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The patient-specific BC Reflex Unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee,
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific BC Reflex Uni™ components fit within an envelope of dimensions that are specific to each patient. The BC Reflex Uni™ femoral component and tibial baseplate are intended for cemented fixation.

The BC Reflex Uni™ Knee System is a patient-specific unicompartmental knee system that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial implants and single-use instruments are manufactured from CAD and CAM files generated from Bodycad software that are based on MRI or CT images of the patient's knee and surgeon input.

This FDA 510(k) summary does not contain information about an AI-powered device or software. It pertains to a physical medical device, the BC Reflex Uni™ Knee System, which is a patient-specific unicompartmental knee system. The submission focuses on changes to sterilization methods and minor design updates, not on a diagnostic or prognostic algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for an AI device. The document does not discuss:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study that proves an AI device meets such criteria.
• Sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for AI ground truth.
• MRMC studies or standalone AI performance.
• Training set details for an AI model.

The "performance data" section (G) in the document refers to validation and verification activities for device sterilization, biocompatibility, packaging, and cleaning processes, which are standard for physical medical devices and unrelated to AI performance.

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The V-PRO® maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and 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 and Fast Non Lumen Cycle.

The Non Lumen Cycle can sterilize: †

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

t: 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 Fast Non Lumen Cycle can sterilize: *

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

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The 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 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

The V-PRO maX 2 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, V-PRO maX and V-PRO 60 Sterilizers.

As with the predicate device (K162413), the V-PRO maX 2 Sterilizer has three preprogrammed cycles (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) with a fourth added (the Fast Non Lumen Cycle). The V-PRO maX 2 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 2 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its four 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.

The provided text describes the V-PRO® maX 2 Low Temperature Sterilization System, a medical device for sterilizing instruments. It is a 510(k) premarket notification, indicating it is intended to be substantially equivalent to a predicate device, not a new type of device requiring extensive clinical trials for efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to performance tests demonstrating substantial equivalence to the predicate device and the general efficacy of the sterilization process.

Here's an breakdown based on your request, interpreting "acceptance criteria" as the required successful outcomes of the performance tests for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily discusses device performance and sterilization efficacy, not diagnostic accuracy where "test sets" of patient data are typically used. Instead, the "test set" here refers to the biological indicators (BIs) and test loads used in the sterilization efficacy studies.

• AOAC Sporicidal Test: "All 720 carriers processed using 3 lots of EOSL sterilant were sterile." This implies a total of 720 biological indicators (carriers).
• Other Efficacy Tests (D-value, Total Kill, 1/2 Cycle Verification, Simulated Use, In Use): These tests involve specific "validation loads" and "worst-case conditions."
  • Non Lumen Cycle: Validation load of two instrument trays for a total weight of 50 lbs (22.7 kg).
  • Fast Non Lumen Cycle: Validation load of one pouched instrument tray for a total weight of 11 lbs (5 kg).
  • Flexible Cycle (Load Config 1): Two flexible endoscopes, each packaged into a tray with silicone mat and light cord.
  • Flexible Cycle (Load Config 2): One flexible endoscope in a tray with silicone mat and light cord, plus an additional instrument tray and one pouch for a total weight of 24 lbs (11 kg).
  • Lumen Cycle: A maximum of 20 lumens per load, using a validation load of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).
  • "Patient-soiled, clinically-cleaned, medical instruments" were used for the in-use test.

Data Provenance: The studies were conducted by the device manufacturer (STERIS Corporation) internally as part of their premarket notification for the Food and Drug Administration (FDA) in the USA. These are laboratory and simulated/actual use tests, not human data. The context implies these are prospective tests designed to prove the device's performance.

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

This information is not applicable in the context of device sterilization validation. "Ground truth" for sterilization is established by scientific principles of microbial inactivation (e.g., whether biological indicators containing a known number of resistant spores are killed), rather than expert consensus on interpretive tasks. The methodology for assessing sterility (e.g., incubation of biological indicators) relies on established microbiological techniques.

4. Adjudication Method for the Test Set:

Not applicable. Sterility tests involve objective outcomes (growth or no growth of microorganisms). There is no "adjudication" in the sense of resolving disagreements between human readers, as for an AI diagnostic tool.

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 is relevant for diagnostic devices where human readers interpret medical images or data, and AI might assist in that interpretation. This document is about a sterilization device, which does not involve human interpretation of output in that manner.

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

The device itself is a "standalone" sterilizer. Its performance is evaluated purely on its ability to sterilize medical instruments, without human intervention in the sterilization process once initiated. The tests performed (e.g., AOAC Sporicidal Test, D-value determination) are indeed standalone assessments of the device's efficacy. There is no "human-in-the-loop" concept for the primary function of sterilization.

7. The Type of Ground Truth Used:

The ground truth used for these performance tests is microbiological eradication/inactivation.

• For the AOAC Sporicidal Test, D-value, and Total Kill Endpoint, the ground truth is the absence of viable microorganisms (specifically, highly resistant bacterial spores like Geobacillus stearothermophilus). This is determined by standard microbiological culture techniques (e.g., incubating biological indicators and observing for growth).
• For the "In Use Test," the ground truth for successful sterilization of patient-soiled instruments would similarly be the absence of microbial growth from processed items.
• For biocompatibility and material compatibility, the ground truth is established through standardized cytotoxicity assays and visual / functional assessment of materials following repeated processing.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical sterilizer and not an AI/machine learning model that undergoes "training." Its operational parameters are designed and validated based on scientific principles of sterilization, not statistical inference from a training dataset derived from "training examples."

