Search Results

The Resoundant Acoustic Driver System is intended for use with magnetic resonance diagnostic devices (MRDD) that include legally marketed MR elastography capabilities. It is indicated for generating acoustic vibrations in the body during an MRI exam, in order to assess tissue elasticity for diagnostic purposes as part of magnetic resonance elastography (MRE). When interpreted by a trained physician, this information can be useful in determining a diagnosis.

The Resoundant Acoustic Driver System includes an Active Driver, connective tubing and a Passive Driver. The system generates transverse acoustic waves in the low-audio frequency range in the body during an MRI exam. This allows assessment of elastic properties of soft tissue to aid in medical diagnosis as part of magnetic resonance elastography (MRE).

The Active Driver component is an electro-mechanical device that consists of a function generator, power-amplifier, linear motor and pump head, along with a microprocessor-based controller and power supply electronics, in an enclosure. The Passive Driver component is connected to the Active Driver through flexible tubing and is used to induce small vibrations in the scan subject. The Passive Driver is a lightweight enclosure containing no electrical components. It features a connection for flexible tubing and a diaphragm that is placed securely over patient clothing.

The Resoundant Acoustic Driver System is not an AI/ML device but an acoustic driver system used in Magnetic Resonance Elastography (MRE). Therefore, the typical acceptance criteria and study designs associated with AI/ML devices do not apply. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance metrics against a clinical ground truth.

However, based on the provided text, we can extract the verification and validation information to describe how the device (not an AI algorithm) meets its acceptance criteria.

1. Table of Acceptance Criteria (from Verification and Validation) and Reported Device Performance

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

This information is not applicable and not provided in the document. The device is a hardware accessory, not a diagnostic algorithm that processes data to produce a result. Its "performance" is evaluated through engineering and safety tests rather than analysis of patient data.

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

This information is not applicable and not provided. Ground truth in the context of diagnostic algorithms refers to a confirmed diagnosis or condition. For a hardware device, ground truth would relate to measurable physical properties or compliance with engineering standards, which are typically assessed by engineers and testing personnel, not medical experts establishing diagnostic ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, particularly in studies involving diagnostic accuracy algorithms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of an AI system on human reader performance. The Resoundant Acoustic Driver System is a hardware component for MRE, not an AI system.

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

No, a standalone performance study was not done because this is not an algorithm. The device's function is to generate acoustic vibrations, which is a physical process, not a computational one.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on engineering specifications, international safety standards (e.g., IEC 60601 series), and functional design requirements. For example, the "ground truth" for electrical safety is compliance with specific clauses of IEC 60601-1-2014. For mechanical performance, it would be adherence to defined dimensional tolerances or operational parameters. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would.

8. The Sample Size for the Training Set

This information is not applicable. The Resoundant Acoustic Driver System is a hardware device; it does not utilize a training set in the context of machine learning.

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

This information is not applicable, as there is no training set for a hardware device.

Ask a specific question about this device