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ACUSON Sequoia and Sequoia Select

The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

ACUSON Origin and Origin ICE

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures). Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text, specifically for the expansion of the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to pediatrics:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Number of individual patients: 105 patients.
  • 40 patients scanned with the DAX transducer.
  • 27 patients with the 5C1 transducer.
  • 38 patients with the 9C2 transducer.
• Number of samples: 525 measurements (Five UDFF measurements were obtained per patient).
• Data Provenance: Data were collected from two institutions in the US and France. The studies tested UDFF in children during clinically indicated MRI procedures.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). It only states that "MRI PDFF was used as the reference standard." The interpretation and establishment of ground truth from MRI-PDFF would typically involve qualified medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The reference standard used was MRI-PDFF, which is a quantitative measure and therefore may not have required such an adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study directly comparing human readers with and without AI assistance was not reported. The study focused on the performance of the UDFF tool itself against a reference standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the testing described appears to be for the standalone performance of the UDFF algorithm. The criteria and results focus on the measurements generated by the UDFF tool (AUROC, ICC, exam time) in comparison to the MRI-PDFF reference standard. While the tool is intended to "aid a physician," the performance metrics presented demonstrate the algorithm's capability independent of direct human interaction in the evaluation setup.

7. The Type of Ground Truth Used

The ground truth used was MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction). Steatosis was defined as MRI-PDFF greater than 5%.

8. The Sample Size for the Training Set

The document explicitly states that the UDFF algorithm remained unchanged and was not retrained for these studies. Therefore, no specific training set sample size for this expansion is provided, as the existing algorithm developed for adults was applied to the pediatric population.

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

Since the UDFF algorithm was not retrained and remained unchanged, the document does not describe how the ground truth for its original training set was established. It only clarifies that the data from these pediatric studies were considered "test data to evaluate the performance of UDFF in children using MRI PDFF."

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syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.

The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The general functionality of the syngo.CT Dual Energy application is as follows:

• · Monoenergetic 1)
• · Brain Hemorrhage
• · Gout Evaluation 1)
• · Lung Vessels
• · Heart PBV
• · Bone Removal
• · Lung Perfusion
• · Liver VNC 1)
• · Monoenergetic Plus 1)
• · Virtual Unenhanced 1)
• Bone Marrow
• · Hard Plaques
• Rho/Z
• · Kidney Stones 1) 2)
• · SPR (Stopping Power Ratio)
• · SPP (Spectral Post-Processing Format) 1)
• · Optimum Contrast 1)

The availability of each feature depends on the Dual Energy scan mode.

1. This functionality supports data from Photon-Counting CT scanners.

2. Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.

Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.

The provided text is a 510(k) summary for the syngo.CT Dual Energy device, specifically addressing modifications that enable its application classes (Liver VNC, Kidney Stones, Gout Evaluation) to support Photon-Counting CT (PCCT) data. While it discusses performance evaluations, it does not present a formal study with acceptance criteria and detailed quantitative results in the format requested.

The document indicates that the acceptance criteria for these modifications were primarily based on ensuring the existing algorithms and functionality, when applied to PCCT data, yield comparable results to their performance with previously approved dual-source dual-energy (DSDE) data or true non-contrast images, as appropriate. The evaluation appears to be a consistency check rather than a comparative effectiveness study against human readers or a standalone performance study with strict statistical endpoints.

Based on the provided text, here's an attempt to answer the questions, highlighting what information is available and what is not:

Acceptance Criteria and Device Performance Study for syngo.CT Dual Energy (K232155 - PCCT data support)

The provided submission summarizes the non-clinical testing performed to demonstrate that the updated syngo.CT Dual Energy, with its new support for Photon-Counting CT (PCCT) data for Liver VNC, Kidney Stones, and Gout Evaluation, continues to perform as intended and is substantially equivalent to its predicate. The "acceptance criteria" are implied by the performance evaluation statements, focusing on agreement and similarity of results between PCCT data and established methods (DSDE data or true non-contrast images).

