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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Amsco 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 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 ≤ 310 mm in length
      or
    • ≥2.8 mm ID and ≤ 317 mm in length
• The validation studies 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 Ibs.

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 lbs.

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 1 mm ID and 1 mm and

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 document is a 510(k) Summary for the Amsco® V-PRO® 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems. The submission's primary purpose is to modify the V-PRO Lumen Cycle's stainless steel lumen claims. The acceptance criteria and supporting studies are detailed for this specific modification.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. However, the "Conclusion" column for each test serves as the acceptance criteria being met (i.e., "PASS"). The reported device performance is integrated within the "Result" column.

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

The document details the lumen configurations tested, which infer the "sample" being tested:

• Single channeled devices: Stainless lumen ≥ 0.77 mm ID and ≤ 500 mm in length.
• Dual channeled devices: Stainless steel lumens ≥ 0.77 mm ID and ≤ 527 mm in length.
• Triple channeled devices: Stainless steel lumens either ≥ 1.2 mm ID and ≤ 310 mm in length OR ≥ 2.8 mm ID and ≤ 317 mm in length.

The validation studies 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. for the Lumen Cycle (and Non Lumen Cycle). For the Flexible Cycle (which is not the primary focus of this submission, though mentioned for context), different configurations of flexible endoscopes and additional instruments were used.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for sterility claims, these would be prospective, laboratory-based validation studies conducted under controlled conditions to demonstrate effective sterilization. The "In Use Test" indicates some testing with "clinically cleaned, patient-soiled medical instruments," suggesting a component of real-world or simulated clinical conditions, but still likely a prospective study.

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

The document does not provide information about the number of experts or their qualifications for establishing the ground truth. For sterilization studies, the "ground truth" is typically defined by the complete eradication of specified biological indicators (e.g., bacterial spores) under rigorous testing parameters, observed by trained microbiology and sterilization validation specialists according to recognized standards.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method with multiple reviewers (e.g., 2+1, 3+1). For sterilization efficacy testing, the outcome is generally a definitive "sterile" or "non-sterile" based on microbiological culturing, which doesn't typically involve human opinion-based adjudication in the same way, for example, a radiology study might.

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 requiring human reader interpretation. No MRMC comparative effectiveness study was performed.

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; it is not an algorithm for diagnosis or image interpretation. The device's performance is inherently "standalone" in its function as a sterilizer, meaning its efficacy is measured directly, not through human-in-the-loop performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is the complete kill of microbial organisms, typically using highly resistant biological indicators (e.g., bacterial spores). The tests refer to "Total Kill Endpoint Verification," "Sterilization Verification," and "Simulated Use Test," all of which fundamentally rely on demonstrating the absence of viable microorganisms after processing. The "In Use Test" further corroborates this with "clinically cleaned, patient-soiled medical instruments."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this device and study. This is a validation of a physical sterilization process using specific parameters and loads, not an AI or machine learning model that requires training data.

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

As there is no "training set" in the context of an AI/ML model, this question is not applicable. For the validation studies, the efficacy (ground truth) was established through scientifically accepted microbiological testing methods to confirm sterility.

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Cardinal Health DuraBlue™ Sterilization Wrap is intended to enclose another medical device that is to be sterilized by a health care provider in the Lumen, and Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX Low Temperature Sterilization Systems. The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) for 30 days. The DuraBlue™ Sterilization Wrap was validated to be effectively aerated during the pre-programmed Amsco® V-PRO® sterilization cycles.

Cardinal Health DuraBlue™ Sterilization Wraps are double layer sterilization wraps made from 100% polypropylene spunbond-meltblown-spunbond (SMS) fabric. They are intended to be used to enclose another medical device that is to be sterilized by a health care provider in the Lumen, or Flexible Cycles in the Amsco® V-PRO® 1, Amsco® V-PRO® 1 Plus and Amsco® V-PRO® maX Low Temperature Sterilization Systems. This wrap design allows for use of the simultaneous doublewrapping technique and also allows for a sterilized pack to be opened aseptically.

This submission covers six different models of Cardinal Health DuraBlue™ Sterilization Wrap. Each model is made from material of a different basis weight, though all models utilize the same material technology.

