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The UGEO WS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial) and Peripheral vessel.

Device Description

The UGEO WS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode: S-Flow), PW Spectral Dopler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real time 4D imaging mode) or as a combination of these modes. The UGEO WS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The UGEO WS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided 510(k) Premarket Notification for the UGEO WS80A Diagnostic Ultrasound System (K133329) does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy, or other quantitative measures) nor does it describe a study designed to prove the device meets such criteria.

Instead, this submission is a Premarket Notification focused on demonstrating substantial equivalence to existing legally marketed devices. As such, the "study" proving the device meets criteria is primarily a comparison of technological characteristics and intended uses to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no specific quantitative acceptance criteria or performance metrics are provided in this regulatory submission. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various features and intended uses.

Feature / Characteristic	Acceptance Criteria (Not explicitly stated in quantitative terms)	Reported Device Performance
Intended Uses	Substantially equivalent to predicate devices (ACCUVIX A30, UGEO HM70A, ACCUVIX XG, ACUSON S2000, iU22) for listed clinical applications.	The UGEO WS80A supports Fetal, Abdominal, Small Organs, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), and Peripheral vessel imaging, which is shown to be consistent with or an expansion of predicate device capabilities.
Modes of Operation	Substantially equivalent to predicate devices for B-mode, M-mode, PW Doppler, Color Doppler, Power Amplitude Doppler, Tissue Harmonic Imaging, 3D/4D imaging, Combined modes.	The UGEO WS80A supports all these modes, demonstrating equivalence to the listed predicate devices.
Safety & EMC Compliance	Conformance to international and national safety and EMC standards (UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2, NEMA UD-2, NEMA UD-3, ISO10993-1, ISO14971).	The device was evaluated and found to conform to all listed applicable standards. (See Section 7: "A brief discussion of the bench and non-clinical tests conducted on the subject device").
Functionality (e.g., Quick Scan, Auto IMT+, Elastoscan, 5D Cine, 5D LB, MPI)	Substantially equivalent to specified functionalities found in predicate devices.	The UGEO WS80A incorporates various advanced functionalities (e.g., Q Scan, SMDR (SMDR evo), Auto IMT+ (Auto IMT), Elastoscan, Panoramic, 3D Imaging, 5D Cine, 5D NT, 5D LB, MPI) in a manner equivalent to or in some cases enhanced from the predicate.
Transducer Compatibility	Ability to operate with the listed transducers (SC1-6, C2-6, E3-12A, VR5-9, L3-12A, L5-13, V4-8, V5-9) for specified clinical applications and modes.	Each transducer listed is cleared for specific clinical applications and modes of operation, demonstrating its intended functionality with the UGEO WS80A system.

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

The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, UGEO WS80A, did not require clinical studies to support substantial equivalence."

Therefore, there was no "test set" in the sense of clinical image data used for performance evaluation that would have a sample size or data provenance. The assessment was based on technical specifications and comparison to predicate devices.

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)

Since no clinical studies or test sets requiring expert-established ground truth were deemed necessary, this information is not applicable and not provided in the submission.

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

Not applicable, as no clinical test set requiring adjudication was used.

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 a diagnostic ultrasound system, not an AI-assisted diagnostic tool for which MRMC comparative effectiveness studies comparing human readers with and without AI assistance are typically conducted.

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

Not applicable. The UGEO WS80A is a diagnostic ultrasound system operated by a human, not a standalone algorithm. While it features some automated measurement and imaging functions (e.g., 5D Cine, 5D NT, Auto IMT+), these are features of the overall system, and their standalone "algorithm performance" is not separately reported in this regulatory documentation. The focus is on the substantial equivalence of the system as a whole.

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

Not applicable, as no clinical studies requiring ground truth were performed. The "ground truth" for demonstrating substantial equivalence relied on technical specifications, functional comparisons, and adherence to recognized safety standards in comparison to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. Since no clinical studies were performed, there was no "training set" of data in the context of machine learning or AI development.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

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