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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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(293 days)
SurgiCube® is a stand-alone device that creates a surgical operating environment with 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 surgical site of the patient is intended to be placed under the air flow which is directed downwards to the surgical site and/or instruments within 32" (80 cm) in length. Device effectiveness may not be reliably detectable at a distance of 32" (80 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area.
The SurgiCube® is an apparatus that provides a localized, optimally HEPA filtered, surgical environment to carry out minimally invasive surgery for ophthalmic procedures. It supplies air around the operating surface using uni directional air flow technique. Possible sources of contamination are sidelined. The patient is physically positioned outside the surgical area; just the operating area is in the field. The surgical team can move around the operating surface without interfering with the air. The uni directional flow together with correct surgical draping create a compact and manageable surgical area that will eliminate airborne contamination risks for patients. The SurgiCube® is equipped with a multiple mechanical filter system, including a High Efficiency Particle Air (HEPA) filter with an efficiency of filtering 99,995% of all particles of 0.3um.
I am sorry, but the provided text describes a medical device, the SurgiCube, for creating a sterile surgical environment, and its regulatory clearance (510(k) submission) by the FDA. The information provided heavily pertains to engineering and performance specifications, and clinical validation for the device's ability to maintain a clean environment.
The request, however, asks for information typically associated with the evaluation of AI/ML-enabled medical devices, specifically:
- Acceptance criteria and device performance in a table format, often related to metrics like sensitivity, specificity, AUC, etc.
- Sample sizes for test sets and data provenance for an AI/ML model.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set and how its ground truth was established.
The provided document does NOT contain any of this information as the SurgiCube is not an AI/ML device. It is an air-handling apparatus designed to reduce microorganisms and particulate matter.
Therefore, I cannot fulfill your request based on the provided text.
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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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(449 days)
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel with the direction of air flow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
The ABS device controls the airborne surgical environment at a specific and limited location adjacent to and over surgical incisions by emitting a non-turbulent flow of HEPA filtered air that displaces the presence of airborne colony-forming units and particulate matter within surgical site dimensions of 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable outside of these dimensions and effectiveness depreciates beyond this specified area. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The ABS Filter/Blower filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air exits the Filter/Blower from an exit port on the top of the unit. The Filter/Blower is nonsterile and reusable. The Air Delivery System, consisting of an Air Supply Hose and Nozzle, is sterile, single-use. The Nozzle portion is applied to the surgery site, on top of the incision drape and adjacent to a surgical incision. The end of the Air Supply Hose is plugged into the Filter/Blower's air exit port. HEPA filtered air then flows through the Air Supply Hose through the Nozzle and directly to the incision site.
Acceptance Criteria and Study Details for the Air Barrier System (ABS)
This document describes the acceptance criteria and the studies that demonstrate the Air Barrier System (ABS) meets these criteria, based on the provided 510(k) summary (K123006).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ABS are primarily defined by its ability to significantly reduce the presence of airborne particulate matter and microorganisms at the surgical site. The reported device performance is based on two clinical studies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Summary of Study Results) |
|---|---|---|
| Reduction of Airborne Microorganisms (CFU/m³) | Statistically significant reduction in airborne microorganism density (colony-forming units per cubic meter) at the surgical site compared to control/sham conditions. | Study 1 (Hip Arthroplasty): Mean microorganism density at ABS area of effect: 1.60 CFU/m³ (Experiment group) vs. 10.73 CFU/m³ (Outside ABS area). Significantly lower (P<0.001) than sham and control groups. Study 2 (Posterior Vertebral Fusion/Laminoplasty): Mean microorganism density at ABS area of effect: 1.55 CFU/m³ (Experiment group) vs. 5.05 CFU/m³ (Control group). Statistically significant reduction (p≤0.0001). |
| Reduction of Airborne Particulate Matter (particles/m³) | Statistically significant reduction in airborne particulate density (particles ≥5µm per cubic foot) at the surgical site compared to control/sham conditions. | Study 1 (Hip Arthroplasty): Mean particulate density (≥5µm) at ABS area of effect: 524 particles/ft³ (Experiment group) vs. 3853 particles/ft³ (Sham) and 4092 particles/ft³ (Control). Significantly lower (P<0.001). Study 2 (Posterior Vertebral Fusion/Laminoplasty): Mean particulate density (≥5µm) at ABS area of effect: 1325 particles/ft³ (Experiment group) vs. 4837 particles/ft³ (Control group). Statistically significant reduction (p≤0.0001). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes two clinical studies, which serve as the test sets for demonstrating the device's efficacy.
Study 1 (Hip Arthroplasty):
- Sample Size: 29 patients, randomized into three groups (ABS active, ABS present but not active (sham), no ABS).