The provided document describes the Cardinal Health DuraBlue™ Sterilization Wrap, a medical device intended to enclose other medical devices for sterilization. The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that their device is "substantially equivalent" to an already legally marketed device (the predicate device) and therefore does not require a new Premarket Approval (PMA) application.

It's important to understand that a 510(k) notification primarily focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as the predicate device. The information provided about acceptance criteria and studies reflects this context.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets for each performance metric, which is common in a rigorous clinical validation study for novel devices. Instead, it describes general compliance with regulatory guidance and substantial equivalence to a predicate device. The performance is reported in terms of demonstrating efficacy and equivalence.

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

The document does not specify a "test set" in the context of a dataset with a specific sample size of cases for an AI/algorithm-based device. For this type of physical device (sterilization wrap), the "testing" involves laboratory and functional performance tests.

• Sample Size: Not explicitly stated as a number of "cases" as would be in AI/imaging studies. The testing involved "all models of DuraBlue™ Sterilization Wrap" across various Amsco® V-PRO® cycles and load configurations. The phrase "extensive performance testing" is used.
• Data Provenance: The studies are "performance testing" of the product itself, likely conducted in a laboratory setting by Cardinal Health or a contracted testing facility. There is no mention of country of origin of data or whether it was retrospective or prospective in the same way an AI study would report. It's inherent to device testing that it's prospective testing of the device's performance.

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

This section is not applicable to this type of device. The "ground truth" for a sterilization wrap is established by standardized testing protocols (e.g., microbial challenge tests, physical property evaluations) and adherence to regulatory guidance, not by expert consensus on "cases" as in diagnostic AI.

4. Adjudication Method for the Test Set

This section is not applicable to this type of device. Adjudication methods like "2+1, 3+1" are characteristic of clinical studies involving human observers interpreting data (e.g., radiology reads) where discrepancies need to be resolved. For a sterilization wrap, performance is typically measured against objective physical or biological criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses improvements in human reader performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a physical sterilization wrap. The "comparison" is to a predicate device's performance through substantial equivalence testing, not against human performance.

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

Not Applicable. This device is not an algorithm or AI system. It is a physical product (sterilization wrap).

7. The Type of Ground Truth Used

For this device, the "ground truth" is established through:

• Standardized Sterilization Efficacy Testing: This involves challenging the wrap with known biological indicators (spores) and verifying their inactivation after sterilization. "Successful completion of the sterilization performance tests" indicated direct measurement of sterilization effectiveness.
• Physical Property Measurements: Objective measurements of material strength, porosity, barrier properties, etc., before and after sterilization.
• Biocompatibility Testing: Adherence to standards like ISO 10993, which involves specific chemical and biological assays.
• Event-Related Sterility Maintenance: Demonstrating the ability to maintain a sterile barrier over time, often through microbial challenge and package integrity testing.

8. The Sample Size for the Training Set

Not Applicable. This device does not use machine learning or AI, and therefore does not have "training data" in that sense. The "training set" for manufacturing and quality control would involve internal testing of material batches and finished products, but not as part of an AI model's development.

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

Not Applicable. As there is no AI training set, there is no ground truth established for it. The performance of the device itself (its "ground truth") is established through the comprehensive testing described in point 7.

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The Amsco® V-PRO™ MAX 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 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:

• 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).
• 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 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilizers are self-contained 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.

The document is a 510(k) premarket notification for the Amsco V-PRO Low Temperature Sterilization Systems, specifically concerning modifications to the VAPROX® HC Sterilant cartridge. The study described focuses on demonstrating substantial equivalence of the modified product to previously cleared predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

Testing demonstrates that cups meet 0 time point and stability specifications at 3 months. |
| Sterilant cartridge design change | (No specific testing or acceptance criteria for design change are detailed in the provided table, but the document implies that the "Sterilant cartridge materials change" testing addresses both aspects.) | (Not explicitly stated for design change alone in the table.) | (Not explicitly stated for design change alone in the table.) |

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

• Sample Size for Test Set: The document does not explicitly state the sample size for the test set in terms of the number of cartridges tested. It mentions "Testing at time 0 and 3 months," suggesting a stability study over time.
• Data Provenance: The document does not specify the country of origin of the data. The study is prospective in nature, as it involves testing the modified product at specific time points (0 and 3 months) to evaluate its characteristics.

