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The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are 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 temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain either:

• A single lumen that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
  • Or two lumens with:

• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length

• And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ++ The flexible endoscope may contain either:

· A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:
  • One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
  • And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

** The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: *

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
• · Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or

2.8 mm ID and 1 mm (~3/64") ID and 1.8 mm (~5/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, using VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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 V-PRO 1, V-PRO 1 Plus, and the V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycles, respectively.

The provided text describes the acceptance criteria and supporting studies for the STERIS Amsco V-PRO Low Temperature Sterilization Systems.

Here's the breakdown:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily describes validation studies for the V-PRO sterilization systems, which are typically performed in a prospective manner.

• Determination of Worst Case Material for VHP: This refers to previous submissions, but the current document specifically highlights Kraton as the "most resistant material." No specific sample size is given for how many materials were evaluated to determine Kraton as the worst case in previous studies.
• Medical Device Material Compatibility: "20 materials" were tested.
• Cytotoxicity Evaluation of Medical Devices: "various medical devices containing [unspecified material components]" were tested.
• Hydrogen Peroxide Residual Analysis of Processed Medical Devices: "19 proposed compatible materials" were tested across "three (3), worst case, back-to-back Lumen Cycles" in the V-PRO 60 Sterilizer.

The provenance of the data (country of origin) is not explicitly stated, but as this is an FDA submission for a U.S. company (STERIS Corporation, Mentor, OH), it's highly probable the studies were conducted in the U.S. or at facilities compliant with U.S. regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This type of information is not applicable to the studies described. The studies are engineering and chemical validation tests for a sterilization system, not diagnostic device studies that would require expert human review or interpretation of medical images or patient data to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the studies are not diagnostic assessments requiring adjudication of human reader interpretations. The acceptance criteria are based on measurable physical and chemical properties and biological effects (sterilization efficacy, material integrity, cytotoxicity, residuals).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool used by human readers. Therefore, no MRMC study or AI assistance improvement metrics are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a sterilization system and there is no algorithm or AI component involved in its operation or performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in these validation studies is established by objective scientific and engineering measurements and standards:

• Sterilization effectiveness: Implicit in the "Worst Case Material" determination, where the goal is sterilization. Sterilization is typically confirmed by biological indicators demonstrating the inactivation of a specific resistant microorganism (e.g., Geobacillus stearothermophilus) to a defined sterility assurance level (SAL). While not explicitly detailed here, this is a standard method for sterilization validation.
• Material compatibility: Visual inspection for defects (crazing, cracks, chipping) and functional testing of devices after processing.
• Cytotoxicity: In vitro assays to assess cellular toxicity, with controls to ensure assay validity.
• Hydrogen peroxide residual analysis: Chemical analytical methods to quantify residual hydrogen peroxide, compared against established biological tolerance limits for mucosal and internal tissue contact.

8. The sample size for the training set

This is not applicable. The device is a sterilization system, not a machine learning model. There is no concept of a "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

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The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

• Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
  • o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
  • o triple channeled devices with stainless steel lumens that are
    • ≥ 1.2 mm ID and ≤ 275 mm in length
    • ≥ 1.8 mm ID and ≤ 310 mm in length
    • or

    • 2.8 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm (~3/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) cycles, respectively.

The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The STERIS V-PRO Low Temperature Sterilization Systems were studied to verify two modifications: the removal of eye-contacting limitations and the addition of polyurethane as a compatible material for the Lumen Cycle.

Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the exact "sample size for the test set" in terms of number of unique devices or materials for each specific test. However, it indicates:

• For residual hydrogen peroxide and cytotoxicity comparison: "materials" were processed.
• For in-device cytotoxicity and tissue residue: "medical devices" were processed.
• For ocular irritation: "Materials coupons" were processed.
• For polyurethane compatibility: "polyurethane-containing device" and "polyurethane material" were evaluated.

