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The ACUSON SC2000 Diagnostic Ultrasound 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: 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 ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with proprietary software and accessories. The function of the ACUSON SC2000 Diagnostic Ultrasound System 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, measurements, calculations, analysis of the human body and fluid flow, etc.

The provided document is a 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it explicitly states that no clinical data was required or conducted to support substantial equivalence for this device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth details, as these clinical study elements were not performed.

The document focuses on non-clinical data to demonstrate safety and performance, primarily through compliance with voluntary standards and compatibility testing with existing catheters.

Here's a breakdown of what can be extracted from the document regarding the device's validation:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable as no clinical study with explicit acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) was conducted or reported in this 510(k) summary. The document focuses on showing compliance with performance standards for ultrasound systems generally and compatibility with specific catheters.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from patients was presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.

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 device is an ultrasound system and there is no mention of AI assistance or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm-only device. Performance evaluations focused on the system's ability to generate ultrasound images and facilitate measurements, as well as its compatibility with certain catheters.

7. The type of ground truth used: Not applicable. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) was used as no clinical study was conducted.

8. The sample size for the training set: Not applicable. This document does not describe the development or training of an AI algorithm, but rather the clearance of an ultrasound system.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device Validation based on the Provided Text:

The ACUSON SC2000 Diagnostic Ultrasound System's substantial equivalence to its predicate device (ACUSON SC2000 Diagnostic Ultrasound System v6.1 (VC11) K211726) is supported by non-clinical data.

• Rationale for No Clinical Data: "The proposed ACUSON SC2000 Diagnostic Ultrasound System did not require clinical studies to support substantial equivalence." (Page 9)
• Non-clinical Data Focus: The submission primarily demonstrates that:
  • The device complies with various voluntary standards related to medical electrical equipment, ultrasound field characterization, biological evaluation of medical devices, usability, risk management, software lifecycle process, and quality management systems (listed on pages 8-9).
  • The ACUSON SC2000 Diagnostic Ultrasound System v6.5 (VC15) is compatible with the AcuNav Crystal Ultrasound Catheter (K233270) and SoundStar Crystal Ultrasound Catheter (K240050), and the SwiftLink Plus Connector. This compatibility testing demonstrates that the system performs as intended with these accessory devices.
• Conclusion: "The non-clinical testing data support the safety of the device and demonstrate that the ACUSON SC2000 Diagnostic Ultrasound System is compatible with the AcuNav Crystal Ultrasound Catheter and the SoundStar Crystal Ultrasound Catheter and the system performs as intended in the specified use conditions. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON SC2000 Diagnostic Ultrasound Systems are as safe and effective with substantially equivalent performance as the predicate device." (Page 9)

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The SC2000 ultrasound imaging system is intended for the following applications: 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

The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, MMode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

The system also supports catheters which are intended for intraluminal 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 has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Vascular Imaging Applications and Analysis

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images. The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Superficial Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic capture of ultrasound images.

Intraoperative Imaging Applications

The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications

The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

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).

The provided text, primarily a 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System, does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-driven medical device.

This document focuses on establishing substantial equivalence of a new version (VC11/v6.1) of an existing ultrasound system to its predicate device (VC10/v6.0) and an earlier clearance (K171766) for the syngo® TrueFusion software feature. The key modification described is an update to the syngo® TrueFusion software from version 1.0 to 2.0 to support "Live Image Overlay."

