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The CARDIARC SPECT IMAGING DEVICE and its predicate device is intended to be used for production of single photon emission computed tomography clinical images of the heart in nuclear medicine applications.

The CARDIARC SPECT IMAGING DEVICE is indicated for use to produce images from the distribution of radioisotopes within the thorax, which are then interpreted by healthcare professionals to assess various anatomical structures and functions (e.g., blood flow to the heart).

The CARDIARC SPECT IMAGING DEVICE consists of an integrated patient chair which adjusts in height but does not rotate, an arc with no external moving parts, which is constructed of an internal rotating slot collimator, horizontal lead vanes separated by foam spacers, cadmium zinc telluride (CZT) detectors, and electronic components, a power supply, cooling system, and hardware and software components.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size and Data Provenance:

   • Test Set:
     • Bench Testing: NEMA NU1 phantom or equivalent phantoms. Not applicable for human subject count or provenance.
     • Cardiac Phantom Imaging: Test phantom. Not applicable for human subject count or provenance.
     • Clinical Imaging: Human subjects (specific number not provided). Data provenance (country of origin) is not explicitly stated. The study appears to be prospective as it mentions "clinical images were obtained using the CARDIARC SPECT IMAGING DEVICE in human subjects."
   • Training Set: Not explicitly stated. The document focuses on demonstrating substantial equivalence, which often leverages existing knowledge rather than a new, large-scale training set for an AI/algorithm-only device.

2. Number of Experts and Qualifications (for Test Set Ground Truth/Assessment):

   • Clinical Imaging: Board-Certified Nuclear Medicine physicians (specific number not provided) at the investigational center. Their years of experience are not specified.

3. Adjudication Method (for Test Set):

   • Not explicitly stated. The document mentions "Tomographic image quality was judged to be excellent by the Board-Certified Nuclear Medicine physicians." It does not detail if multiple physicians independently reviewed and how discrepancies were resolved (e.g., 2+1, 3+1 concensus).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned that measures the effect size of human readers improving with AI vs. without AI assistance. The study focuses on demonstrating that the device's image quality is "at least equal to" predicate devices, which implies an equivalence study rather than an effectiveness study measuring reader improvement.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, a standalone evaluation was performed. The device itself (an imaging system, not explicitly an AI algorithm in the modern sense) was evaluated in bench tests and phantom studies for its image quality and accuracy of reconstruction. Its performance was then compared to predicate SPECT systems. The "algorithm" in this context refers to the image acquisition, processing, and display capabilities of the SPECT system, which were stated to use "predicate device software."

6. Type of Ground Truth Used:

   • Bench Testing/Phantom Studies: Established standards (NEMA NU1 phantom protocols) and known characteristics of the phantoms (simulated defects).
   • Clinical Imaging: Expert consensus/interpretation by Board-Certified Nuclear Medicine physicians. Not pathology or outcomes data.

7. Sample Size for Training Set:

   • Not explicitly stated. The device utilizes "predicate device software for image acquisition, processing and display," suggesting that any training (if applicable to the software) would have been part of the predicate device's development or general SPECT imaging principles, rather than a specific new training dataset for this device.

8. How Ground Truth for Training Set was Established:

   • Not explicitly stated. Given the reliance on "predicate device software," the ground truth establishment for any underlying algorithms would likely refer to the development and validation processes of those predicate software components, which are not detailed in this submission.

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