Data Provenance: The studies were conducted by STERIS Corporation for a 510(k) premarket notification. This implies the data is prospective for the purpose of demonstrating the safety and effectiveness of the proposed changes. The country of origin of the data is not specified but is presumably the USA, where STERIS Corporation is based.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The tests described are primarily laboratory-based evaluations of chemical residues, cytotoxicity, material compatibility, and biological irritation, rather than assessments requiring interpretation by clinical experts. For biocompatibility tests like ocular irritation per ISO 10993-10, trained toxicologists or evaluators would interpret the results.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are laboratory-based experimental validations, not clinical studies requiring independent interpretation or adjudication of outcomes by multiple experts.

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

A MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance to human readers. The STERIS V-PRO System is a sterilizer, and its performance is evaluated through physical, chemical, and biological efficacy studies, not reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done because the device itself is a sterilizer, not an algorithm. Its performance is inherent in its operation (sterilization efficacy, material compatibility, residue levels), not in an algorithmic output.

7. Type of Ground Truth Used

The ground truth used in these studies is based on:

• Quantitative measurements: Residual hydrogen peroxide levels (chemical analysis).
• Biological assays: Cytotoxicity tests (e.g., using live cells to detect toxic effects), ocular irritation tests (per ISO 10993-10 guidelines, likely involving animal models or in vitro alternatives).
• Visual assessment: Material degradation or cosmetic changes.
• Sterilization efficacy: Implied to be based on inactivation of biological indicators with a known sterility assurance level (SAL).

8. Sample Size for the Training Set

This information is not applicable as the V-PRO Sterilization System is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device type.

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The V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

• Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations: (a)
  • o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • o dual channeled devices with stainless steel lumens that are > 0.77 mm ID and 2.8 mm ID and 1 mm ID and 1 mm ID and

The V-PRO 1 Plus and V-PRO maX Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Devices that meet the criteria described within the indications for use and composed of compatible materials are placed within the sterilization chamber and the appropriate cycle selected through the graphic user interface. The preprogrammed cycles all utilize a conditioning phase which prepares the chamber, a sterilize phase in which loaded devices are exposed to the sterilizing agent, VHP, at low pressure and an aeration phase to remove residual hydrogen peroxide. 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 V-PRO 1 Plus Low Temperature Sterilization System provides two cycle options, Lumen and Non Lumen. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cvcle parameters (injection cylinder, vaporizer, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of stainless steel.

The V-PRO maX Low Temperature Sterilization System provides three cycle options, Lumen, Non Lumen and Flexible. The sterilizer contains a 136 L welded aluminum chamber with two shelves for device loading, an onboard printer to provide cycle printouts, a cup interface where the VAPROX HC cups are loaded, a display for the graphic user interface and the components necessary to achieve the desired cycle parameters (injection cylinder, vacuum pump and catalytic converter). The side panels of the sterilizer are composed of plastic.

The purpose of this pre-market notification is to modify the maximum load weight for the Non Lumen Cycle from 19.65 to 50 lbs, to add titanium diffusion-restricted areas to the indications for use of the Non Lumen Cycle, and to remove the term "reusable" from indications for use statement.

The FDA 510(k) summary for the V-PRO® 1 Plus and V-PRO® maX Low Temperature Sterilization Systems describes performance testing to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "PASS" result in the context of sterilization, meaning the device successfully sterilized the test articles under specified conditions. The document acts as a summary, so detailed quantitative acceptance criteria (e.g., specific log reduction of microorganisms) are not explicitly stated in this high-level summary but are inherent to sterilization validation.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for the test set in terms of the number of items sterilized in total. However, it provides details on the load configurations used in the validation studies:

• Lumen Cycle: Maximum of twenty (20) lumens per load, using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
• Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs. (This is a modification from the previous 19.65 lbs of two instrument trays and two pouches).
• Flexible Cycle (Config 1): Two flexible endoscopes (with light cord/mat) with no additional load.
• Flexible Cycle (Config 2): One flexible endoscope (with light cord/mat) and additional non-lumened instruments (instrument tray and one pouch) for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin identified for the data. Given it's a pre-market notification for a medical device by the STERIS Corporation (Mentor, OH, USA), it is highly likely the studies were prospective, conducted by the manufacturer, and likely performed in the USA or under relevant international standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of human experts to establish ground truth for the test set. Sterilization validation typically relies on objective measures, primarily biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) and chemical indicators (CIs). The "ground truth" for sterilization is the complete inactivation of these spores, indicated by no growth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth for sterilization is objective (growth/no growth of biological indicators), not based on human interpretation or adjudication.

