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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (breast, thyroid, testicles, prostate)

The device referenced in this Submission is a highly portable, software-controlled, diagnostic ultrasound system 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 of Safety and Effectiveness for a diagnostic ultrasound system. It addresses an application to add a new clinical application ("Small Organ") to an existing device.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's compliance with various safety and performance standards for ultrasound systems and medical devices. However, it does not specify quantitative performance acceptance criteria (e.g., sensitivity, specificity, resolution) for the imaging quality relevant to the new "Small Organ" application, nor does it provide a table of reported device performance against such criteria.

Instead, the acceptance criteria are implicitly that the device continues to meet the safety and effectiveness standards of its predicate device and applicable recognized consensus standards, with the new clinical application being demonstrated as substantially equivalent.

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

The document explicitly states: "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 there was no specific clinical test set used for this particular submission to evaluate the "Small Organ" application. The data provenance is effectively based on the previously cleared predicate device and the existing SonoSite system.

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

Since no new clinical test set was required and no clinical study was performed for this submission, there were no experts specifically engaged to establish ground truth for a test set related to the "Small Organ" application. The determination of substantial equivalence relies on existing regulatory clearances and technical specifications.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set was used for this submission.

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

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

Not applicable. This is for a diagnostic ultrasound system, not a standalone algorithm.

7. The Type of Ground Truth Used:

The ground truth for this submission is based on the established safety and effectiveness of the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) which already included "Small Organ" as a clinical application. The argument is that the SonoSite system, with its existing cleared technologies, is capable of performing this application equivalently. The document implies that the "anatomical site is amenable to current transducer and post-processing ultrasound technology available with the SonoSite Hand-Carried Ultrasound System (C1 Series) and predicate devices."

8. The Sample Size for the Training Set:

Not applicable. This submission does not involve a machine learning or AI model that requires a training set. The device is a traditional ultrasound system.

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.

Typical examinations performed using the SonoSite hand-carried ultrasound system (C2 Series) are: Abdominal Imaging Applications, Cardiac Imaging Applications, Cephalic 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 SonoSite hand-carried ultrasound system, C2 Series is 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 hand-carried ultrasound system (C2 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 is a 510(k) Summary of Safety and Effectiveness for the SonoSite hand-carried ultrasound system (C2 Series). This document focuses on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics. Crucially, it does not include information about clinical studies, acceptance criteria, or performance metrics in the way a clinical validation study would.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria as envisioned by your request. The document describes the device's technical specifications and intended uses, and lists applicable standards, but not specific performance metrics against acceptance criteria from a clinical study.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

What can be extracted:

• Device Description: The SonoSite hand-carried ultrasound system, C2 Series, is a highly portable, software-controlled ultrasound system for acquiring and displaying high-resolution, real-time ultrasound data in various modes (2D, PW Doppler, CW Doppler, Color Power Doppler, Velocity Color Doppler (VCD), Directional Color Power Doppler). It includes ECG display, measurement capabilities, audio output, cine review, image zoom, labeling, biopsy, storage, printing, recording, and DICOM capabilities.
• Intended Use: The system is intended for numerous clinical applications, including Fetal-OB/GYN, Abdominal, Intra-operative, Laparoscopic, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel. Specific modes of operation are cleared for each application (B-mode, M-mode, PWD, CWD, Color Doppler, Combined modes, and other specialized modes like Color Power Doppler, Directional Color Power Doppler, 3-D Imaging, and Tissue Harmonic Imaging).
• Technological Characteristics:
  • Operates identically to predicate devices, using piezoelectric material in the transducer to transmit and receive sound waves, converting them to electrical signals for display.
  • Conforms to AIUM/NEMA standards for on-screen display of thermal and mechanical acoustic output indices (ALARA principle).
  • Acoustic output limits:
    • ISPTA(d): 720 mW/cm² (Maximum)
    • TIS/TIB/TIC: 0.1 - 4.0 (Range)
    • Mechanical Index (MI): 1.9 (Maximum)
    • ISPPA(d): 0 - 700 W/cm² (Range)
• Transducers: The submission lists multiple transducers (C11/7-4, C11e/10-5, C15/4-2, C60/5-2, HST/10-5, ICT/7-4, C8/8-5, ICTe/10-5, L25/10-5, L38/10-5, L52/10-5, L52S/10-5, and a 2.0 MHz Dual Element Circular Array) with their frequency ranges and cleared indications for use.
• Regulatory Nature: This is a 510(k) premarket notification, indicating a claim of substantial equivalence to legally marketed predicate devices, not a de novo clearance or PMA requiring extensive de novo clinical studies with predefined acceptance criteria for performance endpoints.

What cannot be extracted (and why):

1. A table of acceptance criteria and the reported device performance: This document explicitly states it is a "Summary Of Safety And Effectiveness" and repeatedly references "substantial equivalence" to predicate devices (K014116, K010374, and Philips Ultrasound HDI® 5000 Ultrasound System). Substantial equivalence primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics as predicate devices, or that differences do not raise new questions of safety or effectiveness. It does not typically involve establishing new, quantitative acceptance criteria for performance (e.g., sensitivity, specificity, accuracy) based on clinical data and then proving the device meets those criteria with a new study. The performance is deemed acceptable because it is similar to already cleared devices.
2. Sample size used for the test set and the data provenance: No new clinical test sets or studies are described in this document for the purpose of establishing performance against acceptance criteria. The clearance is based on comparison to existing, already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no new clinical study measuring performance against ground truth is presented, this information is not available.
4. Adjudication method for the test set: Not applicable, as no new test set 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-assisted diagnostic tool in the sense of a software-only device. There is no mention of such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware/software system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new clinical study is detailed.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission is a regulatory document focused on demonstrating equivalence to existing devices through descriptions of technological characteristics and intended uses, rather than a report on a clinical study with predefined acceptance criteria and performance results.

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