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Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystems may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.

The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.

The Precedence SPECT/CT Imaging System is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT sequentially (dual-modality studies) wherein the SPECT and CT studies may be automatically coregistered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuclides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses.

Precedence is constructed from two existing systems, the Skylight SPECT Imaging System and the Brilliance CT with subsystem options of 6, 16, or 64 slice or the CVCT configuration. The Precedence has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance.

Precedence is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The clinical protocols and procedures are that are available on the modified Precedence Imaging System are the same as those on the Predicate Devices Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293). The intended use of the CV configuration CT Scanner is limited to the heart, cardiovascular, and peripheral vascular systems. Acquired SPECT and CT images on the Precedence may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image. The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).

The provided text describes the "Precedence SPECT/CT Imaging System" and its substantial equivalence to predicate devices, rather than a study with detailed acceptance criteria and reported device performance against those criteria in the way typically seen for novel AI/ML devices.

However, based on the information provided, I can infer the "acceptance criteria" relate to regulatory compliance and general system performance, and the "study" is more of a validation of substantial equivalence to a predicate device.

Here's an attempt to structure the information as requested, drawing inferences where specific details are not explicitly stated:

Acceptance Criteria and Device Performance for Precedence SPECT/CT Imaging System

The "acceptance criteria" for the Precedence SPECT/CT Imaging System are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established radiation and electrical safety standards. The "study" mentioned is a system performance test focused on these regulatory and safety compliance aspects.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of a clinical test set. The validation is based on engineering and performance standards compliance, and substantial equivalence to predicate devices. There is no mention of a patient or image test set for evaluating diagnostic performance.
• Data Provenance: Not applicable. The validation is regulatory and technical, not clinical trial-based.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert-reviewed images for diagnostic accuracy, was not established for this submission. The "ground truth" here is compliance with established engineering and safety standards and the performance of predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring ground truth establishment through expert adjudication processes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical specifications and regulatory compliance, not human reader performance with or without AI assistance. The device combines modalities; it does not explicitly state an AI component that assists human readers in a way that would warrant such a study.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The "Precedence SPECT/CT Imaging System" is a combined hardware system, not a standalone algorithm. Its performance is measured through adherence to standards like NEMA NU-1 and a demonstration that the combined system functions as intended without degrading the performance of its constituent parts.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this regulatory submission is adherence to established engineering standards (NEMA NU-1, IEC 60601-1 series), radiation safety regulations (21 CFR 1020.30 & 1020.33), and the demonstrated performance of its predicate devices. There is no mention of clinical ground truth like pathology, expert consensus on patient outcomes, or diagnostic accuracy against a gold standard.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Precedence SPECT/CT Imaging System is described as a hybrid system constructed from existing and cleared SPECT and CT systems. It does not appear to involve a de novo AI/ML component requiring a "training set" in the conventional sense. The "training" for the system refers to its design and calibration based on established physics and engineering principles, not machine learning.

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 an AI/ML algorithm. The "ground truth" for the system's development would stem from the design specifications and performance characteristics of the underlying SPECT and CT technologies, which are assumed to be well-established and validated independently.

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