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The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.

The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.

However, based on the analytical performance studies described, we can extract the following information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).

Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be

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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, 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 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: Fetal, 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 (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.

The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."

Here's an analysis of the acceptance criteria and the study information provided:

Acceptance Criteria and Reported Device Performance

The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.

Study Details for Liver Elastography Optimization (SWE Performance Testing)

The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.

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

   • Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
   • Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.

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

   • Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
   • Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.

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

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.

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

   • Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.

6. The Type of Ground Truth Used:

   • Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.

8. How the Ground Truth for the Training Set Was Established:

   • Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.

Summary regarding AI components:

While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.

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Vantage Fortian/Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

• Proton density (PD) (also called hydrogen density)
• Spin-lattice relaxation time (T1)
• Spin-spin relaxation time (T2)
• Flow dynamics
• Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™ Sigma and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP includes the XGO gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Fortian/Orian MRI System is comparable to the current 1.5T Vantage Fortian/Orian MRI System (K240238), cleared April 12, 2024, with the following modifications.

Acceptance Criteria and Study for Canon Medical Systems Vantage Fortian/Orian 1.5T with AiCE Reconstruction Processing Unit for MR

This document outlines the acceptance criteria and the study conducted to demonstrate that the Canon Medical Systems Vantage Fortian/Orian 1.5T with AiCE Reconstruction Processing Unit for MR (V10.0) device meets these criteria, specifically focusing on the new features: 4D Flow, Zoom DWI, and PIQE.

The provided text focuses on the updates in V10.0 of the device, which primarily include software enhancements: 4D Flow, Zoom DWI, and an extended Precise IQ Engine (PIQE). The acceptance criteria and testing are described for these specific additions.

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criterion for all new features appears to be demonstrating clinical acceptability and performance that is either equivalent to or better than conventional methods, maintaining image quality, and confirming intended functionality. Specific quantitative acceptance criteria are not explicitly detailed in the provided document beyond qualitative assessments and comparative statements.

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

• 4D Flow & Zoom DWI: Evaluated utilizing phantom images and "representative volunteer images." Specific numbers for volunteers are not provided.
• PIQE Clinical Image Review Study:
  • Subjects: A total of 75 unique subjects.
  • Scans: Comprising a total of 399 scans.
  • Reconstructions: Each scan was reconstructed multiple ways with or without PIQE, totaling 1197 reconstructions for scoring.
  • Data Provenance: Subjects were from two sites in USA and Japan. The study states that although the dataset includes subjects from outside the USA, the population is expected to be representative of the intended US population due to PIQE being an image post-processing algorithm that is not disease-specific and not dependent on factors like population variation or body habitus.

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

• PIQE Clinical Image Review Study:
  • Number of Experts: 14 USA board-certified radiologists/cardiologists.
  • Distribution: 3 experts per anatomy (Body, Breast, Cardiac, Musculoskeletal (MSK), and Neuro).
  • Qualifications: "USA board-certified radiologists/cardiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• PIQE Clinical Image Review Study: The study describes a randomized, blinded clinical image review study. Images reconstructed with either the conventional method or the new PIQE method were randomized and blinded to the reviewers. Reviewers scored the images independently using a modified 5-point Likert scale. Analytical methods used included Gwet's Agreement Coefficient for reviewer agreement and Generalized Estimating Equations (GEE) for differences between reconstruction techniques, implying a statistical assessment of agreement and comparison across reviewers rather than a simple consensus adjudication method (e.g., 2+1, 3+1).

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

• Yes, an MRMC comparative effectiveness study was done for PIQE.
• Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: The document states that "the Reviewers' scoring confirmed that: (a) PIQE generates higher spatial in-plane resolution images from lower resolution images (with the ability to triple the matrix dimensions in both in-plane directions, i.e. a factor of 9x); (b) PIQE contributes to ringing artifact reduction, denoising and increased sharpness; (c) PIQE is able to accelerate scanning by reducing the acquisition matrix only, while maintaining clinical matrix size and image quality; and (d) PIQE benefits can be obtained on regular clinical protocols without requiring acquisition parameter adjustment."
  • While it reports positive outcomes ("scored on average at, or above, clinically acceptable," "strong agreement at the 'good' and 'very good' level"), it does not provide a quantitative effect size (e.g., AUC difference, diagnostic accuracy improvement percentage) of how much human readers improve with AI (PIQE) assistance compared to without it. The focus is on the quality of PIQE-reconstructed images as perceived by experts, rather than the direct impact on diagnostic accuracy or reader performance metrics. It confirms that the performance is "similar or better" compared to conventional methods.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone performance was conducted for PIQE and other features.
  • 4D Flow and Zoom DWI: Evaluated using phantom images, which represents standalone, objective measurement of the algorithm's performance against known physical properties.
  • PIQE: Bench testing was performed on typical clinical images to evaluate metrics like Edge Slope Width (sharpness), Ringing Variable Mean (ringing artifacts), Signal-to-Noise ratio (SNR), and Contrast Ratio. This is an algorithmic-only evaluation against predefined metrics, without direct human interpretation as part of the performance metric.

