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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.

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 SC2000™ Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat Panel Display. There is an available off-line workstation (SC2000WP).

Here's an analysis of the acceptance criteria and supporting study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (a 510(k) Summary for the Siemens Acuson SC2000™ Diagnostic Ultrasound System) does not explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with safety and industry standards.

The "performance data" section primarily highlights the design, verification, and validation processes, and adherence to various safety standards. It does not provide specific metrics like sensitivity, specificity, accuracy, or other performance statistics typically seen in an AI/software device.

Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission for a diagnostic ultrasound system:

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

The document does not explicitly mention a "test set" in the context of clinical performance evaluation (e.g., patient data used to evaluate diagnostic accuracy). The "Performance Data" section describes internal design, verification, and validation testing, and compliance with standards. It does not specify sample sizes for any clinical studies or data sets, nor the provenance (country of origin, retrospective/prospective) of such data.

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

This information is not provided in the document. As there's no mention of a clinical test set with ground truth established by experts, this detail is absent.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the device's performance with and without AI assistance or against human readers.

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

The device is a diagnostic ultrasound system intended for use by a clinician, not a standalone AI algorithm. Therefore, a "standalone algorithm only" performance study, as typically understood for AI/CADe devices, is not applicable and not discussed in this document. The document describes the system providing "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

7. The Type of Ground Truth Used

The document does not describe the use of ground truth (expert consensus, pathology, outcomes data, etc.) in the context of evaluating diagnostic accuracy or clinical performance for this ultrasound system. The primary "ground truth" implicitly referred to is adherence to established technical specifications and safety standards.

8. The Sample Size for the Training Set

This information is not provided. The document describes a traditional diagnostic ultrasound system, not a machine learning or AI-driven device that would typically have a distinct "training set."

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

This information is not provided, as the device is not presented as an AI/ML system with a training set and associated ground truth establishment process.

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The Omnia X/XS ultrasound imaging system is intended for the following applications: General The Ommal XIXO ultraoberative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Kaulology, Abdominal, Intraoporative, Gular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis THE System also provide information that is used for clinical diagnosis purposes.

The Omnia X/XS is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect 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, or 3D imaging, on a CRT display.

The provided document is a 510(k) Summary for the Siemens Omnia X/XS Diagnostic Ultrasound System, dated December 19, 2001. It outlines the device description, intended uses, and technological comparison to predicate devices for regulatory clearance.

This document does not contain information about acceptance criteria or specific studies showing device performance against such criteria. The "Indications for Use Form" (Attachments 4-20) lists the clinical applications each transducer is intended for and the available modes of operation, indicating whether these are "new" (N), "previously cleared" (P), or "added under Appendix E" (E) applications. However, these forms do not provide quantitative performance metrics, sample sizes, ground truth establishment, or details about study methodologies.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on regulatory classification and intended use rather than detailed performance study results.

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