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510(k) Data Aggregation
(57 days)
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.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Equivalence to Predicates | "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates." |
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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(65 days)
The Siemens Biograph Horizon PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration 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 Horizon PET/CT 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 Horizon 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 Horizon 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 Bioqraph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include:
- . Corrections to software anomalies and addition of new software features, including:
- Continuous Bed Motion O
- o HD·Chest (including Stitched HD Chest)
- Whole Body Gating O
- HD FoV for Attenuation Correction о
- Phased Matched Gating O
- Low Dose CT Protocols for PET AC O
- SMART Mobile Connect O
- PET Dose Report O
- Enhanced IT Security O
- Scan Protocol Management o
- TeamViewer O
- Dual Topo O
- True Stack O
Additionally, minor modifications have been made to the patient bed electronics due to obsolescence issues. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.
The provided text is a 510(k) Summary for the Siemens Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing results. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Resolution - Full Size | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 4.7 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 5.5 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 7.6 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 5.0 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 7.0 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 11.3 mm | Pass |
| Resolution - 256 x 256 | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 7.3 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 7.6 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 8.9 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 6.1 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 7.3 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 11.9 mm | Pass |
| Count Rate / Scatter / Sensitivity | ||
| Sensitivity @435 keV LLD | ≥ 5.8 cps/MBq≥ 10.9 cps/MBq (TrueV) | Pass |
| Count Rate peak NECR | ≥ 78 kcps @ ≤ 26 kBq/cc≥ 135 kcps @ ≤ 26 kBq/cc (TrueV) | Pass |
| Count Rate peak trues | ≥285 kcps @ ≤ 53 kBq/cc≥ 465 kcps @ ≤ 42 kBq/cc (TrueV) | Pass |
| Scatter Fraction at peak NECR | ≤ 40% | Pass |
| Mean bias (%) at peak NEC | ≤ 6% | Pass |
| Image Quality (4 to 1) - (% Contrast / Background Variability) | ||
| 10mm sphere | ≥ 10% / ≤ 10% | Pass |
| 13mm sphere | ≥ 25% / ≤ 10% | Pass |
| 17mm sphere | ≥ 40% / ≤ 10% | Pass |
| 22mm sphere | ≥ 55% / ≤ 10% | Pass |
| 28mm sphere | ≥ 55% / ≤ 10% | Pass |
| 37mm sphere | ≥ 60% / ≤ 10% | Pass |
All performance testing met the predetermined acceptance values.
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon systems, a 3 ring version and a 4 ring version (TrueV)." NEMA NU2:2012 is a standard for the performance measurements of PET scanners, typically utilizing phantoms rather than human or clinical data. Therefore, the "test set" in this context refers to measurements taken on the physical systems using standardized phantoms. The document does not specify a separate sample size (e.g., number of patients or data points) beyond testing the two system configurations. The data provenance is derived from these physical system tests, not from a specific country of origin or clinical retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given that the performance testing was conducted according to NEMA NU2:2012, which involves standardized measurements using phantoms, the concept of "experts" establishing ground truth in a clinical sense (e.g., radiologists reviewing images) is not applicable here. The "ground truth" for this type of testing is established by the known physical properties and radioactive concentrations within the phantoms used, as measured against the NEMA standard.
4. Adjudication Method for the Test Set
As the performance testing against NEMA NU2:2012 involves direct physical measurements and calculations based on phantom acquisitions, there is no mention of a human adjudication method (like 2+1 or 3+1 consensus) in the document. The "Pass" results indicate that the measured values fell within the predefined acceptance ranges.
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
The provided document describes performance testing of a PET/CT scanner against technical standards (NEMA NU2:2012). It does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies, nor any AI assistance to human readers. Therefore, no effect size for human reader improvement with/without AI can be determined from this document.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document details the performance characteristics of the PET/CT hardware system. It refers to software modifications but these are for anomaly corrections and new features (e.g., Continuous Bed Motion, HD·Chest), not for an "algorithm only" standalone performance evaluation in a diagnostic context. The core performance testing focuses on the system's physical capabilities as measured by NEMA NU2:2012.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was based on physical phantom measurements in accordance with the NEMA NU2:2012 standard. This standard defines precise methodologies for measuring metrics like resolution, sensitivity, and image quality using phantoms with known characteristics.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The testing performed is related to the physical performance of the PET/CT system hardware, not a data-driven model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of the device's performance evaluation in this document, the method for establishing its "ground truth" is not applicable or described.
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(25 days)
The Siemens Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow 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 Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT 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.
The 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 Horizon PET/CT systems and Biograph mCT Flow PET/CT systems that are the subject of this Premarket Notification are identical in design, material, functionality, technology and energy source to the commercially available Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems.
