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Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin 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. Griffin 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 Griffin Imaging System should only be used by trained healthcare professionals.

The Griffin SPECT/CT Imaging System (Griffin) is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT scquentially (dual-modality studies) wherein the SPECT and CT studies may be automatically co-registered 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 radionuctides 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. Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin 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 Griffin 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. Griffin 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 same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin 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 provided document is a 510(k) Premarket Notification for the Griffin SPECT/CT Imaging System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document states that the system performance was tested in accordance with the NEMA-NU-1 standard and compliance with radiation safety standards (21 CFR 1020.30 and 21 CFR 1020.33). However, it does not provide the specific acceptance criteria derived from these standards or the quantitative results of these tests. Instead, it concludes that the device is "substantially equivalent" to predicate devices based on intended use, technological comparison, and system performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information about sample sizes, experts, ground truth, or MRMC studies, as this information is not present in the provided text.

Based on the information available, here's what can be extracted regarding System Performance and Compliance:

System Performance and Compliance (as described in the document)

The document states compliance with general safety and performance standards, rather than presenting a performance study with specific acceptance criteria as you've requested.

Regarding the other requested information, the document does NOT provide the following:

1. Sample sizes used for the test set and the data provenance: No information on test sets, patient data, or data provenance is provided.
2. Number of experts used to establish the ground truth for the test set and qualifications: No information on expert review for ground truth is available.
3. Adjudication method for the test set: Not applicable as no specific test set or adjudication process is described.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document focuses on substantial equivalence to predicate devices, not improvement over human readers with AI assistance.
5. Standalone (algorithm only without human-in-the-loop performance) study: This device is an imaging system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, not a standalone AI algorithm.
6. Type of ground truth used: Not applicable as no specific performance study with a defined ground truth is described.
7. Sample size for the training set: Not applicable, as this is a hardware imaging system, not a machine learning algorithm requiring a training set in the typical sense.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

Conclusion:

The K041218 submission for the Griffin SPECT/CT Imaging System demonstrates substantial equivalence primarily by comparing its intended use, technology, and compliance with general performance and safety standards to predicate devices (Skylight Imaging System and MX8000 IDT CT System). It does not present a detailed study with quantitative acceptance criteria and results as typically found for novel diagnostic algorithms or AI-driven devices.

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