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

This type of information is not applicable to this study. The study focuses on the physical and chemical characteristics of a sterilant cartridge, not on diagnostic accuracy requiring expert interpretation (e.g., radiologists interpreting images). The "ground truth" here is the chemical and physical properties of the sterilant itself.

4. Adjudication Method for the Test Set

This information is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments where consensus is needed to establish ground truth, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical devices that involve human readers (e.g., CAD systems for image analysis), which is not the function of a sterilant cartridge.

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

No, a standalone performance study in the context of an algorithm or AI system was not done. This study concerns the physical and chemical characteristics of a sterilant cartridge and its substantial equivalence to predicate devices, not an independent algorithm's performance.

7. The Type of Ground Truth Used

The ground truth used in this study relates to the chemical and physical specifications of the sterilant. Specifically, the acceptance criteria for "Package Appearance," "Sterilant Color," "Clarity," "Hydrogen Peroxide Concentration," and "Sterilant pH" serve as the ground truth against which the modified sterilant cartridge is evaluated at different time points. These are objective measurements against established specifications.

8. The Sample Size for the Training Set

This study does not involve a "training set" in the context of machine learning or AI. The study is a direct performance and stability test of a medical device component.

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

Since there is no "training set" in this context, this question is not applicable. The "ground truth" for the performance evaluation (chemical and physical specifications) would have been established through a combination of engineering design specifications, industry standards, and regulatory requirements for sterilants.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 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: .
  • 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 o
  • • 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 K.083097 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.

The provided text describes the acceptance criteria and the study conducted for the STERIS Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems. The changes to the device described in this submission are an update to the device Operator Manual to include polyether ether ketone (PEEK) as a compatible material for the V-PRO 1 Cycle and V-PRO 1 Plus Lumen and Non Lumen Cycles; and polyurethane as a compatible material for the V-PRO 1 Plus Non Lumen Cycle.

Here's a breakdown of the requested information:

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 a separate "test set" sample size in the context of typical AI/ML studies (i.e., a dataset used for final model evaluation). Instead, the listed "tests" appear to be validation activities for the material compatibility claims.

• Sample Size: The document mentions that the Biocompatibility, Material Compatibility, ½ Cycle Sterilization Efficacy, Simulated Use Evaluation, and In Use Evaluation tests were completed for both polyurethane and PEEK.
  • For the V-PRO 1 Cycle / V-PRO 1 Plus Lumen Cycle, validation testing for lumen sizes used a maximum of twenty (20) lumens per load. 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. This was for the original K062297 clearance.
  • For the V-PRO 1 Plus Non Lumen Cycle, validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. This was for the original K083097 clearance.
  • The current submission adds PEEK and polyurethane, and these materials were subjected to the tests mentioned in the table. The exact number of PEEK/polyurethane items tested for each specific test is not detailed beyond "all polyurethane and PEEK containing devices" for the In Use evaluation.
• Data Provenance: The document does not specify the country of origin. Given it's a STERIS Corporation submission (located in Mentor, OH, USA) to the FDA, it is highly likely the studies were conducted in the USA or under US regulatory guidelines. The studies appear to be prospective validation studies rather than retrospective data analysis, as they involve performing specific tests to demonstrate safety and effectiveness for the new material claims.

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

This information is not directly applicable in the context of this device and study. The "ground truth" for a sterilizer device typically involves established scientific and regulatory standards for sterility (e.g., no microbial survivors). The validation studies involve laboratory testing and biological indicator challenges, not expert interpretation of outputs in the same way an AI diagnostic imaging system would. Therefore, there's no mention of "experts" establishing ground truth in terms of clinical image interpretation or similar tasks.

4. Adjudication Method for the Test Set

Not applicable. The study is based on laboratory and performance testing of a physical device and its sterilization efficacy, not on human interpretation or adjudication of data.

