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The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

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

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan™ Mode, Multi Image mode(Dual, Quad), Combined modes. 3D/4D mode.

The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D 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 Dopler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode, MV-Flow Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. the RS85 has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.

This document describes the validation of AI-based features for the Samsung Medison RS85 Diagnostic Ultrasound System, specifically focusing on NerveTrack's detection, segmentation, and EzNerveMeasure functionalities, as well as SonoSync.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Sizes and Data Provenance

2. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three participating experts.
• Qualifications of Experts:
  • One anesthesiologist with more than 10 years of experience in pain management performed the initial manual drawing of nerve areas.
  • Other doctors with more than 10 years of experience performed verification of the ground truth.

3. Adjudication Method for the Test Set

The adjudication method appears to be a 2+1 process:

1. Initial ground truth (GT) data was manually drawn by one anesthesiologist.
2. Other doctors (presumably at least two distinct individuals to form a consensus if needed, though the document only states "other doctors") with more than 10 years of experience checked every frame.
3. If discrepancies ("did not agree on nerve locations/contours") arose, necessary corrections were made to finalize the GT. This indicates a consensus-based approach for disagreement resolution, but the specific number for resolving disagreements is not explicitly 2+1; it just states "other doctors."

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed according to the provided text. The studies focus on the standalone performance of the AI algorithms.

5. Standalone Performance Study

Yes, standalone (algorithm only without human-in-the-loop) performance studies were done for NerveTrack's detection, segmentation, and EzNerveMeasure functionalities. The reported results (accuracy, speed, Dice coefficient, Hausdorff distance, and error rates) are direct measurements of the algorithm's performance against established ground truth.

6. Type of Ground Truth Used

The ground truth used was expert consensus. It was established by manual delineation (drawing of nerve areas/contours) by an anesthesiologist with over 10 years of experience, followed by verification and correction (if needed) by other doctors also with over 10 years of experience.

7. Sample Size for the Training Set

The document explicitly states: "Data used for training, tuning and validation purpose are completely separated from the ones during training process, and there is no overlap among the three." However, the exact sample size for the training set is not provided in this document. It only gives the test set sizes.

8. How Ground Truth for the Training Set Was Established

While the exact size of the training set is not given, the method for establishing its ground truth is described similarly to the validation set:

• The GT data for training, tuning, and validation were built by three participating experts.
• Nerve areas were manually drawn by an anesthesiologist with more than 10 years of experience in pain management.
• The doctors who scanned the ultrasound were directly involved in the construction of GT data.
• For verification, other doctors with more than 10 years of experience checked every frame.
• If they did not agree on nerve locations/contours, necessary corrections were made to create the final GT.

This suggests that the ground truth for the training set was also established through expert consensus and manual delineation, following the same "Truthing" process as the test set.

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