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Indicated for use in a healthcare environment to reduce microbial populations typically found on a computer keyboard.

The Vioguard self-sanitizing keyboard, or UVKB50, is a keyboard with touchpad which resides in a motorized tray. The tray retracts into an enclosed UV-C treatment device which irradiates the keyboard with UV-C light of ~ 254 nm wavelength generated by two 25 watt ultraviolet germicidal lamps. The device includes dual safety interlocks intended to prevent operation of the UV lamps unless the keyboard is fully retracted into the unit and the unit door is completely closed. This feature is intended to prevent the device user from exposure to UV-C light. The device operations are controlled by a small 8-bit microcontroller. Reading instructions and data stored permanently in its own internal memory and controlling the hardware directly, the tasks accomplished by device firmware/software are the following:

• Controlling the motorized slide by activating the DC motor and reading the limit switches which are part of the slide mechanism;
• . Controlling the UV-C lamp exposure time, by reading the light sensor and integrating the dosage until a preset exposure is reached;
• Determining the dosage setting by reading an internal potentiometer;
• I Controlling and reading the state of the proximity sensor;
• 트 Calibrating the light sensor at the factory and storing the calibration information in internal non-volatile memory;
• 트 Controlling the LED status indicator;
• 트 Determining if there is keyboard or touch pad activity; and
• l Monitoring the state of the front door.
  The default disinfection cycle takes 80 to 120 seconds to complete.

The Vioguard Self-Sanitizing Keyboard (Model UVKB50) is an ultraviolet radiation (UV) chamber disinfection device. The studies were non-clinical bench studies focused on microbial reduction, electrical and mechanical safety, and software verification/validation.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Microbial Reduction Testing: Not specified for "test set" in terms of number of keyboards or repetitions. The study references "worst case" device sites irradiated.
  • Data Provenance: Conducted by an "independent laboratory." Specific country of origin is not mentioned. The study appears to be a prospective laboratory bench study, not a retrospective analysis of field data.
• Electrical and Mechanical Safety/EMC Testing: Not specified for "test set" in terms of number of devices.
  • Data Provenance: Conducted by an "independent lab." Specific country of origin is not mentioned. These are prospective bench and compliance tests.

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

• Microbial Reduction Testing: The "ground truth" here is the actual microbial load reduction achieved by the device. This is established through standard microbiological plating and counting techniques performed by the "independent laboratory." No mention of "experts" per se in establishing ground truth, rather following established scientific protocols for microbial testing.
• Electrical/Mechanical Safety, EMC, Software: These ground truths are established by adherence to recognized international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, FCC, FDA guidance). The "independent labs" performing the tests are qualified to conduct these standard-based assessments.

4. Adjudication Method for the Test Set

• Not applicable (N/A). The studies described are non-clinical bench tests (microbiology, engineering, software compliance) that do not involve human interpretation or subjective assessments requiring adjudication. The results are quantitative measurements or assessments against predefined technical standards.

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

• No. This device is an automatic disinfection system, not an imaging or diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant or described.

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

• Yes, for the primary function (disinfection efficacy). The microbial reduction testing evaluates the absolute performance of the device's UV disinfection mechanism. The stated performance of "4.0 log10 or greater reduction" is a standalone effectiveness measure.
• Yes, for other functionalities. Electrical safety, EMC, and software validation also represent standalone performance assessments of the device and its internal algorithms/firmware.

7. The Type of Ground Truth Used

• Microbial Reduction Testing: Quantitative microbiological culture and enumeration (CFU/ml reduction), directly measuring the device's effect on microbial populations.
• Electrical/Mechanical Safety, EMC Testing: Adherence to recognized electrical and safety standards (e.g., IEC 60601-1, IEC 60601-1-2, FCC), verified by technical measurements.
• Software Verification/Validation: Compliance with FDA guidance for software in medical devices, assessed against documentation and testing results.

8. The Sample Size for the Training Set

• Not applicable (N/A). This device does not use machine learning or AI that would typically require a "training set" of data in the traditional sense. Its control system is based on fixed firmware and sensor feedback, not learned patterns from a large training dataset.

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

• Not applicable (N/A). As there is no training set mentioned or implied for this device's function, the concept of establishing ground truth for a training set does not apply.

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