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The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is 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 ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The 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, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

This document is a 510(k) Summary for the Siemens Medical Solutions ACUSON S1000, S2000, S3000 Diagnostic Ultrasound System. It asserts substantial equivalence to previously cleared devices (K152369) and does not describe acceptance criteria or a study proving the device meets specific acceptance criteria in the typical sense of a novel algorithm with performance metrics.

Instead, the submission focuses on demonstrating that the modified systems have the same intended use and technological characteristics as their previously cleared counterparts, and that they conform to established medical device safety standards. Therefore, the "acceptance criteria" here refer to conformance with those safety standards and the equivalence of intended use and technological features.

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

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

The document does not present quantitative acceptance criteria or performance metrics for a novel algorithm. Instead, it asserts equivalence to previously cleared devices and compliance with general safety and performance standards.

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. This submission is for an updated version of a previously cleared device, not a novel AI algorithm requiring a new clinical performance study with a test set of patient data. The non-clinical tests mentioned (e.g., electrical safety, biocompatibility) do not typically involve patient data test sets with provenance.

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 noted above, this submission relies on demonstrating equivalence to an existing device rather than a clinical performance study with expert-established ground truth.

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

Not applicable. No new clinical performance study was conducted that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was done, as this is a 510(k) for an updated ultrasound system, not an AI-powered diagnostic aide requiring a comparative effectiveness study. The document explicitly states: "Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

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

Not applicable. This is not an AI algorithm with standalone performance being evaluated. It's a diagnostic ultrasound system.

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

Not applicable. New clinical ground truth was not established for this 510(k) submission. The safety and performance are based on compliance with standards and equivalence to the predicate device.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm or a training set in this submission.

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

Not applicable. There is no mention of an AI algorithm or a training set in this submission.

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BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS.

BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software also automatically generates reports to provide the sub-image and location information of markers annotated during the image review.

This document describes the BR-ABVS Viewer 1.0, a standalone software device intended to assist physicians in visualizing and analyzing 3-D breast ultrasound images generated by the Siemens ACUSON S2000 Automated Breast Volume Scanner (ABVS).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a comprehensive table comparing multiple performance metrics. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device (ABVS Workplace, K092067) in terms of image loading and overall functionality.

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

• Sample Size: "An actual clinical image generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014 was used..." This implies a sample size of one clinical image.
• Data Provenance: The image was "generated by a Siemens ACUSON S2000 Automated Breast Volume Scanner in 2014." The country of origin is not explicitly stated, but the manufacturer (TaiHao Medical Inc.) is based in Taiwan. The image is retrospective as it was generated prior to the study.

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

The document does not mention the use of experts to establish ground truth for the test set or their qualifications. The performance study appears to be a technical comparison of image loading and visualization between the subject device and the predicate device, rather than a clinical accuracy study requiring expert human annotation/diagnosis as ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no indication of multiple readers, consensus, or adjudication in establishing ground truth for the single image used in the comparison. The comparison focused on whether the device could load and display the image as expected, similar to the predicate.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a technical comparison of image loading and display, using a single image, between the subject device and a predicate device. There is no mention of human readers evaluating performance "with AI vs. without AI assistance."

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

The performance testing described is primarily a standalone assessment of the BR-ABVS Viewer 1.0's technical capabilities (image loading, visualization, size accuracy) compared to the predicate device. While the device is intended "to assist the physician," the described study itself evaluates the software's inherent ability to process and display images without explicitly measuring the human-in-the-loop performance or diagnostic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the described performance study appears to be the expected rendering and technical specifications of the 3-D breast ultrasound image when loaded and displayed. The comparison was against the functionality of a legally marketed predicate device (ABVS Workplace) for properties like 3-D image loading, multi-planar visualization, and accurate image sizing based on DICOM tags. It is not an "expert consensus," "pathology," or "outcomes data" type of ground truth.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. This device is described as a "Viewer" and not as an AI/ML-based diagnostic algorithm that requires a training set in the typical sense for learning patterns from data. Its function is to visualize existing 3-D images.

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

Not applicable. As described in point 8, there is no mention or indication of a training set as would be required for machine learning models. The device's primary function is image visualization based on known technical specifications (e.g., DICOM standards).

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The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculo-skeletal (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 peerreviewed 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 lmaging".

