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510(k) Data Aggregation
(56 days)
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
| Criteria | Acceptance Criteria (from Indications for Use) | Reported Device Performance (Operational, from Summary of Testing) |
|---|---|---|
| Microorganism Reduction | Reduce microorganisms to a level of < 5 CFU per m³ at the surgical site and instruments. | Ophthalmic Surgery (Predicate Device K153498): Mean CFU value is 0.4 CFU/m².Orthopedic Surgery (Subject Device): Mean CFU value is 0.52 CFU/m³.Neurosurgery (Subject Device): Mean CFU value is 2 CFU/m³.All reported CFU levels are < 5 CFU, meeting the criteria. |
| Particulate Matter Reduction (HEPA Filter) | HEPA-filtered to reduce the presence of particulate matter. (Implicitly, the stated efficiency below covers this.) | HEPA filtration efficiency > 99.995% against 0.3 µm particles. |
| Particulate Density at Surgical Incision | Not explicitly stated as a numerical acceptance criterion, but the predicate device has a measured average particulate density of 1.1 particulate of 0.5 µm/f³. The subject device has the same reported value. | 1.1 particulate of 0.5 µm/f³ (This matches the predicate device and implies equivalence). |
| Directed Airflow Coverage | Air flow 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. | Smoke test and turbulence tests were conducted to demonstrate airflow patterns, but specific numerical data on coverage within the specified dimensions is not explicitly detailed in the provided text. However, the CFU reduction results within the clinical tests imply effective coverage. |
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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(226 days)
Operio is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic 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 an analysis of the acceptance criteria and study details for the Operio device, based on the provided document:
Acceptance Criteria and Device Performance for Operio
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Operio) |
|---|---|
| Microorganisms at Surgical Site & Instruments: < 5 CFU per m³ | 0.4 CFU/m³ (clinical environment, mean value) |
| Particulate Matter (0.5 µm/f³): Reduction in comparison to predicate device | 1.1 particles of 0.5 µm/f³ (compared to 68,122 particles of 0.5 µm/f³ for predicate) |
| HEPA Filtration Efficiency: At least 99.97% against 0.3 µm particles | At least 99.995% against 0.3 µm particles |
| Airflow Coverage (Width): 20" (50 cm) | Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area. |
| Airflow Coverage (Length): 47" (120 cm) | Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area, with effectiveness depreciating beyond. |
| Airflow Coverage (Height): 15" (40 cm) | Not explicitly stated if tested independently, but the indication mentions this as the intended directed flow area. |
2. Sample Sizes and Data Provenance
- Test Set (Clinical): 31 samples from 23 patients.
- Data Provenance: Clinical tests were carried out in a Swedish University Hospital. The data is prospective as it's stated "measurements were made near the surgical site and over the instruments."
3. Number of Experts and their Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. The clinical tests were performed in a "Swedish University Hospital," suggesting medical professionals were involved in the procedures and data collection, but their specific roles in ground truth establishment for the microbial and particulate counts are not detailed.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the clinical test set (e.g., 2+1, 3+1, none). The CFU and particulate counting results are presented as measured values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the device's performance in reducing airborne contamination, not on evaluating human reader improvement with or without AI assistance. This device is an air-handling apparatus, not an AI diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was done for the device itself. The clinical and non-clinical tests evaluate the device's capability to clean the air and reduce microorganisms and particulates without human intervention in the purification process itself. The "algorithm" here refers to the device's mechanical and filtration processes.
7. Type of Ground Truth Used
The ground truth used was based on direct measurements of:
- Colony Forming Units (CFU): Indicative of microbial load.
- Particulate counts: Indicative of particulate matter.
These are direct, empirical measurements taken from the environment.
8. Sample Size for the Training Set
The document does not mention a training set as this is a physical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the device is inherent in its engineering and design, validated by the tests described.
9. How Ground Truth for the Training Set was Established
Not applicable, as this device does not utilize a training set in the context of machine learning. The "ground truth" for the device's design and operational parameters would be based on engineering specifications, regulatory standards for air quality, and previous research on surgical site infection prevention.
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