The document states:

• "The SC2000 software update to VC11 (v6.1) does not involve any hardware modifications." (Page 11)
• "The VC11A (v6.1) software update and the SC2000 System software has undergone component, integration and system level verification testing. The software verification and regression testing has been performed successfully to meet their previously determined acceptance criteria consistent with Siemens Product Lifecycle Procedure (PLP) and has passed." (Page 11)
• "Since the ACUSON SC2000 VC11 (v6.1) Diagnostic Ultrasound System uses the identical technology and principles of use as the existing predicate devices SC2000, VC10 (v6.0) K202683, clinical studies were not required to support substantial equivalence. The SC2000 VC11A (v6.1) software was fully validated on phantoms by clinical personal with training in Ultrasound technology and has passed." (Page 12)
• "In summary, based on the successful verification and validation testing to the software acceptance criteria, the update for the TrueFusion 2.0 feature does not introduce any new potential safety risks." (Page 12)

This indicates that the modifications were considered minor enough that extensive clinical studies to prove new acceptance criteria were not deemed necessary for the 510(k) clearance, as the device was shown to be substantially equivalent to an already cleared device. The "acceptance criteria" mentioned are likely related to internal software verification and validation, such as functional testing and regression testing, rather than performance metrics for an AI/ML model for clinical diagnosis.

Therefore, I cannot provide the requested information from this document. The document doesn't detail:

1. A specific table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods related to an AI/ML performance study.
3. MRMC study details or standalone performance of an AI/ML algorithm.

The syngo® TrueFusion feature is described as integrating ultrasound with X-Ray Fluoroscopy for "Live Image Overlay" (page 6). While this involves data processing and fusion, the document does not present it as a new AI/ML diagnostic algorithm requiring a specific performance study with clinical endpoints or detailed AI validation metrics. It's more about system integration and data presentation.

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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)

Detailed comparison tables (Table 2 in the original document, not fully reproduced here due to length) consistently list "Identical" for all compared technological characteristics: Reusability, Duration of Use, Scientific Technology, Operating Principles, Type of Previously Cleared Transducers, Acoustic Outputs, Previously Cleared Imaging Modes, and Biocompatibility (ISO 10993-1). |
| Safety and Effectiveness: There are no new safety or effectiveness concerns introduced by the expanded labeling. | - Software Verification and Validation: The CRS (Customer Requirement Specifications) for each device were verified/validated during original development. No software/hardware modifications for this submission.

• Standards Compliance: Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1 - 3.20 (DICOM).
• Risk Management: Risk analysis (ISO 14971:2007) was performed on predicate devices, and mitigation controls were implemented. The expanded labeling does not impact these.
• Cybersecurity: Cybersecurity measures are addressed and conform to requirements to prevent unauthorized access, modification, misuse, or denial of use.
• Clinical Literature Support: The expanded labeling for Lung Ultrasound Imaging (LUS) is supported by clinical literature, indicating that the use of ultrasound for lung imaging is an established and safe practice. Clinical studies were not required for this 510(k) as the technology and operating principles are unchanged. |

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 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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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 AcuNav 8F and 10F Ultrasound Catheter, ACUSON AcuNav™ V 10F Ultrasound Catheter, ACUSON AcuNav™ Volume 12F Ultrasound Catheter, SoundStar™ 8F Ultrasound Catheter, SoundStar™ 10F Ultrasound Catheter, SoundStar™ eco 8F Ultrasound Catheter, and SoundStar™ eco 10F Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

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).

Additional features for the ACUSON SC2000 v5.1 update includes the Joystick remote control accessory that is intended to be used for interventional procedures with the ACUSON AcuNav Volume ICE catheter where remote control of the cursor is desired. The joystick plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press.

This is a premarket notification (510k) for the ACUSON SC2000 Diagnostic Ultrasound System. The information provided heavily references previous clearances for substantial equivalence rather than presenting new studies with acceptance criteria explicitly defined for the current submission.

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 acceptance criteria with corresponding reported device performance metrics for this specific 510(k) submission (K181098). Instead, it relies on the substantial equivalence to previously cleared devices. The "Features on SC2000 System" table in Section 6.1 (pages 25-26) implicitly acts as a comparison to the predicate device, showing that the current device either has the same feature (√) or improved features (e.g., "Updated TEQ", "Added Manual Trace", "New" features). The "Frequencies Supported" are identical across the three compared devices for most applications.

The acceptance criteria here are implicit and based on the predicate device's established performance, meaning the new device must perform at least as well as, or be substantially equivalent to, the predicate in all relevant aspects.