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Liver VNC: "four-phase liver scans"
• Kidney Stones: "phantom data" (unspecified quantity) and "clinical data" (unspecified quantity)
• Gout Evaluation: Unspecified quantity of data for direct comparison.

Data Provenance:
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the mention of "NAEOTOM Alpha" (a Siemens PCCT scanner) suggests it's likely proprietary or internal test data generated for validation purposes. The phrase "already approved" for DSDE data suggests existing, previously validated clinical data might have been used for comparison.

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

This information is not provided in the document. The evaluations described ("agreed well," "similar to," "were the same") imply a comparison method, but the human reference or "ground truth" establishment process for these specific tests is not detailed, nor are the number and qualifications of experts involved.

4. Adjudication method for the test set

This information is not provided in the document. Given the summary nature of the performance data, it's unlikely a formal adjudication process for establishing ground truth for these specific validation tests would be detailed here.

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, a MRMC comparative effectiveness study involving human readers assisting with AI assistance versus without AI assistance was not mentioned or described in this 510(k) summary. The study focuses on the device's performance with new data types (PCCT), not on its impact on human reader performance.

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

Yes, the described performance data appears to be standalone (algorithm only), focusing on the processing capabilities of the syngo.CT Dual Energy software with PCCT data and comparing its output to known values (phantoms) or established results (DSDE data, true non-contrast images). There is no mention of human interaction being part of the evaluation of the algorithm's performance in these specific tests.

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

• Liver VNC: "True non contrast images" served as the ground truth/reference.
• Kidney Stones:
  • For phantom data: "known size and composition of the stones in the phantoms" served as ground truth.
  • For clinical data: "already approved dual-source dual-energy (DSDE) data" likely served as the reference for "similar" performance.
• Gout Evaluation: "results from the already approved DSDE scan mode" served as the reference for comparison.

8. The sample size for the training set

The document does not provide any information about the training set size for the algorithms within syngo.CT Dual Energy. Given that the 510(k) is for modifications to support new data types (PCCT) for existing algorithms, it's implied that the core algorithms were developed and trained previously. This submission specifically addresses the validation of these existing algorithms on the new PCCT data.

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

The document does not provide any information on how the ground truth for the training set (from the original algorithm development) was established.

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The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), Cardiac. Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."

The ACUSON Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other of adult and pediatric patients.

For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.

Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.

The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.

The provided document is a 510(k) Pre-market Notification for several Siemens ACUSON Diagnostic Ultrasound Systems, seeking clearance based on substantial equivalence to previously marketed devices. The document explicitly states that no new features, modifications, or changes were made to the hardware or software of the devices themselves. The entire submission focuses on an "expanded labeling" for lung ultrasound imaging, supported by existing clinical literature.

Therefore, the acceptance criteria and the study proving the device meets these criteria are not related to a new device or a new AI/algorithm feature being validated. Instead, it is about demonstrating that the existing, cleared devices can be marketed with expanded indications for use, supported by references to previously conducted tests and existing clinical literature.

Given this, I cannot provide information on:

• Reported device performance (as no new performance was claimed or tested)
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Sample size for training set or how ground truth for training set was established

The document explicitly states: "clinical studies were not required to support substantial equivalence. The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature." and "There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission."

Below is a table summarizing the acceptance criteria and "device performance" in the context of this 510(k) submission, emphasizing that the "performance" here refers to the device meeting the previously established safety and effectiveness for its predicate indications, which is being extended to a new recognized clinical use case via labeling.

