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The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The RS80A 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, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode.Harmonic imaging. Tissue Doppler imaging. Tissue Doppler Wave. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A 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 RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided 510(k) summary for the RS80A Diagnostic Ultrasound System does not contain information related to acceptance criteria or a study proving the device meets specific acceptance criteria for AI/CAD performance. The document is a premarket notification for a general-purpose diagnostic ultrasound system and its various transducers.

The "study" discussed in this document is a demonstration of substantial equivalence to predicate devices. This is a regulatory pathway in the US for medical devices that are substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device. This type of submission relies on comparisons to existing devices rather than a standalone clinical study to validate novel performance claims against specific acceptance criteria.

Therefore, the requested information cannot be fully provided from the given text. However, based on the document, here's what can be extracted and what is explicitly stated as not applicable:

Non-AI / Non-CAD Acceptance Criteria and Performance (Based on Substantial Equivalence)

The document asserts that the RS80A Diagnostic Ultrasound System is "substantially equivalent with respect to safety, effectiveness, and functionality" to several predicate ultrasound systems (UGEO WS80A, UGEO HM70A, ACCUVIX A30, ACCUVIX XG). This means that the device is deemed to meet the same implicit "acceptance criteria" through comparison.

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

The document does not specify quantitative acceptance criteria. Instead, it relies on a qualitative comparison to predicate devices, asserting equivalence across various features and functionalities. The "reported device performance" is implicitly represented by the "√" (check mark) indicating that the RS80A possesses the same features as the predicate devices.

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

Not applicable. The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence." The evaluation was based on bench and non-clinical tests.

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. No clinical studies were conducted, thus no expert-established ground truth for a test set was required for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. No MRMC study was conducted. The "S-Detect" feature is mentioned as being substantially equivalent to "B-CAD (K050846)," which is likely a Computer-Aided Detection (CAD) system. However, the document does not include a comparative effectiveness study or report an effect size for human reader improvement with this feature.

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

Not applicable. The document does not describe standalone algorithm performance studies for any features. The comparison for "S-Detect" is to an existing CAD system, implying its functionality is similar, but no specific performance metrics are provided.

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

Not applicable. As no clinical studies or performance studies requiring ground truth were conducted for this substantial equivalence submission, no ground truth types are mentioned. The ground truth for proving safety and effectiveness primarily relies on meeting engineering and safety standards (e.g., IEC, UL, NEMA, ISO standards) and demonstrating functional equivalence to predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe any specific training sets as no "AI" or "CAD" algorithms in the modern sense of requiring extensive training data are discussed in terms of their development or validation. The "S-Detect" feature is likely a rule-based or classic image processing CAD system from its predicate date (K050846), which typically would not involve machine learning training sets in the same way modern AI does.

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

Not applicable.

In summary: K141620 is a 510(k) submission based on substantial equivalence to predicate diagnostic ultrasound systems. It focuses on demonstrating that the RS80A Diagnostic Ultrasound System has similar intended uses, technological characteristics, and meets safety standards, thereby not requiring de novo clinical studies with specific acceptance criteria, test sets, or ground truth establishment for novel AI/CAD performance claims. The mention of "S-Detect" is a comparison to an existing CAD system (B-CAD K050846), but no performance data, either standalone or human-in-the-loop, is provided for this feature within this document.

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