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The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

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 the state of their cardiovascular system.

Note: This feature can be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

The ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their functions are to acquire harmonic 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, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaqing on a Flat Panel Display.

This is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML device. Therefore, the typical acceptance criteria and study components related to software performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or provided in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)) by comparing intended use, technological characteristics, and compliance with safety standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device with specific performance metrics like sensitivity/specificity, the 'acceptance criteria' are primarily related to safety, operational modes, and clinical applications, demonstrating equivalence to the predicate device. The performance is implied by its equivalence to a previously cleared device and compliance with established 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 is a submission for a diagnostic ultrasound system, not a software algorithm requiring a test set of patient data to evaluate performance metrics. The evaluation focuses on engineering, safety, and functional equivalence.

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. Ground truth for diagnostic performance evaluation is not relevant for this type of device submission.

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

Not applicable. No test set requiring adjudication of ground truth is mentioned.

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/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm-only device. It's a diagnostic ultrasound system.

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

Not applicable. Clinical performance data is not provided as part of this 510(k) submission, as it relies on substantial equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), 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, transrectal, 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 peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging”.

The ACUSON AcuNav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound svstems 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, 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.

Siemens Medical Solutions USA, Inc. has demonstrated the substantial equivalence of their ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems to previously cleared predicate devices (K162243). This submission (K163635) indicates that clinical studies were not required given the devices' consistent technology and principles with existing, cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical performance metrics in the provided document. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device (K162243) based on identical indications for use and technological characteristics. The "reported device performance" is the confirmation that all features and applications are consistent with the predicate device.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states that "clinical studies were not required to support substantial equivalence" because the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices. Therefore, there is no test set of patient data and consequently no specific sample size or data provenance (country of origin, retrospective/prospective) mentioned for performance testing, as clinical performance was not re-evaluated for this submission. The evaluation focused on non-clinical tests and technological equivalence.

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

Since no clinical test set was used for performance evaluation, there were no experts used to establish ground truth for a test set. The evaluation was based on demonstrating equivalence to a previously cleared device (K162243) and adherence to technical standards.

4. Adjudication Method for the Test Set

As there was no clinical test set involving human interpretation for performance evaluation, no adjudication method was used.

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 done. The submission explicitly states that clinical studies were not required. The product is an ultrasound system and not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.

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

This submission is for an ultrasound diagnostic system, which is a medical imaging device operated by human users. It is not an AI-algorithm intended for standalone diagnostic performance. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The non-clinical tests focused on device safety and operability.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" essentially refers to the established safety and effectiveness of the predicate device (K162243) and adherence to recognized medical device safety and quality standards. These standards (e.g., ISO, IEC, AIUM/NEMA) represent a consensus on best practices and performance requirements for diagnostic ultrasound equipment.

8. The Sample Size for the Training Set

This submission is for a medical device (ultrasound system), not a machine learning algorithm that requires a "training set" of data in the conventional sense. Therefore, there is no training set sample size described. The development process would have involved engineering design, testing, and validation against specifications and standards.

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

As noted above, there is no training set. The "ground truth" for the device's design and validation was established through compliance with established industry and regulatory standards for medical devices, as well as the proven performance and safety of its predicate device, K162243.

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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, transesophageal, transrectal, 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 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) Pre-market Notification from the FDA regarding the Siemens Medical Solutions Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems. It primarily states that the device is substantially equivalent to previously cleared devices (K142876 for the systems, and various K#s for specific transducers).

Therefore, the information regarding acceptance criteria and study details for demonstrating performance against those criteria is limited because the device is cleared based on demonstrating substantial equivalence to a predicate device rather than novel performance claims.

Here's a breakdown of the information that can be extracted, and where limitations exist based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (K142876).

The table provided in the document (pages 33-34) compares the features and indications for use of the current submission device versus the predicate device, showing that they are essentially identical.

Study Information (Based on Substantial Equivalence Logic):

The document explicitly states that clinical data is not required because the device uses the "same technology and principles as existing devices" (referring to the predicate device K142876). This means there was no specific study conducted to prove the device meets specific performance criteria as if it were a de novo device or had new clinical claims.

1. Sample size used for the test set and the data provenance: Not applicable for performance claims, as clinical data was not required for substantial equivalence. The "test set" for this submission would have been comparison to the predicate device's specifications and functionality.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical validation with ground truth establishment was not performed or required for this specific submission because it demonstrated substantial equivalence.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for performance claims.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
5. 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 an AI algorithm evaluated in standalone mode.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for performance claims. The "ground truth" for this submission was the established safety and effectiveness of the predicate device.
7. The sample size for the training set: Not applicable. This document describes an ultrasound system, not an AI/machine learning model that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Tests (from document):

The device was evaluated for:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety

It was found to conform with applicable medical device safety standards, including:

• UL 60601-1
• IEC 60601-2-37
• CSA C22.2 No. 601-1
• AIUM/NEMA UD-3 and UD-2
• 93/42/EEC Medical Devices Directive
• EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2
• ISO 10993-1 Biocompatibility

Conclusion:

The Siemens Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems were granted 510(k) clearance based on demonstrating substantial equivalence to existing, legally marketed predicate devices (K142876). This means that its safety and effectiveness are considered equivalent to the predicate, and therefore, extensive new clinical efficacy studies with specific performance criteria were not required by the FDA for this submission. The validation was primarily based on non-clinical testing to ensure safety, electrical, mechanical, and biocompatibility standards were met, and that its functionalities and technical characteristics matched those of the predicate device.

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