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The MELODY is intended to hold the external ultrasound transducer of cleared ultrasound equipment and provide a remotely-located, expert sonographer the ability to manipulate the transducer in real time through an Internet connection to obtain the ultrasound views required to assess the patient. The MELODY robot frame at the remotely-located patient is prepared and positioned by a trained assistant at the direction of the expert sonographer through a suitable third-party videoconferencing system. Sonograms are transmitted from the patient location from cleared ultrasound equipment through digital telecommunication to the expert sonographer. Indications for the MELODY are tabulated in the Diagnostic Ultrasound Indications table. MELODY may also be used when a physician wants to have a colleague not on-site provide a second opinion.

The objective of the MELODY, Remote Control System for Ultrasound Probe, is to allow an expert sonographer to manipulate the transducer of a third-party ultrasonic device remotely and in real time over an internet or similar connection. The remote expert manipulates the precession, nutation, and intrinsic rotation of the transducer, replicating the motions of the hand, to obtain the exact sonography views that he or she requires. The MELODY solves the problem of a lack of imaging experts in isolated areas, e.g., small or rural hospitals or clinics, remote military medical facilities, ships or oil drilling platforms, prison environment, etc.

The document describes the Melody, a Remote Control System for an Ultrasound Probe, which allows a remote expert sonographer to manipulate an ultrasound transducer.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Over 500 patients.
• Data Provenance: Not explicitly stated, but implies a clinical setting ("clinical studies reported in the scientific literature"). The studies were prospective in nature, comparing remote sonograms to on-site sonograms done by a second expert.

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

• Number of Experts: At least two (the remote expert sonographer using MELODY, and a second "expert sonographer" performing on-site sonograms for comparison/ground truth).
• Qualifications of Experts: Both are referred to as "expert sonographer(s)." Specific qualifications (e.g., years of experience, certifications) are not detailed in this document.

4. Adjudication Method for the Test Set

The document describes a comparison between two sonograms: one performed remotely with MELODY and one performed on-site by a second expert. The "Primary effectiveness endpoint" was whether the "distance sonogram yielded the same visualization, diagnosis, and/or measurement as a sonogram performed at the patient's side." This implies a direct comparison or agreement analysis rather than a formal adjudication method like 2+1 or 3+1. The agreement between the two types of sonograms (remote vs. on-site) served as the basis for effectiveness assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document describes a comparative study where "distance sonograms were compared to sonograms done on location at the patient's side by a second expert sonographer." This is a form of comparative effectiveness. However, it's not explicitly framed as a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" in the typical sense of evaluating human readers with and without AI assistance on a shared set of cases.

Instead, the comparison is between the device-assisted remote clinician and a second human clinician performing an on-site scan. The effect size in terms of human readers improving with AI vs. without AI assistance is not provided, as the study design is more about the performance equivalence of the remote (device-assisted) scan to a traditional on-site scan. The visualization scores (81% to 100% vs. on-site) and statistically non-significant differences in measurements serve as the effectiveness metrics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. The MELODY device is explicitly designed as a "Remote Control System for Ultrasound Probe" and "requires a remotely-located, expert sonographer" to operate it in real-time. The performance metrics listed (visualization scores, measurements) are directly tied to the outcome of this human-in-the-loop remote operation.

7. The Type of Ground Truth Used

The ground truth for the clinical effectiveness study was established by expert sonographer performance from on-site examinations. The "sonograms done on location at the patient's side by a second expert sonographer" were used as the reference against which the remote sonograms were compared for visualization, diagnosis, and measurements.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This device is a robotic remote control system, not an AI/ML diagnostic algorithm that typically requires a large training dataset for model development. The software verification and validation described are for the control system itself, not for a trainable algorithm making diagnostic predictions.

9. How the Ground Truth for the Training Set Was Established

As no training set is discussed or implied for an AI/ML algorithm (since this is a robotic control system), the document does not describe how ground truth for a training set was established.

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