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

Not applicable. This is a sterilization system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone system. The "algorithm" here is the pre-programmed sterilization cycle, and its performance is assessed directly against the ability to sterilize. There is no human intervention in the sterilization process itself; the human selects the cycle and loads the sterilizer. The performance data presented (e.g., ½ Cycle Modified Total Kill Endpoint Verification, Simulated Use Test) are indeed standalone performance of the device without human interpretation of the sterilization outcome itself.

7. Type of Ground Truth Used

The primary ground truth for sterilization efficacy is the inactivation of biological indicators (BIs). The document explicitly mentions:

• "reproducibly sterilized under worst case ½ cycle conditions" for STERIS VERIFY® V24 Self-Contained Biological Indicator (SCBI).
• "all SCBIs were negative for growth under worst case full cycle conditions."

Additionally, chemical indicators (CIs) are used to confirm exposure to the sterilant, showing "complete color change."

8. Sample Size for the Training Set

Not applicable. This device is a physical sterilizer and its associated pre-programmed cycles, not a machine learning model that requires a "training set" in the conventional AI sense. The "training" of the cycles would refer to the developmental and engineering process of determining optimal parameters, which involves a different type of experimental design and validation than data-driven machine learning model training.

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

Not applicable, for the same reasons as point 8. The "ground truth" for developing the sterilizer's parameters (e.g., sterilant injection, exposure time, pressure, temperature) would have been established through extensive empirical experimentation and adherence to sterilization standards (e.g., AAMI, ISO) to achieve a validated Sterility Assurance Level (SAL) of 10^-6 or better. This involves progressively testing parameters with biological indicators to determine the minimum conditions required for sterility.

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The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 60 Sterilizer's Lumen Cycle can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
  • single or dual lumen devices with stainless steel lumens that are ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length
  • triple lumen devices with stainless steel lumens that are
    • ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") 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

The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize

• Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO 60 Sterilizer's Flexible Cycle can sterilize:

• One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any 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

The V-PRO 60 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO maX Sterilizers. As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. The V-PRO 60 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed 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.

This document describes the V-PRO® 60 Low Temperature Sterilization System, a vaporized hydrogen peroxide sterilizer. The acceptance criteria are based on achieving sterility and maintaining material compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document summarizes the "Summary of Nonclinical Tests" performed on the V-PRO 60 Low Temperature Sterilization System to demonstrate its substantial equivalence to the predicate device, the V-PRO maX Low Temperature Sterilization System. The studies aim to prove the device's ability to sterilize various medical devices effectively and safely.

2. Sample Size Used for the Test Set and Data Provenance:

The document provides specific sample sizes for particular tests:

• AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant."
• Validation Loads:
  • Lumen Cycle: "a maximum of twelve (12) lumens per load... consisting of one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg)."
  • Non Lumen Cycle: "a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg)."
  • Flexible Cycle: "one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load."
• Biocompatibility and Material Compatibility: "23 materials" were analyzed.

Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. However, based on the nature of medical device clearance submissions to the FDA (United States Food and Drug Administration), these are typically prospective laboratory and simulated-use studies conducted by the manufacturer or authorized testing facilities, aiming to meet regulatory requirements prior to market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the "number of experts" or their "qualifications" used to establish ground truth. The studies involve standardized microbiological and engineering tests rather than expert interpretation of results in a clinical setting. For sterilization studies, the ground truth is typically established by laboratory methods such as growth/no growth of biological indicators (e.g., Geobacillus stearothermophilus) following exposure to the sterilization process.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective performance evaluations (e.g., sterility, log reduction, material compatibility) rather than interpretation-based assessments that would require an adjudication method like 2+1 or 3+1.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The device is a sterilizer, and its performance is evaluated through objective physical and biological tests, not through human reader interpretation of cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the studies described are standalone performance evaluations of the sterilization device. There is no "human-in-the-loop" interaction in the output or interpretation of the sterilization cycle results beyond operating the device and reading standard indicators. The device itself is the "algorithm only" in the context of its function.

