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The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery.

The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger.

Acceptance Criteria and Device Performance Study for MD-6W Wireless Critical Data Viewer

This document describes the acceptance criteria and the study that proves the MD-6W Wireless Critical Data Viewer meets these criteria, based on the provided 510(k) summary.

Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed statistical analyses for novel devices.

1. Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not explicitly detail a specific "test set" or its sample size in the way one might expect for a de novo performance study involving human subjects or image analysis. The performance testing appears to be centered on engineering and technical validation rather than clinical efficacy measured in a patient cohort.

• Sample Size for Test Set: Not specified. The testing described (optical, electrical, firmware, mechanical) would typically involve testing of device units/components rather than a patient or clinical data set.
• Data Provenance: Not applicable in the context of a clinical test set. The tests are likely internal engineering and quality assurance tests.

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

This information is not applicable or provided in the context of the described performance testing. The "ground truth" for optical, electrical, firmware, and mechanical tests would be defined by engineering specifications and industry standards, not expert consensus from medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the testing focuses on technical performance (optical, electrical, mechanical), there would not be an adjudication method like 2+1 or 3+1 used for expert consensus in a clinical evaluation.

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

No MRMC comparative effectiveness study was mentioned or performed. The 510(k) summary focuses on substantial equivalence to a predicate device and technical performance testing, not on the impact of the device on human reader performance (e.g., medical specialists). Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document. The device is a display tool, not an AI-powered diagnostic aid.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted, but it was purely technical. The summary states, "The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device." This implies an evaluation of the device's technical specifications and functionality independent of human interaction beyond basic usability. It's not a standalone clinical performance study, but a standalone engineering performance evaluation.

7. Type of Ground Truth Used

The "ground truth" for the performance testing cited (optical, electrical, firmware, and mechanical) would be based on:

• Engineering Specifications: The design and performance parameters defined by MicroOptical Corporation.
• Industry Standards: Relevant electrical safety, optical performance, and mechanical durability standards.
• Predicate Device Performance: Implicitly, the performance of the predicate device (MD-6 Critical Data Viewer) sets a benchmark for substantial equivalence.

It does not involve expert consensus, pathology, or outcomes data in the context of clinical "ground truth."

8. Sample Size for the Training Set

Not applicable. This device is a display system, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data. Its function is to display vital signs, and its performance is evaluated based on its ability to do so reliably and according to its specifications.

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.

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MicroOptical's Critical Data Viewers are intended to display video images or patient data while mounted in front of the user's eye(s) anytime a video display is used. Typical applications include display of images from endoscopic cameras, ultrasound imaging systems, magnetic resonance imaging systems, or display of data from any type of patient monitor.

MicroOptical's Critical Data Viewers contain an LCD display unit, nonprescription safety glasses, a control box with signal converter and battery mount, cables from viewer to control box and from control box to signal source, a lithium-ion rechargeable battery and a battery charger. The LCD display unit is mounted on a pair of non-prescription safety glasses and is connected via a fourfoot cable to a small battery-powered control box that can be clipped onto a belt. A cable from the control box connects the control box to the video source. The battery is recharged using a separate battery charger. MicroOptical's Critical Data Viewers operate using a standard VGA signal and displaying it onto a small LCD.

The provided text describes MicroOptical's Critical Data Viewers and their 510(k) submission, listing predicate devices and intended use, but it does not contain information about specific acceptance criteria, device performance metrics, or a detailed study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The "PERFORMANCE TESTING" section states generally: "MicroOptical's Critical Data Viewers have been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device." This is a very high-level statement and does not provide the granular information requested about acceptance criteria, study design, or specific results.

Therefore, many of the requested fields cannot be populated from the provided document.

Here's a breakdown of what can and cannot be answered based on the text:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states "standard optical, electrical, firmware, and mechanical tests" were performed, but no specific acceptance criteria or their corresponding performance results are detailed.

2. Sample sized used for the test set and the data provenance:

• Cannot be provided. No information on specific test sets, sample sizes, or data provenance (country of origin, retrospective/prospective) is given for the "standard tests."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. This is not relevant for the type of device (a head-mounted display) or the type of performance testing mentioned (optical, electrical, mechanical). Ground truth establishment by experts is typically for diagnostic/interpretive devices assessing images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. See point 3.

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:

• Cannot be provided. This device is a display system, not an AI/ML diagnostic or assistive tool. There is no mention of such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Cannot be provided. This is not an algorithmic device. Performance would relate to display quality, robustness, etc., not algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. For "standard optical, electrical, firmware, and mechanical tests," ground truth typically refers to engineering specifications, calibrated measurements, and adherence to established industry standards, not medical ground truth from patient data or expert consensus.

8. The sample size for the training set:

• Cannot be provided. This device does not have a training set in the context of AI/ML.

9. How the ground truth for the training set was established:

• Cannot be provided. See point 8.

In summary: The provided document is a 510(k) summary for a head-mounted display system. Its performance evaluation focuses on engineering and functional capabilities (optical, electrical, mechanical) rather than an AI/ML algorithm's diagnostic accuracy or clinical effectiveness, which would typically involve expert-adjudicated ground truth and specific performance metrics. Therefore, most of the detailed questions regarding study design and AI/ML specific criteria cannot be answered.

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