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

Not applicable, as there is no "training set" in the context of this traditional device validation.

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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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KIMGUARD ONE-STEP* Sterilization Wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132°C for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F/55°C and 40% - 80% relative humidity for 60 minutes. KIMGUARD ONE-STEP* Sterilization Wrap is also intended to be used in the Amsco® V-PRO™ 1 Low Temperature Sterilization System's cycle, the Amsco® V-PRO™ 1 Plus Low Temperature Sterilization System's Lumen (identical to the V-PROTM 1 Cvcle) and Non Lumen Cycles, and the V-PRO™ Low Temperature Sterilization System's Flexible Cycle. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened within the period of time for which performance data demonstrating maintenance of sterility has been provided. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 °C or 12 hours at 43.3 °C. The KIMGUARD ONE-STEP* Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 300, 400, 500, and 600. The KIMGUARD ONE-STEP* Sterilization Wrap was validated to be effectively aerated during the pre-programmed V-PRO™, the V-PRO™ 1 Plus, and the V-PRO™ Flexible Sterilization Cycles.

KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization.

KIMGUARD ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously. The sheets of sterilization wrap are square or rectanqular fabric produced usinq a polypropylene three-layer SMS (spunbond-meltblown-spunbond) process.

The KIMGUARD ONE-STEP* Sterilization Wrap is intended to maintain the sterility of enclosed medical devices until opened, after being sterilized by prevacuum steam, 100% ethylene oxide (EO), or specific Amsco® V-PRO™ Low Temperature Sterilization System cycles.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KIMGUARD ONE-STEP* Sterilization Wrap are related to its ability to maintain sterility after various sterilization methods for specified durations. The reported device performance indicates that the wraps meet these criteria.

Note regarding other criteria: The document also mentions other validated parameters, which, while not presented in a table format with specific acceptance criteria and performance data like sterility maintenance, were assessed for the device. These include:

• Aeration times for EO sterilization: 8 hours at 55 °C or 12 hours at 43.3 °C.
• Dry times for pre-vacuum steam sterilization: 20 minutes for Models 100 and 200; 30 minutes for Models 300, 400, 500, and 600.
• Effective aeration during V-PRO™, V-PROTM 1 Plus, and V-PROTM Flexible Sterilization Cycles.
• Biocompatibility (irritation and sensitization) in compliance with ISO 10993.
• Sterilant penetration characteristics.
• Physical integrity.

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

The document provides specific details for the maximum wrapped package content weights and descriptions of loads used in the sterility maintenance validation studies for each wrap model and sterilization cycle. These descriptions indicate the specific items (e.g., huck towels, fluid-resistant drapes, metal mass) and their quantities/weights that constituted the 'samples' or 'test sets' used for validating sterility maintenance.

• Pre-Vacuum Steam and Ethylene Oxide Sterilization Cycles (Table 1):

  • KC100 (3 lbs): 16 huck towels (17"x 29")
  • KC200 (6 lbs): 2 huck towels (17"x 29"), 2 fluid resistant U-drape (68"x109"), 1 fluid resistant universal bar drape (70" x 108")
  • KC300 (9 lbs):
    • Pre-Vacuum Steam: 15 huck towels (17"x 29"), 1 small fluid resistant drape (60"x 76"), 5 lbs of metal mass
    • EO: 16 huck towels, 2 fluid resistant large drapes (76"x100"), 1 fluid resistant small drape (76"x60"), 1 fluid resistant table cover (60"x 90")
  • KC400 (13 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 11 lbs of metal mass
  • KC500 (17 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 15 lbs of metal mass
  • KC600 (25 lbs): 4 tray liners 20" x 25" stacked, 10" x 10" x 3 ½ " tray containing 23 lbs of metal mass

• Amsco V-PRO™ Low Temperature Sterilization System (Table 2):

  • KC100 (3 lbs): 3 lbs metal mass, 6 forceps
  • KC200 (6.5 lbs): 2.5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC300 (9 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC400 (10 lbs): 6 lbs metal mass, 6 forceps, V-PRO tray (17" x 10" x 3½") at 4 lbs
  • KC500 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs
  • KC600 (10 lbs): 5 lbs metal mass, 6 forceps, V-PRO tray (21" x 10" x 3½") at 5 lbs

The document does not specify the exact number of replicates (i.e., how many times each load/wrap combination was tested) within these studies. The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin, but it is part of a 510(k) submission to the US FDA, implying the studies were conducted to meet US regulatory requirements.

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 sterility maintenance studies of this nature, the "ground truth" is typically established through microbiological culture methods to detect microbial ingress, rather than expert interpretation of images or other subjective assessments.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method, as the sterility maintenance testing would involve objective laboratory assessments (e.g., growth or no-growth in culture media) rather than subjective expert review needing adjudication.

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 wrap, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are irrelevant to its evaluation.

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

This is not applicable for the same reasons as #5. The device is a physical product, not an algorithm.

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

The ground truth for sterility maintenance testing would be based on microbiological assay results (i.e., sterility testing). If a wrapped package is challenged and subsequently tested for the presence of viable microorganisms, the absence of growth would indicate sterility was maintained. This is a direct, objective measure of the device's primary function in this context. Other aspects like biocompatibility (ISO 10993) would use endpoints specified by that standard.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

This is not applicable for the same reasons as #8.

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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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