7. The Type of Ground Truth Used:

The primary type of ground truth used would be:

• Microbiological Negativity/Positivity: For sterilization efficacy tests (AOAC Sporicidal, D-value/Total Kill, ½ Cycle Modified Total Kill Endpoint, ½ Cycle Sterilization Verification, Simulated Use, In Use), the ground truth is established by culturing biological indicators or test organisms and observing the presence or absence of growth. "Sterile" or "no growth" is the ground truth for effective sterilization.
• Physical/Chemical Analysis: For biocompatibility and material compatibility, the ground truth is established through laboratory analyses (e.g., cytotoxicity assays, residue analysis, visual inspection for degradation) and quantitative measurements.
• Process Parameter Verification: For Final Process Qualification, the ground truth is established by objective measurements of process parameters (time, temperature, pressure, sterilant injection weight) and the observed color change of chemical indicators.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device (sterilizer) and not an AI/machine learning model that would require a 'training set' of data in the conventional sense. The development of the sterilizer's cycles and parameters is based on engineering principles and iterative testing, not on data training in the way an algorithm learns from a dataset.

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

Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The physical and biological principles governing sterilization, along with extensive engineering development and testing, define the performance of the sterilizer.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.

The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55 - 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the media ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60 ℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to vellow and/or if the media is turbid.

This document describes two devices, the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Biological Indicator Challenge Pack. Both submissions are focused on qualifying these devices for use with the new V-PRO 60 Low Temperature Sterilization System, demonstrating substantial equivalence to their respective predicate devices.

VERIFY® V24 Self-Contained Biological Indicator (SCBI)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 unit," implying prospective testing for this specific sterilizer. The K numbers (K073244, K090514) indicate prior clearances and associated data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided within the document. The "ground truth" for biological indicators is inherently based on the viability of Geobacillus stearothermophilus spores, which is determined by culturing and observing growth or no-growth.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail, or sterile/non-sterile) for biological indicators is typically a direct observation of microbial growth or lack thereof.

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

This type of study is not applicable as the device is a biological indicator, not an imaging or diagnostic AI tool that involves human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The device, a biological indicator, functions independently without a human in the loop for its direct performance, though human observation is required for interpreting its results (color change, turbidity).

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores. A successful sterilization cycle should kill all spores, resulting in no growth (sterile). If spores survive, they will grow, indicating a sterilization failure. This is effectively a biological assay for sterility.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator. All listed tests are performance evaluations for the device itself rather than training data for an algorithm.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth underpin the ground truth for biological indicators.

VERIFY® V24 Biological Indicator Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 Sterilizer," implying prospective testing for this specific sterilizer. K103331 is cited as the predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided within the document. Similar to the SCBI, the ground truth for the challenge pack relies on the biological viability of Geobacillus stearothermophilus spores and the visual change of the chemical indicator.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail) is based on the biological indicator's growth/no growth and the chemical indicator's color change.

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

This type of study is not applicable as the device is a biological indicator challenge pack.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This is a standalone performance study. The challenge pack, containing a biological indicator and a chemical indicator, functions independently in the sterilizer without a human in the loop for its direct performance. Human observation is required for interpreting the results of both indicators.

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores for the biological indicator component and the color change of the chemical indicator. Both are indicators of effective sterilization.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator challenge pack. All listed tests are performance evaluations for the device itself.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth, along with established chemical indicator responses to sterilization processes, underpin the ground truth.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
• Default Cycle of the STERRAD 100S Sterilizer ●
• Default Cycle of the STERRAD 200 Sterilizer .
• Standard and Advanced Cycles of the STERRAD NX Sterilizer .
• Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System or STERRAD Sterilizer and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 – 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY® V24 Self-Contained Biological Indicator (SCBI) is intended to monitor specific cycles of V-PRO® Low Temperature Sterilization Systems and various STERRAD® Sterilizers. The acceptance criteria and supporting study are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size (number of VERIFY V24 SCBIs) used for each of the performance tests (Half Cycle, Growth Inhibition, Simulated Use).

