(13 days)
The PET/CT Patient Handling System (PHS) is a system component of CPS ECAT PET/CT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic image data are being acquired from the patient.
The ECAT PET/CT scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
The PET and the CT functions of these systems can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.
The subject device is the patient handling system (PHS) or patient bed that is used with the currently marketed CPS ECAT PET/CT scanners. The ECAT PET/CT, ECAT LSO PET/CT and ECAT LSO PET/CT 16 systems are combined position tomography (PET) and X-ray computed tomography (CT) scanners. These three dual modality PET/CT tomographs all utilize the same basic patient handling system (PHS) to support and move the patient through the patient port in the scanner gantry. Currently, vertical positioning of the patient on the bed of these PET/CT scanners is only possible when the PHS bed is fully retracted out of the patient port.
The proposed modification for the PHS used on these three PET/CT scanners, which consists of two added footswitches and revised PHS controller firmware, will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port.
The provided document is a 510(k) summary for a PET/CT Patient Handling System (PHS) modification. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not include detailed information about specific acceptance criteria or a dedicated study with the kind of quantitative performance data, ground truth establishment, or expert involvement typically associated with AI/algorithm-based medical devices.
The document states that "The modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements." However, it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.
Given the nature of the device (a patient handling system modification, not an AI or image analysis algorithm), many of the requested elements for an AI device study (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory submission.
Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for an AI-focused request:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, AUC) are NOT explicitly stated in the 510(k) summary.
The summary broadly states: "The modified PET/CT Patient Positioning System has been tested by CPS and found to meet its predetermined safety and performance requirements."
The "performance" described relates to the functionality of the modification rather than diagnostic accuracy: "The proposed modification... will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to raise/lower PHS bed a limited distance when in scanner FOV/patient port. | The modification "will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port." |
| Improved ability to accurately position the patient in the FOV. | The modification "will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port." |
| Compliance with safety standards (IEC 60601-1, UL 187). | "designed to comply with applicable industry safety standards... and found to meet its predetermined safety and performance requirements." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This is a hardware modification to a patient handling system, not an algorithm that processes data. Therefore, there isn't a "test set" of images or data in the context of an AI device. The testing referenced would be engineering and functional testing of the hardware and firmware.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for diagnostic performance is not relevant for this device type and modification. The "ground truth" for its functionality would be whether the footswitches successfully operate the bed in the specified manner, which is typically verified through engineering tests.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic test set requiring adjudication is mentioned or relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, as it's not relevant for this type of device modification. The device is a direct patient handling system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical patient handling system with firmware. The concept of "standalone algorithm performance" does not apply. The performance is inherently linked to human operation.
7. The Type of Ground Truth Used
For the functionality of the device, the ground truth would be the direct observation of the PHS bed raising/lowering as intended with the new footswitch controls, and verification that it operates within specified mechanical and electrical tolerances and safety parameters. This is typically established through direct engineering measurement and functional testing. For safety, compliance with listed standards (IEC 60601-1, UL 187) would be the "ground truth" requirement.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.