(59 days)
The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners 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.
The CTI PET Systems ECAT HRRT is a new positron emission tomography (PET) scanner system. The ECAT HRRT PET scanners utilize flat panel detector heads, combined LSO (Lutetium Oxyortho-Silicate) / LYSO (Lutetium Yttrium Oxyortho-Silicate) crystal detector technology. The HRRT consists of eight detector panels in an octagonal arrangement completely encircling the bore of the Gantry. A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry. The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk. Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.
Acceptance Criteria and Study for ECAT HRRT PET Scanner (K040933)
Based on the provided 510(k) summary for the ECAT HRRT PET Scanner (K040933), the device's acceptance criteria and the study proving its performance are described below. It is important to note that the provided document is a summary and does not contain detailed study protocols or comprehensive data.
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." However, the specific quantitative acceptance criteria or detailed performance specifications are not explicitly listed in the provided document. The document asserts substantial equivalence to predicate devices, implying that the HRRT's performance is at least comparable to or better than the predicate devices (ECAT ACCEL and E.CAM LSO 311).
Without explicit criteria, a table cannot be fully populated. However, based on the general description of PET scanners, typical performance specifications would include:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Spatial Resolution | Not explicitly stated (implied to be improved due to "enlarged data sets (due to increased resolution)") |
| Sensitivity | Not explicitly stated |
| Noise Equivalent Counts (NEC) | Not explicitly stated |
| Count Rate Performance | Not explicitly stated |
| Image Uniformity | Not explicitly stated |
| Scatter Fraction | Not explicitly stated |
| Timing Resolution | Not explicitly stated |
The document mentions "enlarged data sets (due to increased resolution)" as a modification handled by the software, suggesting an improvement in resolution compared to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing is described generically as "tested by CPS."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided document does not mention the use of experts or the establishment of ground truth for any test set. The performance assessment appears to be based on technical specifications rather than diagnostic accuracy studies involving expert interpretation of images.
4. Adjudication Method
As there is no mention of a test set involving human interpretation or diagnostic outcomes, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the device's technical specifications and substantial equivalence to predicate devices. Therefore, no effect size for human reader improvement with AI assistance is provided.
6. Standalone Performance Study
The summary states, "Performance of the ECAT HRRT system has been tested by CPS and found to meet its predetermined PET performance specifications." This implicitly describes a standalone performance evaluation of the algorithm-only (or system-only) without human-in-the-loop performance. However, the details of this testing are not provided.
7. Type of Ground Truth Used
Given that the performance evaluation appears to be based on meeting "predetermined PET performance specifications" rather than diagnostic accuracy, the type of "ground truth" would likely be based on physical phantom measurements, simulated data, or predefined technical benchmarks typically used to characterize PET scanner performance (e.g., measuring spatial resolution from a point source, sensitivity from a uniform phantom). The document does not specify the exact methods.
8. Sample Size for the Training Set
The document does not mention any training set or machine learning components with a quantifiable sample size. The software is based on "Standard ECAT software (7.x)" with modifications for the new acquisition system and larger data sets. This indicates that the software is likely an updated version of a commercially available and established application, rather than a newly developed AI/ML model requiring a specific training set to establish its core functionality.
9. How Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing its ground truth is not applicable or provided.
§ 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.