(56 days)
The Vereos PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and Xray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The Philips Vereos PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.
The proposed Vereos PET/CT systems is an integrated diagnostic X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) system designed for a wide range of diagnostic applications. Computerized Tomography (CT) is a medical imaging technique that uses X-rays to obtain cross sectional images of the head or body. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images provide useful diagnostic information. Positron Emission Tomography (PET) uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional images of biochemical and metabolic processes of organs within the body. The proposed Vereos PET/CT system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for therapeutic planning. The system also provides tools for the quantifying results from the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease. The system is comprised of the following system components/subsystems: positron emission tomography (PET); X-ray computed tomography (CT); a patient table; Operating station; Reconstruction Servers. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. These components of the proposed Vereos PET/CT are identical to the currently marketed and predicate device Ingenuity TF Digital PET/CT (K123599) with respect to technological specifications.
The document provided describes a 510(k) submission for the Vereos PET/CT system, asserting its substantial equivalence to a predicate device (Ingenuity TF Digital PET/CT, K123599). The majority of the document focuses on demonstrating that changes made to the Vereos PET/CT do not impact device safety and effectiveness, and that its fundamental scientific technology, intended use, and performance are identical or equivalent to the predicate.
Therefore, the "acceptance criteria" discussed are largely in reference to maintaining equivalence with the predicate device's performance, as measured against established industry standards for PET/CT systems, rather than defining novel performance benchmarks for a new device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the entire device as a new product with novel performance claims. Instead, it details how specific changes to the device (from the predicate) were verified to ensure they meet existing standards and do not degrade performance.
The "acceptance criteria" here are therefore related to demonstrating that the modified Vereos PET/CT remains compliant with relevant standards and performs comparably to the predicate device.
| Performance Metric (Acceptance Criteria) | Reported Device Performance (as per verification) |
|---|---|
| CT Slice Thickness (Reconstruction): Range of CT slice thickness. | Changed from 0.5-12mm to 0.5-15mm. The document states 0.5mm is available using 2x0.5mm collimation with Ultra-High resolution mode in an axial scan, and 15mm is available using 12x1.25mm collimation with CCT protocol, introduced with iPatient software from Ingenuity CT (K160743). This change does not impact safety/effectiveness as the CT Gantry itself is identical to the Philips Ingenuity CT System (K160743). |
| Operating Temperature of PET Detector Tiles: Operating range for PET detector tiles. | Increased operating temperature. This change mitigates condensation risk and improves cooling system reliability. |
| System Sensitivity (NEMA NU-2 standard): ≥ 5.5 cps/kBq | Changed to ≥ 5.1 cps/kBq. The document attributes this change to the increased operating temperature. It states that "Image quality assessment during the system verification determined that the image quality was acceptable and no recognizable artifacts were identified." This implies the new sensitivity, while lower, still meets acceptable image quality standards. |
| Scatter Fraction (NEMA NU-2 standard): ≤ 30% | Changed to ≤ 35%. The document clarifies that "The system meets the essential performance threshold for NEMA NU2 scatter fraction of less than or equal to 46%." This change is described as a "refinement of the requirement based on verification testing data" and "acceptable without affecting system performance." |
| Cardiac Scan Reconstruction Tagging: Correct tagging functionality. | Software patch released to fix defect. The verification results "indicated that there are no changes in safety and performance of the proposed Vereos PET/CT." |
| Detector Material - LSO vs. LYSO: Performance equivalence between different crystal materials. | New Detector material LSO added (in addition to LYSO). Verified for "Spatial Resolution, Sensitivity, Scatter Fraction Count Losses and Randoms Measurement and Corrections, Image Quality, Accuracy of Attenuation and scatter Corrections." Verification results "indicated that there are no changes in safety and performance of the proposed Vereos PET/CT." |
| Couch Horizontal Maximum Speed: Couch movement speed. | Changed from 170 mm/s to 185 mm/s. This change "does not impact clinical performance of the device." The couch design remains compliant with IEC 60601-1 and 60601-2-44 standards. |
| Couch Drive Chain and 10 mm Stop Distance: Reliability and noise reduction. | Design changes implemented. "No changes to performance requirements" implied, indicating that the original performance characteristics are maintained or improved in reliability/noise. |
| Compliance to International and FDA Recognized Consensus Standards and Guidance Documents (e.g., IEC 60601 series, NEMA NU-2:2012, ISO 14971, cybersecurity guidance). | Demonstrated compliance. "Non-clinical performance testing has been performed on the proposed Vereos PET/CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s)." This is a blanket statement of conformance to a long list of standards (listed in the "Summary of Non-Clinical Performance Data" section). |
| Image Quality: Acceptable image quality. | "Image quality assessment during the system verification determined that the image quality was acceptable and no recognizable artifacts were identified." (Specific to sensitivity change). "Sample clinical images were provided with this submission, which were reviewed and evaluated by certified radiologists. All images were evaluated to have good image quality." (General) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data or case numbers for clinical evaluation. The verification and validation activities described are largely engineering and technical performance tests on the device itself.
- Sample Size for Test Set: Not explicitly stated as patient or case numbers. Non-clinical performance testing involved testing the device against various standards and design input requirements.
- Data Provenance: Not applicable as no specific patient data or clinical images for a separate "test set" are mentioned beyond "sample clinical images" which were evaluated for good image quality. The primary evaluation method was demonstrating compliance with engineering standards and comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified for establishing ground truth for a discrete clinical "test set."
- Qualifications: "Certified radiologists" are mentioned as having reviewed and evaluated "sample clinical images" for good image quality. No further details on their number or experience are provided. It's important to note this was for general image quality assessment, not for establishing ground truth for a specific diagnostic task against a test set.
4. Adjudication Method for the Test Set
Not applicable, as no formal clinical test set requiring ground truth adjudication based on expert consensus is described. The evaluations were primarily technical performance tests and assessment of image quality by radiologists.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study is not mentioned as having been performed. The submission relies on demonstrating substantial equivalence to a predicate device through technical performance, adherence to standards, and general image quality assessment, not improved human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Vereos PET/CT is a diagnostic imaging device (hardware and integrated software) and not an AI-driven algorithm designed to perform a diagnostic task independently. The improvements cited are in the device's technical specifications and system components.
7. Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" implicitly used is adherence to established industry standards (e.g., NEMA NU-2, IEC 60601 series) and the device's own established design input requirements. For image quality, the "ground truth" was the assessment of "good image quality" by certified radiologists. There is no mention of pathology or outcomes data being used as ground truth.
8. Sample Size for the Training Set
Not applicable. The Vereos PET/CT is a medical imaging device comprising hardware and software for image acquisition and reconstruction, not an AI model that requires a "training set" in the conventional machine learning sense for diagnostic purposes. The software changes mentioned are bug fixes or feature extensions, not typically requiring large training datasets as described for AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI algorithm is mentioned.
§ 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.