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The Siemens Biograph mCT 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 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.

Device Description

The Biograph mCT 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 mCT 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 mCT 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 software for the Biograph mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:

Additional configuration license options
Improvement of performance characteristics of the PET and CT, and
Optimization of workflows

AI/ML Overview

This 510(k) premarket notification describes modifications to the Siemens Biograph mCT systems. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K081453) rather than presenting a performance study with acceptance criteria for a new device's clinical efficacy regarding a specific diagnostic task.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to a specific diagnostic task or a clinical study proving new performance claims. The modifications are described as:

Additional configuration license options
Improvement of performance characteristics of the PET and CT
Optimization of workflows

These are technical modifications and workflow improvements, not changes that require a new clinical trial to establish diagnostic performance against specific metrics like sensitivity or specificity for a disease. The safety and effectiveness section refers to risk management and compliance with industry standards, not a clinical performance study.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria: Not specified in terms of clinical diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a specific condition). The notification focuses on technical equivalence and compliance with safety standards (e.g., ISO 14971, IEC 60601-1, 21 CFR 1020.30, 21 CFR 1020.33).
Reported Device Performance: No specific performance metrics (like accuracy, sensitivity, specificity, or lesion detection rates) are reported in the context of a new study proving these modifications meet specific clinical acceptance criteria. The document states "Improvement of performance characteristics of the PET and CT," but does not quantify these improvements or link them to clinical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable. The document does not describe a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No clinical performance study is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. No clinical performance study 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:

Not Applicable. This is a clearance for modifications to a PET/CT scanner, not an AI-assisted diagnostic device, and no MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. Not an algorithm-only device in the context of a new diagnostic claim.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. No clinical performance study is described.

8. The sample size for the training set:

Not Applicable. No machine learning or AI model training is described for new diagnostic claims. The "improvements" are likely engineering changes and software optimizations, not AI model updates.

9. How the ground truth for the training set was established:

Not Applicable. No machine learning or AI model training is described.

Summary of Document Focus:

This 510(k) is for modifications to an existing device (Biograph mCT systems) to demonstrate substantial equivalence to a previously cleared predicate device (K081453). The modifications primarily relate to:

Technical/System Improvements: "Improvement of performance characteristics of the PET and CT" and "Optimization of workflows."
Software Enhancements: "Additional configuration license options."

The safety and effectiveness section refers to compliance with risk management (ISO 14971) and electrical/radiation safety standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33), which are typical for hardware and software modifications in imaging devices. It does not outline new clinical performance studies to prove quantitative improvements in diagnostic accuracy for specific conditions. The "Indications for Use" remain broad, covering general diagnostic purposes of PET/CT.

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K Number

K083852

Device Name

BIOGRAPH 16 TRUE POINT SYSTEMS

Manufacturer

SIEMENS MEDICAL SOLUTIONS USA, INC.

Date Cleared

2009-03-23

(89 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K060631,K081453,K050297

Intended Use

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 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.

Device Description

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.

AI/ML Overview

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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