- Data Provenance: Not explicitly stated, but implies clinical setting in the US. This study was part of the previous submission [K092801]. It is retrospective information for the current submission, even if it was prospective when originally conducted for K092801.
Study 2 (Posterior Vertebral Fusion or Laminoplasty):
- Sample Size: 38 surgery cases (from 41 patients actually enrolled). Randomized into two groups (ABS device, no ABS device).
- Data Provenance: Conducted at the Michael E. DeBakey VA Medical Center (MEDVAMC), implying the United States. The study was prospective and randomized.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For both clinical studies, the "ground truth" was established through direct measurement of airborne particulate and microorganism counts. This does not involve expert review or consensus in the typical sense of image analysis or diagnostic studies. Instead, it relies on quantitative measurements from environmental sampling.
Therefore, the concept of "number of experts used to establish the ground truth" and "qualifications of those experts" does not directly apply to this type of device performance study. The ground truth is objective, quantifiable measurements of environmental air quality parameters (CFU and particles) collected by trained personnel using standardized methods.
4. Adjudication Method for the Test Set
The studies described are not based on subjective interpretation or classification that would require an adjudication method like 2+1 or 3+1. The results are quantitative measurements of airborne particles and microorganisms. Therefore, no adjudication method was used or needed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an environmental control system, not a diagnostic aid that would involve human readers interpreting output. The studies directly measure the physical effect of the device on the surgical environment.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence. The clinical studies performed are standalone evaluations of the device's ability to reduce airborne contamination. The device (ABS) operates without continuous human intervention during the procedure to achieve its effect. Its performance is measured directly by environmental sampling, independent of human operators' perception or interpretation.
7. The Type of Ground Truth Used
The ground truth used in both clinical studies was objective, quantitative measurements of environmental parameters:
- Colony-forming units (CFU) per cubic meter: Measured microorganisms (bacteria and fungal spores).
- Particles per cubic foot: Measured particulate matter of a specific size (≥5µm).
These measurements were collected at specific locations within and outside the ABS area of effect during actual surgical procedures.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI model development. The Air Barrier System (ABS) is a physical device that functions based on mechanical and filtration principles, not a software algorithm that requires training data. The studies conducted are performance validations, not model training.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" for an algorithm, this question is not applicable. The device's efficacy is demonstrated through performance studies rather than machine learning training.
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(616 days)
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, and (3) the incision dimensions are within: 6″ (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The Filter/Blower is nonsterile and reusable. The Air Delivery System is sterile, single-use. The ABS Filter/Blower captures and filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air leaves the Filter/Blower via the exit port where it is connected to the Hose portion of the sterile, single-use Air Delivery System. The Hose ends in the Nozzle portion of the Air Delivery System; the Nozzle is gently applied to the incision drape adjacent to a surgical incision. The Nozzle delivers HEPA filtered air directly to the surgical site area to reduce the presence of airborne particulate and microorganisms.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal/Endpoint) | Reported Device Performance (Experiment Group vs. Control/Sham) |
|---|---|
| Microorganism Density Reduction at the surgical site | Mean microorganism density: 1.60 CFU/m³ (experiment group) vs. 10.73 CFU/m³ (outside ABS area of effect, likely representative of control/sham levels) - Significantly lower (P<0.001) |
| Particulate Reduction (5µm) at the surgical site | Mean 5µm particulate count: 524 particles/ft³ (experiment group) vs. 3853 particles/ft³ (sham) and 4092 particles/ft³ (control) - Significantly lower (P<0.001) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 29 patients
- Data Provenance: The study was a "clinical study at a single investigator." The text does not specify the country of origin but implies it was conducted in a clinical setting in the same jurisdiction as the submission (US). It was a prospective study, as patients were randomized into groups for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. The ground truth for this device (an Air Barrier System) is established by directly measuring physical quantities (microorganism density and particulate counts) in the surgical environment, rather than expert interpretation of images or patient outcomes. Therefore, this section is not applicable in the context of this device and study design.
4. Adjudication Method for the Test Set
Not applicable. This was a study measuring physical parameters rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This study is focused on the device's ability to reduce contaminants, not on improving human reader performance.
- Effect size of human readers improve with AI vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in essence. The study's experiment group used the device "active" without human intervention beyond its installation and operation. The performance metrics (microorganism and particulate reduction) were measured directly as a result of the device's operation. This can be considered a standalone performance evaluation of the device's effect on the environment.
7. Type of Ground Truth Used
The ground truth used was direct measurements of environmental parameters:
- Colony-forming units per cubic meter (CFU/m³) for microorganisms.
- Particles per cubic foot (particles/ft³) for particulate matter.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning, as this is a medical device for physical intervention, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the AI/ML context.
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