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510(k) Data Aggregation
(54 days)
For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.
This document describes the C! SPECT Imaging System. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance (as per submission) |
|---|---|
| Performance met or exceeded predicate devices | Performance of the C! device met or exceeded that of predicate devices (using NEMA NU1 phantoms and NEMA Standard test protocols). |
| Tomographic image quality at least equal to predicate devices | Clinical images obtained in human subjects demonstrated tomographic image quality at least equal to images produced by reference predicate devices. |
| Electrical safety met applicable standards | Electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical images were obtained using the C! in human subjects," but it does not specify the sample size for this clinical test set.
The data provenance is prospective as clinical images were "obtained ... in human subjects." The document does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used, nor their qualifications, for evaluating the clinical images. The evaluation states "Tomographic image quality was at least equal to images produced by reference predicate devices," implying an expert comparison, but details are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the clinical image evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size for human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The C! SPECT Imaging System is a hardware and software system for image acquisition. The performance testing described focuses on the overall system's image quality and does not specifically detail a standalone algorithm-only performance assessment separate from the imaging system. The performance testing refers to the "C! device" as a whole.
7. The Type of Ground Truth Used
For the phantom studies, the ground truth is based on the known physical properties of NEMA NU1 phantoms and NEMA Standard test protocols, which provide objective benchmarks.
For the clinical images, the ground truth appears to be a qualitative comparison to "reference predicate devices" by unspecified evaluators. It is not explicitly stated if this was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The device is a SPECT imaging system, and its performance evaluation focuses on its ability to acquire images, not on an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as the device is an imaging system, not an AI algorithm trained on data for interpretation), this question is not applicable.
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