The data provenance is for testing the device's compatibility with STERRAD Sterilizers. The context implies that the testing was likely conducted in a controlled laboratory or clinical setting in the United States, given that the sponsor and manufacturing facilities are in Mentor, OH, USA, and the submission is to the FDA. The study appears to be prospective, specifically designed to demonstrate the device's performance with the new sterilizer indications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For biological indicators, the ground truth is typically established by observing the growth or non-growth of the bacterial spores, which is a direct, objective biological outcome. It doesn't usually rely on expert interpretation in the same way an imaging diagnostic might.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. Given the nature of a biological indicator, where the outcome is a clear biological response (growth or no growth, indicated by a color change), an adjudication method by multiple experts is generally not applicable. The results are typically objectively measured.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and often AI assistance. The VERIFY V24 Self-Contained Biological Indicator is a direct biological indicator without a human-in-the-loop component for reading the primary outcome.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a standalone indicator. Its performance is evaluated directly based on the biological outcome (spore inactivation and subsequent growth or no growth of Geobacillus stearothermophilus). This is essentially a standalone performance evaluation in that there is no "human-in-the-loop" for the primary interpretation of the device's result (color change or turbidity).

7. The type of ground truth used

The ground truth used is the biological outcome – specifically, the successful inactivation of Geobacillus stearothermophilus spores and the presence or absence of their growth after exposure to a sterilization process. This is determined by observing the color change of the media (orange to yellow) and/or turbidity, which indicates viable spores. The specification ranges for D-value, survival time, and kill time are also integral to establishing the efficacy (ground truth) of the indicator.

8. The sample size for the training set

The document does not detail a separate "training set" or its size, as this device is a biological indicator and not an AI/ML-based system that typically requires a training set. The existing biological indicator has been previously cleared, and the current submission focuses on extending its use to additional sterilizers.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this biological indicator. The existing performance characteristics of the Geobacillus stearothermophilus spores and the indicator's components (media, etc.) were established through previous studies (K073244, K090514) according to FDA guidance for biological indicators.

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The Amsco V-PRO I, V-PRO I Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:

• Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
  • single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
  • triple channeled devices with stainless steel lumens that are either
    • ≥ 1.2 mm ID and ≤ 275 mm in length
    • ≥ 1.8 mm ID and ≤ 310 mm in length
    • or
    • ≥ 2.8 mm ID and ≤ 317 mm in length
• The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) 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 two instrument trays and two pouches for a total weight of 19.65 lbs.
  The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394 and K111810, can sterilize:
• Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
  • The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 Ibs.
    The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:
• 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
     The flexible endoscopes may contain either:
• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• or two lumens with:
  • one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
  • and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
• The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
• 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
     The flexible endoscope can contain either:
• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• or two lumens with:
  • one lumen that is ≥ 1 mm ID and ≤ 998 mm in length
  • and the other lumen that is > 1 mm and ≤ 850 mm in length
• The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 Ibs.

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed V-PRO cycles all utilize a conditioning phase, a sterilization 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.

The provided text describes the 510(k) summary for the Amsco V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems. It focuses on updating the indications for use statement for the Lumen Cycle.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the successful demonstration of sterilization capability under various test conditions for the device's Lumen Cycle, especially for the modified stainless steel lumen claims. The "Conclusion" column in the table below explicitly states "PASS" for all tests, indicating that these criteria were met.

Study Details

Based on the provided text, the document describes nonclinical tests primarily focused on verifying the sterilization efficacy of the device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The exact number of individual devices or lumens tested for each specific test is not explicitly stated in numerical form. However, for the "Lumen Cycle," the validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. The validation load consisted of two instrument trays and two pouches for a total weight of 19.65 lbs.
   • Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements. The studies appear to be prospective validation studies conducted by the manufacturer, STERIS Corporation, for the purpose of demonstrating the device's efficacy.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of experts or their qualifications for establishing the ground truth. Sterilization efficacy studies like these typically rely on microbiological testing (e.g., spore-kill assays) to establish an objective "ground truth" of sterility, rather than expert human interpretation.

