(56 days)
The uEXPLORER PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.
This system is intended to be operated by qualified healthcare professionals to assist in the detection, diagnosis, staging, restaging, treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
The uEXPLORER PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy. The PET system has time-of-flight capability with a timing resolution of 430ps. It has a 1940mm-long axial field of view (FOV) and the system sensitivity is 191 cps/kBq.
The uEXPLORER PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.
The provided text describes the uEXPLORER PET/CT system, but it does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy with human interpretation.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (uMI 780 PET/CT) primarily through:
- Comparison of technical specifications: Showing similar physical characteristics and performance specs (e.g., sensitivity, resolution) with the predicate.
- Adherence to recognized standards: Confirming compliance with various electrical safety, EMC, performance, software, and biocompatibility standards.
- Non-clinical testing: Mentioning dosimetry and system performance tests.
- No Clinical Testing: Explicitly stating that "No Clinical Study is included in this submission."
Therefore, based solely on the provided text, I cannot populate all the requested fields, especially those related to clinical performance, human reader studies, or explicit acceptance criteria for diagnostic capability.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily in the form of meeting or exceeding technical specifications and regulatory standards, rather than clinical performance metrics. The reported performance is a comparison to the predicate device and adherence to standards.
| Acceptance Criteria Type | Specific Criteria | Reported Device Performance |
|---|---|---|
| PET Specification | ||
| Sensitivity | ≥170cps/kBq (for uEXPLORER) | >/=170cps/kBq (Matches/Exceeds predicate's >/=15cps/kBq) |
| NECR Peak Value | ≥1400kcps@16kBq/cc (for uEXPLORER) | >/=1400kcps@16kBq/cc (Matches/Exceeds predicate's >/=165kcps@16kBq/cc) |
| Peak True Count Rate | ≥4500kcps@28kBq/cc (for uEXPLORER) | >/=4500kcps@28kBq/cc (Matches/Exceeds predicate's >/=500kcps@30kBq/cc) |
| PET Scatter Fraction | Not explicitly stated as acceptance criteria, but listed in comparison table. | =0.44 |
| Count Rate Bias | Not explicitly stated as acceptance criteria, but listed in comparison table. | =±5% |
| Axial FWHM@1cm | Not explicitly stated as acceptance criteria, but listed in comparison table. | =3.5mm |
| Transaxial FWHM@1cm | Not explicitly stated as acceptance criteria, but listed in comparison table. | =3.5mm |
| Axial FWHM@10cm | Not explicitly stated as acceptance criteria, but listed in comparison table. | =4.0mm |
| Transaxial FWHM@10cm | Not explicitly stated as acceptance criteria, but listed in comparison table. | =4.0mm |
| CT Specification | ||
| Scan Regime | Continuous Rotation Topo | Continuous Rotation Topo (Same as predicate) |
| Scan Modes | Axial Scan, Helical Scan | Axial Scan, Helical Scan (Same as predicate) |
| Z-plane coverage | 40mm | 40mm (Same as predicate) |
| Number of detector rows | 80 | 80 (Same as predicate) |
| Minimum slice thickness | 0.5mm | 0.5mm (Same as predicate) |
| Rotation speed | Up to 0.3 sec for 360° rotation | Up to 0.3 sec for 360° rotation (Same as predicate) |
| Table Maximum Weight | 250kg | 250kg (Same as predicate) |
| Safety and Standards | ||
| Electrical Safety | Conformance to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Claimed conformance and testing conducted in accordance with this standard. |
| EMC | Conformance to IEC 60601-1-2 Edition 4.0 2014-02 | Claimed conformance and testing conducted in accordance with this standard. |
| Biocompatibility (Patient Contact Materials) | No cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10) | Patient Contact Materials were tested and demonstrated no cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10). (Same as predicate) |
| Software | Conformance to NEMA PS 3.1-3.20(2011) DICOM, IEC 62304, FDA Guidance for Content of Premarket Submissions for Software, and Cybersecurity Guidance. Software specifications meeting acceptance criteria, V&V acceptable. | Claimed conformance, risk analysis completed, risk control implemented, testing results show software specifications met acceptance criteria, V&V found acceptable. Conforms to Cybersecurity requirements. |
Study Proving Device Meets Acceptance Criteria:
The document refers to "Non-Clinical Testing" and adherence to various standards (listed under "Product Particular Standards", "Performance Verification", "Software", etc.) as the primary study or evidence that the device meets its specified (technical) acceptance criteria. There is no specific clinical study proving diagnostic performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable as no clinical test set for diagnostic accuracy is described. The "test set" implies phantom data and engineering tests.
- Data Provenance: Not specified for non-clinical tests, but typically involves laboratory settings and phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set requiring human expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring expert adjudication is described.
5. 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 was done. The document explicitly states: "No Clinical Study is included in this submission." The device is a diagnostic imaging system rather than an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is an imaging system, not a standalone AI algorithm for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance verification, the ground truth would be based on physical phantom measurements and engineering specifications (e.g., NEMA NU 2-2012 for PET performance, IEC standards for CT imaging performance). For safety, it would be compliance with defined electrical, EMC and biocompatibility thresholds.
8. The sample size for the training set:
- Not applicable/Not provided, as this is an imaging system, not a machine learning algorithm whose performance is being evaluated from a user perspective. The software aspects mentioned are related to system control, reconstruction, and image display, conforming to established software development life cycle standards (IEC 62304).
9. How the ground truth for the training set was established:
- Not applicable/Not provided for the reasons stated above.
§ 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.