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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.

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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, 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.

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