7. Type of Ground Truth Used

• 4D Flow & Zoom DWI:
  • Phantom Studies: Known physical values (e.g., known flow values for velocity measurement, known distortion levels, known ADC values).
• PIQE:
  • Bench Testing: Quantitative imaging metrics derived from the images themselves (Edge Slope Width, Ringing Variable Mean, SNR, Contrast Ratio) are used to assess the impact of the algorithm. No external ground truth (like pathology) is explicitly mentioned here, as the focus is on image quality enhancement.
  • Clinical Image Review Study: Expert consensus/opinion (modified 5-point Likert scale scores from 14 board-certified radiologists/cardiologists) was used as the ground truth for image quality, sharpness, ringing, SNR, and feature conspicuity, compared against images reconstructed with conventional methods. No pathology or outcomes data is mentioned as ground truth.

8. Sample Size for the Training Set

The document explicitly states that the 75 unique subjects used in the PIQE clinical image review study were "separate from the training data sets." However, it does not specify the sample size for the training set used for the PIQE deep learning model.

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

The document does not provide information on how the ground truth for the training set for PIQE was established. It only mentions that the study test data sets were separate from the training data sets.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.

This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.

If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• · Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• · Inflammatory joint disease including rheumatoid arthritis
• · Correction of functional deformity including congenital hip dysplasia
• · Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi- hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• · Acute femoral head or neck fracture
• · Fracture dislocation of the hip
• · Avascular necrosis of the femoral head
• · Non-union of femoral neck fractures
• · Certain high subcapital and femoral neck fractures in the elderly
• · Degenerative arthritis involving only the femoral head

The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Regulatory classification and product codes for the device.
• Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document states:

• "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
• "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."

This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.

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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: Fetal, 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 lmaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

This document describes the acceptance criteria and study that proves the device called ACUSON Sequoia Diagnostic Ultrasound System from Siemens Medical Solutions USA, Inc. meets the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The submission details two AI features: "AI Abdomen" and "Trace AI."

AI Abdomen

Trace AI

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

AI Abdomen:

• Sample Size: 105 exams from individual patients, resulting in 1,785 images extracted (15 B-Mode images per view and per transducer).
• Data Provenance: Retrospective, collected from 3 institutions in the United States.

Trace AI:

• Sample Size: 10 different adult patients, from which 24 volumes were extracted.
• Data Provenance: Retrospective, collected from three institutions in the US, Mexico, and Germany.

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

AI Abdomen:

• Number of Experts: Three clinical users.
• Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.

Trace AI:

• Number of Experts: Three clinical users.
• Qualifications: All registered Clinical Sonographers with ARDMS accreditation (or equivalent), each with at least 3 years of clinical experience.

4. Adjudication Method for the Test Set

AI Abdomen:

• For view classification, the ground truth was associated with each image at the time of imaging using a system protocol, implying a single determination at the point of acquisition.
• For semi-automated measurements, ground truth measurements were provided by three clinical users. The document does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for these measurements, but the acceptance criterion of Individual Equivalence Coefficient (IEC) suggests a comparison of the algorithm's results against these expert measurements.

Trace AI:

• Ground truth measurements were provided by three clinical users. Each sonographer independently refined the initial circle provided by Trace AI to annotate the underlying orifice structure. They could only see their own annotations. The contour created by sonographers (Ground Truth) was then compared with the contour detected by Trace AI (Detection Truth). This implies a comparison against each expert's delineation, potentially implying an aggregation or statistical analysis of agreement rather than a formal consensus adjudication before comparison with the AI.

