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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 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 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 and Soundstar Ultrsound Catheter are 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 SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, 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 Acunav and Soundstar Ultrsound 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.

The Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with 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.

Here's a summary of the acceptance criteria and study information based on the provided text, focusing on the request details:

Acceptance Criteria and Device Performance

The document describes the Siemens SC2000/X300 Diagnostic Ultrasound System and its various transducers. The acceptance criteria essentially focus on demonstrating substantial equivalence to previously cleared devices. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices and meets safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document explicitly states: "Since the modified devices use the same technology and principles as existing devices, clinical data is not required." This indicates that no clinical test set with human patients was used specifically for this 510(k) submission. The evaluation was based on nonclinical tests and comparison to predicate devices. Therefore, there is no sample size, country of origin, or information on retrospective/prospective data for a clinical test set.

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

As there was no clinical test set for this 510(k) submission, there is no mention of experts used to establish ground truth for a test set. The review focused on engineering and performance standards, and comparison to previously cleared devices.

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

Not applicable, as no clinical test set was used.

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. The document describes a diagnostic ultrasound system and its transducers, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.

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

Not applicable. This device is a diagnostic ultrasound system, not a standalone algorithm.

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

For the nonclinical tests conducted, the "ground truth" would be established by the specifications and performance metrics outlined in the various referenced safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, etc.). For the substantial equivalence claim, the ground truth is the performance and safety profiles of the predicate devices.

8. The sample size for the training set

Not applicable, as this is a traditional diagnostic ultrasound system, not an AI/ML-based device requiring a training set.

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

Not applicable, as no training set was used.

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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 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. 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 Siemens ACUSON X300 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 Doppier Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

The provided text describes a Special 510(k) Submission for the ACUSON X300 Diagnostic Ultrasound System. This submission is for modifications to a previously cleared device, not for a new device requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the information typically found in such a study (like detailed acceptance criteria with performance values, sample sizes, ground truth establishment methods, or multi-reader multi-case studies) is not present in this document.

Instead, the submission focuses on substantial equivalence to predicate devices. This means the manufacturer demonstrates that the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The performance data presented indicates nonclinical tests were performed.

Here's a breakdown of the available information regarding acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "The modifications to the Siemens ACUSON X300 Diagnostic Ultrasound System are verified and validated according to the company's design control process." It then lists the following voluntary standards that the system complies with. These standards implicitly serve as the acceptance criteria for the nonclinical performance of the device. The "reported device performance" is the statement of compliance with these standards.

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

The document does not describe a clinical test set with a specific sample size. The "tests" mentioned are nonclinical evaluations for safety and performance against established standards. There is no information provided about data provenance (e.g., country of origin, retrospective/prospective) because this submission relies on engineering verification and validation, and compliance with recognized standards, rather than new clinical data.

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

This information is not applicable to the type of submission presented. The "ground truth" for nonclinical tests would be the specifications and requirements of the voluntary standards themselves, not expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of medical results requiring adjudication. The compliance is determined by engineering testing and verification.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical effectiveness of a new device or software feature, especially when involving AI, by comparing human reader performance with and without the aid of the device. This submission is for modifications to an existing ultrasound system, focusing on nonclinical performance relative to predicate devices.

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

Not explicitly stated as a "standalone" algorithm-only study in the context of AI performance. The document describes a diagnostic ultrasound system with various imaging modes and measurement packages. While these involve algorithms, the "performance data" mentioned refers to the system's compliance with safety and acoustic output standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy. The Arterial Health Package (AHP) software is mentioned with its capability to measure Intima Media Thickness and reference normative tables, but no details of a standalone performance study for this software are provided in this summary.

7. The Type of Ground Truth Used:

For the nonclinical tests conducted, the "ground truth" is adherence to the specified voluntary standards (e.g., UL, IEC, AIUM/NEMA, ISO) for aspects like acoustic output, biocompatibility, electrical safety, etc. This is a form of standard-based ground truth rather than expert consensus, pathology, or outcomes data from patients.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe any machine learning or AI models with training sets in the context of this 510(k) summary. The submission is for an ultrasound system, not for a new AI-based diagnostic algorithm requiring a specific training dataset.

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

Not applicable, as no training set for an AI model is described in this submission.

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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 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. 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 X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment
• EN/IEC 60601-1
• EN/IEC 60601-1-1
• EN/IEC 60601-1-2
• EN/IEC 60601-1-4
• EN/IEC 60601-1-6
• EN/IEC 60601-2-18
• EN/IEC 60601-2-25
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided 510(k) submission for the Siemens ACUSON X300 Diagnostic Ultrasound System does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the typical format of a clinical performance study with quantitative metrics (like sensitivity, specificity, or AUC) compared against a predefined threshold.

Instead, the submission primarily focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearance. Substantial equivalence is demonstrated by showing that the new device has the same intended use and similar technological characteristics to the predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness.

The "Performance Data" section (Section E) states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that internal testing and verification/validation activities were performed to ensure the device functions as intended and meets its design specifications, but specific details of these tests, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not provided in this summary.

