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The SPECTRADigital™ Series V250DSP system with 5/8" crystal option are identical to the intended uses of the SPECTRADigital™Series V250DSP camera cleared under K954129 including acquisition of SPECT, planar, and wholebody imaging of all organ systems utilizing FDA approved radiopharmaceuticals in the energy range from 50 to 511 keV. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination.

Imaging capabilities with the Thick Crystal (5/8") Nal(TI) option include:

• All SPECT and Planar procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling
• High and normal count-rate dynamic planar and SPECT
• In conjunction with additional options for Coincidence and transmission based imaging, the detector performance and characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs)
• Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.

The SPECTRADigital™ series gamma camera systems are area detectors designed to detect gamma rays emitted from the decay of radioisotopes injected into a patient. The position of the decay is calculated (a ray from the event to the detector) by the system, and stored. The positions of a large number of decay events forms an electronic image of the location of the radioactive material. This image can be displayed on a CRT or transferred to photographic film for review. The collection of data at multiple detector positions allows three dimensional information to be obtained by tomographic means. The addition of thicker Nal(TI) crystals enhance efficiency of detection at higher energies with minimal loss of imaging performance over energy ranges used routinely.

The provided text is a 510(k) summary for the Hitachi SPECTRADigital™ V250DSP Gamma Camera System with a thick NaI(Tl) crystal. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and human reader performance.

Here's an analysis based on the information provided, highlighting why some requested sections cannot be fully addressed:

Device: Hitachi SPECTRADigital™ V250DSP Gamma Camera System with thick NaI(Tl) crystal

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing technical performance characteristics under NEMA NU1-1994 standards.

Summary of the study that "proves" the device meets acceptance criteria:

The study conducted was a technical comparison against a predicate device using the NEMA NU1-1994 standards. This is a non-clinical, bench-top type of evaluation, rather than a clinical trial assessing patient outcomes or diagnostic accuracy with human readers. The core of the argument for acceptance is that the new device (with the thicker crystal) maintains the same fundamental technology and offers comparable, or improved (for higher energies), performance characteristics as the already cleared predicate device.

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

• Test Set Description: The "test set" in this context refers to the measurements and characterizations performed on the gamma camera system according to NEMA NU1-1994 standards, rather than a set of patient cases.
• Sample Size: Not applicable in the sense of patient cases. The evaluation involved testing the physical and performance characteristics of the device itself.
• Data Provenance: The NEMA NU1-1994 standards are general industry standards for performance measurements of gamma cameras. The tests were likely performed in a laboratory setting by Hitachi Medical Corporation. The document does not specify the country of origin of the data beyond "Hitachi Medical believes..." implying internal testing. It is a prospective technical evaluation of the device.

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

Not applicable. This was a technical comparison of device performance against a predicate and industry standards, not a clinical study requiring expert interpretation of medical images to establish ground truth about patient conditions.

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

Not applicable. There was no clinical ground truth requiring adjudication by experts.

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, an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable. This device is a gamma camera system, a hardware device for acquiring images, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. The device itself (gamma camera) has standalone performance in terms of image acquisition, but this is characterized by technical specifications using NEMA standards, not an "algorithm only" performance. There is no AI algorithm being evaluated here.

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

The "ground truth" for this submission is the NEMA NU1-1994 standards for gamma camera performance and the established performance of the predicate device (SPECTRADigital™ V250DSP with 3/8" crystal). The thick crystal option aims to achieve comparable performance, or improved detection efficiency for higher energies, while maintaining the predicate's overall characteristics.

8. The sample size for the training set

Not applicable. This is a hardware device submission, not a machine learning model. There is no training set in the AI/ML sense.

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

Not applicable, as there is no training set.

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