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The Vereos PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and Xray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The Philips Vereos PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

The proposed Vereos PET/CT systems is an integrated diagnostic X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) system designed for a wide range of diagnostic applications. Computerized Tomography (CT) is a medical imaging technique that uses X-rays to obtain cross sectional images of the head or body. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images provide useful diagnostic information. Positron Emission Tomography (PET) uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional images of biochemical and metabolic processes of organs within the body. The proposed Vereos PET/CT system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for therapeutic planning. The system also provides tools for the quantifying results from the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease. The system is comprised of the following system components/subsystems: positron emission tomography (PET); X-ray computed tomography (CT); a patient table; Operating station; Reconstruction Servers. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. These components of the proposed Vereos PET/CT are identical to the currently marketed and predicate device Ingenuity TF Digital PET/CT (K123599) with respect to technological specifications.

The document provided describes a 510(k) submission for the Vereos PET/CT system, asserting its substantial equivalence to a predicate device (Ingenuity TF Digital PET/CT, K123599). The majority of the document focuses on demonstrating that changes made to the Vereos PET/CT do not impact device safety and effectiveness, and that its fundamental scientific technology, intended use, and performance are identical or equivalent to the predicate.

Therefore, the "acceptance criteria" discussed are largely in reference to maintaining equivalence with the predicate device's performance, as measured against established industry standards for PET/CT systems, rather than defining novel performance benchmarks for a new device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the entire device as a new product with novel performance claims. Instead, it details how specific changes to the device (from the predicate) were verified to ensure they meet existing standards and do not degrade performance.

The "acceptance criteria" here are therefore related to demonstrating that the modified Vereos PET/CT remains compliant with relevant standards and performs comparably to the predicate device.

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

The document does not specify a distinct "test set" in terms of patient data or case numbers for clinical evaluation. The verification and validation activities described are largely engineering and technical performance tests on the device itself.

• Sample Size for Test Set: Not explicitly stated as patient or case numbers. Non-clinical performance testing involved testing the device against various standards and design input requirements.
• Data Provenance: Not applicable as no specific patient data or clinical images for a separate "test set" are mentioned beyond "sample clinical images" which were evaluated for good image quality. The primary evaluation method was demonstrating compliance with engineering standards and comparison to a predicate device.

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

• Number of Experts: Not specified for establishing ground truth for a discrete clinical "test set."
• Qualifications: "Certified radiologists" are mentioned as having reviewed and evaluated "sample clinical images" for good image quality. No further details on their number or experience are provided. It's important to note this was for general image quality assessment, not for establishing ground truth for a specific diagnostic task against a test set.

4. Adjudication Method for the Test Set

Not applicable, as no formal clinical test set requiring ground truth adjudication based on expert consensus is described. The evaluations were primarily technical performance tests and assessment of image quality by radiologists.

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

No, an MRMC comparative effectiveness study is not mentioned as having been performed. The submission relies on demonstrating substantial equivalence to a predicate device through technical performance, adherence to standards, and general image quality assessment, not improved human reader performance with AI assistance.

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

Not applicable. The Vereos PET/CT is a diagnostic imaging device (hardware and integrated software) and not an AI-driven algorithm designed to perform a diagnostic task independently. The improvements cited are in the device's technical specifications and system components.

7. Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" implicitly used is adherence to established industry standards (e.g., NEMA NU-2, IEC 60601 series) and the device's own established design input requirements. For image quality, the "ground truth" was the assessment of "good image quality" by certified radiologists. There is no mention of pathology or outcomes data being used as ground truth.

8. Sample Size for the Training Set

Not applicable. The Vereos PET/CT is a medical imaging device comprising hardware and software for image acquisition and reconstruction, not an AI model that requires a "training set" in the conventional machine learning sense for diagnostic purposes. The software changes mentioned are bug fixes or feature extensions, not typically requiring large training datasets as described for AI algorithms.

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

Not applicable, as no training set for an AI algorithm is mentioned.

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The Siemens Biograph Vision 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 Vision systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations.

The Biograph Vision 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 Vision 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 Vision PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph mCT (K173578). The key difference between the Biograph mCT (predicate device) and the Biograph Vision PET/CT is the replacement of PhotoMultiplier Tubes (PMT) with Silicon PhotoMultipliers (SiPM). SiPMs are a photon sensitive technology built by combining a solid state photodiode array and a silicon substrate. The SiPMs allow close coupling to the scintillators (crystals) and a higher active area of detectors to scintillators. This combination results in superior performance compared to the photomultiplier tubes design used in previous generation PET block detectors.

The provided text is a 510(k) Summary for the Siemens Biograph Vision PET/CT system. It details the device, its intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document primarily focuses on the physical performance characteristics of the PET component of the Biograph Vision system, tested according to NEMA NU2:2012 standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study described is Performance Testing in accordance with NEMA NU2:2012, conducted on the Biograph Vision 600.

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

• Sample Size: The document does not specify a "sample size" in terms of patient images or clinical cases. The testing appears to involve physical phantoms and measurements as per NEMA NU2:2012 standards, not a clinical test set of patient scans. Therefore, sample size in the context of clinical images is not applicable here.
• Data Provenance: Not applicable as this is performance testing of the device itself using phantom measurements, not clinical data collection. The testing was conducted by Siemens Medical Solutions USA, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The ground truth for this type of performance testing is defined by the NEMA NU2:2012 standard itself, which specifies the phantoms, measurement procedures, and calculation methods. It does not involve human expert interpretation for establishing ground truth.