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

• No MRMC comparative effectiveness study was explicitly mentioned in the provided text, and therefore, no effect size of human readers' improvement with AI vs. without AI assistance can be determined from this information. The studies described are performance evaluations of the AI algorithms themselves against ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, the studies described for both "AI Abdomen" and "Trace AI" are standalone performance evaluations of the algorithms. They assess the algorithms' accuracy in view classification, semi-automated measurements, and segmentation (DICE coefficient) against established ground truth without a human-in-the-loop component for the performance measurement. The "AI Abdomen" notes testing "with and without users editing the landmark locations" for measurements, implying that the algorithm's initial measurement (standalone) was evaluated. "Trace AI" describes experts refining initial circles given by Trace AI, and then comparing the expert-refined contour to the contour detected by Trace AI algorithm, further confirming a standalone evaluation of the algorithm's output.

7. Type of Ground Truth Used

AI Abdomen:

• View Classification: Ground truth view labels were associated with each image at the time of imaging using a system protocol. This suggests a form of expert labeling or pre-categorization at the point of data capture.
• Semi-automated Measurements: Expert consensus (or at least independent expert measurements) provided by three registered Clinical Sonographers.

Trace AI:

• Expert consensus/independent expert annotations: Ground truth measurements (delineations of orifice structures) were provided by three registered Clinical Sonographers independently.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set for either AI Abdomen or Trace AI. It only focuses on the test set and ensures its independence from the training data.

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

• The document does not explicitly state how the ground truth for the training set was established. It only mentions that the testing dataset was from different clinical sites than those used for training, to ensure independence.

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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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Vantage Fortian/Orian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:

·Proton density (PD) (also called hydrogen density) ·Spin-lattice relaxation time (T1) ·Spin-spin relaxation time (T2) ·Flow dynamics ·Chemical Shift

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Fortian (Model MRT-1550/ WK, WM, WQ)/Vantage Orian (Model MRT-1550/ A3, A4, A7, A8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard gradient system.

The Vantage Orian (Model MRT-1550/ UC, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP, Upgrade only: A3, A4, A7, A8, AC, AD, AG, AH) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models MRT-1550/ UC, UG, UH, UK, UL, UO, UP, Upgrade only: A3, A4, A7, A8 use 1.4 m short and 4.1 tons light weight magnet while the Vantage Orian models MRT-1550/ AK, AL, AO, AP, Upgrade only: AC, AD, AG, AH use 1.4 m short and 3.8 tons light weight magnet. All of the aforementioned models include the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP includes the XGO gradient system. The Model MRT-1550/ A3, A4, A7, A8, AC, AD, AG, AH include the standard gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Fortian/Orian MRI System is comparable to the current 1.5T Vantage Fortian/Orian MRI System (K222968), cleared October 25, 2022, with the following modifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

This table focuses on the specific features detailed in the "Testing" section of the document, as these are the ones with explicit performance criteria and evaluation results.

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

• PIQE (Precise IQ Engine):

  • Sample Size: 36 unique subjects (patients).
  • Data Provenance: Two sites in France.
  • Nature of Data: Clinical cases, prospectively collected for the study (scanned to provide test data sets separately from training data).

• NeuroLine+:

  • Sample Size: 15 clinical cases (4 male, 11 female).
  • Data Provenance: France (implied from national identities, although not explicitly stated as collected in France).
  • Nature of Data: Clinical images, newly collected, and entirely separate from the training group.

• Iterative Motion Correction (IMC):

  • Bench Testing: 12 clinical datasets (without subject motion and with mathematically simulated motion added). Data provenance not specified.
  • Clinical Image Review (Phase 1): 18 volunteers. Data provenance not specified.
  • Clinical Image Review (Phase 2): 49 image volumes from 15 typical clinical patients with pathology and motion. Data provenance not specified.
  • Nature of Data:
    • Bench testing: Clinical datasets with simulated motion.
    • Clinical review (Phase 1): Volunteers imaged with and without motion.
    • Clinical review (Phase 2): Clinical patients with pathology and motion.
    • All testing data acquired separately and independently from training data.

• Free Breathing Dynamic DLR:

  • Arterial Phase Detection: 11 clinical cases (5 male, 5 female, 1 unknown).
  • Clinical Image Review: 29 contrast-enhanced Free Breathing Dynamic liver studies from 29 patients (14 male, 14 female, 1 unknown).
  • Data Provenance: France and USA for arterial phase detection; United States, France, and Japan for clinical image review.
  • Nature of Data:
    • Arterial phase detection: Clinical images from patients receiving clinically indicated contrast.
    • Clinical image review: Contrast-enhanced Free Breathing Dynamic liver studies.
    • All testing data acquired separately and independently from training data.

