(15 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 cross-sectional 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, head, 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.
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 left-ventricular 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 GXL, a combined PET/CT system, but it does not include a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. The document focuses on regulatory compliance, hardware specifications, and comparison to a predicate device.
Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:
Acceptance Criteria and Device Performance Study
The document does not detail specific "acceptance criteria" related to diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a disease) or a study proving the device meets such criteria. Instead, it refers to industry performance standards for the hardware and safety.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance/Compliance |
|---|---|---|
| Radiation Safety | Compliance with Performance Standards for Ionizing Radiation Emitting Products | - Adherence and certification to 21CFR 1020.30 and 21CFR 1020.33 (Computed Tomography Equipment). |
- Radiation safety product report filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health (CDRH). |
| Electrical and Mechanical Safety| Compliance with Applicable Safety Standards | - Adherence and certification to the applicable standards in the IEC 60601-1 series. |
| PET/CT System Performance | Measurement of device performance | - Device performance measured in accordance with the NEMA-NU2 standard. (Specific results of this measurement are not provided, only that it was conducted according to the standard). |
| Substantial Equivalence | Comparison to Predicate Device (Gemini System K041955) based on intended use, technological comparison, and system performance | - Intended use is similar. - Technological differences noted: option of 6, 10, or 16 slice CT; larger PET bore size; removal of Cs-137 transmission source; modification of various PET performance specifications; modifications to reconstruction.
- Conclusion: Substantially equivalent to predicate devices based on similar intended use, technological comparison, and system performance (implies that modifications did not raise new questions of safety or effectiveness, and the device performs comparably to the predicate). |
Missing Information:
- There are no specific performance metrics (e.g., image resolution, contrast, artifact levels, clinical accuracy, sensitivity, specificity, AUC) and corresponding acceptance thresholds for these metrics.
- The results of the NEMA-NU2 standard measurements are not provided. NEMA-NU2 details methods for measuring PET scanner performance, but the document only states it was measured "in accordance" with the standard, not the specific results obtained.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. The provided text does not describe a clinical study with a "test set" of patient data for evaluating diagnostic performance. The performance tests mentioned (radiation, electrical/mechanical safety, NEMA-NU2) are related to the physical properties and technical performance of the device, typically using phantoms or engineering tests, not patient data for diagnostic evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. As there is no clinical test set described for diagnostic performance evaluation, there is no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study or any study comparing human reader performance with or without AI assistance. The device description is for the PET/CT system itself, not an AI software component for image interpretation.
6. Standalone (Algorithm Only) Performance Study:
- No. The document does not describe any standalone algorithm performance study. The Gemini GXL is a hardware imaging system.
7. Type of Ground Truth Used:
- Not Applicable. For the technical performance tests mentioned (NEMA-NU2), the "ground truth" would be the known physical properties of the phantoms used or the established specifications of the test equipment. For clinical diagnostic performance, no such ground truth is discussed.
8. Sample Size for the Training Set:
- Not Applicable. The document describes a medical imaging device (hardware and its inherent software for image acquisition and reconstruction), not a machine learning or AI algorithm that would typically require a "training set." The software mentioned for image processing, analysis, and display is likely rule-based or conventional algorithmic software, not deep learning requiring large training datasets.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As no training set is mentioned, this question is not relevant.
In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of a new PET/CT system (Gemini GXL) to a previously cleared predicate device. It addresses regulatory compliance for safety and technical performance standards (like NEMA-NU2) but does not include a clinical study with acceptance criteria related to diagnostic accuracy, patient data analysis, or the use of expert ground truth, which are typically found in submissions for AI/ML-based diagnostic software.
§ 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.