The provided document describes a 510(k) Premarket Notification for Siemens Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems. The purpose of this submission is not to introduce a new device, but to support an additional indication for use for low dose lung cancer screening in high-risk populations. The key information for this request revolves around demonstrating that the CT component of these combined PET/CT systems is substantially equivalent to standalone SOMATOM CT systems (K142955) that already have this specific indication.
Therefore, the "proof" is based on demonstrating equivalence to an already cleared device, rather than a de novo clinical study proving effectiveness or a multi-reader, multi-case study in the context of AI assistance. The document explicitly states: "No additional performance testing beyond what was cleared in the original Premarket Notifications is required." This means that the original performance tests for the standalone CT systems are being leveraged.
Below is an attempt to structure the information based on your request, noting that some of your specific categories (like AI assistance, ground truth for training sets, number of experts for ground truth, and adjudication methods for a novel device) are not directly applicable to this specific 510(k) submission due to its nature as an "additional indication for use" based on substantial equivalence.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
The acceptance criteria for the new indication for use (low dose lung cancer screening) are based on demonstrating that the performance of the CT component within the Biograph Horizon PET/CT and Biograph mCT/mCT Flow PET/CT Systems is identical to that of the previously cleared standalone SOMATOM CT systems (K142955) for this specific application.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (for CT Component) | Specific Criterion (Performance Parameter Comparison) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|---|
| Imaging Performance | CT number accuracy | "no differences exist in the parameters" |
| CT number uniformity | "no differences exist in the parameters" | |
| Spatial resolution (MTF, max in-plane resolution) | "no differences exist in the parameters" | |
| Slice thickness/sensitivity profile (min slice width) | "no differences exist in the parameters" | |
| Noise properties (NPS and image Noise (std dev)) | "no differences exist in the parameters" | |
| Contrast to Noise Ratio | "no differences exist in the parameters" | |
| Operational Performance | Maximum scan speed | "no differences exist in the parameters" |
| Minimum reconstructed slice interval | "no differences exist in the parameters" | |
| Overall Equivalence | Design, material, functionality, technology, energy source | "identical" (to commercially available predicate systems) |
| Intended Use | "no difference in the intended use of the device" | |
| Radiation Safety Standards | Compliance with 21 CFR 1020.30, 1020.33, 1040.10, 1040.11 | |
| Electrical/Mechanical Safety Standards | Compliance with IEC 60601-1 series and AAMI / ANSI ES60601-1 | |
| Software Lifecycle Standards | Compliance with IEC 62304 | |
| Risk Management | Compliance with ISO 14971 |
Conclusion from performance testing: "The test results demonstrate that the subject devices perform the same as the standalone SOMATOM CT systems. Since the standalone systems have been identified as suitable for lung cancer screening (K142955), the use of the CT component of the Biograph Horizon PET/CT systems and Biograph mCT and mCT Flow PET/CT systems is likewise suitable for lung cancer screening."
Study Details Proving Device Meets Acceptance Criteria
This submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the standalone SOMATOM CT systems (K142955) that were previously cleared for low dose lung cancer screening. Therefore, the "study" is primarily a comparative analysis of technical parameters and design specifications, rather than a new clinical trial.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of patient data for this specific 510(k). The "test set" here refers to the technical parameters of the devices.
- Data Provenance: The comparison is made between the technical specifications and existing performance validation (from previous 510(k) clearances) of the Biograph Horizon/mCT/mCT Flow PET/CT systems and the SOMATOM CT systems (K142955). This is an engineering and regulatory comparison of device characteristics and previously validated performance, not a new retrospective or prospective clinical data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not directly applicable. The "ground truth" for this submission is whether the technical parameters of the CT component in the PET/CT system are demonstrably identical to those of the predicate standalone CT system. This is established through engineering specifications, previous performance reports, and adherence to recognized standards, rather than expert consensus on a scan dataset for a new device. The original clearance for the predicate CT system would have involved relevant expert input.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation of images that would require an adjudication method.
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 versus without AI assistance:
- No MRMC study was conducted for this 510(k) submission. The device (PET/CT system) is an imaging equipment; it is neither an AI algorithm nor an AI-assisted diagnostic tool in the sense of the question. The request is to add an indication for a human-interpreted CT scan for screening.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The CT component itself is a standalone imaging modality within the PET/CT system. The "performance" assessment was of these physics/engineering parameters to ensure they are identical to the predicate CT system. There is no AI algorithm being evaluated for standalone performance in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this specific submission, the "ground truth" is the proven performance and technical specifications of the predicate device (SOMATOM CT systems K142955) regarding its suitability for low dose lung cancer screening. The comparison aims to establish that the subject device's CT component matches these established characteristics.
- The basis for the predicate device's clearance for lung cancer screening likely involved referencing clinical literature, such as the National Lung Screening Trial (NLST), and guidelines from professional medical societies, which would implicitly rely on outcomes data and expert consensus for defining suitable screening parameters and populations.
8. The sample size for the training set:
- Not applicable. This submission is for an imaging device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable (as above).
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