Description of Acceptance Criteria and Evidence for ACUSON Diagnostic Ultrasound Systems (K202683)

This 510(k) submission (K202683) by Siemens Medical Solutions, USA, Inc., is a Special 510(k). This type of submission is used when changes to a cleared device do not alter its fundamental scientific technology or intended use, but may expand its labeling or functionality within its established safety and effectiveness profile. In this specific case, the submission focuses on expanded labeling for Lung Ultrasound Imaging (LUS), utilizing the existing capabilities of the cleared ACUSON Diagnostic Ultrasound Systems and their associated transducers.

Crucially, the document states that no modifications were made to the software or hardware of the devices. Therefore, the "acceptance criteria" and "proof" are based on demonstrating substantial equivalence to previously cleared predicate devices and leveraging existing validation data for those predicates, rather than presenting new performance metrics for a novel algorithm or device.

1. Acceptance Criteria and Reported Device "Performance" (Meeting Substantial Equivalence)

2. Sample Size and Data Provenance for Test Set

• Test Set Description: Not applicable. For this Special 510(k), no new test set data for device performance was generated or presented. The submission relies on existing validation data for the predicate devices.
• Data Provenance: The underlying data for previously cleared predicate devices would have been generated through rigorous internal testing and validation processes during their initial development and clearance. The document implies that this data exists and supports the current device. The document explicitly states: "Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission."

3. Number, Qualifications, and Adjudication Method for Experts

• No new expert assessment: Not applicable for this Special 510(k). Since no new AI/algorithm features or changes to device performance were introduced, there was no independent expert review of a new test set for the purpose of this submission. The "ground truth" for the expanded labeling (Lung Ultrasound) is based on established clinical recognition and existing peer-reviewed literature.
• Adjudication method: Not applicable.

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

• No new MRMC study: Not applicable. This submission does not involve a new AI or algorithm that would require an MRMC study to demonstrate human improvement with AI assistance.

5. Standalone (Algorithm Only) Performance Study

• No standalone algorithm: Not applicable. The submission is for diagnostic ultrasound systems, not a standalone algorithm. The core functionality is the ultrasound imaging, and the "expansion" is in the labeling for an existing modality.

6. Type of Ground Truth Used for Device Functions

• Existing Validated Performance: For the predicate devices, the ground truth and validation would have been established through a combination of:
  • Direct measurement and engineering specifications: For image quality, acoustic output, and system performance.
  • Clinical validation: Through various means including phantom studies, retrospective/prospective clinical data, and expert consensus for the initial indications.
• Clinical Literature/Consensus for Expanded Indication: For the new labeling related to Lung Ultrasound Imaging (LUS), the "ground truth" or justification is based on:
  • Established clinical practice: Recognition within the medical community for the utility of ultrasound in lung assessment.
  • Peer-reviewed studies and professional guidelines: As explicitly stated, the LUS labeling is "supported by clinical literature." This effectively implies that the medical community's consensus on the utility of LUS (as documented in such literature) serves as the "ground truth" for its clinical relevance.

7. Sample Size for Training Set

• No new training set: Not applicable. As no new AI/algorithm components were introduced or modified, there was no "training set" for the purpose of this specific 510(k) submission.

8. How Ground Truth for Training Set was Established

• No new training set: Not applicable.

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The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.

The software supports the following clinical application packages:

• · eSie Volume Viewer
• eSie LVA
• · eSie PISA
• · eSie Valves

syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).

The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.

The syngo® Ultrasound Apps Suite™ (sUSAS) is a software-only product intended for image processing, manipulation, and quantification of ultrasound images from the ACUSON SC2000™ Ultrasound System on a PACS workstation. It supports several clinical application packages (CAPS): eSie Volume Viewer, eSie LVA, eSie PISA, and eSie Valves.

The device's acceptance criteria and proven performance are primarily established through a demonstration of substantial equivalence to a predicate device (eSie Apps Suite, K143254) and a secondary predicate (ACUSON SC2000 Diagnostic Ultrasound System v6.0, K200585), rather than through a standalone clinical study with specific performance metrics against an independent ground truth. The submission emphasizes that the subject device utilizes the same fundamental scientific technology and intended use/indications for use as the predicate device. Non-clinical testing for verification and validation was performed.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance results for human readers or algorithm-only performance. Instead, substantial equivalence is claimed based on functional and technological characteristics matching or improving upon the predicate devices. The "performance" is demonstrated through alignment with the predicate's capabilities and additional updated features.

