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The MRIaudio PREM System with MRIview is intended to provide audio and visual entertainment to patients and facilitate patient communication in MRI environments up to, and including, 3.0 Tesla. The product is not intended for medical diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.

The MRIaudio PREM System with MRIview is an MRI conditional audio and video solution that provides MRI patients with music, direct communication, and hearing protection. With the addition of the MRIview technology, the system provides MRI patients with video and allows technologists to view the patient.

The provided document is a 510(k) summary for the MRIaudio PREM System with MRIview. This document primarily focuses on establishing substantial equivalence to a predicate device and does not detail specific acceptance criteria for a new performance claim or a comprehensive study proving a device meets such criteria in the way typically seen for AI/CADe devices.

In this case, the device is an MRI conditional audio and video solution intended to provide entertainment and communication in MRI environments, not for medical diagnosis or treatment. The performance data presented focuses on safety and not on diagnostic accuracy metrics.

Here's a breakdown based on the information provided, addressing your requested points directly where possible, and noting where the information is not applicable or unavailable in this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. For the "Magnetic field interactions at 3-Tesla" and electrical/EMC testing, these are typically conducted on a limited number of device units (prototypes or production samples). For the "clinical images," it's mentioned that "sample clinical images submitted exhibit a mix of pulse sequences and imaging options," but a specific number is not provided, implying this was a qualitative assessment rather than a quantitative study with a defined test set.
• Data Provenance: Not specified. The clinical images seem to have been used to assess the device's impact on MRI image quality, but details regarding their origin (country, retrospective/prospective) are absent.

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

• Not Applicable. The device is not intended for medical diagnosis or treatment, so there is no diagnostic "ground truth" to establish through expert review for its primary function. The assessment of MR image quality implies expert review, but the number and qualifications of experts are not mentioned.

4. Adjudication Method for the Test Set

• Not Applicable. As there's no diagnostic ground truth derived from expert review mentioned, an adjudication method is not described.

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

• No. An MRMC study is not mentioned as this device is not a diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• No. This device is an audio/video system, not an algorithm, so a standalone performance study in the context of diagnostic algorithms is not applicable.

7. The Type of Ground Truth Used

• For the safety and performance tests (magnetic interactions, electrical safety, EMC), the "ground truth" is defined by the standards and test protocols themselves, which specify passing/failing criteria.
• For the assessment of MR image quality, the "ground truth" is based on qualitative expert assessment that the device does not adversely affect MR image production. This is inferred from the statement "No adverse events were reported; therefore, the subject MRIaudio PREM System with MRIview does not adversely affect MR image production in the worst-case environment."

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As this device does not use an AI/ML algorithm requiring a training set, ground truth for a training set was not established.

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The MRlaudio PREM system is intended to provide audio entertainment and facilitate patient communication in MRI environments, up to, and including, 3.0 Tesla. The product is not intended for medical diagnosis or treatment. Technologist control units are intended to be used outside of the MRI scan room.

The MRIaudio PREM system is an MRI conditional audio solution that provides MRI patients with music, direct communication, and hearing protection.

The provided text describes the 510(k) premarket notification for the MRIaudio PREM System, a device intended to provide audio entertainment and facilitate patient communication in MRI environments. It is important to note that this device is not an AI-powered diagnostic tool, but rather an accessory for MRI machines. Therefore, the typical acceptance criteria and study designs used for AI/ML-based medical devices (such as those involving sensitivity, specificity, MRMC studies, expert adjudication, and large training/test sets for image analysis) are not applicable here.

The performance data presented focuses on the device's physical and electrical characteristics and its compatibility with MRI environments, rather than its diagnostic accuracy or AI performance.

Here's a breakdown based on the information provided, framed to address the original request topics where relevant, but highlighting the fundamental difference in the device type:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an accessory device, the "acceptance criteria" relate to safety, functionality within an MRI environment, and compliance with general medical device standards. There are no performance metrics related to diagnostic accuracy, sensitivity, or specificity as it is not a diagnostic device.

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

The "test set" here refers to the physical units of the MRIaudio PREM System that underwent bench and clinical testing. The document does not specify a numerical "sample size" in the context of patients or data points for diagnostic purposes, because the device is an accessory, not a diagnostic tool.

• Sample Size: Not applicable in the context of an AI device's test dataset (e.g., number of images, patients). Refers to the physical units tested to ensure MR compatibility, safety, and performance. The document implies that the testing was performed on the device itself.
• Data Provenance: Not applicable in the context of patient data provenance for an AI model. The "clinical data" section refers to the evaluation of the device's impact on MR image production, not data used to train or test a diagnostic algorithm. The document states "clinical data submitted exhibits a mix of pulse sequences and imaging options in the axial, sagittal and coronal planes as recommended in the FDA guidance...". This refers to the environment in which the device was evaluated, rather than a patient dataset collected retrospectively or prospectively from specific countries.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth establishment. The "clinical data" involved assessing the device's impact on image quality, which would typically be done by qualified MR technologists or radiologists, but this is not about establishing a "ground truth" for a diagnosis.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic "ground truth" to adjudicate.

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

No. This type of study is for evaluating the impact of an AI diagnostic aid on human reader performance. The MRIaudio PREM System is an accessory for patient comfort and communication, not a diagnostic aid.

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

No. This device does not contain an AI algorithm for standalone diagnostic performance.

7. The Type of Ground Truth Used

Not applicable. There is no diagnostic "ground truth" for this device. The "ground truth" for its acceptance is based on engineering specifications, safety standards compliance, and non-interference with MRI image quality.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that undergoes a training phase with a dataset.

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

Not applicable. There is no AI training set or associated ground truth.

Summary regarding the device:

The MRIaudio PREM System is an MRI-conditional audio solution intended for patient entertainment and communication during MRI scans. Its acceptance criteria and testing focused on:

• Its ability to provide noise reduction.
• Its compatibility and safety within strong magnetic fields (MR Conditional rating).
• Compliance with electrical safety and electromagnetic compatibility standards.
• Biocompatibility of materials.
• Demonstrating that it does not adversely affect the quality of MR images.

The study that "proves the device meets the acceptance criteria" consists of bench testing (e.g., noise reduction, magnetic field interaction) and clinical evaluation demonstrating no adverse effects on MR image production. No AI/ML performance metrics are involved as it is not an AI-powered diagnostic device.

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