(89 days)
The CPS/Siemens ECAT Vision 3000 and Vision 5000 PET systems are positron emission tomography (PET) scanners that are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
CPS ECAT Vision 3000 and ECAT Vision 5000 positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to detect the location and distribution of injected positron-emitting radionuclides in the body and produce cross- sectional images through computer reconstruction of the data.
The ECAT Vision 3000 and Vision 5000 are new positron emission tomography (PET) scanner systems. The ECAT Vision series PET scanners utilize rotating flat panel detector heads, LSO crystal detector technology and coincidence point source transmission scan capability. The ECAT Vision series scanners are produced and marketed under two distinct models, the ECAT Vision 3000 and the ECAT Vision 5000. The two models of the ECAT Vision are configured with either: 1) three detector heads in the ECAT Vision 3000, or 2) five detector heads in the ECAT Vision 5000.
A Patient Handling System (PHS) is provided with the Vision series scanners, which is a slightly modified version of the PHS included with the CPS ECAT EXACT series PET scanners (K962797). Vertical bed travel, horizontal scanning range and all other PHS operating characteristics are the same for the PHS provided with the Vision series scanners as those of the PHS provided with the ECAT EXACT series scanners. The maximum patient weight specification for the Vision series PHS, is 182 kg (400 lbs).
The acquisition computer system is an ACS III system, similar to that used for the ECAT PET/CT system (K002715). Image reconstruction for the ECAT Vision scanners is performed using a dedicated reconstruction computer. The reconstruction algorithm is FOREJ rebinning and 2D Attenuation Normalization Weighted OSEM (ANW-OSEM). The reconstruction system interfaces with the acquisition raid disk system for access to the basic acquired data.
The operating console computer is an updated version of the existing ECAT PET/CT operating console. The console runs Siemens Syngo software, with CPS ECAT PET acquisition and application software overlaying the Siemens software. This computer is based on an Intel Pentium system running Microsoft's Windows 2000, or later, operating system. Operating in a syngo-based, NT environment, the ECAT Vision operating software provides acquisition, display, diagnostic, application, system, archival, and retrieval support capabilities. Initially, whole-body oncology applications and visualization tools are being provided.
This is a 510(k) premarket notification for the ECAT Vision 3000 and ECAT Vision 5000 PET Scanners. It's a submission for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical efficacy studies with acceptance criteria in the typical sense for AI/software devices.
The document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9. This is because the submission is for a hardware device (a PET scanner) and emphasizes technological equivalence and device specifications rather than performance against a clinical ground truth for a diagnostic task.
Here's why the requested information is absent and what the document does provide:
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Acceptance Criteria & Reported Performance (Point 1): No specific acceptance criteria table or reported device performance against a clinical ground truth (e.g., sensitivity, specificity for disease detection) is provided. This is typical for a hardware scanner 510(k) where the focus is on physical specifications, image quality parameters (which are implicitly compared to predicate devices but not quantified in this way), and safety.
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Sample Size, Data Provenance (Point 2); Number of Experts (Point 3); Adjudication Method (Point 4); MRMC Study (Point 5); Standalone Study (Point 6); Type of Ground Truth (Point 7); Training Set Sample Size (Point 8); Training Set Ground Truth (Point 9): All these points are related to studies that would typically be performed for AI algorithms or diagnostic software where the output of the device is a diagnosis or a quantitative measurement requiring validation against a clinical gold standard. This PET scanner itself is an imaging modality, not a diagnostic algorithm. Its "performance" is more about image quality, resolution, acquisition speed, and patient throughput, which are assessed through engineering tests and phantom studies, and then compared to predicate devices' established performance.
What the document does describe and emphasize:
- Device Description: It details the hardware components (detector heads, LSO crystal technology, patient handling system, acquisition computer, reconstruction computer, operating console) and the imaging technique (positron emission tomography, FOREJ rebinning, 2D Attenuation Normalization Weighted OSEM).
- Predicate Devices: The submission clearly identifies previously cleared PET systems (ECAT EXACT, E.CAM LSO 311, ECAT PET/CT) as predicate devices and explains how the new ECAT Vision systems leverage or modify components from these proven technologies. This is the core of a 510(k) for a physical device – demonstrating substantial equivalence to a legally marketed device.
- Indications for Use: The intended purpose is to "image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body." This indicates the device is an imaging tool, not one that automates diagnosis.
In summary, this 510(k) is for a physical medical imaging device (PET scanner), not a software algorithm that performs a diagnostic task. Therefore, the requested information regarding acceptance criteria, study sizes, expert involvement, and ground truth establishment, which are typical for software-as-a-medical-device (SaMD) or AI product submissions, is not present in this document.
§ 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.