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510(k) Data Aggregation
(123 days)
The V-PRO® s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
- The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
- ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length
-
1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
- Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).
The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
- Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length - ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length
@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (21 5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length > 1.8 mm (~5/64") ID and < 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length ^ Validation testing for all lumen sizes was conducted using a maximum of twelve
(12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).
V-PRO 60 Low Temperature Sterilization System
The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize: t Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO 60 Sterilizer Flexible Cycle can sterilize: @
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
- The flexible endoscope may be a single or dual lumen device with lumens . that are ≥ 1 mm (~3/64") internal diameter (ID) and ≤ 990 mm (38-63/64") in.
- Additional load, up to 11 lb (5 kg) can include stainless steel lumens with . the following dimensions
- ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
- ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
- ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length
@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
- . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") ID and ≤ 410 mm (16-9/64") in length > 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
- Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and < 275 mm (~10-53/64") in length ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or
- ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).
The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.
The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.
The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed cycles all utilize a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.
The information provided describes the acceptance criteria and a study proving the device meets these criteria for the V-PRO® 60 Low Temperature Sterilization Systems and V-PRO® s2 Low Temperature Sterilization Systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| For V-PRO s2 Sterilizer Non Lumen Cycle:Sterilization of non-lumened instruments (including non-lumened general medical instruments, non-lumened rigid, semi-rigid, and flexible endoscopes) with a maximum load of one instrument tray weighing 25 lbs (11.3 kg). | PASS: Validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg). |
| For V-PRO s2 Sterilizer Fast Cycle:Sterilization of medical devices including single, dual, and triple channeled rigid and semi-rigid endoscopes with specific lumen configurations:- Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.- Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.Maximum of eight (8) lumens per load. Validation load of one pouched instrument tray and two pouched devices outside the tray with a total weight of 4.0 lbs (~1.8kg). | PASS: Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.) |
| For V-PRO s2 Sterilizer Flexible Cycle:Sterilization of one surgical flexible endoscope (single or dual lumen, ≥ 1 mm ID and ≤ 990 mm length) or bronchoscope with light cord (if not integral).Additional load, up to 11 lb (5 kg), including stainless steel lumens with:- ≥ 0.76 mm ID and ≤ 233 mm length- ≥ 1.0 mm ID and ≤ 254 mm length- ≥ 1.8 mm ID and ≤ 542 mm length.Validation load of two instrument trays (one with flexible endoscope, mat, organizers, light cord; second with additional load and twelve stainless steel lumens) for a total load weight of 11 lbs (5 kg). | PASS: Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated; previous 2mm ID x 400mm length removed as it falls within the new claim). |
| For V-PRO s2 Sterilizer Lumen Cycle:Sterilization of medical devices including single, dual, and triple channeled rigid and semi-rigid endoscopes with specific lumen configurations:- Single/dual channeled stainless steel lumens: ≥ 0.77 mm ID and ≤ 410 mm length, OR ≥ 1.8 mm ID and ≤ 542 mm length.- Triple channeled stainless steel lumens: ≥ 1.2 mm ID and ≤ 275 mm length, OR ≥ 1.8 mm ID and ≤ 310 mm length, OR ≥ 2.8 mm ID and ≤ 317 mm length.Maximum of twelve (12) stainless steel lumens per load. Validation load of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). | PASS: Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). (New claim for ≥ 1.8 mm ID x ≤ 542 mm length added and demonstrated.) |
| General Sterilization Effectiveness:Successful sterilization (achieving a Sterility Assurance Level, typically 10^-6, meaning a 1 in a million chance of a non-sterile unit) as demonstrated by biological indicators (BI) in ½ cycle total kill endpoint verification and simulated use tests. | PASS: - ½ Cycle Modified Total Kill Endpoint Verification: Demonstrated for sterilizer cycles. Standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load. Partial positives or all survive results were seen at lower injection weights. - Simulated Use Test: Verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. |
The tables for V-PRO 60 cycles are identical to the V-PRO s2 cycles for Non Lumen, Flexible, and Lumen cycles, indicating the same acceptance criteria and performance were met for V-PRO 60.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states:
- "Validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg)" for the Non Lumen Cycle.
- "Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load... using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg)" for the Fast Cycle.
- "Validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope... and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg)" for the Flexible Cycle.
- "Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load... using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg)" for the Lumen Cycle.
The specific number of individual sterilization cycles performed for these validation studies (e.g., number of replicates for the biological indicator and simulated use tests) is not explicitly stated in the provided text.
Data Provenance: The document implies these studies were conducted by STERIS Corporation, the manufacturer, in support of their 510(k) submission to the FDA. The nature of these tests (validation studies, half-cycle kill, simulated use) strongly suggests they are prospective, experimentally designed studies within a controlled environment. The country of origin for the data is not specified beyond the fact that the company is located in Mentor, Ohio, USA, and is submitting to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This is an electromechanical sterilization device, not an AI or imaging device that typically uses human experts for ground truth. The "ground truth" for sterilization devices is established by microbiological testing (biological indicators) and chemical indicators which show whether a Sterility Assurance Level (SAL) has been met. These are objective, quantitative measures of microbial inactivation.
Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists for image interpretation) does not apply here. The "experts" would be the microbiologists and engineers who design, execute, and interpret the standardized sterilization test methods.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI device requiring consensus from multiple readers. For sterilization devices, the results of biological indicator and chemical indicator tests (e.g., growth/no growth, color change) are objective and typically do not require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a sterilization device, not an AI diagnostic tool. No human readers or AI assistance in a diagnostic context are involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical sterilization system, not an algorithm. The device performance itself is the "standalone" performance in its intended function.
7. Type of Ground Truth Used
The ground truth used is based on biological indicators (BIs) and simulated use testing.
- Biological Indicators: Viable spores of a highly resistant microorganism (e.g., Geobacillus stearothermophilus) are placed in challenging locations within the device or test load. After the sterilization cycle, these BIs are cultured. No growth indicates successful sterilization to a defined Sterility Assurance Level (SAL).
- Simulated Use Testing: Involves placing inoculated test devices (with the resistant microorganism) into the sterilizer and running the cycle to verify sterilization effectiveness under conditions simulating actual use.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning model that requires a training set. The "design" and "development" of such a system would involve engineering principles and iterative testing, not algorithmic training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a device of this type.
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(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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