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

The document does not specify a separate "test set" in the context of clinical performance evaluation with human readers or an algorithm-only study. The submission relies on non-clinical verification and validation testing of the software to ensure it meets specifications and claims of functioning identically or with minor beneficial updates compared to the predicate device. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not provided as it would typically be for a clinical performance study.

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

As no specific clinical test set and human performance comparison is detailed, information regarding the number of experts or their qualifications for establishing ground truth is not applicable or provided in this submission for determining substantial equivalence based on clinical outcomes. Ground truth for non-clinical software testing would be based on design specifications and expected behavior.

4. Adjudication Method for the Test Set

Since no clinical test set requiring expert adjudication for ground truth establishing is described, information on the adjudication method (e.g., 2+1, 3+1, none) is not applicable or provided.

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

No MRMC comparative effectiveness study is mentioned. The submission states, "clinical studies were not required to support substantial equivalence" because the device uses the "same technology and operating principles as the predicate device." Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.

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

The document does not describe a standalone (algorithm only) performance study against a specific ground truth. The device is software that launches clinical application packages. Its effectiveness is tied to its functional equivalence to existing validated software on predicate devices. The "performance" is therefore inherent in the established and proven functionality of the CAPS, not a new standalone AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the claims of substantial equivalence and based on the non-clinical verification and validation, the ground truth is implicitly the established and validated functionality and performance of the predicate device (eSie Apps Suite) and the ACUSON SC2000 Diagnostic Ultrasound System v6.0. This refers to adherence to specifications, expected software behavior, and the established clinical utility of the underlying CAPS, rather than a clinical ground truth derived from pathology or outcomes data specifically for this submission.

8. The Sample Size for the Training Set

The document does not describe a training set for a machine learning or AI algorithm. The device is primarily an application suite with image processing and quantification tools, not a newly developed AI algorithm requiring a dedicated training set as described in clinical AI/ML regulatory submissions.

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

Since no training set is described, information on how its ground truth was established is not applicable.

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The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined sys tem maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and obligue crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their label ing. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P.

• Improvement of the SPACE pulse sequence type with:
• CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592)
• Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast.
• Implementation of "CP-only" RF transmission mode based on the । requirements of 60601-2-33 Ed. 3.2:2015.

I am unable to conduct a detailed analysis of the acceptance criteria and study as the provided text is a 510(k) summary for a medical device (Biograph mMR with syngo MR E11P-AP01 system software) and does not contain the specific information required to complete your request.

Here's why and what's missing:

• No Explicit Acceptance Criteria: The document describes modifications to an existing device (software updates, new head coil). It states that nonclinical data "suggests that the feature bear an equivalent safety and performance profile as that of the predicate device." However, it does not define specific quantitative acceptance criteria for performance metrics (e.g., specific thresholds for image quality, signal-to-noise ratio, diagnostic accuracy, etc.) that the device must meet.
• No Detailed Study Results: While it mentions "nonclinical tests" were conducted and "clinical images are provided to support the migrated coil as well as the improved software features," it does not provide the results of these tests. It only makes a general statement that the device "performs as intended."
• Lack of Specifics for Your Questions: The text is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study report. Therefore, it does not include:
  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, or details about patient cohorts (e.g., country of origin, retrospective/prospective nature).
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
  • Details of standalone algorithm performance.
  • Specific types of ground truth used (beyond general "clinical images").
  • Sample size or ground truth establishment methods for training sets.

In essence, the document confirms that testing was done to ensure the modified device is substantially equivalent to its predicate, but it does not delve into the granular details of those tests, their results, or the precise acceptance criteria used, which would be found in a more comprehensive study report or internal validation documentation.

