(27 days)
The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.
The Cardius model cameras are gantry (open gantry, upright seated) devices designed for single- (Cardius-1) or dual-detector (Cardius-2) cardiac nuclear imaging studies. The device includes an acquisition/processing station, a gantry, one or two detectors, and a gantrymounted patient imaging chair. The patient imaging chair is mechanized to accommodate patient loading and cardiac centering in the detector field of view.
The imaging chair motion control allows for acquisition of Cardiac SPECT and planar studies, including static, dynamic, gated/non-gated SPECT (circular orbit only).
The provided text describes the regulatory clearance for the Digirad Cardius-1 and Cardius-2 SPECT imaging systems, focusing on their substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill in all sections of the requested acceptance criteria and study design.
Specifically, the document states: "Comprehensive verification and validation testing was performed with the Cardius-1 and Cardius-2 devices including; hardware, software, electrical safety, and clinical imaging. All test results met pre-defined acceptance criteria. The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices."
This statement confirms that testing was done and acceptance criteria were met, but it does not provide the specific acceptance criteria, reported device performance metrics, or details about the clinical study itself.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The text only states that "All test results met pre-defined acceptance criteria" and "The quality of the clinical images produced were similar to the quality of the predicate devices." It does not specify what those acceptance criteria were (e.g., specific sensitivity, specificity, image quality metrics) or the exact reported performance against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document vaguely mentions "clinical imaging" as part of the testing. There is no information on the sample size of any test set, the country of origin of data, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information is given about how ground truth was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information on adjudication is present.
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
- Cannot be provided. The device is a SPECT imaging system, not explicitly an AI/CAD device for interpretation. The document doesn't mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Cannot be determined. This device is an imaging system (hardware and software for acquisition and basic processing), not a standalone diagnostic algorithm. No information about algorithm-only performance is available.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The document does not specify the type of ground truth used for any clinical testing.
8. The sample size for the training set
- Cannot be provided. There is no mention of a "training set." The device is an imaging system, and while it would have been developed using some data, the text doesn't describe a formal "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. As there's no mention of a training set, there's no information on how its ground truth was established.
Summary of available information:
The document focuses on establishing substantial equivalence to predicate devices (Digirad 2020tc SPECT Imaging System and ADAC Forte). The primary evidence cited for meeting acceptance criteria is that "All test results met pre-defined acceptance criteria" and "The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices." This implies that the acceptance criteria primarily revolved around demonstrating performance similar to or not worse than existing cleared devices, rather than establishing absolute performance benchmarks with detailed clinical study metrics as would be expected for a novel diagnostic algorithm.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.