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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 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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