3. Adjudication method for the test set:

   • Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or subjective assessments. This document describes objective performance testing (sterilization efficacy), so such adjudication methods are not applicable and therefore not mentioned.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a study on a sterilization device, not an AI-assisted diagnostic device that would involve human readers. Therefore, an MRMC study and related effect sizes are not relevant or described.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense. The tests described are "standalone" performance evaluations of the sterilization system's ability to achieve sterility without direct human intervention during the sterilization cycle itself. The device is an automated sterilizer, so its performance is inherently "algorithm-only" in its operation. However, no "algorithm" in the typical AI sense is discussed.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth in these sterilization studies is microbiological sterility. The "½ Cycle Modified Total Kill Endpoint Verification" and "½ Cycle Sterilization Verification" tests indicate the use of biological indicators (spores) to definitively determine if sterilization was achieved (total kill/survival results). The "In Use Test" also mentions sterilization of "patient-soiled medical instruments," implying a microbiological assessment of sterility. Biocompatibility is assessed by "residue analysis."

7. The sample size for the training set:

   • This document describes validation and verification studies for a physical sterilization device, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable and not mentioned.

8. How the ground truth for the training set was established:

   • As there is no training set for an AI algorithm, this information is not applicable.

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The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO maX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
  • an inside diameter of 1 mm or larger and a length of 125 mm or shorter
  • an insider diameter of 2 mm or larger and a length of 250 mm or shorter
  • an inside diameter of 3 mm or larger and a length of 400 mm or shorter
    The validation testing for all lumen sizes was conducted using a maximum of twenty (20) 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 two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
   The flexible endoscopes may contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
   The flexible endoscope can contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.

The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization 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.

The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.

The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.

The provided 510(k) summary (K112760) describes a modification to the Amsco V-PRO maX Low Temperature Sterilization System, involving minor software changes to enhance usability. The study submitted for this modification is a Software Validation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the software validation test set (e.g., number of test cases run, or specific inputs). It only indicates that "Software Validation" was performed.

Regarding data provenance, the document does not specify country of origin for the validation data. The nature of the study (software validation) suggests it would be conducted in a controlled environment, likely by the manufacturer (STERIS Corporation, based in Mentor, Ohio, USA). The study is retrospective in the sense that the software was already developed and then validated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the software validation. For a software validation, ground truth would typically be defined by the software requirements and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the software validation. For software validation, discrepancies (bugs) are typically identified and fixed, not adjudicated by independent parties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The Amsco V-PRO maX is a sterilizer, and its effectiveness is determined by its ability to reliably sterilize medical devices, not by human interpretation of its output in a clinical setting. Therefore, an MRMC study with human readers and AI assistance is not applicable to this device.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, a standalone study was performed. The "Software Validation" is an assessment of the algorithm (software)'s performance against its specifications and intended function without human intervention in its operation other than initiating the process and evaluating the outcome of the software's execution.

7. Type of Ground Truth Used

For the "Software Validation," the ground truth would be defined by the software requirements and specifications. The software's performance is validated against these pre-defined functional and non-functional requirements to ensure it operates as intended.

8. Sample Size for the Training Set

The document does not mention a "training set" because this is a software validation for a sterilizer. The software for a sterilizer is typically developed based on engineering principles and verified through testing against specifications, rather than being "trained" on a dataset like a machine learning algorithm.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

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The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and can sterilize: *

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors .
• Medical devices with a single stainless steel lumen with: .
  • o an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o an insider diameter of 2 mm or larger and a length of 250 mm or shorter o an inside diameter of 3 mm or larger and a length of 400 mm or shorter
  • • The validation testing for all lumen sizes was conducted using a maximum of twenty (20) 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 two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K083097 and can sterilize: **

Non-lumened instruments including non-luments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.

• ** The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.

Here's an analysis of the provided text regarding the acceptance criteria and study for the STERIS® Amsco® V-PRO™ 1 and V-PRO™ 1 Plus Low Temperature Sterilization Systems:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Odor Filter: Implied sample size based on "running continuous Non-Lumen cycles." No specific number of cycles or devices is given.
• Vacuum pump oil: Testing was performed "concurrently with the ARS Filter testing." No specific number of devices or cycles is given.
• ARS Filter: "Nine filters of each variety were run either until an oil smell was detected or 750 cycles were reached."
• Gas Ballast Filter: "The proposed filters (a total of 5) was tested by running until a failure was detected."
• Software Modifications: No specific sample size mentioned, just "Software Validation."

Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective, as they involve testing proposed modifications against existing versions to determine equivalency or improvement.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for this set of performance tests. The acceptance criteria are objective and measurable (e.g., presence of oil smell, performance comparison, software validation).

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurement against pre-defined criteria rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. These tests are focused on the hardware and software performance of a sterilization system, not on human interpretation or diagnostic efficacy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This concept is not applicable here. The device is a sterilization system, not an algorithm, and its performance is inherently standalone in its function (sterilizing medical devices). The tests described evaluate the device's components and software in isolation from human intervention in the sterilization process itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective performance metrics and pre-defined standards comparing the modified components/software against the existing, predicate device components/software. For example:

• Absence/presence of oil smell
• Equal or better performance of filters
• Appropriate verification and validation of software

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to the performance testing of a physical sterilization device and its components/software. These tests are evaluations, not machine learning model training.

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

As there is no training set in the context of this device's performance evaluation, this question is not applicable.

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The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle].

The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four V-PRO Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Trays.

The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.

This document describes the acceptance criteria and study proving the STERIS Sterilization Mats meet these criteria for use in V-PRO Sterilizers.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size for each test category. However, it does provide details about the validation loads used in the sterilization efficacy tests for the various V-PRO cycles:

• Lumen Cycle: Validation load consisted of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. This testing used a maximum of twenty (20) lumens per load.
• Non Lumen Cycle: Validation load consisted of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
• Flexible Cycle (Configuration 1 - Two endoscopes): Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. Each endoscope was packaged into a tray with a silicone mat, 20 instrument organizers, and a light cord.
• Flexible Cycle (Configuration 2 - One endoscope + non-lumened instruments): One flexible endoscope in a tray with a silicone mat, 20 instrument organizers, and a light cord. Also included was an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective performance tests conducted by the manufacturer, STERIS Corporation, to demonstrate the device's efficacy and safety.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of submission (510(k) for sterilization accessories) typically relies on standardized test methods and quantitative measurements (e.g., microbial lethality assays, chemical analysis for residuals, visual inspection for material compatibility). Therefore, the "ground truth" is established through objective scientific measurements and established protocols, rather than expert consensus on diagnostic images or clinical outcomes. The document does not mention the involvement of external experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Given the nature of the tests (sterilization efficacy, biocompatibility, material compatibility, cleaning evaluation), an adjudication method like 2+1 or 3+1 typically used for subjective diagnostic assessments is not applicable. The results are based on direct measurements and qualitative observations against predefined scientific criteria. A "PASS" or "FAIL" determination is likely made based on whether the measured outcomes meet the quantitative or qualitative acceptance criteria.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The STERIS Sterilization Mats are a sterilization accessory, and their performance is assessed through objective physical and biological tests, not through human interpretation of diagnostic output.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (i.e., algorithm only without human-in-the-loop performance). The tests evaluate the performance of the sterilization mats themselves within the context of the V-PRO sterilization cycles, independent of human operators assisting an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by reproducible sterilization of worst-case test articles under worst-case ½ cycle conditions. This implies the use of biological indicators or similar methods to confirm microbial kill, which is an objective outcome measure.
• Biocompatibility: Measured by assessing cytotoxicity and residual hydrogen peroxide levels. These are objective laboratory tests.
• Material Compatibility: Assessed by observing the absence of incompatibilities (e.g., degradation, discoloration) after exposure to multiple cleaning and sterilization cycles. This is based on qualitative visual assessment against established standards for material integrity.
• Cleaning Evaluation: Assessed by the ease of cleaning, likely through standardized cleaning protocols and visual inspection for cleanliness.

In summary, the ground truth is primarily based on objective scientific measurements, established chemical and biological testing protocols, and qualitative assessments of physical and material integrity.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning components. This device is a physical accessory evaluated through traditional engineering and biological performance testing, not an AI-powered device. Therefore, the concept of a "training set" is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI component, the ground truth for a training set was not applicable and therefore not established.

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