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Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of < 5 CFU per m3 at the surgical site and instruments.

The air flow is intended to be directed parallel to the surgical site and/or instruments within: 20" (50 cm) in width, 47" (120 cm) in length and 15" (40 cm) in height. Device effectiveness may not be reliably detectable at a distance of 47 inches (120 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.

The air zone unit Operio is used in a surgical operating room for cleaning the air in a given area by re-circulating the ambient air and cleaning it from airborne particles. The air is filtered through a HEPA filter and the air is generated over the areas where the demands of clean air are especially high. The air zone unit Operio is equipped with a control panel for adjustments and for positioning of the unit.

The air zone unit Operio is a mobile unit that with the help of castors easily can be moved around the patient to an optimal position or, when needed, transported inside the hospital between wards. It is also equipped with an optional instrument tray.

By using a unique sterile shield as a protective barrier the air zone unit can be placed close to the OR table and deliver HEPA filtered air to the surgical site and instruments to reduce the presence of airborne particulate and microorganisms.

Here's a summary of the acceptance criteria and study information for the Operio device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary acceptance criterion highlighted in the document for the expanded indications (Orthopedic and Neurosurgery) is the microorganism reduction to < 5 CFU/m³.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical tests (CFU measurements): 302 CFU measurements.
  • Patients: 82 patients.
• Data Provenance: The clinical tests were conducted in "Swedish Hospitals." The text does not specify if the data was retrospective or prospective, but clinical measurements for the purpose of regulatory submission are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish ground truth or their qualifications for the clinical studies. Instead, the ground truth for microorganism levels (CFU) and particulate levels appears to be established through direct laboratory and clinical measurements conducted by the manufacturer.

4. Adjudication Method for the Test Set

• The document does not mention an adjudication method for the test set. The reported CFU values appear to be direct measurements rather than interpretations requiring adjudication.

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

• No MRMC comparative effectiveness study was done using human readers with and without AI assistance. The device is an air-handling unit, not an imaging or diagnostic AI device that would typically involve human reader performance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done in a functional sense, as the device's performance was evaluated based on its ability to reduce particulate matter and microorganisms independently. The "Summary of testing" details non-clinical tests (particulate counting, CFU counting, air velocity, air leakage, smoke, turbulence tests) and clinical tests where the device's effect on CFU levels was measured. The device functions as an algorithm/machine for air purification.

7. Type of Ground Truth Used

• Microorganism levels: Direct microbiological measurements (Colony Forming Units - CFU) at the surgical site and over instruments.
• Particulate matter levels: Direct particulate counting measurements.
• Airflow characteristics: Measured through air velocity tests, smoke tests, and turbulence tests.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of an AI/machine learning model. The Operio device is an air-handling apparatus, not a software algorithm that undergoes a "training" phase. Its design and performance are based on engineering principles and physical testing.

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

• As there is no mention of a "training set" for an AI/ML model, this question is not applicable to the Operio device. The device's performance is driven by its physical design, HEPA filtration, and airflow mechanics, validated through physical and microbiological measurements.

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