• Exsper 3D, Slice Shim, UTE CG Recon, Ringing Correction, Auto Scan Assist, Ceiling Camera:

  • The text states "phantom images" or "clinical images" were used, but specific sample sizes and data provenance for these components (beyond PIQE, NeuroLine+, IMC, and Free Breathing Dynamic DLR, which are highlighted deeper) are not detailed.

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

• PIQE (Precise IQ Engine):

  • Number of Experts: 6 radiologists (3 per anatomy - brain and knee).
  • Qualifications: USA board certified radiologists.

• NeuroLine+:

  • Number of Experts: 2.
  • Qualifications: Experienced ARRT licensed MR technologists (for manual annotation of target planes).

• Iterative Motion Correction (IMC):

  • Number of Experts: 3.
  • Qualifications: US board certified radiologists, specializing in neuro imaging.

• Free Breathing Dynamic DLR:

  • Arterial Phase Detection: "Experienced radiologists" (number not specified for ground truth selection).
  • Clinical Image Review: 2 US board certified radiologists.

4. Adjudication Method for the Test Set

• PIQE (Precise IQ Engine): Randomized, blinded to the reviewers. Scored by 3 reviewers per anatomy. The text implies a consensus or averaging approach for reaching conclusions, as it states "all scored at, or above, clinically acceptable by three board-certified Radiologists per anatomy" and "reviewers exhibited a strong agreement".
• NeuroLine+: Manual annotation by two experienced ARRT licensed MR technologists. The text implies their annotations served as the reference for accuracy, but does not detail an adjudication process if disagreements occurred.
• Iterative Motion Correction (IMC): Randomized and blinded review by 3 US board certified radiologists.
• Free Breathing Dynamic DLR:
  • Arterial Phase Detection: "Gold standard phase as manually selected by experienced radiologists." (Implies expert consensus or selection, but not specific adjudication).
  • Clinical Image Review: 2 US board certified radiologists read and scored the images. The conclusion is based on the "average of visual scores."

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.

• Yes, MRMC studies were done for PIQE, IMC, and Free Breathing Dynamic DLR.
  • These studies involved multiple readers assessing multiple cases, and comparing images processed with the new AI/DL features (PIQE, IMC, Free Breathing Dynamic DLR) against conventional methods or images without the feature applied.
  • **However, these studies were designed as a comparison of image quality from the new AI-enhanced reconstruction/correction methods versus conventional methods, not a comparative effectiveness study measuring human reader improvement with AI assistance vs. without AI assistance (i.e., human-in-the-loop performance). The radiologists were evaluating the reconstructed images themselves, not their diagnostic performance with and without AI tools integrated into their workflow.
  • Effect Size: The document does not provide a quantitative effect size in terms of how much human readers improve with AI assistance. Instead, it reports on the quality of the AI-processed images relative to conventional images, often concluding that the AI-processed images are "same or better," "meet acceptance criteria" for clinical acceptability (e.g., Likert scores), or provide "significant reduction" in artifacts.
    • PIQE: "Confirmed PIQE generates higher spatial in-plane resolution images...contributes to ringing artifact reduction, denoising and increased sharpness... is able to accelerate scanning by reducing the acquisition matrix only, while maintaining clinical matrix size and image quality."
    • IMC: "Significantly reducing motion artifacts, and improving overall image quality metrics... IMC corrected images are the same as, or better than, images without IMC applied."
    • Free Breathing Dynamic DLR: "Providing acceptable diagnostic confidence."

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

• Yes, standalone performance was evaluated for several features, primarily through bench testing and quantitative metrics.
  • Exsper 3D: Evaluated using phantom images, confirmed artifact reduction compared to conventional method.
  • Slice Shim: Evaluated using clinical images, confirmed image quality equal to or better than standard shim.
  • UTE CG Recon: Evaluated using phantom and clinical images, confirmed better maintenance of resolution and SNR.
  • Ringing Correction: Evaluated using phantom and clinical images, confirmed ringing reduction.
  • PIQE: Underwent performance (bench testing) using ACR phantom images and typical clinical images (brain and knee). Metrics included SNR, signal intensity profiles for ringing and sharpness, Edge Slope Width, Ringing Variable Mean, Signal-to-Noise ratio, and Contrast Change Ratio. This is a clear standalone evaluation of the algorithm's output metrics.
  • NeuroLine+: Underwent performance (bench) testing using clinical images. Autopositioning success rate was evaluated against manually annotated ground truth. This is a standalone evaluation of the algorithm's accuracy.
  • Iterative Motion Correction (IMC): Underwent performance (bench testing) using clinical datasets with simulated motion. Metrics of peak SNR and structural similarity (SSIM) were used. This is a standalone evaluation of the algorithm's effectiveness.
  • Free Breathing Dynamic DLR (Arterial Phase Detection): Underwent performance (bench) testing using clinical images, assessing the success rate of the automatic detection against manually selected gold standard phases. This is a standalone evaluation of the algorithm's accuracy.

