modifications to a CT scanner system. Therefore, there is no specific sample size of images or patients for a test set mentioned, nor is there information on data provenance (country of origin, retrospective/prospective). The study focuses on system-level verification and validation against technical specifications and regulatory standards.

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

Not applicable, as no test set requiring expert-established ground truth for an AI/CAD algorithm is described. The evaluation is for a CT scanner system's performance and safety.

4. Adjudication method for the test set:

Not applicable, as no test set requiring adjudication for an AI/CAD algorithm 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:

Not applicable. This submission is for a medical imaging device (CT scanner), not an AI or CAD software intended to assist human readers. Therefore, an MRMC study related to AI assistance is not described.

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

Not applicable. This submission is for a CT scanner, not a standalone AI algorithm.

7. The type of ground truth used:

Not applicable in the context of an AI/CAD algorithm. For the CT scanner system, the "ground truth" implicitly refers to established engineering specifications, performance metrics (e.g., image quality parameters, dose), and compliance with international safety and performance standards. The device's performance is verified and validated against these objective measures.

8. The sample size for the training set:

Not applicable. This submission is for a CT scanner hardware and integrated software system, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model described in this submission.

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