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510(k) Data Aggregation
(57 days)
The 'ANCORIS' PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
The proposed device 'ANCORIS' is a PET system providing volume measurements of metabolic and physiologic processes. It is the same as the legally market device, name 'ECAT ACCEL PET scanner', K002584, from CTI PET Systems (now Siemens Medical), combined with the legally market device, name 'ECAT Scintron PET', K130269 from MiE GmbH. It is designed to close the economical gap between the demand and availability of stand-alone PET scanner. 'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices. The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).
The provided text describes the ANCORIS PET Scanner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The document focuses on:
- Regulatory clearance: Obtaining 510(k) clearance based on substantial equivalence.
- Device description: How ANCORIS combines elements of existing, cleared PET scanners.
- Key differences from predicates: Primarily a patient handling system (PHS) for higher patient weights and an integrated trigger unit and graphical user interface.
- Performance verification and validation: Stating that performance was successfully checked and meets specifications, and that safety tests (IEC 60601-1) were conducted.
- Transmission technology: Confirmation that the Ge68 rod source transmission technology is similar to that of a predicate device.
Therefore, I cannot provide the requested information for the following items based on the given text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria for diagnostic accuracy/clinical performance are mentioned.
- Sample size used for the test set and the data provenance: No clinical test set or data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
- Adjudication method for the test set: Not applicable as no clinical test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI assistance is mentioned. The device is a PET scanner, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a PET scanner, not a standalone algorithm.
- The type of ground truth used: Not applicable as no diagnostic ground truth for a clinical study is described.
- The sample size for the training set: Not applicable as no training set for an AI algorithm is described.
- How the ground truth for the training set was established: Not applicable as no training set for an AI algorithm is described.
The document instead highlights engineering verification and validation which confirm the device functions as intended and meets safety standards, rather than clinical performance criteria. The "Conclusion" states that the manufacturing, design, and development processes conform to valid standards and that the system is substantially equivalent, implying that its performance is expected to be comparable to the predicate devices it is based upon.
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(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.
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(9 days)
The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and Xray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is 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 cross-sectional 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 this system 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.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient. }
The ECAT LSO PET/CT is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT PET/CT (K002715) and will utilize the same CT component from the Siemens SOMATOM EMOTION (CT) Scanner. However, in place of the PET component that uses 288 BGO crystal block detectors, the ECAT LSO PET/CT will be configured with the CPS ECAT ACCEL PET (K002584) using 144 LSO crystal block detectors, in combination with the Siemens Somatom EMOTION CT. As with the predicate system, 2D PET acquisition and the PET transmission sources are not included in the modified ECAT LSO PET/CT. PET acquisition data is acquired only in 3D and PET attenuation correction map data is obtained from the CT. The PET and CT components will be integrated as in the original ECAT PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system.
The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), and workstations will remain essentially the same as the ECAT PET/CT system with only minor modifications to accommodate the different PET detectors. In addition, the ECAT LSO PET/CT as well as the HR+ based ECAT PET/CT will also be offered with either the Siemens single slice EMOTION CT (K991764) or the dual slice EMOTION MS CT (K003074), for the CT component of the system. The EMOTION MS CT with two rows of X-ray detectors does not otherwise affect performance of the ECAT LSO PET/CT.
This is a 510(k) premarket notification for the ECAT LSO PET/CT Scanner, a combined Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner. This is a medical device, and the documentation provided describes its intended use and a comparison to a predicate device. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance metrics.
The document is a US FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting detailed performance studies with acceptance criteria in the way a clinical trial or a robust standalone performance study would.
Therefore, I cannot extract the requested information such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about clinicians establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone performance study details.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
The provided text only includes:
- Device Proprietary Name: ECAT LSO PET/CT Scanner
- Common Name: Combination Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT)
- Classification Name: Emission Computed Tomography System per 21 CFR 892.1200
- Predicate Device: ECAT PET/CT from CTI PET Systems (CPS), 510(k) Number K002715
- Device Description: It's a modified version of the ECAT PET/CT (K002715), utilizing the same CT component (Siemens SOMATOM EMOTION) from a predicate CT scanner (K002713, K991764, K003017 for single/dual slice versions) but replacing the 288 BGO PET crystal block detectors with 144 LSO crystal block detectors from the Siemens ECAT ACCEL PET (K002584). It integrates PET, CT, and combined PET/CT imaging.
- Intended Use/Indications for Use:
- To image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for determining metabolic and physiologic functions.
- To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (from axial or spiral planes).
- The PET and CT functions can be used in combination for high-resolution, noise-free CT attenuation correction maps for PET images, and to produce fused CT and PET images for detailed anatomic and metabolic function information.
Conclusion:
This document is a regulatory submission demonstrating substantial equivalence, not a performance study report. It states that "The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), workstations will remain essentially the same as the ECAT PET/CT system (ACS 3), with only minor modifications to accommodate the different PET detectors." This implies that the performance characteristics are expected to be similar to the predicate device due to the nature of the modification (a change in detector type within the PET component, while other major systems remain the same or are sourced from predicate devices). However, specific performance criteria and studies demonstrating their fulfillment are not detailed in this 510(k) summary.
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