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510(k) Data Aggregation
(89 days)
BIOGRAPH 16 TRUE POINT SYSTEMS
The Siemens Biograph True Point 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.
The Biograph True Point systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph True Point 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.
Biograph True Point software is a command based program used for patient management. data manaqement, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The Biograph True Point systems which are the subject of this application are substantially equivalent to the commercially available Biograph mCT and Biograph True Point 64/40 systems and the Siemens Somatom CTs. Modifications include the integration of CT, PET and Patient Handling Systems to create an additional model to the Biograph True Point family of systems, and update of the system software.
The provided text details a 510(k) Premarket Notification for the Siemens Biograph True Point System, a combined CT and PET scanner. However, it does not contain specific acceptance criteria, a study design, or performance metrics for an algorithm or AI. Instead, it describes the device itself, its intended use, claims of substantial equivalence to predicate devices, and regulatory compliance.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, ground truth for test and training sets) cannot be extracted from this document as the information is not present.
Here's a summary of what can be extracted:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or reported device performance in the manner typically associated with an AI or algorithm study (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices and compliance with relevant industry standards and regulations.
Table of Acceptance Criteria and Reported Device Performance (as inferable from the document):
| Acceptance Criteria Category | Description | Reported Device Performance (as inferred) |
|---|---|---|
| Substantial Equivalence | The device is substantially equivalent to legally marketed predicate devices. | The FDA determined the device is substantially equivalent to the Biograph mCT and Biograph True Point 64/40 systems, and Siemens Somatom CTs (K060631, K081453, K050297). The modifications involved integrating CT, PET, and patient handling systems, and updating system software. |
| Safety and Effectiveness | The device labeling contains instructions, cautions, and warnings for safe and effective use. Risk management is performed in compliance with ISO 14971. The device adheres to recognized industry standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33) to minimize electrical, mechanical, and radiation hazards. | The FDA letter implicitly confirms that Siemens provided adequate documentation regarding safety and effectiveness for the device to be cleared for marketing, noting that the device is subject to general controls provisions of the Act (e.g., good manufacturing practice, labeling, prohibitions against misbranding and adulteration). |
| Intended Use Fulfillment | The system provides registration and fusion of high-resolution physiologic and anatomic information, and maintains independent functionality for single-modality CT and/or PET diagnostic imaging. It aids in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function for various medical conditions, and can be used for radiotherapy treatment planning and interventional radiology procedures. | The FDA accepted the Indications for Use as described, which means they found sufficient evidence or justification within the 510(k) submission to support the device performing these functions as intended. |
Missing Information Not Present in the Document:
- Sample size used for the test set and the data provenance: Not applicable as this is not an AI/algorithm study. The 510(k) focuses on hardware and software system equivalence, not a performance trial using a clinical dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a imaging system, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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