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The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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 SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately wained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (including monitoring of the ovarian follicle development), 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 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 ACUSON P200 ultrasound imaging system is intended for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures; fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculosketal (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 ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including live), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic. Neonatal, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (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 Society 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 of adult and pediatric patients.

For ACUSON NX3: The ACUSON NX3 ultrasound imaging system is intended for the following applications: Fetal Abdominal (including liver), Pediatric, Small Parts (Small Organ), Neonatal Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal and Urology 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.

For ACUSON NX3 Elite: The ACUSON NX3 Elite ultrasound imaging system is intended for the following applications: Fetal, Abdominal (including liver, intra-operative), Pediatric, Small Parts (Small Organ including intra-operative), Neonatal Cephalic, Adult Cephalic, Transcranial, OB/GYN, Pelvic, Neonatal, Cardiac(including Transesophageal), Vascular (including Peripheral Vessel, intra-operative), Musculoskeletal, Superficial Musculoskeletal and Urology 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.

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.

Note: 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 Society of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Medicine."

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

All of the transducers and the catheter-based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON systems.

Note: Some ACUSON Diagnostic Ultrasound configurations of components, accessories and/or software may vary from device brands and within device families. There are no modifications, additions or labeling changes to components, accessories and/or software for each device indicated.

The ACUSON Diagnostic Ultrasound systems are intended to be used by trained medical professionals at various locations where patient care, evaluation, monitoring or research is performed.

The provided document is a 510(k) Pre-market Notification for several Siemens ACUSON Diagnostic Ultrasound Systems, seeking clearance based on substantial equivalence to previously marketed devices. The document explicitly states that no new features, modifications, or changes were made to the hardware or software of the devices themselves. The entire submission focuses on an "expanded labeling" for lung ultrasound imaging, supported by existing clinical literature.

Therefore, the acceptance criteria and the study proving the device meets these criteria are not related to a new device or a new AI/algorithm feature being validated. Instead, it is about demonstrating that the existing, cleared devices can be marketed with expanded indications for use, supported by references to previously conducted tests and existing clinical literature.

Given this, I cannot provide information on:

• Reported device performance (as no new performance was claimed or tested)
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Sample size for training set or how ground truth for training set was established

The document explicitly states: "clinical studies were not required to support substantial equivalence. The expanded Labeling for Lung Ultrasound imaging (LUS) is supported by clinical literature." and "There are no software or hardware modifications to any device under this review and the expanded labeling has no impact on the individual ACUSON ultrasound device, therefore, testing results are not included in this Special 510(k) submission."

Below is a table summarizing the acceptance criteria and "device performance" in the context of this 510(k) submission, emphasizing that the "performance" here refers to the device meeting the previously established safety and effectiveness for its predicate indications, which is being extended to a new recognized clinical use case via labeling.

Description of Acceptance Criteria and Evidence for ACUSON Diagnostic Ultrasound Systems (K202683)

This 510(k) submission (K202683) by Siemens Medical Solutions, USA, Inc., is a Special 510(k). This type of submission is used when changes to a cleared device do not alter its fundamental scientific technology or intended use, but may expand its labeling or functionality within its established safety and effectiveness profile. In this specific case, the submission focuses on expanded labeling for Lung Ultrasound Imaging (LUS), utilizing the existing capabilities of the cleared ACUSON Diagnostic Ultrasound Systems and their associated transducers.

Crucially, the document states that no modifications were made to the software or hardware of the devices. Therefore, the "acceptance criteria" and "proof" are based on demonstrating substantial equivalence to previously cleared predicate devices and leveraging existing validation data for those predicates, rather than presenting new performance metrics for a novel algorithm or device.

1. Acceptance Criteria and Reported Device "Performance" (Meeting Substantial Equivalence)

Detailed comparison tables (Table 2 in the original document, not fully reproduced here due to length) consistently list "Identical" for all compared technological characteristics: Reusability, Duration of Use, Scientific Technology, Operating Principles, Type of Previously Cleared Transducers, Acoustic Outputs, Previously Cleared Imaging Modes, and Biocompatibility (ISO 10993-1). |
| Safety and Effectiveness: There are no new safety or effectiveness concerns introduced by the expanded labeling. | - Software Verification and Validation: The CRS (Customer Requirement Specifications) for each device were verified/validated during original development. No software/hardware modifications for this submission.

