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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), Intra-operative (Neuro.), 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, Trans-esophageal (card.), Peripheral vessel.

Typical examinations performed using the SonoSite High-Resolution Ultrasound System (C3 Series) are: Abdominal Imaging Applications, Cardiac Imaging Applications, Gynecology and Infertility Imaging Applications, Interventional and Intraoperative Imaging Applications, Obstetrical Imaging Applications, Pediatric and Neonatal Imaging Applications, Prostate Imaging Applications, Superficial Imaging Applications, Vascular Imaging Applications.

The system includes the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.

The SonoSite High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.

The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler 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 the ability to measure the intima-media thickness (IMT) of the carotid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.

The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.

The SonoSite High-Resolution Ultrasound System (C3 Series) 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.

The provided text describes the SonoSite High-Resolution Ultrasound System (C3 Series) and its transducers. However, it does not include information about specific acceptance criteria or a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness study details).

Instead, the document focuses on:

• 510(K) Summary of Safety and Effectiveness: This section aims to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to provide detailed performance metrics against specific acceptance criteria.
• Device Description: Outlines the functionalities and features of the ultrasound system.
• Intended Use: Lists the clinical applications for which the system is designed.
• Technological Characteristics: Describes the device's operating principles and acoustic output limits, which conform to standards rather than setting specific acceptance criteria for diagnostic accuracy or performance.
• Transducer Model Numbers and Indications for Use: Provides tables detailing which transducers are cleared for specific clinical applications and modes of operation.

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in this 510(k) summary.

The document states that the device conforms to certain standards and that its acoustic output limits are the same as predicate Track 3 devices (e.g., ISPTA, TI, MI limits). However, these are technical specifications and compliance statements, not performance acceptance criteria linked to a validation study.

To answer your request, a different type of document, such as a detailed clinical validation study report or a more comprehensive performance specification document, would be needed.

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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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