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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are:

Cardiac Imaging Applications and Analysis
Vascular Imaging Applications and Analysis
Superficial Imaging Applications
Intraoperative Imaging Applications
Transcranial Imaging Applications

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

I am sorry, but the provided text is a 510(k) premarket notification for the ACUSON SC2000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or its data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document explicitly states in "Part 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence" that: "Since the ACUSON SC2000 VC10A (v6.0) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000. VB21A (v5.1) K181098, clinical studies were not required to support substantial equivalence."

The non-clinical tests mentioned in Part 7 are related to device safety standards (acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety), not performance against clinical acceptance criteria.

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For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

The ACUSON NX3 Elite and ACUSON NX3 Diagnostic Ultrasound Systems are a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

This document is a 510(k) premarket notification from Siemens Medical Solutions USA, Inc. for their ACUSON NX3 Diagnostic Ultrasound System and ACUSON NX3 Elite Diagnostic Ultrasound System. It aims to demonstrate substantial equivalence to previously cleared predicate devices (K173957).

Analysis of Acceptance Criteria and Study Design:

This document describes a submission for a change to Indications for Use for an existing device, rather than a clinical study establishing performance of a new device or software. Therefore, the typical structure of acceptance criteria and a study design proving a device meets these criteria (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) is not present in this document.

Instead, the document asserts substantial equivalence based on:

1. Technological Characteristics: The devices are fundamentally the same as their predicates, with the same core function (ultrasound imaging), modes of operation, and most features.
2. Expanded Indications for Use: The main purpose of this submission is to expand the stated Indications for Use for the existing ACUSON NX3 and ACUSON NX3 Elite systems, and specifically to update the Indications for Use for the VF13-5sp transducer. These expansions primarily involve applications (e.g., "cardiac (including transesophageal)" and "small parts to the intra-operative clinical application") that were already cleared on the predicate devices or with other transducers.

Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" as typically applied to performance claims (e.g., for an AI/ML algorithm) needs to be reinterpreted in the context of a 510(k) for an updated Indications for Use of an existing ultrasound system.

Therefore, the "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for an expanded intended use, which primarily relies on technological similarity and safety/performance data already established for the predicate device.

Here's an attempt to answer your questions based on the provided document, noting that many items will be answered as "Not Applicable" or "Not Provided" because this is a 510(k) for an existing device with expanded indications, not a performance study for a novel AI/ML algorithm:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) for expanding indications of an existing ultrasound system, not a new AI/ML device with specific performance claims (e.g., sensitivity, specificity), a direct "acceptance criteria" table with performance metrics isn't explicitly defined in the document. The acceptance criterion is "substantial equivalence" to the predicate, demonstrated by listing comparable technological characteristics and intended uses.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. This submission is for expanded indications of an existing ultrasound system, not a clinical study with a test set for performance evaluation of a new algorithm. The manufacturer states that "clinical data is not required" because the devices use the "same technology and principles as existing devices."
• Data Provenance: Not applicable for a new clinical study. The existing data supporting the predicate device's clearance would have been used. The document does not specify the provenance of data for the original predicate clearance (K173957), but it did not rely on
  clinical data. The AHP feature references peer-reviewed studies, but these are not for the device's performance, but for the underlying normative tables.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No new clinical test set requiring expert-established ground truth was performed for this 510(k) submission.

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

• Not applicable. No new clinical test set requiring adjudication was performed for this 510(k) submission.

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 not an AI-assisted device; it is a diagnostic ultrasound system. No MRMC study was performed.

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

• Not applicable. This is not an algorithm, but a diagnostic imaging system.

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

• Not applicable for a new clinical study. The existing predicate device was cleared without new clinical data. The AHP feature bases its normative tables on "peer-reviewed studies" and "ASE Consensus Statement."

