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Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

Surfacide Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices.

Helios+ delivers a defined dose to a defined distance and area sufficient for 2-log microbial reduction of vegetative bacteria and Clostridioides difficile spores.

Helios+ is used in operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present.

Helios+ includes 1-3 UV-C emitters, 1-3 safety sensors, a control tablet, and 2 joiners that link the emitters for transport and serve as warning stands when the device is in use. Simultaneous use of multiple UV-C emitters can reduce shadowed areas by providing multiple direct lines of sight to non-critical medical device surfaces.

The provided FDA 510(k) clearance letter for the Helios+ UV-C System (K242604) pertains to a whole-room microbial reduction device. This document focuses on the device's technical specifications, non-clinical performance (microbial reduction, safety, materials compatibility, etc.), and a comparison to a predicate device.

Crucially, the document explicitly states under "Non-Clinical Tests Summary" that "CLINICAL TESTING – Non – Applicable."

This means that this device's acceptance criteria and proven performance are based solely on non-clinical (laboratory and simulated use) studies, not on clinical studies involving human patients, human readers, or human interpretation of outputs. Therefore, several of the requested categories related to clinical study design, human expert adjudication, and multi-reader multi-case studies are not applicable to the information provided in this 510(k) summary.

Here's a breakdown of the applicable information based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Criteria for Helios+ UV-C System

The Helios+ UV-C System is a Whole Room Microbial Reduction Device, and its clearance is based on non-clinical performance data demonstrating its ability to reduce microbial load.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of surfaces tested, number of rooms in in-use testing). It indicates "select bacterial organisms and C. difficile spores" were tested for microbial reduction and "Patient rooms, bathrooms, and operating rooms were sampled" for in-use testing.
• Data Provenance: The document does not explicitly state the country of origin of the data. Given it's an FDA 510(k) submission, the testing would typically be conducted by or for the submitting company, PreventaMed Technologies, Inc., dba Surfacide Manufacturing, Inc., which is based in Waukesha, Wisconsin, United States. The studies are described as non-clinical tests, encompassing lab-based and simulated use environments, rather than prospective or retrospective clinical studies.

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

• Not Applicable. The acceptance criteria and testing for this device are based on objective, quantifiable physical and microbial measurements (e.g., log reduction, ozone levels, material degradation standards, electrical safety standards). There is no "ground truth" established by human experts in a subjective interpretation sense (like radiologists interpreting images).

4. Adjudication Method for the Test Set

• Not Applicable. As the testing is non-clinical and relies on objective measurements, no adjudication by human experts is described or required.

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

• Not Applicable. No MRMC study was done because the device is a whole-room microbial reduction system, not an AI or imaging device that assists human readers. The document explicitly states "CLINICAL TESTING – Non – Applicable."

6. Standalone Performance

• Yes, in the context of device function. The "Non-Clinical Tests Summary" describes tests of the device's standalone performance in achieving microbial reduction and meeting various safety and performance standards without human intervention beyond operation. For example, "Simulated use performance testing demonstrated microbial log reduction..." and "Performance testing was completed to demonstrate the system will prevent exposure and ensure that device operation can only occur in an unoccupied environment."

7. Type of Ground Truth Used

• The ground truth for the non-clinical tests was established through:
  • Microbiological assays: Measuring log reduction of specific bacterial and spore organisms (e.g., on test coupons/surfaces).
  • Physical and Chemical Measurements: Quantifying UV-C dosage, ozone levels, material strength/degradation, electrical parameters.
  • Compliance with Industry Standards: Adherence to established standards like IEC 62471, ISO 4582, ASTM D256-10, ASTM A370-22, IEC 61010-1, IEC 61326-1, and 29 CFR 1910.1000.

8. Sample Size for the Training Set

• Not applicable in the typical AI/ML sense. The Helios+ UV-C System is a physical device that performs a function (UV-C disinfection), not a software or AI algorithm that "learns" from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here. The device's parameters (e.g., UV-C output, cycle times) would be determined through engineering design and optimization based on scientific principles of UV-C disinfection, informed by tests like the optimized kill curve.

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

• Not applicable. As explained above, there is no "training set" in the context of an AI/ML algorithm for this device. The underlying scientific principles for UV-C effectiveness (e.g., wavelength, intensity, exposure time, distance) are well-established. The device's design and operating parameters are based on these principles and validated through the non-clinical tests described.

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The Xenex LightStrike™+ is a pulsed, broad-spectrum, high-intensity, germicidal UV light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. LightStrike+ is intended for use in unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

LightStrike+ is a system that emits UV germicidal light to reduce the microbial load present on non-porous, non-critical medical device surfaces in healthcare environments, after manual cleaning and disinfection practices. Designed for microbial reduction cycles, the system will achieve the labeled log reductions through the utilization of Xenon lamp technology for the generation of UV germicidal light in the system's intended use environments. It is designed to be moved to targeted locations within a facility. The graphical user interface allows operators (trained cleaning staff) to select preprogrammed rooms and their associated protocols for cycle execution. The system is for use in unoccupied areas and includes design and redundant safety features to help prevent accidental exposure to the UV light.

