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The ImagenUniversaJTM system is a software. application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive software for interpretation. The use of this system is limited to qualified, licensed healthcare providers (radiologists or nuclear med icine physicians) trained in the use of nuclear medicine imaging devices.

ImagenUniversal™ is a Windows application which allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise. The system processes perfusion and gated PET reconstructed emission and transmission data to create corrected 3D tomographic data. The user can select correction parameters, filter settings, range of reconstruction, and registration setting. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided text describes the ImagenUniversal™ system, a software application designed to correct myocardial perfusion PET images. While the document is a 510(k) summary, it does not contain the detailed study information or acceptance criteria typically found in a clinical study report.

The document states:

• "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates." This implies that the device was evaluated against existing, legally marketed predicate devices (Siemens Biograph 64 and 40 (K060631), Siemens Biograph mCT (K151486), and ImagenPRO (K050366)) to demonstrate substantial equivalence, a common pathway for 510(k) clearances. However, the specifics of this "testing and comparison" are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

Based on the information available, a summary can be constructed, but with significant gaps.

Summary of Acceptance Criteria and Study Information (Based on Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed performance metrics for the ImagenUniversal™ system. The primary claim is substantial equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text mentions the system processes "raw PET and/or PET/CT data," implying clinical data, but no further details are given.

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

• Number of Experts: Not specified.
• Qualifications: Not specified. The device's intended users are "qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices." It is plausible that such experts would be involved in any evaluation, but this is not stated.

4. Adjudication Method for the Test Set:

• Not specified.

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

• Not explicitly stated. The submission focuses on substantial equivalence to predicates, not a comparative effectiveness study demonstrating performance improvement with or without AI assistance. The device is described as a software application for correction, not necessarily an AI-assisted diagnostic tool in the sense of directly interpreting images.

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

• Not explicitly stated in terms of a formal standalone performance study. The device's function is to "correct" raw data into tomograms that "can be exported to cardiac interpretive software for interpretation." This implies an upstream processing role rather than a direct interpretive role, so a standalone diagnostic performance evaluation in the traditional sense might not be directly applicable or detailed here. However, the "testing and comparison of technological characteristics" would inherently involve evaluating the algorithm's performance in generating corrected images.

7. The Type of Ground Truth Used:

• Not specified. Given the nature of the device (correcting for transmission/emission misregistration, scatter, prompt gamma), ground truth would likely relate to the accuracy of these corrections compared to an ideal or gold standard measure, or the resultant image quality and diagnostic utility as assessed by experts. However, these specifics are not provided.

8. The Sample Size for the Training Set:

• Not specified. The document does not mention a training set, which may or may not be relevant depending on the specific algorithms employed for corrections (e.g., if machine learning models are used).

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

• Not applicable / Not specified. As no training set is mentioned, the method for establishing its ground truth is also not provided.

In conclusion, the provided FDA 510(k) summary focuses on establishing substantial equivalence to predicate devices based on "testing and comparison of technological characteristics and intended uses." It does not provide the detailed study design, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical study report to explicitly "prove" device performance against specific, quantifiable acceptance criteria.

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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):

Missing Information Not Present in the Document:

1. 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.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to:

• o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
• Produce cross-sectional images of the body by computer reconstruction of o XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

The Biograph 6 PET/CT provides registration and fusion of high-resolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

The Biograph 6 TruePoint scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology, and cardiology examinations. They provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO PET scanner and the Siemens Somatom Emotion 6 CT.

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT component provides fast attenuation correction for PET studies as well as precise anatomical reference through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631). The notable changes incorporated in this application consist of the addition of a water-cooled gantry option and an optional computer.

Here's a breakdown of the acceptance criteria and study information for the Biograph 6 TruePoint device, based on the provided text:

Important Note: The provided 510(k) summary focuses heavily on establishing substantial equivalence to previously cleared devices rather than detailing the direct performance testing of the Biograph 6 TruePoint against specific numerical acceptance criteria. The text explicitly states, "The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631)." This implies that the performance of the Biograph 6 TruePoint is considered acceptable because it is demonstrably similar to devices already on the market and cleared by the FDA for the same intended use. Therefore, the "acceptance criteria" are intrinsically tied to the performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for this specific device are not presented in the provided text. The "acceptance" is based on substantial equivalence to the predicate devices. However, we can infer the expected performance that formed the basis for this equivalence.

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

The provided text does not include information on a specific test set, its sample size, or data provenance for the Biograph 6 TruePoint itself. The submission relies on demonstrating substantial equivalence to pre-existing, cleared devices. Therefore, there's no mention of a separate test set used to independently validate the Biograph 6 TruePoint's performance in a clinical setting against acceptance criteria.

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

Since there is no mention of a specific test set or clinical study for the Biograph 6 TruePoint in the provided document, there is no information on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a test set, there is no information on an adjudication method.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating substantial equivalence, not on comparing performance with or without AI assistance (as this is a medical imaging device, not an AI-driven interpretation tool in this context).

6. Standalone Performance Study

While the device operates "stand-alone" in the sense that it performs its imaging functions independently, the document does not describe a specific standalone performance study that rigorously evaluated its performance against predefined metrics, separate from the human-in-the-loop clinical use context. The substantial equivalence argument implicitly serves this purpose by referencing the proven performance of predicate devices.

7. Type of Ground Truth Used

Given the nature of a 510(k) submission focused on substantial equivalence for an imaging device, the "ground truth" for the predicate devices (and thus, implicitly for this device) would have been established through methodologies typical for medical imaging, likely involving:

• Clinical correlation: Comparing imaging findings with other diagnostic tests, patient outcomes, or surgical/biopsy results.
• Expert consensus: Interpretations by experienced radiologists or nuclear medicine physicians.
• Physical phantom studies: For technical performance metrics like resolution, signal-to-noise ratio, etc.

However, the provided document does not explicitly state the specific type of ground truth used for the original predicate device clearances, nor for any new studies conducted for the Biograph 6 TruePoint.

8. Sample Size for the Training Set

This document describes a medical imaging device (PET/CT scanner), not typically an AI/machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this submission.

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

Since the concept of a "training set" as understood in AI/machine learning is not applicable here, this information is not present in the document.

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