8. The sample size for the training set:

• Not applicable. This is hardware (ultrasound system) with software, not a machine learning model requiring a training set.

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

• Not applicable. This is hardware (ultrasound system) with software, not a machine learning model.

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Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectroscopic images and or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yicld information that may assist in diagnosis.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Vida with software syngo MR XA11B includes new and modified component, features and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the new and modified features is provided below:

Hardware
New Hardware

• Nose Marker for Inline Motion Correction
  Software
  New Features and Applications
• TFL with Inline Motion Correction: Tracking of motion of the head during 3D MPRAGE head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
• i GOLiver: GOLiver is a set of optimized pulse sequence for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
• TSE_MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.
• SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients i with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
• Angio TOF with Compressed Sensing: The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
• SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple i slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
• i SPACE with Compressed Sensing: The Compressed Sensing (CS) functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
• RT Respiratory self-gating for FL3D_VIBE: Non-contrast abdominal and thoracic i examination in free breathing with reduced blur induced by respiratory motion.
  Other Modifications and / or Minor Changes
• i Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Vida MR systems.
• i Noise masking: a mechanism to remove the noise floor in outer regions is now available for RESOLVE and QDWI.

The provided FDA 510(k) summary for the MAGNETOM Vida (K183254) does not contain the specific details for acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or devices with new diagnostic functionalities.

This 510(k) is for an updated version of an existing MRI system (MAGNETOM Vida with software syngo MR XA11B) compared to its predicate (MAGNETOM Vida with syngo MR XA11A). The changes primarily involve new hardware (1 mention) and several new or modified software features for image acquisition and processing (e.g., motion correction, optimized pulse sequences, metal artifact correction, accelerated imaging techniques).

The document states: "No clinical tests were conducted to support substantial equivalence for the subject device; however, sample clinical images were provided to support the new/modified component and software features per the FDA guidance document 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', dated November 18, 2016."

This indicates that the primary focus of the submission was on demonstrating that the new features maintain the safety and performance profile of the predicate device through non-clinical testing (image quality assessments, software verification/validation) and by providing sample clinical images (not a formal clinical study with acceptance criteria).

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text because such a detailed study with acceptance criteria, ground truth, expert readers, and effect sizes was not performed or described in this 510(k) submission for this specific device clearance.

Below, I will indicate which information is not present in the document and briefly explain why, based on the nature of this 510(k) (which is for an updated MRI system, not an AI/ML diagnostic algorithm).

Acceptance Criteria and Study for MAGNETOM Vida (K183254)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: NOT PRESENT. The document mentions "sample clinical images were provided," but it does not specify the number of images or patients used for these samples, nor does it describe a formal "test set" in the context of a diagnostic performance study.
• Data Provenance (country of origin, retrospective/prospective): NOT PRESENT. The origin of the "sample clinical images" is not specified.

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

• NOT APPLICABLE/NOT PRESENT. Since no formal clinical study with a defined "test set" and "acceptance criteria" was described for diagnostic performance, there's no mention of experts establishing ground truth for such a study. The product is an MRI system, and interpretations are made by "trained physicians."

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

• NOT APPLICABLE/NOT PRESENT. No formal adjudication method is described, as no specific clinical diagnostic performance test set requiring such expert consensus was presented in this 510(k).

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 study was not conducted or described for this submission. This device is an MRI scanner with new and modified acquisition and processing features, not an AI-assisted diagnostic tool that directly aids human readers to improve diagnostic accuracy.

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

• NO. This is an MRI system. Its "performance" is inherently tied to image acquisition and quality, which are then interpreted by a human. It does not perform a standalone diagnostic function like an AI algorithm for disease detection.

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

• NOT APPLICABLE/NOT PRESENT. No formal ground truth definition is provided for a clinical performance study since one was not conducted for the purpose of demonstrating substantial equivalence. The device's performance was evaluated through non-clinical tests (e.g., image quality assessments).

