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510(k) Data Aggregation
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The Siemens Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces 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 subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
This CT system can be used for low dose lung cancer screening in high risk populations. *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
The software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph Horizon PET/CT systems and Biograph mCT Flow PET/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems.
The provided document describes a 510(k) Premarket Notification for Siemens Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems. The purpose of this submission is not to introduce a new device, but to support an additional indication for use for low dose lung cancer screening in high-risk populations. The key information for this request revolves around demonstrating that the CT component of these combined PET/CT systems is substantially equivalent to standalone SOMATOM CT systems (K142955) that already have this specific indication.
Therefore, the "proof" is based on demonstrating equivalence to an already cleared device, rather than a de novo clinical study proving effectiveness or a multi-reader, multi-case study in the context of AI assistance. The document explicitly states: "No additional performance testing beyond what was cleared in the original Premarket Notifications is required." This means that the original performance tests for the standalone CT systems are being leveraged.
Below is an attempt to structure the information based on your request, noting that some of your specific categories (like AI assistance, ground truth for training sets, number of experts for ground truth, and adjudication methods for a novel device) are not directly applicable to this specific 510(k) submission due to its nature as an "additional indication for use" based on substantial equivalence.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The acceptance criteria for the new indication for use (low dose lung cancer screening) are based on demonstrating that the performance of the CT component within the Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems is identical to that of the previously cleared standalone SOMATOM CT systems (K142955) for this specific application.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (for CT Component) | Specific Criterion (Performance Parameter Comparison) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|---|
| Imaging Performance | CT number accuracy | "no differences exist in the parameters" |
| CT number uniformity | "no differences exist in the parameters" | |
| Spatial resolution (MTF, max in-plane resolution) | "no differences exist in the parameters" | |
| Slice thickness/sensitivity profile (min slice width) | "no differences exist in the parameters" | |
| Noise properties (NPS and image Noise (std dev)) | "no differences exist in the parameters" | |
| Contrast to Noise Ratio | "no differences exist in the parameters" | |
| Operational Performance | Maximum scan speed | "no differences exist in the parameters" |
| Minimum reconstructed slice interval | "no differences exist in the parameters" | |
| Overall Equivalence | Design, material, functionality, technology, energy source | "identical" (to commercially available predicate systems) |
| Intended Use | "no difference in the intended use of the device" | |
| Radiation Safety Standards | Compliance with 21 CFR 1020.30, 1020.33, 1040.10, 1040.11 | |
| Electrical/Mechanical Safety Standards | Compliance with IEC 60601-1 series and AAMI / ANSI ES60601-1 | |
| Software Lifecycle Standards | Compliance with IEC 62304 | |
| Risk Management | Compliance with ISO 14971 |
Conclusion from performance testing: "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems is likewise suitable for lung cancer screening."
Study Details Proving Device Meets Acceptance Criteria
This submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the standalone SOMATOM CT systems (K142955) that were previously cleared for low dose lung cancer screening. Therefore, the "study" is primarily a comparative analysis of technical parameters and design specifications, rather than a new clinical trial.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of patient data for this specific 510(k). The "test set" here refers to the technical parameters of the devices.
- Data Provenance: The comparison is made between the technical specifications and existing performance validation (from previous 510(k) clearances) of the Biograph Horizon/mCT/mCT Flow PET/CT systems and the SOMATOM CT systems (K142955). This is an engineering and regulatory comparison of device characteristics and previously validated performance, not a new retrospective or prospective clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not directly applicable. The "ground truth" for this submission is whether the technical parameters of the CT component in the PET/CT system are demonstrably identical to those of the predicate standalone CT system. This is established through engineering specifications, previous performance reports, and adherence to recognized standards, rather than expert consensus on a scan dataset for a new device. The original clearance for the predicate CT system would have involved relevant expert input.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation of images that would require an adjudication method.
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 versus without AI assistance:
- No MRMC study was conducted for this 510(k) submission. The device (PET/CT system) is an imaging equipment; it is neither an AI algorithm nor an AI-assisted diagnostic tool in the sense of the question. The request is to add an indication for a human-interpreted CT scan for screening.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The CT component itself is a standalone imaging modality within the PET/CT system. The "performance" assessment was of these physics/engineering parameters to ensure they are identical to the predicate CT system. There is no AI algorithm being evaluated for standalone performance in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this specific submission, the "ground truth" is the proven performance and technical specifications of the predicate device (SOMATOM CT systems K142955) regarding its suitability for low dose lung cancer screening. The comparison aims to establish that the subject device's CT component matches these established characteristics.
- The basis for the predicate device's clearance for lung cancer screening likely involved referencing clinical literature, such as the National Lung Screening Trial (NLST), and guidelines from professional medical societies, which would implicitly rely on outcomes data and expert consensus for defining suitable screening parameters and populations.
8. The sample size for the training set:
- Not applicable. This submission is for an imaging device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable (as above).
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