The document lists various product safety and biocompatibility standards that the device has been designed to meet. These standards themselves include acceptance criteria for their respective domains (e.g., electrical safety, acoustic output, biocompatibility). Compliance with these standards is a form of meeting acceptance criteria but doesn't involve clinical performance metrics in the way a comparative effectiveness study would.

The "Indications for Use Form" for the main system and each transducer lists the clinical applications and modes of operation ("P" for previously cleared, "N" for new indication). For the new indications, the assumption is that the new functionalities (like the Arterial Health Package) have been validated, but the details of this validation are not present in this document.

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, details of MRMC studies, or standalone algorithm performance, as requested in the input, cannot be extracted.

The document describes the intended use of the device for various applications and mentions the Arterial Health Package (AHP) software, which provides capabilities to measure Intima Media Thickness and reference normative tables "validated and published in peer-reviewed studies." This implies that the underlying science for AHP's clinical utility is derived from external, peer-reviewed research, rather than a de novo clinical study conducted for this specific 510(k) submission.

Summary of available information related to performance/validation:

• Acceptance Criteria & Device Performance: Not explicitly stated as quantitative metrics against a specific threshold in this summary. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, which implies similar safety and effectiveness.
• Study Type: No specific clinical study is described in detail for performance evaluation of the ACUSON X300 or its specific new features (beyond stating "modifications are verified and validated according to the company's design control process"). The AHP software references "normative tables that have been validated and published in peer-reviewed studies," indicating reliance on existing scientific literature for its clinical basis, not a new study.
• Sample Size (Test Set & Training Set): Not provided.
• Data Provenance: Not provided.
• Number of Experts/Qualifications (Test Set Ground Truth): Not provided.
• Adjudication Method: Not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance (Algorithm Only): Not mentioned, as this is an ultrasound system with associated software, not typically a standalone AI algorithm.
• Type of Ground Truth: Not specified for any performance evaluation in this summary. For AHP, the ground truth for normative tables is implicitly from "peer-reviewed studies."
• How Ground Truth for Training Set was Established: Not applicable as training set details are not provided.

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Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intracperative, 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 for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Siemens Acuson X300 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire 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, 3D Imaging, or Harmonic Imaging and 4D imaging on a FPD(Flat Panel Display) display.

This Siemens Acuson X300 Diagnostic Ultrasound System 510(k) submission does not contain information about acceptance criteria or a study proving the device meets said criteria. This document is a summary of safety and effectiveness, focused on establishing substantial equivalence to predicate devices and detailing the intended uses for various transducers. It does not include specific performance metrics, clinical study design, or results that would typically be found in a study demonstrating adherence to acceptance criteria.

The provided text lists the product safety standards the device has been designed to meet:

• UL 60601-1, Safety Requirements for Medical Equipment
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment (EN 60601-1, EN 60601-1-1, EN 60601-1-2)
• IEC 61157 Declaration of Acoustic Power
• ISO 10993 Biocompatibility

However, it does not provide any acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) or reported device performance against such criteria. The document states that the device has been designed to meet these standards, but it does not present data from a study demonstrating active compliance or performance metrics.

Therefore, I cannot populate the requested table or answer most of the other questions, as the information is not present within this 510(k) summary. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results and acceptance criteria for performance. For clinical effectiveness data, one would typically look for a full clinical study report, which is not part of this summary document.

Here's a breakdown of why each specific point cannot be addressed:

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

   • Reason Not Found: The document lists general safety and acoustic output standards but does not define specific performance acceptance criteria (e.g., image quality metrics, diagnostic accuracy thresholds) nor does it report any device performance against such metrics. It mentions that "analysis packages... provide information that is used for clinical diagnosis purposes" but provides no performance data for these.

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

   • Reason Not Found: There is no mention of a test set, clinical data, or studies that would involve a sample size. The submission focuses on device design and comparison to predicate devices, not clinical performance evaluation with a test set.

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)

   • Reason Not Found: As no test set data is provided, there is no mention of experts or ground truth establishment.

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

   • Reason Not Found: No test set or related adjudication method is described.

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

   • Reason Not Found: This document is about a diagnostic ultrasound system (hardware and general software capabilities), not an AI-assisted diagnostic tool. There is no mention of an MRMC study or AI assistance.

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

   • Reason Not Found: This is not an algorithm-only device; it's a general-purpose ultrasound system. No standalone algorithm performance is discussed.

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

   • Reason Not Found: No ground truth information is provided, as clinical performance data is absent.

8. The sample size for the training set

   • Reason Not Found: No training set or data used for training (e.g., for an AI algorithm) is mentioned in this submission.

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

   • Reason Not Found: As no training set is indicated, there's no information on how its ground truth would have been established.

In summary, this 510(k) submission establishes the substantial equivalence of the Siemens Acuson X300 Diagnostic Ultrasound System to existing predicate devices based on technological characteristics and intended uses. It does not provide the kind of detailed performance study data, acceptance criteria, or clinical validation results that would address the specific questions posed.

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