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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 AcuNav 8F and 10F Ultrasound Catheter, ACUSON AcuNav™ V 10F Ultrasound Catheter, ACUSON AcuNav™ Volume 12F Ultrasound Catheter, SoundStar™ 8F Ultrasound Catheter, SoundStar™ 10F Ultrasound Catheter, SoundStar™ eco 8F Ultrasound Catheter, and SoundStar™ eco 10F Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. Catheters are intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The ACUSON SC2000 Diagnostic 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 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, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display. The transducer and catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a).

Additional features for the ACUSON SC2000 v5.1 update includes the Joystick remote control accessory that is intended to be used for interventional procedures with the ACUSON AcuNav Volume ICE catheter where remote control of the cursor is desired. The joystick plugs into the system and allows selected control panel and cursor events to be triggered via joystick movement and button-press.

This is a premarket notification (510k) for the ACUSON SC2000 Diagnostic Ultrasound System. The information provided heavily references previous clearances for substantial equivalence rather than presenting new studies with acceptance criteria explicitly defined for the current submission.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics for this specific 510(k) submission (K181098). Instead, it relies on the substantial equivalence to previously cleared devices. The "Features on SC2000 System" table in Section 6.1 (pages 25-26) implicitly acts as a comparison to the predicate device, showing that the current device either has the same feature (√) or improved features (e.g., "Updated TEQ", "Added Manual Trace", "New" features). The "Frequencies Supported" are identical across the three compared devices for most applications.

The acceptance criteria here are implicit and based on the predicate device's established performance, meaning the new device must perform at least as well as, or be substantially equivalent to, the predicate in all relevant aspects.

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

The document explicitly states: "clinical studies were not required to support substantial equivalence" (Part 8, page 29). Therefore, there is no test set sample size mentioned, nor any data provenance (country of origin, retrospective/prospective). The submission relies on non-clinical tests (acoustic output, biocompatibility, safety standards compliance) and comparison to predicate devices.

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

Since no clinical studies were performed for this submission, there is no mention of experts or their qualifications for establishing ground truth. The substantial equivalence is based on technical specifications and adherence to recognized standards.

4. Adjudication Method for the Test Set:

As no clinical studies were conducted, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MrMC comparative effectiveness study was done or reported as clinical studies were deemed unnecessary due to substantial equivalence to predicate devices. Therefore, no effect size of human reader improvement with AI vs. without AI assistance is mentioned.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

No standalone performance study of an algorithm is described or reported. The device is an ultrasound system with accessories, not an AI/algorithm-only product.

7. Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" is established through adherence to recognized medical device safety standards (e.g., AAMI / ANSI ES60601-1, IEC series, ISO 10993-1) and comparison of technological characteristics to already cleared predicate devices. Clinical outcomes data or expert consensus for new evaluations were not used for this submission's substantial equivalence determination.

8. Sample Size for the Training Set:

The document does not mention any training set or its sample size, as it does not involve a de novo AI/ML model development requiring such data for this 510(k) submission.

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

Since no training set is discussed, the method for establishing its ground truth is not provided.

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