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510(k) Data Aggregation
(90 days)
CELESTEION, PCA-9000A/2
The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET component images the distribution of PBT radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.
This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, therapeutic planning and therapeutic outcome assessment of {but not limited to) cancer, cardiovascular disease and brain dysfunction. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.
Celesteion, PCA-9000A, is a large bore, TOF, PET-CT system, which combines a high-end CT system with a high-throughput PET system. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 900 mm and a maximum scanning field of 700 mm. The high-throughput PET system has a time of flight (TOF) detector with temporal resolution of 450 ps. Celesteion, PCA-9000A, is intended to acquire PET images of any desired region of the whole body and CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of positron emitting radiopharmaceuticals in the body with the obtained images. This device is used to gather the metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist research, diagnosis, therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner.
Here's a breakdown of the acceptance criteria and study information for the Celesteion, PCA-9000A/2 device, based on the provided text:
Acceptance Criteria and Device Performance
The provided text details performance specifications for the Celesteion, PCA-9000A/2, and explicitly states that it met established specifications through phantom testing. Although the document doesn't explicitly list "acceptance criteria" as a separate table, it compares the device's measured performance against the predicate device (Gemini Raptor). We can infer that meeting comparable or improved performance to the predicate device, or meeting specified technical thresholds, constitutes the acceptance criteria.
Table of Acceptance Criteria (Inferred from Predicate Comparison and "Established Specifications") and Reported Device Performance:
| Item | Acceptance Criteria (Implied / Predicate Value) | Reported Device Performance (Celesteion PCA-9000A/2) | Notes |
|---|---|---|---|
| PET Specifications | |||
| Sensitivity (cps/kBq) | 6.6 (Gemini Raptor) | ≥ 3.6 | The Celesteion is lower in sensitivity, which the document implicitly acknowledges by stating "the Celesteion requires a longer imaging duration (user selectable) to obtain equivalent data and image quality as compared to the predicate device." This suggests they have an acceptable trade-off for other features or image quality. |
| Count rate maximum NECR (kcps) | 90 (Gemini Raptor) | 61 ± 10 | The Celesteion is lower in maximum NECR. This also likely contributes to the need for longer imaging duration. |
| System energy resolution (%) | 11.7% (Gemini Raptor) | ≤ 13.7% | The Celesteion's energy resolution is higher (worse) than the predicate device. |
| System timing resolution (ps) | 495 ps (Gemini Raptor) | ≤ 450 ps | The Celesteion's timing resolution is better than the predicate device. |
| Scatter fraction (%) | 26 (Gemini Raptor) | ≤ 42.7 | The Celesteion's scatter fraction is higher (worse) than the predicate device. |
| Spatial Resolution FWHM at 1cm | 4.7 (Gemini Raptor) | ≤ 5.1 | The Celesteion's spatial resolution is higher (worse) than the predicate device. |
| CT Specifications | |||
| CT scan FOV | 60 cm (Gemini Raptor) | 70 cm | The Celesteion has a larger FOV, which is generally an improvement. |
| CT Detection System | 16 row Solid State Detector (Gemini Raptor) | 16 row Solid State Detector | Equivalent to predicate. |
| Output capacity | 60 kW (Gemini Raptor) | 72 kW (max) | The Celesteion has a higher output capacity, indicating potentially more powerful X-ray generation. |
| X-ray Tube Voltage | 90, 120, 140 kVp (Gemini Raptor) | 80, 100, 120 and 135 kV | Different ranges for Celesteion, with a 135 kV option not present in the Gemini Raptor. Compared to Aquilion LB Triton, it's equivalent. |
| X-ray Tube Current | 20-500 mA (Gemini Raptor) | 10 mA to 600 mA | The Celesteion has a wider range, including lower minimum and higher maximum current. |
| X-ray Tube Heat Capacity | 8 MHU (Gemini Raptor) | 7.5 MHU | The Celesteion has a slightly lower heat capacity. |
| X-ray Tube Cooling Rate | 1,608 kHU/min (max) (Gemini Raptor) | 1,386 kHU/min (max) / 1,008kHU/min (actual) | The Celesteion has a lower maximum cooling rate. |
| Focal Spot Size (IEC) | 0.5mm x 1.0mm (small) / 1.0mm x 1.0mm (large) | 0.09mm x 0.8mm (small) / 1.6mm x 1.4 mm (large) | Different focal spot sizes for the Celesteion, indicating different X-ray beam characteristics. Compared to Aquilion LB Triton, it's equivalent. |
| Lowest couch height | Not available (Gemini Raptor) | 475 mm (includes moving base) | Provided for Celesteion. |
| Couch-top stroke | Not available (Gemini Raptor) | 2390 mm | Provided for Celesteion. |
| Other Performance Specifications | |||
| Scan Regions | Whole body | Whole body | Equivalent. |
| Scan System | CT: 360° continuous rotate/rotate | CT: 360° continuous rotate/rotate | Equivalent. |
| CT Image Quality Metrics | Substantially equivalent to predicate | Validated as substantially equivalent to predicate | Spatial resolution, CT number, contrast-to-noise ratio, and noise properties were validated through phantom testing to be substantially equivalent to the predicate device (Aquilion LB Triton). |
| PET Image Quality Metrics | Met established specifications | Met established specifications | Spatial resolution, sensitivity, NECR, energy/timing resolution, and PET/CT alignment were validated through phantom testing to meet established specifications. |
Study Details
The provided text describes the testing done to support the 510(k) submission, focusing on technical performance verification.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in terms of cases or patient data. Instead, it mentions that studies were performed using phantoms.
- Data Provenance: The studies were phantom-based bench testing and are implicitly prospective in nature as they were conducted as part of the device's premarket submission. No information about country of origin of patient data is relevant as patient data was not used for this specific testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the test sets. The testing involved objective measurements of physical properties (e.g., spatial resolution, sensitivity) using phantoms, rather than subjective interpretation of diagnostic images by clinicians.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (Not applicable): Since the described testing involved objective phantom measurements and did not use human interpretation or ground truth derived from expert consensus, an adjudication method for human readers is not relevant.
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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, an MRMC comparative effectiveness study was not done. The submission focuses on the technical performance of the combined PET-CT system itself, not on a human-in-the-loop AI assistance tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of device performance metrics. The testing described ("CT image quality metrics were performed, utilizing phantoms," and "PET image quality metrics were performed") assesses the inherent performance characteristics of the imaging device (the algorithm/hardware combined) in a standalone manner. It evaluates how well the system itself performs its core functions of image acquisition and reconstruction in terms of physical parameters. It's not an "algorithm" in the sense of a separate AI diagnostic tool, but the performance of the integrated imaging system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Phantom-based physical measurements: The ground truth for the technical performance metrics (e.g., spatial resolution, energy resolution, sensitivity) was established using known physical properties of phantoms and standardized measurement protocols (e.g., NEMA standards implicitly for PET metrics).
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The sample size for the training set:
- Not applicable / Not specified. The document does not describe any machine learning or AI algorithm development that would involve a "training set" in the traditional sense. The device is a PET-CT imaging system, not a diagnostic AI software tool that requires training on a dataset of images to learn patterns.
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How the ground truth for the training set was established:
- Not applicable. As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is irrelevant to this submission.
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