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ACUSON P500 Ultrasound System
The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology 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 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.

ACUSON P500 ICE Ultrasound System
The ACUSON P500 ICE ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN (useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular (including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology 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 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.

The ACUSON P500 and P500 ICE Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

The provided text is an FDA 510(k) clearance letter for the ACUSON P500 and P500 ICE Ultrasound Systems. It does not contain the specific details of acceptance criteria or a study proving the device meets those criteria. The document explicitly states:

"Since the ACUSON P500 and P500 ICE Ultrasound Systems use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."

This means that a specific clinical study with acceptance criteria, test sets, expert ground truth, etc., as requested in your prompt, was not performed or submitted for this particular clearance, as the device was deemed substantially equivalent to a previously cleared predicate device.

Therefore, I cannot provide the requested information from the given text.

If you have a document that describes the specific acceptance criteria and a study that proves the device meets them, please provide that document.

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The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN(useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure 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.

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

The ACUSON P500 Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

This document is a 510(k) summary for the ACUSON P500 Ultrasound System, seeking clearance for a modified device. It declares substantial equivalence to previously cleared predicate devices by the same company, the ACUSON P500 (K163396), ACUSON Juniper (K201130), and ACUSON Redwood (K210743).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or corresponding reported device performance values in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, asserting that the modified ACUSON P500 Ultrasound System (this submission) operates in the same manner and has similar technological characteristics as the previously cleared devices.

The "Determination of Substantial Equivalence" section (page 6-8) lists the features and characteristics of the submitted device and compares them to the predicate and reference devices. The core argument for acceptance is that the added features (transducers, applications, software features) and expanded clinical applications were already cleared on the reference devices.

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

The document explicitly states: "Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (page 11, Section 8).

Therefore, there is no specific test set or associated sample size for a clinical study to prove the device meets acceptance criteria. The data provenance for performance relies on the previous clearances of the predicate and reference devices.

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

As no new clinical study was conducted for this submission, there were no experts specifically engaged to establish ground truth for a new test set for this clearance. The ground truth for the predicate and reference devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set:

Since no new clinical study testing performance was performed for this 510(k), no adjudication method was specified or used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI-assisted performance or its effect size on human readers. The ACUSON P500 is an ultrasound system with various imaging modes and measurement packages, not an AI-driven diagnostic assistance tool in the context of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document does not report any standalone algorithm performance studies. The device is an ultrasound system intended for use by "appropriately trained healthcare professional in a clinical setting" (page 2, 5).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

As per the answer to point 2, no new clinical study was conducted for this submission. The basis for clearance is substantial equivalence to existing devices. Therefore, no new ground truth was established for this specific submission. The original ground truth for the clearances of the predicate and reference devices would have been established through methods appropriate for diagnostic ultrasound systems (e.g., expert interpretation of images, correlation with other diagnostic modalities or clinical outcomes). The Arterial Health Package (AHP) software, a feature of the device, references "normative tables that have been validated in peer-reviewed studies," which implies a form of ground truth based on established medical knowledge and research.

8. The Sample Size for the Training Set:

Since no new clinical study or algorithm development (in the context of this clearance) requiring a training set is discussed, no training set sample size is reported.

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

As no training set is discussed for this submission, the method for establishing its ground truth is not applicable or provided.

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The ACUSON P500 ultrasound imaging system is intended for the following applications:

Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, OB/GYN(useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Pelvic, Neonatal, Cardiac, IntraCardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal, and Urology applications.

The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Imaging."

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

The ACUSON P500™ 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 harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Tissue Doppler Image, Power (Amplitude) Doppler Mode and a combination of modes on a Flat Panel Display.

I understand you're looking for information on the acceptance criteria and the study proving the device meets those criteria for the ACUSON P500 Ultrasound System (K163396).

Based on the provided document, which is an FDA 510(k) Premarket Notification, there is a key piece of information that dictates the nature of the "study" that proves the device meets acceptance criteria:

"Since the ACUSON P500™ Ultrasound System uses the same technology and principles as existing devices, clinical data is not required." (Page {24}, Section F)

This statement means that the device's substantial equivalence to previously cleared predicate devices is established primarily through non-clinical testing and comparison of technological characteristics, rather than through a new, a-la-carte clinical effectiveness study with human subjects. Therefore, many of the questions regarding sample size, expert adjudication, MRMC studies, and ground truth for a clinical study would not be applicable in this context.

Here's a breakdown of the information that is available in the document, formatted to answer your questions where possible:

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

The document primarily focuses on substantial equivalence to predicate devices rather than reporting specific performance metrics against pre-defined quantitative acceptance criteria from a standalone clinical study. The acceptance criteria essentially stem from demonstrating that its features, indications for use, and technological characteristics are equivalent to the cleared predicate devices, and that it meets relevant safety and performance standards.

The table below summarizes the comparison of the ACUSON P500 Submission Device against several predicate devices for Indications for Use and Modes, which serves as the primary "performance" data to establish substantial equivalence. Where a feature is present in the submission device, it is considered to meet the "acceptance criteria" of being equivalent to or better than a predicate possessing that feature.

Table: Acceptance Criteria (Equivalence to Predicates) and Reported Device Performance (Presence of Feature)

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

As explicitly stated, clinical data (and thus a clinical test set with human data) was not required for this 510(k) submission as the device uses the same technology and principles as existing cleared devices. Therefore, there is no sample size for a clinical test set or information on data provenance.

The "test set" in this context refers to the comparison of the device's technical specifications against established standards and predicate devices (as shown in the table above and Section E of the document).

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 a clinical study with human patients requiring expert ground truth was not performed. The "ground truth" for the device's substantial equivalence is established by its adherence to recognized standards and its equivalent technical characteristics to predicate devices.

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

Not applicable, as a clinical study requiring expert adjudication was not performed.

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 type of study is for evaluating the effectiveness of a device when used by human readers, often involving AI. As no clinical study was required, no MRMC study was performed, and the device is a diagnostic ultrasound system, not explicitly described as having an AI assistance feature.

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

This question is typically relevant for AI/Machine Learning devices. The ACUSON P500 is a diagnostic ultrasound system. While it has proprietary software and calculation packages (like Arterial Health Package), the document does not describe it as an "AI algorithm only" device. Its performance is inherent in its ability to acquire and display ultrasound data and perform measurements. The non-clinical tests relate to the physical and software functioning of the device.

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

For the non-clinical tests mentioned (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic and mechanical safety), the "ground truth" refers to the established requirements and limits defined by the referenced voluntary standards (e.g., ANSI/AAMI ES 60601-1, AIUM/NEMA UD-3, IEC 62359, ISO 10993-1). The device is found to "conform with applicable medical device safety standards" (Page {24}, Section E).

8. The sample size for the training set

Not applicable, as a new clinical study or AI model requiring a training set was not described or required for this 510(k) submission. The device's substantial equivalence relies on its underlying technology being the "same technology and principles as existing devices."

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

Not applicable, as no training set was used or described.

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