8. The sample size for the training set:

• NOT APPLICABLE/NOT PRESENT. The document describes software modifications including some advanced imaging techniques (e.g., Compressed Sensing). While these might involve optimization based on data, the submission does not describe a traditional "training set" in the context of an AI/ML algorithm development or a diagnostic study. The software development and testing follow IEC 62304 and other relevant standards.

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

• NOT APPLICABLE/NOT PRESENT. As no "training set" in the context of diagnostic AI/ML was described, no information on its ground truth establishment is provided.

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The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.

Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

The "syngo Application Software" (VD20) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image-guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image quided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens "syngo Application Software" (VD20) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the "syngo Application Software" (VD20) cleared in K163285 with the exception of the added new software feature "syngo TrueFusion".

The provided document describes the acceptance criteria and a study proving that the "syngo TrueFusion" software feature, added to the "syngo Application Software" (VD20), meets these criteria.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for "syngo TrueFusion"

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

• Sample Size: 28 phantom test data sets.
• Data Provenance: The document does not specify the country of origin. It indicates the data was generated from "phantom test data sets," which are typically controlled, lab-based experiments. It is a retrospective analysis of this phantom data.

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

• Number of Experts: One (1) board certified cardiologist.
• Qualifications of Experts: The document states "a board certified cardiologist" performed the measurements and clinically accepted the results.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). It states that the measurements were performed from different directions by "a board certified cardiologist" and "All results were clinically accepted by a board certified cardiologist." This suggests a single expert's assessment was used to clinically validate the numerical results.

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

• No, an MRMC comparative effectiveness study was not done. The study focuses on the technical performance of the "syngo TrueFusion" feature in a phantom setting (mean deviation and standard deviation) and its clinical acceptance by a single expert. It does not evaluate human reader improvement with or without AI assistance.

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

• Yes, the performance metrics (mean deviation and standard deviation) appear to be a standalone evaluation of the algorithm's accuracy in co-registration on phantom data. While a cardiologist "performed multiple measurements" and "clinically accepted" the results, the core performance metrics are objective measurements of the algorithm's output against implied ground truth on the phantom. This is an evaluation of the software's inherent performance.

7. The Type of Ground Truth Used

• The ground truth was established by phantom measurements. The acceptance criteria are based on the deviation from some reference or true value on the phantom, and those measurements were clinically accepted by a board-certified cardiologist.

8. The Sample Size for the Training Set

• The document does not specify a sample size for a training set. The study pertains to the validation of a new software feature, "syngo TrueFusion," which includes "probe detection enhanced by machine learning" (Claim 8). However, it only details the test data used for validation (28 phantom test data sets) and does not provide information about the data used for training the machine learning component.

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

• Since the document does not specify a training set, it does not describe how ground truth for the training set was established.

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The Siemens Symbia Intevo Bold is intended for use 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.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques; Planar imaging, and tomographic imaging for isotopes with energies up to 588 keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.

The Siemens Symbia Intevo Bold consist of Sinqle Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. 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 system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.

Symbia Intevo Bold implements software version syngo MI Applications VB20A.

Modifications include:

1. Incorporation of the commercially available SOMATOM Scope Power CT system (K151749)

2. Software updates include modifications to support features available with the CT and SPECT subsystems

3. Expansion of commercially available xSPECT Quant (Symbia 5.0 K131634) to support quantification of additional isotopes

4. Four additional touchpad sensors to cover detectors' light rails and L-arms.

Commercially available xSPECT Quant (Symbia 5.0 K131634) was expanded to support quantification of additional isotopes such as I-123 and In-111. For these isotopes, dose calibrator independent quantification is enabled by a NIST traceable sensitivity calibration method. In addition, cross calibration capabilities were added to remove dose calibrator biases and variations in SUV calculations. The system allows cross calibration of multiple dose calibrators and, once calibrated, automatically adjusts for their biases.