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 ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function on borevire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

This document is a 510(k) Pre-market Notification for a diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI-based device. Therefore, much of the requested information regarding "acceptance criteria" for AI performance simply isn't present in this type of submission.

However, I can extract information related to the device's technical characteristics and how its equivalence was established.

Analysis of the Provided Text:

The document describes the Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems manufactured by Siemens Medical Solutions, Inc. The submission aims to demonstrate substantial equivalence to previously cleared versions of the same systems (K132804).

Key Findings relevant to your request, but with caveats:

• No specific "acceptance criteria" are defined for AI/algorithm performance. This submission is for an ultrasound system, not a specific AI algorithm. The closest it comes to a performance claim for a specific component is the "Arterial Health Package (AHP) software," which "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." However, no acceptance criteria for this device's measurement capacity are presented, nor is there a study within this document proving the device meets them. The AHP feature itself relies on external, peer-reviewed studies for its normative tables, not on studies conducted for this 510(k) submission to validate the specific device's measurement accuracy against defined criteria.
• No "study that proves the device meets the acceptance criteria" is included for a novel AI component. The document explicitly states: "Since the S1000, S2000, S3000 systems use the same technology and principles as existing devices, clinical data is not required." This indicates that the submission relies on the established safety and effectiveness of the predicate devices and the underlying technology, not on new clinical trials or performance studies for novel features.
• "Device Performance" is inherently tied to being "substantially equivalent" to the predicate. The performance is deemed acceptable because it is demonstrably similar to a device already on the market.

Here's how I can address your points based on the provided text, heavily noting limitations:

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

As explained above, no specific quantitative acceptance criteria for algorithm performance are presented for this ultrasound system or its features. The core "acceptance criteria" in a 510(k) for a device like this are primarily related to safety, electrical safety, biocompatibility, and functional equivalence to a predicate device.

The "reported device performance" is essentially that it functions equivalently to the predicate device, offering various imaging modes, frequencies, and features, and meets relevant voluntary safety standards.

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 (N/A) for this submission. The document explicitly states: "Since the S1000, S2000, S3000 systems use the same technology and principles as existing devices, clinical data is not required." This implies that no new test set of patient data (clinical or image-based) was used to prove the device's performance against specific acceptance criteria. The submission relies on non-clinical engineering and safety tests and the established equivalence to the 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)

• N/A. No test set requiring expert ground truth was described or presented in this 510(k). The clinical data requirement was waived due to substantial equivalence. The "Arterial Health Package (AHP) software" feature mentions "normative tables that have been validated in peer-reviewed studies," implying external expert validation for those tables, but not for its integration into this specific device as part of this submission.

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

• N/A. No test set requiring an adjudication method was described or presented.

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

• N/A. No MRMC study was performed or referenced. This is not an AI-assisted diagnostic device, but a diagnostic ultrasound system. Clinical data, including MRMC studies, was not required.

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

• N/A. This submission is for an ultrasound system, not a standalone algorithm. While it contains software (like the AHP), its performance is not evaluated as a standalone AI given the nature of the submission. The AHP's function is "to provide the physician with the capability to measure" and "reference normative tables," suggesting a human-in-the-loop scenario where the physician retains clinical diagnosis responsibility.

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

• N/A as a primary method for this submission. For establishing the safety and performance of the overall ultrasound system, the ground truth is primarily based on compliance with established engineering and safety standards and the known performance of the predicate device. For the AHP feature, its normative tables were based on "peer-reviewed studies," which would have their own ground truth (likely clinical data, pathology, or outcomes depending on the study) but this is not data directly generated or verified for this 510(k).

8. The sample size for the training set

• N/A. This submission does not describe a machine learning model requiring a training set.

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

• N/A. No training set for a machine learning model is mentioned in this submission.

Summary of the document's approach:

This 510(k) submission for the Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that:

• The device uses the same technology and principles of operation as previously cleared devices.
• It has the same intended uses as the predicate.
• Any differences in technological characteristics do not raise new questions of safety or effectiveness.
• Non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, electrical/mechanical/thermal/EM safety, software validation, transducer/wireless performance) confirm compliance with recognized medical device safety standards.
• Clinical data (and thus specific "acceptance criteria" and studies to meet them for novel algorithmic performance) were explicitly deemed not required because the systems utilize established technology and principles.

Therefore, the requested information about acceptance criteria and studies to meet them, particularly concerning AI or complex algorithmic performance, is not present in this type of 510(k) submission which focuses on substantial equivalence for a general diagnostic imaging system.

