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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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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 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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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 SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in 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 on a Flat Panel Display.

The provided 510(k) summary for the Siemens SC2000 Ultrasound System focuses on demonstrating substantial equivalence to previously cleared devices rather than outlining detailed acceptance criteria and a specific study proving device performance against those criteria. The submission is for a modification to an existing device (SC2000 Diagnostic Ultrasound System) and a new feature (Clarify VE).

Therefore, this document does not contain the specific information requested about acceptance criteria and a study demonstrating performance against them in the way a submission for a novel AI device might. Instead, it relies on demonstrating that the modified device continues to meet existing safety and performance standards, and that the new feature is substantially equivalent to a feature already cleared on another Siemens device.

However, I can extract information related to the performance data and the comparison to predicate devices, which implicitly serves as the "proof" of meeting acceptance criteria for a substantial equivalence determination.

Here's the breakdown of the requested information based on the provided text, along with notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity targets) for a new algorithm or feature in the way a novel AI medical device submission would. Instead, the "acceptance criteria" are implicitly met by demonstrating compliance with established safety and performance standards and showing substantial equivalence to predicate devices.

The "reported device performance" is described qualitatively as meeting these standards and having similar technological characteristics and intended uses as cleared predicates.

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 provided in the document. The submission focuses on substantial equivalence based on prior clearances and the nature of the modifications (Clarify VE being identical to a previously cleared feature on another system, and the new transducer being similar to existing ones). There is no mention of a specific clinical test set for 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)

This information is not provided as there is no specific clinical test set described in this 510(k) summary for establishing ground truth for a novel AI algorithm. The device is an ultrasound system with enhanced imaging features, not an AI diagnostic algorithm requiring expert-labeled ground truth for evaluation in this context.

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

This information is not provided for the same reasons as point 3.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study would typically be performed for new AI-powered diagnostic aids, which is not the primary focus of this 510(k) submission (which is for a modification to an existing ultrasound system including a feature like Clarify VE, which enhances image quality rather than providing a direct diagnostic output that would assist human readers in a comparative effectiveness study).

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

This is not applicable and not mentioned. The device described is an ultrasound system, not a standalone algorithm. Clarify VE is an image enhancement feature integrated into the system, not a standalone algorithm output.

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

This information is not provided for a test set, as no specific clinical test set for new feature evaluation is detailed. The "performance data" section focuses on engineering verification and validation against safety and performance standards for the ultrasound system itself, not the clinical accuracy of a diagnostic output.

8. The sample size for the training set

This information is not provided. The document describes an ultrasound imaging system with a new image enhancement feature, not a machine learning model that would have a distinct training set.

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

This information is not provided for the same reasons as point 8.

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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 Abdominal, 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.

The Acuson SC2000™ 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; Safety and EMC Requirements for Medical Equipment; IEC 60601-1; IEC 60601-1-1; IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

This 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System is a Special 510(k), indicating a minor change to a previously cleared device. Therefore, a comprehensive de novo clinical study demonstrating performance against acceptance criteria for a novel device is not part of this submission. Instead, the performance data section explicitly states: "No performance data required to support this modification, as there is no change to any hardware or software, or method of use."

The submission focuses on demonstrating substantial equivalence to a previously cleared device (K123622) by only renaming three transducers. As such, the typical elements of a study proving a device meets acceptance criteria (like a test set, ground truth, experts, and statistical results) are not provided in this document.

However, I can extract the acceptance criteria implied by this type of submission, which is the determination of substantial equivalence to the predicate device for the specified indications for use.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for a Special 510(k) for Renaming Transducers): The modified device, specifically the renamed transducers, must demonstrate substantial equivalence to the previously cleared predicate device concerning intended use and technological characteristics, with no changes to hardware, software, or method of use.

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

• Sample Size for Test Set: Not applicable. No new performance testing with a specific test set was conducted for this Special 510(k) given the nature of the modification (renaming transducers).
• Data Provenance: Not applicable. No new data was generated or analyzed for this submission. The basis for substantial equivalence relies on the established performance of the predicate device and the claim that the changes are confined to nomenclature.

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

• Number of Experts: Not applicable. No new ground truth establishment was required as no new performance data was generated.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This submission does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is an ultrasound imaging system, not an AI algorithm requiring standalone performance evaluation in the context of this submission.
• The document states there is "no change to any hardware or software," implying no new algorithms or software features are being introduced that would require such testing.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for new performance evaluation. The "ground truth" for this Special 510(k) is implicitly the established safety and effectiveness of the predicate device (K123622), to which the modified device (with renamed transducers) is claimed to be substantially equivalent without any functional changes.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of any new algorithms or software components.

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

• Ground Truth Establishment for Training Set: Not applicable.

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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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