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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 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 mCT family 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 updates to the Biograph mCT systems which are the subject of this application are considered substantially equivalent to the commercially available Biograph mCT software. Major modifications to the family of systems include:

• Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
• · Updated gantry control buttons, and patient call button;
• Updated computer hardware;
• Updated software including:
  • updated operating system; 0
  • additional user configurable options and workflows
  • cardiac gating updates to provide for improved gating characteristics :; o
  • updated workflows for ease of use; and ಂ
  • improvements in image quality. o

The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT Family of PET/CT Systems:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states: "PET Testing in accordance with NEMA NU2.2007 was conducted on two different configurations of the Biograph mCT systems, a 3 ring version and a 4 ring version."

• Sample Size for Test Set: The sample size is not explicitly stated in terms of number of cases or patients. Instead, the testing was performed on two physical configurations of the device (a 3-ring and a 4-ring version). NEMA NU2.2007 is a standard for and performance measurements of PET scanners, implying testing on phantoms or standardized objects rather than patient data.
• Data Provenance: The document does not specify country of origin for data. Given it's a Siemens Medical Solutions USA, Inc. submission, the testing would likely have taken place in the US or at Siemens facilities. The testing appears to be prospective in nature, as it's a conformity assessment against a standard for a new or updated device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This document describes a technical performance testing of a PET/CT scanner against established engineering and physics standards (NEMA NU2.2007). It does not involve clinical studies with human image interpretation or diagnostic accuracy assessment. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation is not applicable to this submission. The "ground truth" here is derived from objective physical measurements and comparisons to NEMA standards.

4. Adjudication Method for the Test Set

As this is technical performance testing against a standard and not a clinical study involving human interpretation, an adjudication method in the typical sense (e.g., 2+1, 3+1 for clinical consensus) is not applicable. The "adjudication" is inherent in the objective measurement and comparison to the NEMA NU2.2007 standard. If a measurement falls within the specified range (e.g., <= 6.5 mm for resolution), it "Passes."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. This submission focuses on the technical performance specifications of the PET/CT hardware and updated software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a way. The "Performance Testing" section describes the device's technical performance in a standalone context, as objectively measured against NEMA NU2.2007 standards. The results (e.g., resolution, sensitivity, count rate) are measures of the algorithm and hardware's intrinsic performance, independent of a human operator's diagnostic interpretation.

7. Type of Ground Truth Used

The ground truth used for this performance testing is based on objective physical measurements against an established industry standard: NEMA NU2.2007. This standard defines precise methods and acceptable ranges for various performance metrics of PET scanners. It is not expert consensus, pathology, or outcomes data, but rather a technical benchmark.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This submission is for an updated PET/CT system, and the "updated software" mentioned (including "improvements in image quality") are likely traditional image processing algorithms rather than deep learning models requiring large training datasets. Therefore, a "training set" as commonly understood in AI/ML is not applicable here.

9. How the Ground Truth for the Training Set Was Established

Since no training set for AI/ML is mentioned, the method for establishing its ground truth is not applicable.

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