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

The document explicitly states: "clinical studies were not required to support substantial equivalence" (Part 8, page 29). Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The submission relies on non-clinical tests (acoustic output, biocompatibility, safety standards compliance) and comparison to predicate devices.

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

Since no clinical studies were performed for this submission, there is no mention of experts or their qualifications for establishing ground truth. The substantial equivalence is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, no adjudication method is described.

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

No MrMC comparative effectiveness study was done or reported as clinical studies were deemed unnecessary due to substantial equivalence to predicate devices. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is mentioned.

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

No standalone performance study of an algorithm is described or reported. The device is an ultrasound system with accessories, not an AI/algorithm-only product.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is established through adherence to recognized medical device safety standards (e.g., AAMI / ANSI ES60601-1, IEC series, ISO 10993-1) and comparison of technological characteristics to already cleared predicate devices. Clinical outcomes data or expert consensus for new evaluations were not used for this submission's substantial equivalence determination.

8. Sample Size for the Training Set:

The document does not mention any training set or its sample size, as it does not involve a de novo AI/ML model development requiring such data for this 510(k) submission.

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

Since no training set is discussed, the method for establishing its ground truth is not provided.

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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, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information 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
The system transmits ultrasound energy into adult, pediativ, neonatal, and fetal cardiac patients creating 2D (B). 3D. M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intraluminal 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 system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and arteries in the arms and legs and abdomen; and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system, with an on-screen display for thermal and mechanical indices, related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data, and display it in the following modes (The following modes below can be operated in combination or individually):

• B-Mode
• M-Mode
• Pulsed (PWD) Doppler Mode
• Continuous (CWD) Doppler Mode
• Color Doppler Mode
• Amplitude Doppler Mode
• Color Velocity Imaging
• 3D Imaging,
• 4D Imaging (3D imaging in real time)

This document, a 510(k) Premarket Notification for the Siemens Acuson SC2000 Diagnostic Ultrasound System, focuses on demonstrating substantial equivalence to a previously cleared predicate device (K170315) rather than proving the detailed performance of a new AI/algorithm-based device against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for test and training sets) is not present in this document.

The document explicitly states: "The ACUSON SC2000™ Ultrasound System is a class II device, and uses the same technology and operating principle as the predicate devices; clinical data is not required for substantial equivalence." (Page 24)

This indicates that the submission relies on the established safety and effectiveness of the predicate device and the fact that the modifications to the Acuson SC2000 are not significant enough to warrant new clinical performance studies or specific acceptance performance metrics typically associated with novel AI/algorithm-driven devices.

In summary, this document does not provide the information requested about acceptance criteria and study details for proving a device meets those criteria, because such studies were not deemed necessary for this 510(k) submission based on its substantial equivalence to an existing device.

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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, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information 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 for thermal and mechanical indices, related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data, and display it in the following modes (The following modes below can be operated in combination or individually):

• B-Mode
• M-Mode .
• Pulsed (PWD) Doppler Mode .
• Continuous (CWD) Doppler Mode
• Color Doppler Mode .
• Amplitude Doppler Mode
• Color Velocity Imaging .
• 3D Imaging,
• 4D Imaging (3D imaging in real time) .

The provided document is a 510(k) premarket notification for the Siemens ACUSON SC2000™ Diagnostic Ultrasound System (K170315). It primarily details the device's indications for use and asserts substantial equivalence to a previously cleared predicate device (K162221). The document states that clinical data was NOT required for substantial equivalence, as the device is a Class II device and uses the same technology and operating principles as the predicate.

Therefore, the submission does not include any studies proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy in a clinical context. The review focuses on technical parameters, safety, and equivalence to a predicate.

However, based on the information provided, I can infer the implied acceptance criteria through compliance with standards and the "Substantial Equivalence Table" (page 22).

