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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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Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial 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 CV70 system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already proprietary boxware, under the following 510(k) Premarket Notification number: K032111 (July 18, 2003) cleared as ACUSON CV70™ Cardiovascular System. The CV70 functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate two-dimensional images of structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. The predicate device provides specialized measurements of structures and flow, and provide various calculations functions.

This document is a 510(k) submission for the ACUSON CV70™ Cardiovascular System, an ultrasound device. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K032111) and detailing its intended uses and compliance with safety standards.

Based on the provided text, there is NO information about acceptance criteria, study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies regarding the device's performance.

The document is not a study report demonstrating the device meets performance criteria in the way described in your request (i.e., evaluation of AI/algorithm performance against a defined ground truth). Instead, it's a regulatory submission affirming that the updated model of an existing device is substantially equivalent to its predicate.

However, I can extract the intended uses of the device and its various transducers as a proxy for what the device is designed to do, which effectively serves as the "acceptance criteria" for its functionality as an ultrasound system in a regulatory context when demonstrating substantial equivalence.

Summary of Acceptance Criteria and Reported Device Performance (as demonstrated by intended uses and substantial equivalence):

The "acceptance criteria" in this context are the previously cleared intended uses and performance of the predicate device (ACUSON CV70™ Cardiovascular System, K032111). The reported device performance is that the new ACUSON CV70™ Cardiovascular System is substantially equivalent and performs in the same manner as the predicate, transmitting and processing ultrasonic energy to display real-time images and perform measurements.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for a diagnostic ultrasound system, the "acceptance criteria" are defined by the cleared Intended Uses and modes of operation for each transducer, which are considered substantially equivalent to the predicate device. The "reported device performance" is implicitly that the device successfully performs these functions as intended and is as safe and effective as the predicate.

Below is a combined table summarizing the overarching intended uses and modes of operation for the ACUSON CV70™ Cardiovascular System across its various transducers. "P" indicates previously cleared indications, and "E" indicates new indications added under Appendix E for a specific transducer. "N" indicates new indications for a specific transducer. "BMDC" stands for B-mode, M-mode, Doppler (PWD-Pulsed Wave, CWD-Continuous Wave), and Color Doppler.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a "test set" in the context of an algorithm or AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device, relying on technical comparison, safety standards compliance, and previous clearances.
• Data Provenance: Not applicable. There is no mention of specific clinical data or patient data used for performance testing in this 510(k) summary. The comparison is primarily against the established performance of the legally marketed predicate device (K032111) and compliance with recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. No specific "ground truth" establishment by experts for a test set is described in this regulatory submission.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. No test set requiring expert adjudication is described.

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:

• MRMC Study: No. This document does not present any MRMC comparative effectiveness studies. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool.

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

• Standalone Performance Study: No. This document does not describe a standalone algorithm performance study.

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

• Type of Ground Truth: Not applicable. The submission for substantial equivalence relies on the established performance and safety profile of the predicate device, not on a new ground truth established for a specific clinical outcome or diagnostic accuracy study.

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 an AI algorithm; therefore, there is no training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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