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D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.

Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.

This 510(k) summary describes a modification to an existing SPECT device, the D-Spect™ Cardiac Scanner System, with the primary change being the addition of a Processing Station that incorporates Cedars-Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software. The submission focuses on demonstrating the substantial equivalence of the modified device to the predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "gold standard Cedars-Sinai test cases" for computer platform testing but does not quantify the number of cases or patients.
• Data Provenance: The "gold standard Cedars-Sinai test cases" suggest that the data was generated at Cedars-Sinai Medical Center. The text does not specify if the data was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The term "gold standard Cedars-Sinai test cases" implies a pre-established, authoritative reference, but the method for their creation or any subsequent adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The clinical validation was for the QGS and QPS programs themselves, conducted by Cedars-Sinai Medical Center, rather than a comparison of human reader performance with and without AI assistance. The QPS and QGS software modules are considered quantitative analysis tools within the SPECT system, not explicitly "AI assistance" in the context of improving human reader interpretation in a comparative study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the performance testing described for the QGS and QPS programs ("Functionality tests" and "Computer platform testing... using gold standard Cedars-Sinai test cases") can be considered a standalone assessment of the algorithms' ability to process and quantify SPECT data according to their specifications. These tests focus on the software's output based on input data, without explicit human intervention in the interpretation loop during these specific validation steps.

7. The Type of Ground Truth Used

• Ground Truth Type: "Gold standard Cedars-Sinai test cases" were used. While the specific nature of this "gold standard" isn't detailed, in the context of QPS and QGS (quantitative perfusion and gated SPECT), the ground truth would likely be established from well-characterized clinical datasets with confirmed diagnoses or outcomes, possibly correlated with other imaging modalities or invasive procedures to determine actual perfusion defects or cardiac function. It implies a high level of confidence in the accuracy of these reference cases.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document focuses on the validation of existing software (QPS and QGS), which implies these programs were already trained prior to their integration into the D-Spect system. The FDA submission is about the device's substantial equivalence and the functionality of the integrated software, not the development or training of the QPS/QGS algorithms themselves.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: Not explicitly stated. As mentioned above, the focus is on the validation of pre-existing QPS/QGS software. The methodology for establishing ground truth during the original development and training of these Cedars-Sinai algorithms is not part of this 510(k) submission.

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