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The S1000™ 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 adiunctively 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 S1000™ 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. It is substantially equivalent to the S3000 system (K122825) which is a legally marketed device.

The provided 510(k) summary for the Acuson S1000™ Diagnostic Ultrasound System does not include a separate section for acceptance criteria or details regarding a study specifically designed to prove the device meets performance acceptance criteria.

Instead, the submission primarily focuses on demonstrating substantial equivalence to a predicate device (Acuson S3000 Ultrasound System (K122825)) rather than providing detailed performance metrics or clinical study results for the S1000 itself.

Here's an analysis based on the information provided, addressing the requested points where possible, and noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Acuson S3000 Ultrasound System). Therefore, direct numerical performance metrics or acceptance criteria for the S1000 are not detailed. The "performance" is implicitly tied to meeting the same functional capabilities and safety standards as the predicate device.

The tables in sections {6} (Summary of Technological Characteristics - New Device Compared to Predicate) and {7}-{29} (Diagnostic Ultrasound Indications for Use Form for various transducers) indicate that the S1000 system and its transducers support various clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) "P" (previously cleared by FDA), indicating equivalence to the predicate's capabilities.

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

This information is not provided. As clinical data was "not required" (see point 8 below), there wouldn't be a test set with patient data for clinical performance evaluation.

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

This information is not provided. Given that clinical data was not required, there was no independent test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. See point 3.

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

There is no mention of an MRMC study, AI assistance, or any effect size related to human reader improvement. The device is a diagnostic ultrasound system, and the submission does not indicate any AI components or human-in-the-loop performance studies of that nature.

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

This information is not applicable/not provided. The device is an ultrasound system, not an AI algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided for the device itself. For the Arterial Health Package (AHP) software feature, it mentions referencing "normative tables that have been validated and published in peer-reviewed studies." This implies that the ground truth for these normative tables was established through published research, but it doesn't specify if new ground truth was established for this submission.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" in the context of device performance or algorithms in this submission.

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

This information is not provided. See point 8.

Summary of Device Acceptance Approach:

The core of this 510(k) submission for the Acuson S1000 Diagnostic Ultrasound System is the argument of substantial equivalence to an existing, legally marketed predicate device (Acuson S3000 Ultrasound System (K122825)).

The submission states:

• "The S1000™ Ultrasound System is substantially equivalent to the company's own S3000 Ultrasound System (K122825)." {1-0}
• "Since the S1000 uses the same technology and principles as existing devices, clinical data is not required." {3-0}

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the S1000:

1. Has the same intended use as the predicate device {1-0, 1-1, 6-0}.
2. Has similar technological characteristics to the predicate device {1-1, 6-0}. The tables in section {6} highlight the features and characteristics that are common or equivalent between the S1000 and S3000.
3. Complies with relevant safety and performance standards for medical devices (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1 for biocompatibility) {3-0}. These non-clinical tests would serve as the primary evidence for safety and basic performance conformance.

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