The LightStrike+ is a whole room microbial reduction device that uses pulsed UV light to reduce microbial load on non-porous, non-critical medical device surfaces after manual cleaning and disinfection. The device is intended for use in unoccupied healthcare environments as an adjunct to existing cleaning practices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily assessed through its ability to achieve a sufficient microbial reduction and its safety. The acceptance criteria are largely derived from the "Special Controls" and the outcomes of the "Performance Testing - Bench" section.

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

The document does not explicitly state a single dedicated "test set sample size" in the context of typical AI/ML model evaluation (i.e., a dataset held out for final performance assessment). The testing described is primarily bench-top, laboratory-simulated performance testing rather than a clinical study evaluating diagnostic accuracy or similar AI outcomes.

• Microbial Reduction Testing: The "simulated-use tests" involved "all inoculated surfaces" to achieve the 2-log reduction. The specific number of surfaces, microorganisms, and replicates is not provided.
• Safety Testing (Ozone, Chemicals, Photobiological): These involved specific test setups and measurements compliant with relevant standards (e.g., 21 CFR 801.415, 29 CFR 1910.1000, IEC 62471). The sample size here refers to the number of tests performed or measurements taken, which is not detailed.
• Material Compatibility: "metallic and non-metallic materials commonly present in healthcare environments" were tested. The exact number or types of materials is not specified.

Data Provenance:

• Given the nature of the tests (bench studies, simulated use, compliance with US and international standards), the data provenance is likely laboratory-generated data from Xenex's own testing facilities or accredited third-party labs.
• The data is retrospective in the sense that the studies were completed to support the De Novo application. There's no mention of prospective clinical trial data in human patients or real-world "in-use" data to assess patient outcomes or infection rates.
• Country of Origin: The sponsor is Xenex Disinfection Services, Inc., located in San Antonio, TX, USA. It's highly probable the testing was conducted in the USA or by labs commissioned by the US-based company.

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

This information is not applicable in the traditional sense for this device. Ground truth, in this context, is established by:

• Quantitative measurements: Log reduction achieved, chemical concentration levels, light intensity measurements, material degradation measurements.
• Compliance with established standards: IEC, ASTM, CFR regulations.
• Biological assay results: Live/dead microbial counts from inoculated surfaces.

The "experts" involved would be the scientists, microbiologists, engineers, and clinical staff who designed, executed, and interpreted these bench-top studies and ensured compliance with the relevant standards. Their specific number or qualifications are not detailed, but their expertise is implied by the successful completion and acceptance of the studies by the FDA. There is no human diagnostic interpretation involved that would require a panel of experts for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where human readers or multiple reviewers establish a ground truth for subjective interpretations (e.g., medical image diagnosis). For the LightStrike+, ground truth is based on objective, repeatable scientific measurements and compliance with quantitative thresholds defined by regulations and standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed.

• MRMC studies are relevant for evaluating the impact of AI on human performance in diagnostic tasks (e.g., radiologists reading images with or without AI assistance).
• The LightStrike+ is a disinfection device, not a diagnostic AI tool. Its effectiveness is measured by microbial reduction.
• The submission explicitly states: "The magnitude of the clinical benefit (i.e., transmission reduction) has not been established based on the non-clinical testing provided by the sponsor." This confirms the absence of studies evaluating its impact on human infection rates when used in a real-world setting.

Effect Size: Since no MRMC study was done, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

Yes, in spirit. The performance tests described (e.g., "simulated-use tests demonstrating microbial reduction") represent the device's standalone performance in achieving microbial reduction. This is an "algorithm only" or "device only" performance in that it measures the physical effect of the UV light on microorganisms under controlled conditions, without human intervention in the disinfection process itself beyond setup and activation. The device is designed to operate autonomously in an unoccupied room.

7. The Type of Ground Truth Used

The ground truth for the LightStrike+ device's performance is established by:

• Quantitative Microbial Reduction: Direct measurement of viable microbial colonies before and after device operation on inoculated surfaces, yielding a calculated log reduction. This is a scientific and laboratory-based ground truth.
• Compliance with Regulatory Standards: For safety aspects (ozone, toxic chemicals, photobiological safety, electrical safety, EMC), the ground truth is defined by specific quantitative limits set forth in regulations (e.g., 21 CFR 801.415, 29 CFR 1910.1000) and international standards (e.g., IEC 62471, IEC 60601-1-6, IEC 60601-1-2).
• Material Integrity: Adherence to material degradation standards (ISO 4582, ASTM D256-10, ASTM A370-22).

This is primarily a laboratory-based, direct measurement, and standards-compliance ground truth, rather than clinical outcomes or expert consensus on subjective data.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of artificial intelligence/machine learning is not directly applicable here. The LightStrike+ is a physical medical device that emits UV light, not an AI model that learns from a dataset.

• While it has "Software" components, these appear to be primarily for control, user interface, and safety features (e.g., "room guide," "cycle execution," "motion detection," "wireless communications") rather than data-driven learning or prediction for its primary function of microbial reduction.
• The "training" of the device is analogous to its engineering design and optimization to achieve the desired UV output and safety features.

Therefore, there is no "training set" in the common AI/ML sense.

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

As there is no AI/ML training set, this question is not applicable. The "ground truth" for the device's design and optimization would be the physical and biological principles of UV light inactivation of microorganisms, safety standards, and engineering specifications. This is established through established scientific methods, engineering principles, and iterative design/testing, rather than data labeling for machine learning.

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