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510(k) Data Aggregation
(80 days)
The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.
Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.
The ClearVision Nuclear Medicine Imaging System acquires and processes cardiac data including gated and non-gated Single Photon Emission Computed Tomography (SPECT) studies. After completion of an acquisition, the operator can select the resulting acquisition data file to generate both qualitative and quantitative results for review by a physician. This includes processing using Release 5.6 of Segami Corporation's Mirage processing software that was previously cleared under 510(k) number K043441 dated 13-January-2005.
The acquisition system consists of either a single or dual small field-of-view detectors with each mounted on top of a tower that contains system electronics. To support the acquisition of SPECT data, the patient chair rotates up to 360 degrees in either clockwise or counterclockwise direction.
Prior to a patient scan, the following system features are used to ensure the myocardium is centered within each detector's field of view (FOV):
- . Each tower can be moved horizontally along rails mounted to the floor plate.
- . The patient chair seat pan can be moved side-to-side.
- Vertical and a horizontal beam lasers are mounted to side of detector.
The ClearVision system's compact footprint and small FOV detector are specifically designed for placement in a facility lacking adequate floor space for a typical nuclear medicine imaging system.
The provided document is a 510(k) summary for the GVI Medical Devices ClearVision Nuclear Imaging System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for the ClearVision system itself.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The document describes a comparison of features and performance characteristics to a predicate device (Digirad Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems, K070542) to establish substantial equivalence.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather presents a "Feature Comparison Summary" to demonstrate substantial equivalence to the predicate device. The performance characteristics listed are NEMA (National Electrical Manufacturers Association) standards, which are common for SPECT systems and implicitly serve as performance benchmarks.
| Feature | Acceptance Criteria (Predicate) | Reported ClearVision Performance | Does it meet acceptance criteria? |
|---|---|---|---|
| NEMA Reconstructed Spatial Resolution | 11.00 mm (for predicate) | 9.8 mm (central), 7.6 mm (tangential), 8.4 mm (radial) | The ClearVision's spatial resolution values (smaller numbers indicate better resolution) are superior to the predicate's 11.00 mm, indicating it meets or exceeds this aspect. |
| NEMA System Sensitivity | 160 cpm / uci (for predicate) | 147 cpm / uci | ClearVision's sensitivity is slightly lower than the predicate, but this is presented in the context of substantial equivalence, implying it is within an acceptable range for the intended use given other features. The document explicitly states "performs as well as the predicate". |
| NEMA Energy Resolution |
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