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

Not applicable. This is not an AI-assisted diagnostic device, but a sterilization system. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used in these studies is based on established sterilization principles and methods, primarily:

• Absence of Microbial Survivors: Demonstrated through biological indicators (e.g., spore strips) or direct microbial culture methods, particularly for "½ Cycle sterilization efficacy" and "Simulated Use evaluation."
• Biocompatibility Standards: Referring to established methods (e.g., ISO standards for cytotoxicity and residue analysis).
• Material Functionality: Assessed through engineering and functional tests to ensure the device maintains its intended performance after sterilization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no "training set." The studies are validation efforts for material compatibility of a physical sterilization system.

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

Not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device

The Amsco V-PROTM MAX 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 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
    a 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 Ibs.

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.
b 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
    C 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
    d 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 (subject of this submission). 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Amsco V-PRO MAX Low Temperature Sterilization System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "PASS" conclusion for each test, indicating that the device met the pre-defined success metrics for that particular test. The document provides a summary of test results and conclusions.

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

The document does not explicitly state a consolidated "test set" sample size in terms of the number of medical devices. However, it provides details for specific tests:

• AOAC Sporicidal Test: "All 720 carriers processed" - this implies a sample size of 720 biological indicator carriers for this specific test.
• Lumen Cycle Validation: "maximum of twenty (20) lumens per load."
• Non Lumen Cycle Validation: Validation load consisting of "two instrument trays and two pouches."
• Flexible Cycle Validation:
  • Load 1: "Two flexible endoscopes with a light cord"
  • Load 2: "One flexible endoscope with a light cord... and additional non-lumened instruments."
• Biocompatibility / Material Compatibility: "23 materials" were evaluated.
• Accessory Validation (SCBIs, Process Indicators): "Three lots" were tested for each accessory.

The data provenance is implicitly prospective testing conducted by STERIS Corporation. There is no mention of country of origin for the data, but it is a submission to the US FDA, so the studies would ideally follow relevant US or international standards for medical device testing.

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

This type of information is not provided in the document. Sterilization validation studies typically rely on established microbiological methods (e.g., spore log reduction, sterility testing of biological indicators) rather than human expert consensus for "ground truth" in the same way clinical diagnostic studies might. The "ground truth" here is the biological inactivation (sterility).

4. Adjudication Method for the Test Set

This information is not applicable for these types of technical performance studies. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human readers interpret images or make diagnoses, and a consensus is needed for the "ground truth." Here, the outcomes are objective (e.g., presence/absence of microbial growth, color change, successful sterilization).

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 used for diagnostic devices involving human interpretation (e.g., radiologists reading images and the AI assisting them). The Amsco V-PRO MAX is a sterilization system, and its effectiveness is determined by objective measures of microbial inactivation, not human diagnostic performance.

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

This concept is not applicable in the traditional sense for a sterilization device. The device itself (the Amsco V-PRO MAX Sterilization System) operates in a "standalone" fashion to sterilize instruments. Its performance is evaluated intrinsically through various tests described, without a human "algorithm interpreter" in the loop for its primary function. The "algorithm" here is the sterilization cycle itself.

7. Type of Ground Truth Used

The ground truth used in these studies is primarily microbiological sterility, based on the inactivation of highly resistant bacterial spores (Biological Indicators, e.g., using Geobacillus stearothermophilus spores which are highly resistant to hydrogen peroxide). Other ground truths include:

• Physical/Chemical Indicators: Color changes in chemical indicators (CIs) and process indicators (PIs) demonstrating exposure to sterilant.
• Material Compatibility: Physical integrity and biocompatibility verified through lab tests.
• Lumen Sterilization: Direct testing of the sterilization efficacy within lumens of various sizes.

8. Sample Size for the Training Set

Not applicable/Not provided. This is a physical device (sterilizer) and not a software algorithm that undergoes machine learning training. Therefore, there is no "training set" in the context of AI/ML. The device's parameters and cycles are designed and validated through engineering and scientific principles, not by learning from a data set.

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

Not applicable. As stated above, there is no training set for this type of device. The "ground truth" in its development would have been established through extensive research, development, and iterative testing, guided by microbiology, engineering, and material science principles to define optimal sterilization parameters.

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