Here's a breakdown of the requested information based on the provided text, recognizing the absence of clinical performance studies:

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

Since no clinical performance metrics are reported, the "acceptance criteria" here are implied by the safety and technical standards compliance and the "Same" performance claims against the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document explicitly states that "clinical data is not required for substantial equivalence" (page 24). The evaluation was based on non-clinical tests (acoustic output, biocompatibility, cleaning, thermal, electromagnetic, and mechanical safety) and comparison to a predicate device.

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 clinical test set or expert-established ground truth is mentioned. The assessment was based on engineering and safety standards.

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

Not applicable. No clinical test set.

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/CADe device, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This is a diagnostic ultrasound system, not an algorithm, and no standalone performance study is mentioned.

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

Not applicable. For the determination of substantial equivalence, the "ground truth" was compliance with established medical device safety and performance standards (e.g., IEC 60601 series, NEMA UD series, ISO 10993-1) and the technical specifications of the predicate device (K162221).

8. The sample size for the training set

Not applicable. No algorithms requiring a training set are discussed in the context of this 510(k) submission.

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

Not applicable. No algorithms requiring a training set are discussed.

Ask a specific question about this device

The SC2000 ultrasound imaging system is intended for the following applications: Cardiac. Neo-natal and Fetal Cardiac. Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, 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 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
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intra-cardiac and intraluminal 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 system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck: superficial and arteries in the arms and legs and abdomen: and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Superficial Imaging Applications
The system transmits ultrasound energy into varis of the body of adult patients creating 2D (B). Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.

Intraoperative Imaging Applications
The system transmits ultrasound energy into varis of the body of adult patients creating 2D (B), Color Dopbler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during intraoperative procedures.

Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology. The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system, with an on-screen display for thermal and mechanical indices, related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data, and display it in the following modes (The following modes below can be operated in combination or individually):

• B-Mode .
• M-Mode .
• Pulsed (PWD) Doppler Mode ●
• Continuous (CWD) Doppler Mode .
• Color Doppler Mode
• . Amplitude Doppler Mode
• Color Velocity Imaging ●
• 3D Imaging,
• . 4D Imaging (3D imaging in real time)

This is a 510(k) premarket notification for a predicate device modification. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (ACUSON SC2000™ Diagnostic Ultrasound System, K142628) rather than presenting a new study with explicit acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes.

The document states that the ACUSON SC2000™ Diagnostic Ultrasound System is a "modification to the previously cleared ACUSON SC2000™ Ultrasound System (K142628) and substantially equivalent." It emphasizes that "The ACUSON SC2000™ Diagnostic Ultrasound System is a class II device using the same technology and operating principle as the predicate devices, no clinical data is required." This means that the acceptance criteria are not related to a specific clinical performance study, but rather demonstrate that the modified device maintains the safety and effectiveness of the predicate device.

Therefore, the requested information elements related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, and training set information) are not applicable or explicitly provided in this document as no new clinical study was required or performed for this specific submission.

However, the document does list the technical and regulatory standards that the device adheres to, which effectively serve as its acceptance criteria for non-clinical performance.

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification. The submission relies on non-clinical tests and equivalence to a previously cleared device.

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, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

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

Not applicable, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

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 a traditional ultrasound system, not an AI-powered device, and no MRMC study was mentioned.

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

Not applicable. This is a traditional ultrasound system, not an AI/algorithm-only device.

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

Not applicable, as no new clinical test data for diagnostic performance was submitted for this 510(k) modification.

8. The sample size for the training set

Not applicable. This is a traditional ultrasound system, which generally does not involve machine learning "training sets" in the context of diagnostic performance studies for regulatory clearance in the way AI devices do. The testing described is primarily for engineering, safety, and performance standards.

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

Not applicable.

Ask a specific question about this device

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 SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system, with an on-screen display for thermal and mechanical indices, related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data, and display it in the following modes (The following modes below can be operated in combination or individually): B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, Color Velocity Imaging, 3D Imaging, 4D Imaging (3D imaging in real time).

