(70 days)
The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.
A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.
Here's a breakdown of the acceptance criteria and study information for the C-Quest System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Cardiocam K011611) | Reported Device Performance (C-Quest) |
|---|---|---|
| Intrinsic spatial resolution - Center FOV | FWHM: ≤2.8mm | |
| FWTM: ≤2.9mm | FWHM: ≤3.5mm | |
| FWTM: ≤7.4mm | ||
| Intrinsic spatial resolution - Useful FOV | FWHM: ≤5.4mm | |
| FWTM: ≤5.6mm | FWHM: ≤3.7mm | |
| FWTM: ≤7.6mm | ||
| Intrinsic Spatial Linearity - Center FOV | Differential: 0.18mm | |
| Integral: 0.38mm | Differential: ≤0.4mm | |
| Integral: ≤0.8mm | ||
| Intrinsic Spatial Linearity - Useful FOV | Differential: 0.20mm | |
| Integral: 0.40mm | Differential: ≤0.5mm | |
| Integral: ≤1.0mm | ||
| Intrinsic Uniformity - Center FOV | Integral: +/- 2.4% | |
| Differential: +/- 1.9% | Integral: +/- 2.5% | |
| Differential: +/- 1.5% | ||
| Intrinsic Uniformity - Useful FOV | Integral: +/- 2.9% | |
| Differential: +/- 2.4% | Integral: +/- 3.0% | |
| Differential: +/- 2.0% |
Note: The acceptance criteria are inferred from the predicate device's performance, as the document states that the C-Quest system performs "as well as the predicate device" and provides a direct comparison table of technical characteristics. The C-Quest device generally shows performance that is either comparable to or slightly different from the predicate, but implicitly accepted as meeting the "as well as" criterion for 510(k) substantial equivalence. For spatial resolution (FWHM, FWTM), the C-Quest performs worse in the center FOV compared to the predicate, but better in the useful FOV. For spatial linearity and uniformity, the C-Quest's reported maximums are often higher than the predicate's reported values, indicating slightly worse performance in some technical aspects, yet still deemed substantially equivalent.
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain information about a test set involving patient data for clinical performance evaluation. The study presented focuses on a technical comparison of intrinsic device characteristics against a predicate device. Therefore, clinical sample size and data provenance are not applicable to the information given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study does not involve expert review of patient data to establish ground truth.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.
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
No. This document does not mention an MRMC comparative effectiveness study. This device is a cardiac gamma camera system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The evaluation presented is a standalone technical performance study of the C-Quest system's physical characteristics (e.g., spatial resolution, linearity, uniformity) compared to its predicate. It is not evaluating an algorithm in isolation, but rather the intrinsic imaging capabilities of the hardware.
7. The type of ground truth used
The "ground truth" for this technical study is established by physical measurements and phantom studies for parameters like intrinsic spatial resolution, linearity, and uniformity, conforming to industry standards for gamma cameras. The 510(k) summary implicitly uses the established performance of the predicate device (Cardiocam) as a benchmark.
8. The sample size for the training set
Not applicable. This document describes a medical imaging device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI model, there is no training set mentioned or ground truth associated with it.
§ 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.