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The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK Plus 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 2.4 mm or larger and a length of 280 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of five (5) 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 with a total weight of 3 .97 lbs.

Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The materials compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).

The maximum load weight that can be placed in the Tyvek® roll is:

• · 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus
• 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer
• 1.54 pounds (0.7kg) for CHAMBER mode of STERLINK mini sterilizer

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1 :2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK sterilizer.

The Tyvek® Roll with CI for STERLINK Sterilizer is offered in the follow 1 type: · Sterilization roll. Flat

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.

Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterlization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

The self-contained biological indicator and chemical processing indicators are intended for use with.

• · CHAMBER mode of FPS-15s Plus sterilizer
• · CHAMBER mode of STERLink plus sterilizer
• · CHAMBER mode of STERLINK mini sterilizer

The STERLINK plus sterilizer with STERLOAD™ cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method.

This system consists of a main device connected pump module and cassette which are called the STERLINK plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant.

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or Mini-Bio Auto-Readers Incubators.

Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper, and plastic.

This document describes the acceptance criteria and supporting study for the STERLINK™ plus Sterilizer with STERLOAD™ Cassette and associated components (Tyvek® Roll with CI for STERLINK™ Sterilizer, Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), and Terragene Cintape® (CT40)).

The document asserts substantial equivalence to a predicate device (STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, K212200), and therefore, the acceptance criteria are generally met by demonstrating compliance with recognized standards and establishing equivalence in performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission demonstrating substantial equivalence to a predicate, specific numerical "acceptance criteria" for novel performance metrics are not explicitly stated in the provided text as they would be for a de novo device. Instead, the acceptance criteria are implicitly that the device performs as well as or better than the predicate device and meets established standards for sterilization, packaging, and indicators. The reported device performance is presented as "Pass" for compliance with these standards.

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 does not explicitly state the sample sizes used for each specific test or the country of origin/provenance of the data. It refers to various ISO and ASTM standards, which typically specify test methodologies and sample size requirements. The studies are non-clinical, likely laboratory-based evaluations to demonstrate performance against these standards. The submission originates from Plasmapp Co., Ltd. in South Korea, suggesting studies were likely conducted either internally or by contract research organizations, potentially in South Korea, in accordance with international standards. The studies would be prospective in nature, as they are tests performed on the device to prove its compliance with standards and equivalence.

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). The applicant is Plasmapp Co., Ltd., BVC-111, 125, Gwahak-ro, Yuseong-gu, Daejeon, 34141, Rep. of Korea (South Korea).
• Retrospective or Prospective: Implied to be prospective as the tests were conducted to demonstrate device performance against defined standards.

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

This submission is for a sterilization system and associated components, which are evaluated based on defined physical, chemical, and biological performance standards (e.g., sporicidal activity, material compatibility, chemical indicator color change) rather than interpretation of complex medical images or patient data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense (e.g., radiologists for an imaging device) is not directly applicable here. The "ground truth" is established by the well-defined parameters and pass/fail criteria of the referenced ISO and ASTM standards for sterility, material science, and indicator performance.
The experts involved would be laboratory technicians and engineers performing and verifying the tests, and potentially subject matter experts in sterilization science and engineering within Plasmapp and the regulatory body. Their qualifications are not specified but would be implicit in their roles and adherence to the testing standards.

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

Not applicable. This is a technical performance study against objective standards, not a diagnostic study requiring adjudication of expert interpretations.

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 device is a sterilization system and its accessories, not an AI-based diagnostic device intended for use by human readers.

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

Not applicable. This device is a physical sterilization system, not an algorithm.

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

The "ground truth" for the performance evaluation of sterilization devices and accessories typically refers to:

• Biological inactivation: Complete kill of test microorganisms (e.g., Geobacillus stearothermophilus spores) for sterilizers and biological indicators, confirmed through culture methods.
• Physical and chemical parameters: Confirmation that specified physical conditions (temperature, pressure, time) were met and chemical indicators changed appropriately, as defined by industry standards and internal specifications.
• Material integrity: No degradation or adverse effects on device materials after sterilization, as per material compatibility tests.
• Packaging integrity: Maintenance of sterility barrier, confirmed by physical and microbial barrier tests.

These 'ground truths' are established through validated laboratory tests against international and national standards (ISO, ASTM, AOAC).

8. The sample size for the training set

Not applicable. This is a hardware device (sterilizer, packaging, indicators) and not an AI/machine learning model that requires a training set.

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

Not applicable. As this is not an AI/machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in pouch plus mode and chamber mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The maximum load weight that can be placed in the Tyvek® roll is 1 lb (450g) for pouch plus mode and 3.97 bs (1.8kg) for chamber mode.

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2015) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the following one type:

· Sterilization roll, Flat

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

This prompt describes a medical device, specifically a "Tyvek® Roll with CI for STERLINK™ Sterilizer," and provides information about its regulatory submission (K223025) and comparison to a predicate device (K212198). The document focuses on regulatory approval based on demonstrating substantial equivalence, primarily through non-clinical testing.

However, the provided text does not describe an AI/ML powered medical device and therefore does not contain information typically associated with acceptance criteria or studies used to prove performance for such devices. The questions in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types) are all relevant to the validation of AI/ML algorithms, not to the physical properties and sterilization efficacy of a sterilization wrap.

Therefore, I cannot directly answer your detailed questions about acceptance criteria and study design as if this were an AI/ML device. The information provided is for a traditional medical device (sterilization wrap with a chemical indicator).

Here's how I can address the request based on the actual content of the document:

The document provides a summary of non-clinical testing performed to demonstrate that the subject device (Tyvek® Roll with CI for STERLINK™ Sterilizer) is substantially equivalent to a predicate device, focusing on its ability to maintain sterility and the performance of its chemical indicator.

