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510(k) Data Aggregation
(71 days)
Medical Visors MV100 is intended for use in an MRI environment to provide audio-visual entertainment in order to improve patient comfort and calm patients.
The Medical Visors MV100 have been shown to be "MR Conditional" for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only.
Medical Visor MV100 is not recommended for diagnostic exams of the eyes, eye canal, ear, ear canal and nose. The user is instructed to keep the control unit outside of the imaging field of view.
The patient must be given the standard ear plug hearing protection for the MRI used. The MV100 is not a hearing protection device. The MV100 should not be used if the MR noise level with ear plug protection is within 6dB of noise limit. The MV100 should not be used if the technician has critical communication with the patient, such as a lung scan.
Medical Visors MV100 is a self-contained video and audio entertainment system to be worn by patients during an MRI procedure. A patient wears a system comprised of video glasses and headphones unit on their head and holds a controller in their hand.
The provided document is a 510(k) summary for the Medical Visors MV100. It focuses on demonstrating substantial equivalence to a predicate device and MRI compatibility rather than clinical performance or diagnostic accuracy. Therefore, several aspects of the requested information, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types for clinical performance, are not applicable or not provided in this regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this device is an accessory to MRI for patient comfort and has "no medical purpose," the acceptance criteria are related to its safety and compatibility within an MRI environment, rather than typical diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance (Medical Visors MV100) |
|---|---|---|
| MRI Compatibility | Torque and Displacement: No significant torque or displacement within the static magnetic field or spatial gradient (for 3.0T MRI, 5 T/m spatial gradient). | "The Medical Visors MV100 did not exhibit any torque or displacement effects within the influence of the 3.0T static field or the spatial gradient of 5 T/m associated with the 3.0T static field." |
| Image Artifacts: Acceptable impact on MRI image quality. | "The Medical Visors MV100 can reduce MRI image intensity by more than 20% in localized areas for the MRI images." (Note: The context implies this level of reduction is considered acceptable given the device's non-diagnostic purpose, and the overall conclusion is that it's equivalent to an MRI without the device for regulatory class 892.1000). | |
| RF Heating: Acceptable temperature rise of metallic components due to RF pulses. | "The metal surface rises less than 2ºC from RF pulses of a SAR of 2W/Kg." | |
| Patient Contact Materials: Materials in contact with patients must be FDA approved and provide insulation from heated components. | "No metal surface comes into contact with the patients; all metal surface are heat insulated by 34 inch silicone foam or hard plastic. The body and cable of Medical Visors MV100 System, which does come in contact with the patients, are fabricated from FDA approved materials." | |
| Safety Standards Conformance | Conformance with relevant medical electrical equipment safety standards for general safety and particular requirements for MR equipment. | "Medical Visors MV100 conforms to standard IEC 60601-1, 'Medical Electrical Equipment—Part 1: General Requirements for Safety' and IEC 60601-2-33 (2008) 'Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis.'" |
| MRI Conditional Labeling | Device must be determined "MR Conditional" for specified field strengths and operating modes. | Labeled as "MRI Conditional" with safety warnings for abnormal operation. "The Medical Visors MV100 have been shown to be 'MR Conditional' for field strengths up to (and including) 3T and with the MR system operating in the Normal Operating Mode (average WB SAR <2W/kg) only." |
| Functional Equivalence | The device's use in an MRI environment should be equivalent to an MRI without the device, for the purposes of regulatory classification (i.e., not introducing unacceptable risks or interference that would change its classification). | "An MRI with Medical Visors MV100 is equivalent to a MRI without a Medical Visors MV100, which conforms to standard for a regulatory class 892.1000 device." This is a general statement summarizing the findings related to MRI safety and compatibility, ensuring the device doesn't negatively impact the MRI's primary diagnostic function beyond acceptable limits. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The tests were likely conducted on the device itself and its components in an MRI environment.
- Data Provenance: The study was conducted by "Exponent" (www.exponent.com), an independent testing lab. The location/country of the testing is not specified, but the submission is from the USA. These are engineering/physics tests, not clinical patient studies. The data is prospective (tests performed specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the conventional sense. The "ground truth" here is compliance with engineering standards and pre-defined safety limits for MRI compatibility. The experts would be the engineers and scientists at Exponent performing the tests and comparing results against established international standards (IEC 60601-1, IEC 60601-2-33) and MRI safety guidelines. Their specific qualifications (e.g., MR physicists, biomedical engineers) are not listed.
4. Adjudication Method for the Test Set
Not applicable. This was not a subjective review of images or diagnoses requiring adjudication. It was objective physical testing against performance criteria.
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. This device is an entertainment system, not an AI-powered diagnostic tool, and no MRMC study was performed. It doesn't assist human readers in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware system for entertainment, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Established engineering safety standards (e.g., IEC 60601-1, IEC 60601-2-33).
- Pre-defined safety limits and thresholds for MRI compatibility (e.g., torque, displacement, temperature rise, image artifact levels considered acceptable for a non-diagnostic accessory).
- Material compatibility (FDA-approved materials).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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