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

• Expert Consensus/Annotation:

  • PIQE: Clinically relevant categories (ringing, sharpness, SNR, overall IQ, feature conspicuity) scored by board-certified radiologists on a Likert scale, with >=3 considered clinically acceptable.
  • NeuroLine+: Manual annotation of angle and position of target planes by experienced ARRT licensed MR technologists.
  • IMC: SNR, tissue contrast, image sharpness, and diagnostic confidence scored by board-certified radiologists on a Likert scale.
  • Free Breathing Dynamic DLR:
    • Arterial phase detection: "Gold standard phase as manually selected by experienced radiologists."
    • Clinical image review: Overall SNR, overall IQ, feature conspicuity, and diagnostic confidence scored by board-certified radiologists on a Likert scale.

• Quantitative/Objective Metrics:

  • Exsper 3D: Artifact reduction compared to conventional method.
  • Slice Shim: Image quality comparison to standard shim.
  • UTE CG Recon: Maintenance of image resolution and SNR.
  • Ringing Correction: Reduction of ringing.
  • PIQE (bench): SNR, signal intensity profiles for ringing and sharpness, Edge Slope Width, Ringing Variable Mean, Signal-to-Noise ratio, Contrast Change Ratio.
  • NeuroLine+ (bench): Angular error and autopositioning success rate (comparison to manual annotations).
  • IMC (bench): Peak SNR and structural similarity (SSIM).
  • Ceiling Camera: Percentage of successful patient orientation detection and cases requiring no correction.

• Pathology/Outcomes Data: Not explicitly mentioned as a direct ground truth for the performance evaluation of these specific software features. The IMC study did use clinical patients with pathology, but the evaluation was still based on image quality and diagnostic information as assessed by radiologists, not a direct comparison to pathology reports or long-term outcomes.

8. The sample size for the training set

• The document consistently states for PIQE, NeuroLine+, IMC, and Free Breathing Dynamic DLR that "All testing data were acquired separately and independently from the training data after the machine learning training was completed."
• However, the specific sample sizes for the training datasets themselves are not provided in this document.

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

• Again, the document states that training data was used, particularly for features utilizing Deep Learning (e.g., PIQE, IMC, Free Breathing Dynamic DLR, NeuroLine+ via Machine Learning).
• However, the document does not detail how the ground truth for these training sets was established. It only clarifies that the test data was independent of the training data.

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ACUSON Sequoia and ACUSON 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, 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 patients with hepatic steatosis.

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.

ACUSON Origin

The ACUSON Origin 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: 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 ACUSON Sequoia, Sequoia Select, and Origin Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an onscreen display of thermal and mechanical indices related to potential bio-effect 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.

The provided FDA 510(k) summary describes the Siemens ACUSON Sequoia, ACUSON Sequoia Select, and ACUSON Origin Diagnostic Ultrasound Systems, focusing on new software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) that incorporate Machine Learning algorithms for cardiac imaging.

The document includes summaries of validation testing for each of these AI features.

1. Table of Acceptance Criteria and Reported Device Performance

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

3. Number of Experts and Qualifications for Ground Truth

4. Adjudication Method for the Test Set

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to measure the effect size of human readers improving with AI vs. without AI assistance. The studies performed focus on the standalone performance of the AI algorithms, often with user edits being factored in, but not a direct comparison of human performance with and without AI.

6. Standalone Performance Study

Yes, standalone performance studies were done for each AI feature:

• AI Assist: Evaluated the algorithm's ability to successfully place Color Box and Doppler Gate based on expert sonographer scoring of its output (99.3% success). This is a standalone assessment of the algorithm's initial placement accuracy.
• 2D HeartAI: Evaluated the accuracy of the 2D HeartAI "as measured by comparison of 2D HeartAI with user edits compared to a reference standard ground truth." While user edits are mentioned, the reported correlation coefficient and bias (0.81 or higher, bias

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The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen).