• Standards Compliance: Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1 - 3.20 (DICOM).
• Risk Management: Risk analysis (ISO 14971:2007) was performed on predicate devices, and mitigation controls were implemented. The expanded labeling does not impact these.
• Cybersecurity: Cybersecurity measures are addressed and conform to requirements to prevent unauthorized access, modification, misuse, or denial of use.
• Clinical Literature Support: The expanded labeling for Lung Ultrasound Imaging (LUS) is supported by clinical literature, indicating that the use of ultrasound for lung imaging is an established and safe practice. Clinical studies were not required for this 510(k) as the technology and operating principles are unchanged. |

2. Sample Size and Data Provenance for Test Set

• Test Set Description: Not applicable. For this Special 510(k), no new test set data for device performance was generated or presented. The submission relies on existing validation data for the predicate devices.
• Data Provenance: The underlying data for previously cleared predicate devices would have been generated through rigorous internal testing and validation processes during their initial development and clearance. The document implies that this data exists and supports the current device. The document explicitly states: "Non-clinical Testing has been conducted during product development for each of the predicate ACUSON Diagnostic Ultrasound device described in this submission."

3. Number, Qualifications, and Adjudication Method for Experts

• No new expert assessment: Not applicable for this Special 510(k). Since no new AI/algorithm features or changes to device performance were introduced, there was no independent expert review of a new test set for the purpose of this submission. The "ground truth" for the expanded labeling (Lung Ultrasound) is based on established clinical recognition and existing peer-reviewed literature.
• Adjudication method: Not applicable.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No new MRMC study: Not applicable. This submission does not involve a new AI or algorithm that would require an MRMC study to demonstrate human improvement with AI assistance.

5. Standalone (Algorithm Only) Performance Study

• No standalone algorithm: Not applicable. The submission is for diagnostic ultrasound systems, not a standalone algorithm. The core functionality is the ultrasound imaging, and the "expansion" is in the labeling for an existing modality.

6. Type of Ground Truth Used for Device Functions

• Existing Validated Performance: For the predicate devices, the ground truth and validation would have been established through a combination of:
  • Direct measurement and engineering specifications: For image quality, acoustic output, and system performance.
  • Clinical validation: Through various means including phantom studies, retrospective/prospective clinical data, and expert consensus for the initial indications.
• Clinical Literature/Consensus for Expanded Indication: For the new labeling related to Lung Ultrasound Imaging (LUS), the "ground truth" or justification is based on:
  • Established clinical practice: Recognition within the medical community for the utility of ultrasound in lung assessment.
  • Peer-reviewed studies and professional guidelines: As explicitly stated, the LUS labeling is "supported by clinical literature." This effectively implies that the medical community's consensus on the utility of LUS (as documented in such literature) serves as the "ground truth" for its clinical relevance.

7. Sample Size for Training Set

• No new training set: Not applicable. As no new AI/algorithm components were introduced or modified, there was no "training set" for the purpose of this specific 510(k) submission.

8. How Ground Truth for Training Set was Established

• No new training set: Not applicable.

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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, cardiac, 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 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 bioeffect 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.

The provided text is a 510(k) premarket notification for Siemens Medical Solutions USA, Inc.'s Acuson S1000/S2000/S3000 Diagnostic Ultrasound Systems. This document outlines the device's features, intended use, and its substantial equivalence to previously cleared predicate devices. It explicitly states that clinical data is not required for this submission because the systems use the same technology and principles as existing, already cleared devices. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance related to new clinical studies to prove the device meets acceptance criteria.

The submission focuses on establishing substantial equivalence based on technological characteristics and intended use compared to its own previously cleared S1000, S2000, and S3000 systems (K140959), and for one accessory (biopsy needle guide) to a guide for the X700 Ultrasound System (K123001).

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

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

This information is not explicitly detailed in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting performance against specific acceptance criteria for a novel device. The document states that the device "has been found to conform with applicable medical device safety standards" and "complies with the following voluntary standards." These standards could be considered broad acceptance criteria, but specific performance metrics against those criteria are not provided.

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

This information is not applicable as the document explicitly states: "Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical data is not required." Therefore, there was no test set derived from human or animal subjects for performance evaluation in this 510(k) submission.

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 clinical data or test set requiring expert ground truth was used for this submission.

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

Not applicable, as no clinical data or test set requiring adjudication was used for this submission.

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 does not mention any AI assistance or MRMC studies.

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

Not applicable, as the device is an ultrasound system and its transducers, not a standalone AI algorithm.

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

Not applicable, as no clinical data was required or used for this submission. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable, as no new algorithms or clinical training sets were mentioned or required for this submission.

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

Not applicable, as no new algorithms or clinical training sets were mentioned or required for this submission.

In summary, the provided document demonstrates substantial equivalence through a comparison of technological characteristics and intended use to previously cleared devices, rather than through new clinical performance studies.

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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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