(17 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 510(k) summary (K051170) is for the Philips Medical Systems Gemini GXL, a hybrid PET/CT imaging system. However, it does not contain explicit acceptance criteria or a detailed study description with specific performance metrics such as sensitivity, specificity, or accuracy for diagnosing disease.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on safety, intended use, technological comparison, and compliance with recognized industry standards. The "study" mentioned is primarily a verification of compliance with these standards, not a comparative clinical performance study in the way modern AI/CAD device submissions typically require.
Here's an attempt to answer your questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from K051170) |
|---|---|
| Safety: Compliance with Ionizing Radiation Emitting Products standards (21 CFR 1020.30 & 1020.33) and Electrical/Mechanical safety (IEC 60601-1 series). | Device adheres to recognized and established industry practice. Radiation safety assured by compliance and certification to 21 CFR 1020.30 & 1020.33. Electrical and mechanical safety assured by adherence and certification to IEC 60601-1 series. |
| Performance: Measurement in accordance with NEMA NU-2 standard for PET performance. | Device performance was measured in accordance with the NEMA-NU2 standard. |
Substantial Equivalence: Similar intended use, technological characteristics, and system performance as predicate devices (Philips Plus CT Scanner (K0333326) and Gemini System (K042935)). | The device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance. Key differences noted: option for a 64-slice CT subsystem, and addition of Syntermed NeuroO Software Application. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of patient or image data for clinical performance evaluation. The "test" mentioned refers to engineering and radiation safety performance testing.
- Data Provenance: Not applicable in the context of clinical data performance testing as described in the summary. The performance tests would have been conducted internally by Philips Medical Systems.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. The submission does not detail a study involving expert readers establishing ground truth for diagnostic accuracy, as it's primarily about demonstrating safety and technical performance standards.
4. Adjudication Method for the Test Set
- Not Applicable. No clinical test set with adjudicated ground truth is described.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. This type of study was not conducted or reported in this 510(k) summary. The device pre-dates the widespread use of AI/CAD for which such studies are now common. The
Syntermed NeuroO Software Applicationis mentioned, but its performance metrics or a human-in-the-loop study with it are not provided.
6. Standalone (Algorithm Only) Performance Study
- No. A standalone algorithm performance study as understood for AI/CAD devices was not reported. The "device" itself is the imaging system, not a specific autonomous algorithm for diagnosis.
7. Type of Ground Truth Used
- Not Applicable (for clinical performance). For the technical performance aspects, the "ground truth" would be established by physical measurements and adherence to engineering specifications and regulatory standards (e.g., NEMA NU-2 protocols). There's no clinical ground truth (like pathology or outcomes) reported for diagnostic accuracy.
8. Sample Size for the Training Set
- Not Applicable. This submission is for an imaging device, not a machine learning model requiring a specific training set of clinical images.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. (See point 8)
Summary of Device and Approval Context:
This 510(k) (K051170) is from 2005 for a PET/CT scanner. At that time, 510(k) clearances for imaging devices primarily focused on demonstrating safety (radiation, electrical, mechanical) and technical performance (e.g., image quality metrics defined by standards like NEMA NU-2) against established predicate devices. The "study" mentioned is a verification of compliance with these engineering and regulatory standards. It is not a clinical study designed to measure diagnostic accuracy (sensitivity, specificity, AUC) against a clinical ground truth, which is a common requirement for AI/CAD devices today. The mention of Syntermed NeuroO Software Application hints at post-processing capabilities, but its clinical performance is not detailed in this premarket notification.
§ 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.