In addition to dose calibrator independent quantification for I-123 and In-111 support for dose calibrator dependent quantification was added for a broad range of SPECT isotopes and collimators (Broad Quantification). Dose calibrator dependent quantification neither supports NIST traceable calibration nor cross calibration and relies on sensitivity measurements based on a local dose calibrator.

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

1. Table of Acceptance Criteria and Reported Device Performance

The documents primarily focus on the quantitative accuracy and reproducibility of the "xSPECT Quant" and "Broad Quantification" features within the Symbia Intevo Bold system.

Additionally, general performance testing against NEMA NU-1:2012 standards was conducted, with a general statement that "All Performance testing met the predetermined acceptance values." This includes intrinsic spatial resolution, intrinsic spatial linearity, intrinsic energy resolution, intrinsic flood field uniformity, multiple window spatial registration, intrinsic count rate performance in air, system spatial resolution with LEHR, SPECT reconstructed spatial resolution, intrinsic flood field uniformity at 25% busy time, intrinsic energy resolution at 25% busy time, energy peak position stability, and system spatial resolution at 25% busy time.

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

The documents do not specify the sample size in terms of number of patient cases or images for either the quantitative accuracy or reproducibility testing. The tests utilized "phantoms."

• Data Provenance: The data provenance is not explicitly stated as retrospective or prospective patient data. Given the use of "phantoms," the data is synthetically generated and controlled within a laboratory setting, not derived from human subjects. 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

This information is not provided in the document. The ground truth for xSPECT Quant accuracy was established directly through reference to the National Institute of Standards and Technology (NIST) traceable precision sources for calibration. For reproducibility, the ground truth standard is the initial measurement against which subsequent measurements are compared. These methods do not inherently require human expert consensus for establishing the ground truth values.

4. Adjudication Method for the Test Set

An adjudication method is not applicable and not mentioned. The quantitative accuracy and reproducibility tests rely on direct comparison to known physical standards (NIST traceable sources) or statistical measures of variance, rather than human interpretation that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned and likely not performed for this submission. The device (Symbia Intevo Bold) is an imaging system, not an AI-assisted diagnostic software in the sense of providing automated interpretations or workflow enhancements to human readers that would be typically evaluated in an MRMC study focused on reader performance improvement. The "MI Applications software" is a "display and analysis package" to aid clinicians in assessment and quantification, but the provided studies do not evaluate its impact on human reader performance.

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

Yes, the performance testing described for "xSPECT Quant" and "Broad Quantification" falls under a standalone (algorithm only) evaluation. The system's ability to accurately quantify isotopes or reproduce measurements is tested intrinsically, separate from a human operator's diagnostic interpretation. The NEMA NU-1:2012 testing also evaluates the physical performance of the SPECT and CT components in a standalone manner.

7. The Type of Ground Truth Used

• xSPECT Quant (Quantitative Accuracy): The ground truth was based on a NIST traceable precision source. This is a highly accurate, objectively verifiable physical standard.
• Broad Quantification (Reproducibility): The ground truth for reproducibility essentially refers to the initial, measured values from dose calibrator dependent quantification against which subsequent measurements are compared for consistency.

8. The Sample Size for the Training Set

The documents do not provide information regarding a "training set" sample size. The Symbia Intevo Bold is a medical imaging system, and while it includes software (syngo MI Applications), the described testing focuses on the physical and quantitative performance of the imaging hardware and associated quantification algorithms, not a machine learning model that would typically have a distinct training set. The software updates mention "modifications to support features" and "software improvements," suggesting iterative development rather than a single distinct training phase for a new AI model.

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

Since no specific "training set" for a machine learning model is mentioned, details on how its ground truth was established are not provided. If the software components involve internal calibration or optimization routines, these would use internal reference data, but it's not discussed in the context of an external, validated training set as one might find for a deep learning algorithm.

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