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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".

The Acuson Acunav Ultrsound 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 S2000™ Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with and 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, 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.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System (Acuson S2000™).
It does not contain specific quantitative acceptance criteria or detailed performance metrics from a clinical study for the device itself in terms of sensitivity, specificity, accuracy, etc. Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by comparing technological characteristics and intended uses.

Therefore, a table of acceptance criteria and reported device performance in the typical sense of measuring diagnostic accuracy cannot be constructed from this document. The "performance" demonstrated here is the device's compliance with safety standards and similarity in features/indications for use compared to existing cleared devices.

Acceptance Criteria (Implied by 510(k) Submission):
The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device(s). This is achieved by showing that the device:

• Has the same intended use as the predicate device.
• Has the same technological characteristics as the predicate device OR has different technological characteristics but demonstrates that these differences do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Reported Device Performance (Based on Substantial Equivalence Claim):
The document asserts that:

• The modified Acuson S2000™ Ultrasound System is substantially equivalent to the company's own Acuson Antares and S2000 Ultrasound Systems (Section 3).
• The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards (Section 7).
• Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines (Section 9).
• The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance (Section 9).
• The FDA's review concludes the device is substantially equivalent (page 4, FDA letter).

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

• No specific sample size for a test set is reported. The document explicitly states: "Since the S2000 uses the same technology and principles as existing devices, clinical data is not required." (Section 8). This indicates that no new clinical study (and thus no test set of patients/data) was performed for this 510(k) submission to demonstrate performance in a clinical setting.
• Data Provenance: Not applicable, as no new clinical data was generated or used for a test set. The submission relies on the established safety and effectiveness of the predicate devices.

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

• Not applicable. As no clinical study or test set requiring expert ground truth was performed for this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. As no clinical study or test set requiring ground truth adjudication was performed.

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

• No, an MRMC comparative effectiveness study was not done. The document states that clinical data was not required for this submission.

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

• Not applicable. The Acuson S2000™ is an ultrasound imaging system, not a standalone algorithm. The submission is for the entire device, which would always involve a human operator (the sonographer/clinician).

7. The Type of Ground Truth Used:

• Not applicable for a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices and compliance with recognized safety standards. The new device is deemed safe and effective because it is substantially equivalent to these predicates and meets general safety requirements. The Arterial Health Package (AHP) software, a specific feature, states it provides an option to reference "normative tables that have been validated and published in peer-reviewed studies," implying external, previously established "ground truth" for normative values, not new ground truth generated for this submission.

8. The Sample Size for the Training Set:

• Not applicable. The document describes a traditional medical device submission (an ultrasound system), not an AI/ML-based device that typically involves training sets. The "training" for such a device is likely part of its initial design and engineering, rather than a data-driven algorithmic training set described in this context.

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

• Not applicable. As no training set and corresponding ground truth for an algorithm was used or described in this submission.

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