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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for peripheral nerve block procedures.

The devices referenced in this Submission are highly portable. software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

The provided text is a 510(k) summary for SonoSite ultrasound systems. It describes the addition of a new clinical application ("intra-operative (neurological)") to existing ultrasound devices. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

Instead, the "Testing" section (Section 7 on page 3) states:

• "Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions."
• "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."

This indicates that the acceptance criteria for this 510(k) submission are related to:

1. Compliance with general medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety). These were already met and documented in previous predicate submissions (K030949 and K014116), for which this document serves as an update adding a new indication for use.
2. Substantial equivalence to predicate devices that already have 'intra-operative (neurological)' as a clinical application. The argument is that since the new indication is not novel and the anatomical site is amenable to the systems' existing technology, no additional clinical testing is needed to prove effectiveness for this specific added use.

Therefore, the requested information components (table of acceptance criteria and performance, sample size, ground truth, adjudication, MRMC studies, standalone performance, training set size, etc.) are not available in this document because the submission relies on substantial equivalence and prior safety testing, rather than a new performance study proving diagnostic accuracy for the added indication.

Specifically, for the questions asked:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance and substantial equivalence to predicate devices for the new indication, not a new performance study with specific metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for the added indication. The submission relies on the fact that existing systems already meet safety standards, and the new indication is covered by predicate devices without requiring new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This submission is for an ultrasound system, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new performance study in this submission.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

The SonoSite TITAN™ high-resolution ultrasound systemis a highly portable. software controlled ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, Velocity Color Doppler (VCD) and Directional Color Power Doppler, or in a combination of these modes. The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data for M-mode measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The system includes Digital Imaging and Communications (DICOM) to capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images. The SonoSite TITAN™ high-resolution ultrasound system is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

This is a general ultrasound system and hence no specific disease is mentioned. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to various standards for safety and performance. There is no information regarding clinical studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies for AI integration. This is typical for a 510(k) submission for a general-purpose diagnostic ultrasound system.

The "acceptance criteria" for this device are its conformity to recognized industry standards for medical electrical equipment, acoustic output, and biological safety, and its substantial equivalence to predicate devices. The "study" that proves it meets these criteria is the comprehensive testing and documentation demonstrating this conformity and equivalence, as laid out in the 510(k) submission.

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

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No specific test set or patient data is mentioned in this 510(k) summary. The submission focuses on technical and safety standard compliance and comparison to predicate devices, rather than a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The submission does not describe a clinical study requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication process 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:

Not applicable. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. Therefore, no MRMC comparative effectiveness study was conducted regarding AI assistance.

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

Not applicable. This device is an imaging system, not an algorithm, and does not operate in a standalone algorithmic capacity as described.

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

Not applicable. The submission does not describe a clinical performance study that would require establishing ground truth in this manner. The "ground truth" implicitly relies on established industry standards and the performance of predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm that requires a training set.

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