The provided text describes a 510(k) premarket notification for the Siemens Acuson SC2000™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K132654) due to modifications. The document does not describe an AI or algorithm-based device or a study involving an algorithm's performance.

Therefore, many of the requested categories (acceptance criteria for an algorithm, AI performance, MRMC study, training set information, ground truth methods for an algorithm) cannot be extracted or are not applicable to the provided content.

The information primarily concerns the intended uses and technical characteristics of an ultrasound system and its transducers, demonstrating that new components (like the Z6Ms transducer) and updated catheters still fall within the scope of the predicate device.

However, based on the general principles of medical device 510(k) submissions, I can infer what "acceptance criteria" and "study" would generally mean in this context for a non-AI ultrasound device, and extract relevant performance information.

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

For a standard diagnostic ultrasound system like the Acuson SC2000™, the "acceptance criteria" are intrinsically tied to meeting established safety and performance standards for ultrasound devices, as well as demonstrating that the device performs as intended for its specified clinical applications. The "reported device performance" refers to the results of testing confirming compliance with these standards and the functionality for the intended uses.

• AIUM/NEMA UD-3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
• AIUM/NEMA UD-2 (Acoustic Output Measurement Standard)
• IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests)
• IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment)
• IEC 62304 (Medical device software – Software life cycle processes)
• IEC 62366 (Medical devices – Application of usability engineering to medical devices)
• ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) |
  | Intended Use Functionality | The system and its transducers must reliably perform imaging and measurement functions for specified clinical applications (e.g., Cardiac, Pediatric, Fetal, Abdominal, Vascular, Intraoperative, Transcranial, Musculoskeletal). | The system creates 2D(B), 3D, M-Mode, Color Doppler, Color Power Doppler, Pulsed Wave Doppler, and Continuous Wave Doppler images/data to obtain images and blood flow velocity, enabling evaluation of pathology and provision of measurement/calculation packages for diagnostic purposes across all stated applications. The system supports various transducers (e.g., V5Ms, 4Z1c, Z6Ms, CW2, 4V1c, 6CIHD, 8V3, 9L4, 10V4, AcuNav 8F/10F, AcuNav V 10F, SoundStar 10F) for these applications. |
  | Technological Characteristics | Key characteristics (e.g., array type, dimensional imaging, mechanical controls, modes of operation, multi-Hertz imaging, output display, dual screen, acoustic clip capture, Cardiac/Vascular measurements, DTI, Contrast Imaging, Connectivity via Wireless/DICOM) must be maintained or be substantially equivalent to the predicate device. | The system maintains similarity in product codes, transducer types, modes of operation, multi-Hertz multiple frequency imaging, output display standard compliance, dual screen functionality, acoustic clip capture, Cardiac/Vascular Measurements and Calculations, DTI™, Contrast Pulse Sequencing Technology (CPS), TEQ and NTEQ ultrasound technology, Spatial Compounding, Semi Auto Doppler Option (Trace Assist), Transcranial Imaging, and connectivity features (Wireless Network Connectivity, DICOM Compatibility) as compared to the predicate K132654. The new Z6Ms transducer's array type, dimensional imaging, and mechanical controls are deemed substantially equivalent to existing transducers (4Z1c and V5Ms). |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not directly specify a "test set" in the context of an algorithm or diagnostic performance study with patient data. For a non-AI ultrasound system like this, compliance is typically demonstrated through:

• Engineering verification and validation (testing of components, software, and integrated system against specifications).
• Bench testing for acoustic output and electrical safety.
• Potentially, limited clinical evaluations or comparisons to the predicate device to confirm imaging quality and diagnostic utility for the new or modified components.

The submission states, "Final testing of the SC2000™ included various safety and performance testing designed to ensure the device meets all of its specifications." However, no specific sample size (e.g., number of patients or images) for a clinical "test set" is provided, nor is the data provenance explicitly stated. This information is typically proprietary to the manufacturer and not fully disclosed in the 510(k) summary, especially for devices establishing substantial equivalence through technical modifications rather than new clinical claims requiring large-scale trials.

