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

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

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

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device with specific performance metrics like sensitivity/specificity, the 'acceptance criteria' are primarily related to safety, operational modes, and clinical applications, demonstrating equivalence to the predicate device. The performance is implied by its equivalence to a previously cleared device and compliance with established safety and performance standards.

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

Not applicable. This is a submission for a diagnostic ultrasound system, not a software algorithm requiring a test set of patient data to evaluate performance metrics. The evaluation focuses on engineering, safety, and functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

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

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

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

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

8. The sample size for the training set

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

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

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

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

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the “ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging”.

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

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound svstems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode. Color Doppler Mode. Amplitude. Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

2. Sample Size for the Test Set and Data Provenance

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

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

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

4. Adjudication Method for the Test Set

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

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states that clinical studies were not required. The product is an ultrasound system and not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

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

The ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude, Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

This document is a 510(k) Pre-market Notification from the FDA regarding the Siemens Medical Solutions Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems. It primarily states that the device is substantially equivalent to previously cleared devices (K142876 for the systems, and various K#s for specific transducers).

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

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

Acceptance Criteria and Reported Device Performance

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

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

Study Information (Based on Substantial Equivalence Logic):

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

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

Summary of Non-Clinical Tests (from document):

The device was evaluated for:

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

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

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

Conclusion:

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

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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, cardiac, 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 normalive 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 Carolid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardionraphy: 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 onscreen 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.

The provided document is a 510(k) summary for the Siemens S-Family Ultrasound Systems. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria for a novel AI/CAD device.

Based on the information provided, here's an analysis of the acceptance criteria and

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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 Siemens Acuson X150 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.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Siemens ACUSON X150 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, or Harmonic Imaging and 3D Imaging on a Flat Panel Display.

This Siemens ACUSON X150™ Diagnostic Ultrasound System 510(k) submission (K121646) is a special 510(k) for an update to an existing device (K081121). Special 510(k)s by definition do not require clinical performance data for substantial equivalence and focus on verification and validation of design control processes. Therefore, the information provided primarily pertains to the system's intended use and compliance with technical standards rather than a study demonstrating clinical performance or acceptance criteria in the traditional sense of a clinical trial for a novel device or AI algorithm.

However, based on the provided text, I can infer the "acceptance criteria" as the claimed functionalities and indicated uses of the device, and the "reported device performance" as the assertion that these functionalities are present and the device complies with safety standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for an updated ultrasound system, "acceptance criteria" here refers to the device's ability to perform its stated diagnostic imaging and fluid flow analysis functions across various clinical applications and modes of operation, and its compliance with relevant safety and performance standards. The "reported device performance" is the manufacturer's assertion that the device meets these criteria through verification and validation efforts, as is typical for a special 510(k).

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

The document does not describe a clinical study with a "test set" in the sense of a dataset used to evaluate the performance of a novel algorithm or diagnostic metric. This submission is for an updated diagnostic ultrasound system and focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation. Therefore, there are no specific sample sizes for a 'test set' or data provenance mentioned in relation to real clinical data for performance evaluation in this 510(k) summary. The performance data section states, "The modifications to the Siemens ACUSON X150 Diagnostic Ultrasound System are verified and validated according to the company's design control process."

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

Not applicable. As explained above, there is no "test set" or ground truth established by experts for a clinical performance study in this 510(k) summary. The evaluation focuses on technical and safety compliance.

4. Adjudication Method for the Test Set

Not applicable. No "test set" that would require an adjudication method is described.

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

No. The document explicitly states that the submission device is "substantially equivalent to the predicate with regard to both intended use and technological characteristics," implying that a full MRMC comparative effectiveness study was not deemed necessary for this special 510(k) submission. No effect size of human readers improving with AI vs. without AI assistance is mentioned because this is not an AI/CAD device.

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

Not applicable. This is not a submission for an algorithm or AI device; it is for a diagnostic ultrasound system. Therefore, standalone algorithm performance is not relevant or evaluated here.

7. The Type of Ground Truth Used

Not applicable in the context of clinical study ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is adherence to established engineering specifications, safety standards, and performance characteristics as verified through design control processes. The "Indications for Use" tables define the intended clinical applications and operating modes, which are part of the device's functional "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would involve a training set.

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

Not applicable. As there is no training set mentioned, there is no description of how ground truth for it would be established.

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