Acceptance Criteria and Study for a Traditional Medical Device (Sterilization Wrap):

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test but states "Pass" for all performed tests, indicating that the device met the requirements of the standards cited. The acceptance criteria are implicitly defined by the successful completion of the referenced standards.

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

• The document does not specify the exact sample sizes for each of the non-clinical tests listed.
• Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. The tests were performed as part of the regulatory submission by Plasmapp Co., Ltd. (South Korea) and its manufacturer Sigma Medical Supplies Corp.

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

• This is not applicable to the non-clinical performance testing of a sterilization wrap. "Ground truth" in the context of material science and sterilization efficacy is established by validated laboratory testing against specified standards, not expert human interpretation.

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

• This is not applicable as the evaluation involves meeting established engineering and biological standards, not human interpretation requiring 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 as the device is a physical sterilization wrap, not an AI-assisted diagnostic or decision-support tool.

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

• This is not applicable as the device is a physical sterilization wrap.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by validated laboratory testing against recognized international and national standards (e.g., ISO 14937, ANSI/AAMI/ISO 11140-1, ASTM series, DIN 58953-6). For biocompatibility, it's ISO 10993-5. For chemical indicator performance, it involves observable color changes under controlled sterilization conditions as per ISO 11140-1.

8. The sample size for the training set:

• This is not applicable as there is no AI/ML algorithm involved that would require a training set.

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

• This is not applicable for the same reason as above.

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The STERLINK mini sterilizer with STERLOAD™ mini cassette 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. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK mini 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 1.6 mm or larger and a length of 200 mm or shorter

*The validation testing was conducted using a maximum of five (5) 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 with a total weight of 1.54 lbs.

Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The materials compatible for use in the Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in Chamber mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HDPE), Polypropylene (PP), Polytetrafluoroethylene (PTFE) and Silicone (Hardness 50).

The maximum load weight that can be placed in the Tyvek® roll is:

• · 3.97 pounds (1.8 kg) for CHAMBER mode of FPS-15s Plus sterilizer
• · 1.54 pounds (0.7 kg) for CHAMBER mode of STERLINK mini sterilizer

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140 1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.

Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

The self-contained biological indicator and chemical processing indicators are intended for use with:

• · CHAMBER mode of FPS-15s Plus sterilizer
• · CHAMBER mode of STERLINK mini sterilizer

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This system consists of a main device connected pump module and cassette which are called the STERLINK mini and STERLOAD™ mini cassette, respectively. The STERLOAD™ mini cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed medical devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINKIM Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or MiniBio Auto-Readers Incubators.

Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.

The provided text describes acceptance criteria and study results for medical sterilization devices (STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, and Sterilization Process Indicator for STERLINK Sterilizer).

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

1. Table of Acceptance Criteria and Reported Device Performance

Device: STERLINK mini Sterilizer with STERLOAD™ mini Cassette

• Test with gas inoculum: Only a maximum 15 colonies should grow out of a total of 10 bacterial permeability testers. The number of colonies in each bacterial permeability tester should not be greater than five. | Pass |
  | Residual sterilant on Tyvek® validation | To confirm the time required for the residual sterilant to be reduced to a safe amount after sterilization in accordance with the internal test standard. | ≤ 0.05 ppm | Pass |
  | Biocompatibility test | To confirm the biological safety after sterilization in accordance with ISO 10993-5. | ≤ Grade 2 | Pass |

Device: Sterilization Process Indicator for STERLINK™ Sterilizer (BT96, CD42, CT40)

Additional Study Information:

The provided text describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, not clinical studies involving human patients or complex AI algorithms requiring ground truth from experts. The devices are sterilizers and sterilization indicators, which are typically evaluated through microbiological and engineering performance testing.

Therefore, many of the specific questions about "test set," "ground truth," "experts," "adjudication," and "AI assistance" are not directly applicable to the type of device and testing described in this document.

For completeness, here's what can be extracted or inferred:

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

   • Sample size: Not explicitly stated as a single "test set" size. The text mentions "maximum of five (5) lumens per load" for lumen sterilization validation and "a validation load with a total weight of 1.54 lbs." for the sterilizer. For the Tyvek roll microbial barrier test, it mentions "a total of 10 bacterial permeability testers." Specific quantities for other tests are not provided.
   • Data provenance: Not specified. These are non-clinical engineering and microbiological tests, likely conducted in a laboratory setting by the manufacturer (Plasmapp Co., Ltd. and Terragene S.A.). The country of origin of the manufacturer is South Korea for Plasmapp and presumably Argentina for Terragene (as it's a known Argentinian company). The studies are "non-clinical tests," implying they were conducted in a controlled environment, not on human subjects.

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): Not applicable. The tests are laboratory-based and use established microbiological and engineering standards (e.g., ISO, ASTM, AOAC). "Ground truth" is determined by scientific measurements and observation of bacterial kill, physical properties, or chemical indicator changes, not by expert consensus on subjective interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., radiological reads) where multiple experts might disagree. These tests are objective measurements against defined standards.

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. These devices do not involve "human readers" interpreting "cases" with or without "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm component to these devices described in the document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these sterilization and chemical indicator tests is based on:

   • Microbiological kill: Demonstrating the inactivation of a specified population of resistant spores (e.g., Geobacillus stearothermophilus) to a defined Sterility Assurance Level (SAL), typically 10^-6^. This is confirmed through laboratory culture methods.
   • Physical and chemical property measurements: Adherence to established engineering standards (e.g., tensile strength, burst pressure, color change properties of chemical indicators).
   • Safety standards: Compliance with international safety and electromagnetic compatibility standards.

8. The sample size for the training set: Not applicable. These devices do not involve machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

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