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

Again, this document does not describe an AI or algorithm-based device that would require a ground truth established by experts for a test set. For a diagnostic ultrasound system, "ground truth" for demonstrating diagnostic utility would typically involve comparison to other established diagnostic modalities or expert clinical interpretation. However, the document does not provide details on such a study for "ground truth" establishment.

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

Not applicable, as no external "test set" requiring expert adjudication is described for an AI algorithm.

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, as the document concerns a medical imaging device (ultrasound system and transducers), not an AI algorithm intended to assist human readers.

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

Not applicable, as the device is not an AI algorithm.

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

Not explicitly stated for the purpose of validating the diagnostic accuracy of the ultrasound system in a formal study. For an ultrasound device, diagnostic accuracy is often evaluated relative to established clinical standards, other imaging modalities, or direct observation (e.g., during surgery or pathology). However, the submission focuses on demonstrating safety, technical performance, and substantial equivalence to a predicate device, rather than providing details of a de novo diagnostic accuracy trial with a specific "ground truth."

8. The sample size for the training set

Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm that undergoes "training."

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

Not applicable, as the device is an ultrasound system and transducers, not an AI algorithm.

Ask a specific question about this device

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 SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode. Color Doppler Mode. Amplitude Doppler Mode, a combination of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

The provided 510(k) summary for the Siemens SC2000 Ultrasound System focuses on demonstrating substantial equivalence to previously cleared devices rather than outlining detailed acceptance criteria and a specific study proving device performance against those criteria. The submission is for a modification to an existing device (SC2000 Diagnostic Ultrasound System) and a new feature (Clarify VE).

Therefore, this document does not contain the specific information requested about acceptance criteria and a study demonstrating performance against them in the way a submission for a novel AI device might. Instead, it relies on demonstrating that the modified device continues to meet existing safety and performance standards, and that the new feature is substantially equivalent to a feature already cleared on another Siemens device.

However, I can extract information related to the performance data and the comparison to predicate devices, which implicitly serves as the "proof" of meeting acceptance criteria for a substantial equivalence determination.

Here's the breakdown of the requested information based on the provided text, along with notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity targets) for a new algorithm or feature in the way a novel AI medical device submission would. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with established safety and performance standards and showing substantial equivalence to predicate devices.

The "reported device performance" is described qualitatively as meeting these standards and having similar technological characteristics and intended uses as cleared predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on substantial equivalence based on prior clearances and the nature of the modifications (Clarify VE being identical to a previously cleared feature on another system, and the new transducer being similar to existing ones). There is no mention of a specific clinical test set for this 510(k) submission.

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)

This information is not provided as there is no specific clinical test set described in this 510(k) summary for establishing ground truth for a novel AI algorithm. The device is an ultrasound system with enhanced imaging features, not an AI diagnostic algorithm requiring expert-labeled ground truth for evaluation in this context.

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

This information is not provided for the same reasons as point 3.

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 is not mentioned in the document. This type of study would typically be performed for new AI-powered diagnostic aids, which is not the primary focus of this 510(k) submission (which is for a modification to an existing ultrasound system including a feature like Clarify VE, which enhances image quality rather than providing a direct diagnostic output that would assist human readers in a comparative effectiveness study).

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

This is not applicable and not mentioned. The device described is an ultrasound system, not a standalone algorithm. Clarify VE is an image enhancement feature integrated into the system, not a standalone algorithm output.

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

This information is not provided for a test set, as no specific clinical test set for new feature evaluation is detailed. The "performance data" section focuses on engineering verification and validation against safety and performance standards for the ultrasound system itself, not the clinical accuracy of a diagnostic output.

8. The sample size for the training set

This information is not provided. The document describes an ultrasound imaging system with a new image enhancement feature, not a machine learning model that would have a distinct training set.

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

This information is not provided for the same reasons as point 8.

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