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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.

AI/ML Overview

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.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety).	The SonoSite Hand-Carried Ultrasound System (C1 Series) was evaluated for academic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety, and was found to conform to applicable medical device safety standards (listed in Section 4). These reports were included in previous predicate submissions.
Substantial equivalence in safety and effectiveness to the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) for the "Small Organ" application.	The applicant believes that the testing and analysis (referencing previously submitted reports and the fact that the added indication is not novel) demonstrates that the SonoSite Hand-Carried Ultrasound System (C1 Series) and the "Small Organ" indication on the C60/5-2 5.0-2.0 MHz Curved Array transducer are substantially equivalent with respect to safety and effectiveness to the identified predicate device. No new clinical testing was required as the added indication is not a novel indication and the anatomical site is amenable to current transducer and post-processing ultrasound technology.

Acceptance Criteria (Implicit)

Reported Device Performance

Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety).

The SonoSite Hand-Carried Ultrasound System (C1 Series) was evaluated for academic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety, and was found to conform to applicable medical device safety standards (listed in Section 4). These reports were included in previous predicate submissions.

Substantial equivalence in safety and effectiveness to the predicate device (Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)) for the "Small Organ" application.

The applicant believes that the testing and analysis (referencing previously submitted reports and the fact that the added indication is not novel) demonstrates that the SonoSite Hand-Carried Ultrasound System (C1 Series) and the "Small Organ" indication on the C60/5-2 5.0-2.0 MHz Curved Array transducer are substantially equivalent with respect to safety and effectiveness to the identified predicate device. No new clinical testing was required as the added indication is not a novel indication and the anatomical site is amenable to current transducer and post-processing ultrasound technology.

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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