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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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