The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

ORi is a device that provides an adjunct oximeter function that extends the monitoring resolution of hemoglobin oxygen saturation at elevated oxygen levels (e.g., due to the administration of supplemental oxygen). The feature is intended to be used in conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature utilizes the similar principles of operation as pulse oximetry, utilizing hemoglobin wavelength absorption characteristics to determine relative blood oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen disassociation curve, ORi provides visibility to the transition from normoxia to hyperoxia.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ORi device are not explicitly laid out in a pass/fail table with specific metrics. Instead, the document discusses various performance aspects and mitigation measures for identified risks. However, we can infer some criteria from the "Risks to Health" and "Special Controls" sections, specifically focusing on the clinical performance aspect. The most direct performance claim for ORi is its ability to monitor hyperoxia.

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

The clinical studies involved a total of 206 subjects and 2330 data pairs (SpO2, SaO2) used for calculating ORi values.

• Masimo Clinical Lab Study:
  • Sample Size (Subjects): 52 healthy volunteers
  • Data Pairs: 939
  • Provenance: Retrospective (Masimo desaturation laboratory study)
  • Ground Truth: Reference PaO2 blood gas values from an ABL blood gas analyzer.
• Loma Linda University Study:
  • Sample Size (Subjects): 126 hospitalized participants
  • Data Pairs: 1251
  • Provenance: Retrospective (Data previously collected prospectively)
  • Ground Truth: ABG convenience samples obtained as part of standard of care.
• UC Davis Study:
  • Sample Size (Subjects): 28 hospitalized patients
  • Data Pairs: 140
  • Provenance: Prospective
  • Ground Truth: ABG (Arterial Blood Gas) drawn at specific time points.

Overall Data Provenance:

• Country of Origin: Not explicitly stated, but the institutions (Masimo, Loma Linda University, UC Davis) suggest United States.
• Retrospective/Prospective: Two studies were retrospective (Masimo Clinical Lab and Loma Linda), and one was prospective (UC Davis). The retrospective studies utilized data previously collected prospectively.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It states that:

• For the Masimo Clinical Lab study and UC Davis study, the reference PaO2 blood gas values were collected by an ABL blood gas analyzer and ABG, respectively. This implies that the ground truth for PaO2 was based on laboratory analysis of arterial blood samples, which is the gold standard, rather than expert consensus on image interpretation or clinical diagnosis.
• For the Loma Linda University study, ABG convenience samples were obtained as part of standard of care.

Therefore, the ground truth was primarily objective physiological measurement via ABG analysis, not expert interpretation.

4. Adjudication Method for the Test Set

There was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus clinical diagnosis. The ground truth was established by direct physiological measurement (Arterial Blood Gas analysis), which is considered objective and definitive for blood gas values.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described for evaluating human reader improvement with AI vs. without AI assistance. The study focused on the performance of the ORi device itself in relation to PaO2, and its benefit as an "adjunct" to SpO2, implying general clinical utility rather than a direct comparison of human performance with and without ORi assistance. The statement "benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone" suggests a comparison between ORi + SpO2 vs. SpO2 alone, but not specifically quantified for human reader improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The studies evaluated the performance of the ORi algorithm by comparing its output directly to the reference standard (PaO2 from ABG analysis). This is evidenced by:

• "ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data."
• "The pooled data demonstrated an AUC >0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2." (This is a statistical assessment of the algorithm's output).
• "The percentage of ORi was greater than that of SpO2 for the same PaO2 values."

The device's mechanism of action and the way its output (a numeric index on a 0-1 scale) is calculated based on light absorption implies an algorithm-only function. The ORi is intended to be an adjunct to SpO2 and not a stand-alone diagnostic device, but its performance was evaluated as a standalone output (an index related to PaO2).

7. Type of Ground Truth Used

The primary type of ground truth used was Arterial Blood Gas (ABG) analysis, specifically PaO2 values. This is an objective, physiological measurement and is explicitly referred to as the "gold standard in diagnosis of hypoxemia."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a separate training set. The studies described are presented as evaluations of the device, implying they are test sets for validation. It is common for device algorithms to be developed and refined using internal datasets before these validation studies are performed, but details of such a training set are not provided here. The 206 subjects and 2330 data pairs are described as being "submitted by the sponsor for calculation of the ORi values," which might imply they were used in part for validating the final algorithm, but not necessarily for initial training.

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

Since a dedicated training set is not explicitly described, the method for establishing its ground truth is also not mentioned. If the validation data itself (or portions of it) was also used for initial algorithm development or parameter tuning, then the ground truth would have been established by Arterial Blood Gas (ABG) analysis as described for the test set.

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