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V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.

ACUSON Antares Ultrasound System: The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON CV70 Cardiovascular System: The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON Cypress Ultrasound System: The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes

ACUSON S1000/S2000 Ultrasound System: The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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."

ACUSON SC2000 Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, 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.

ACUSON Sequoia Ultrasound System: The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON X300 Ultrasound System: The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides measurement of anatomical structures and 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 reqarding 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 V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

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

Acceptance Criteria and Study Details for V5Ms Transesophageal Transducer

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission document does not explicitly state quantitative acceptance criteria or specific device performance metrics in the way one might expect for a new or significantly modified device. Instead, the submission relies heavily on substantial equivalence to a previously cleared predicate device (Siemens V5Ms Transesophageal Transducer, K052021). The key "performance data" presented is that "Performance data is not required for this modification as there is no change to software or hardware." This implies that the device is expected to perform identically to its predicate because the changes are limited to patient contact materials.

Therefore, the acceptance criteria are implicitly met by demonstrating that the modifications do not negatively impact the established performance of the predicate device.

Implicit Acceptance Criteria and Reported Performance (Based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable (N/A). The document explicitly states, "Performance data is not required for this modification as there is no change to software or hardware." Therefore, there was no clinical performance test set used. The evaluation centered on non-clinical tests for biocompatibility and asserting substantial equivalence.
• Data Provenance: N/A for clinical performance data. For biocompatibility testing, the data would typically originate from a laboratory (likely in the USA or a facility that adheres to international standards like ISO). The origin is not specified beyond "Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation)."

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

• N/A. As no clinical performance test set was conducted, there was no need for experts to establish ground truth. The primary "experts" involved in the submission would be Siemens' own regulatory and engineering teams, and subsequently, FDA reviewers.

4. Adjudication Method for the Test Set

• N/A. Since no clinical performance test set was conducted, no adjudication method was used.

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

• No. No MRMC study was conducted. The submission is a 510(k) for substantial equivalence based on minor modifications (patient contact materials) to an existing device, not a new clinical effectiveness study.

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

• N/A. The device is a diagnostic ultrasound transducer, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• N/A for clinical effectiveness. For biocompatibility, the "ground truth" is defined by the ISO10993-1 standard for cytotoxicity, sensitization, and irritation. This involves standardized biological tests.

8. The Sample Size for the Training Set

• N/A. This device is a hardware component (transducer) and does not involve machine learning or AI, and therefore does not have a "training set."

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

• N/A. As there is no training set for this device, this question is not applicable.

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The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures (fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 S2000™ has been designed to meet the following product safety standards:

• l UL 60601-1, Safety Requirements for Medical Equipment
• l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• li AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• t 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment 트
  • . EN/IEC 60601-1
  • . EN/IEC 60601-1-1
  • I EN/IEC 60601-1-2
• IEC 1157 Declaration of Acoustic Power 트
• ISO 10993-1 Biocompatibility l

This 510(k) submission (K093812) for the Siemens Acuson S2000 Ultrasound System describes the device's technical specifications and intended uses, and asserts substantial equivalence to a predicate device. However, it does not contain information regarding a specific clinical study with acceptance criteria and device performance metrics, as would be expected for a novel AI-powered diagnostic device.

The document primarily focuses on:

• Device Description: Listing safety standards the system meets (e.g., UL 60601-1, IEC 60601-2-37).
• Intended Use: Broad applications for ultrasound imaging across various anatomical regions and patient populations.
• Transducer Information: Detailed tables indicating the modes of operation (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging) and additional features (e.g., tissue harmonic imaging, spatial compounding) cleared for each specific transducer.
• Predicate Device: Stating the Acuson S2000 is substantially equivalent to the Acuson Antares Ultrasound System.

The "Arterial Health Package (AHP) software," which provides "capability to measure Intima Media Thickness and the option to reference normative tables," mentions that these tables "have been validated and published in peer-reviewed studies." However, it does not provide details of an internal study conducted by Siemens to prove that their device's AHP functionality meets specific acceptance criteria based on these peer-reviewed studies.

Therefore, I cannot populate the requested tables and information as a study proving device performance against acceptance criteria is not present in the provided text. The document is a regulatory submission for device clearance based on substantial equivalence, rather than a detailed report of a performance study.

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