(8 days)
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.
Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:
- The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
- The detection, localization, and staging of tumors and diagnosing cancer patients.
- Treatment planning and interventional radiology procedures.
The device includes software that provides a quantified analysis of regional cerebral activity from PET images.
Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of leftventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.
Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.
The provided text describes the GEMINI Condor system, a combined PET/CT scanner, and its 510(k) submission. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or adjudication methods.
The document focuses on:
- General Information: Device name, classification, predicate devices, and intended use.
- Safety and Performance Standards: Mentions adherence to 21 CFR 1020.30 & 1020.33 (Performance Standards for Ionizing Radiation Emitting Products) and NEMA NU-2 standard for device performance measurement.
- Comparison to Predicate Devices: States that the device is substantially equivalent based on similar intended use, technological comparison, and system performance, but without presenting a comparative study.
- FDA Clearance Letter: Confirms the 510(k) clearance for marketing.
Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I describe a study that explicitly proves the device meets those criteria with the requested details.
The document implies that the device performance was measured according to NEMA NU-2 standards, which are general performance standards for PET scanners (and combined PET/CT systems). To fulfill your request, specific quantitative acceptance criteria derived from these standards, and the actual measured performance values from a study, would be needed.
If the information were available in the provided text, here's how I would structure the answer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (e.g., Spatial Resolution) | Acceptance Value/Range | Reported Device Performance | Unit |
|---|---|---|---|---|
| [Example] PET Performance | Axial Spatial Resolution | 6.0 kcps/MBq | 6.2 kcps/MBq | - |
| [Example] CT Performance | CTDIvol (Head) | X % at Y lp/cm | Z % at Y lp/cm | % |
| ... (Additional metrics as per NEMA NU-2 and CT standards) ... |
2. Sample size used for the test set and the data provenance:
Information not available in the provided text. The document refers to "System Performance Test/ Summary of Studies" but doesn't detail specific test sets or data provenance. It only states that performance was "measured in accordance with the NEMA-NU2 standard." This standard typically involves phantom studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Information not available in the provided text. As this is a performance evaluation of the imaging system itself (likely using phantoms and physical measurements), human experts for ground truth establishment are not typically involved in the initial performance characterization described here.
4. Adjudication method for the test set:
Information not available in the provided text. Not applicable for performance testing of a physical system based on physical measurements or phantom images.
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:
Information not available in the provided text. The document describes an imaging device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be expected.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Information not available in the provided text. This is a physical imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Information not available directly in the provided text, but inferred. For a performance evaluation against NEMA NU-2 and CT standards, the ground truth would be based on physical phantom measurements and known characteristics of the phantoms (e.g., known activity concentrations, known lesion sizes, known material densities).
8. The sample size for the training set:
Information not available in the provided text. The document does not describe a machine learning algorithm that requires a training set. The "software that provides a quantified analysis" and cardiac imaging software are features of the device, but there's no mention of a machine learning component requiring a distinct training set for its development.
9. How the ground truth for the training set was established:
Information not available in the provided text. Not applicable given the lack of information on a training set.
In summary, the provided 510(k) document is a regulatory submission for a medical device and confirms its substantial equivalence to predicate devices, focusing on safety, intended use, and general performance standards adherence. It does not contain the detailed study results and performance metrics requested for acceptance criteria.
§ 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.