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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 1.8 mm (~5/64") ID 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

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

• 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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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

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

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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

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.

Ask a specific question about this device

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

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

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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.

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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

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