4. Adjudication Method for the Test Set:
Not applicable. As the testing involves objective physical measurements and calculations based on a recognized standard (NEMA NU2:2012), there is no need for human adjudication of results.

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, an MRMC comparative effectiveness study was not done. The document describes a PET/CT scanner and its physical performance, not an AI-powered diagnostic tool requiring human reader studies to demonstrate improved performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, the performance testing described is "standalone" for the device's physical capabilities. The NEMA NU2:2012 tests evaluate the intrinsic imaging performance of the PET component (resolution, sensitivity, count rate, image quality based on phantom measurements) without human interpretation in the loop.

7. The Type of Ground Truth Used:
The ground truth used for this performance testing is the physical properties and known measurements of standardized phantoms as defined by the NEMA NU2:2012 standard. This is a technical ground truth, not a medical ground truth (like pathology, expert consensus, or outcomes data).

8. The Sample Size for the Training Set:
Not applicable. This is a hardware device (PET/CT scanner), not a machine learning algorithm that requires a "training set" of data for development.

9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.

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The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

*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 Philips Ingenuity CT consists of three system configurations, the Philips Ingenuity CT, the Philips Ingenuity Core and the Philips Ingenuity Core128. These systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of Jung nodules that may represent cancer*.

The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips Ingenuity CT have the same fundamental design characteristics and are based on comparable technologies as the predicate.

The main system modules and functionalities are:

• 1. Gantry. The Gantry consists of 4 main internal units:
  • a. Stator a fixed mechanical frame that carries HW and SW.
  • b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator.
  • c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame.
  • d. Data Measurement System (DMS) a detectors array, fixed to the Rotor frame.
• 2. Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan.
• 3. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer.

In addition to the above components and the software operating them, each system includes a workstation hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) submission for a CT scanner (Philips Ingenuity CT), which focuses on demonstrating substantial equivalence to a predicate device (Philips Plus CT Scanner), rather than establishing new performance claims with specific acceptance criteria and clinical trial results typical for entirely novel AI/ML devices. Therefore, much of the requested information, particularly regarding AI-specific performance (like effect size of human reader improvement with AI, standalone AI performance, ground truth for training AI models) is not directly present. The clinical evaluation described is a comparative image quality assessment rather than a diagnostic accuracy clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are primarily established against international and FDA-recognized consensus standards for medical electrical equipment and CT systems, and against the performance of the predicate device. The "reported device performance" refers to the successful verification against these standards and equivalence to the predicate.

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

The document does not specify a distinct "test set" sample size in the sense of a number of clinical cases or patient images used for a diagnostic accuracy study. Instead, it refers to:

• Bench tests: These involved phantom images and physical testing of the system (e.g., patient support/gantry positioning repeatability and accuracy, laser alignment accuracy, CT image quality metrics testing). No sample size for these is given.
• Clinical Evaluation: An "image evaluation" was performed involving "images of the brain, chest, abdomen and pelvis/peripheral orthopedic body areas." The number of images or patient cases used for this evaluation is not specified.
• Data Provenance: Not explicitly stated, but given it's a Philips product, it's likely internal development and validation data. There is no mention of external datasets or specific countries of origin. The evaluation compares FBP and iDose4 reconstructions of the same images. The clinical evaluation implicitly relates to retrospective data as it compares reconstructed images.

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

• Number of Experts: "a qualified radiologist". So, one expert.
• Qualifications of Experts: Described only as "a qualified radiologist." No specific experience (e.g., years of experience, subspecialty) is provided.

4. Adjudication Method for the Test Set

The evaluation was performed by a single radiologist using a 5-point Likert scale. Therefore, no adjudication method (like 2+1, 3+1 consensus) was used as there was only one reviewer.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document describes an image evaluation by a single radiologist, not multiple readers. It also describes a comparison of image quality between reconstruction techniques (FBP vs. iDose4), not a comparison of human reader diagnostic performance with vs. without AI assistance.

• Effect size of human readers improving with AI vs without AI assistance: This information is not applicable as this type of study was not performed. The study evaluated if iDose4-reconstructed images (which is an iterative reconstruction technique for image quality improvement and dose reduction, not an AI for diagnosis) maintained diagnostic quality compared to standard FBP.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, in spirit, the primary evaluation is about the algorithm's output quality. The iDose4 iterative reconstruction algorithm directly produces images without human intervention, and these images were then evaluated by a radiologist. The core of this 510(k) is about the technical performance and safety of the CT scanner and its components, including its reconstruction algorithms. The evaluation described ("image evaluation...") is a standalone assessment of the image quality produced by the iDose4 algorithm compared to standard FBP. It is not an "AI diagnostic algorithm" standalone performance, but rather an "image reconstruction algorithm" standalone performance.

7. The Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" was established by the evaluation of a qualified radiologist using a 5-point Likert scale to determine if images were of "diagnostic quality" and for comparing image quality between reconstruction methods. This could be considered a form of "expert consensus," albeit from a single expert in this case. There is no mention of pathology or outcomes data being used as ground truth for this specific image quality assessment.

8. The Sample Size for the Training Set

Not applicable in the context of this 510(k) as presented.

The device (Philips Ingenuity CT) is a hardware CT scanner with associated software, including image reconstruction algorithms (like iDose4). While iterative reconstruction algorithms might involve some form of "training" or optimization during their development, the document does not speak to a "training set" in the sense of a dataset used to train a machine learning model for a specific diagnostic task that would typically be described in an AI/ML device submission. The description focuses on technical modifications and adherence to engineering and safety standards, and performance against a predicate device.

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

Not applicable for the reasons stated above (no "training set" for an AI/ML diagnostic model described).

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