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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.

Ask a specific question about this device

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 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 the STERLINK™ FPS-15s Plus sterilizer when operating in pouch plus and chamber mode.

Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are single-use 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 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 single-use 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 is a 510(k) premarket notification for sterilization process indicators (biological and chemical). It describes the devices, their intended use, and comparison to existing predicate devices. However, the document does not contain the specific details about acceptance criteria, the study design, sample sizes, expert involvement, or adjudication methods that would be relevant for an AI/ML-based medical device where the AI algorithm's performance is being evaluated.

The document is about physical indicators and readers used to monitor sterilization processes, not an AI/ML device that analyzes data or images. Therefore, many of the questions asked in the prompt (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not applicable to the information contained in this 510(k) submission.

The "Performance Data" section (page 7 of the PDF) simply lists the standards that were used for non-clinical testing and states that the device "Pass"ed those tests. It does not provide the numerical results or the methodology for proving "Pass" beyond stating compliance with the standards.

Given the content, I can only provide information relevant to the type of device described:

Based on the provided document (K223023 for physical sterilization process indicators and readers):

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

The document does not detail specific quantitative acceptance criteria or reported device performance beyond stating compliance with established standards. The general "performance" is indicated by "Pass" for various tests as per the relevant ISO/ANSI/AAMI standards.

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

The document does not specify exact sample sizes for each test. The testing is based on compliance with international and FDA standards (e.g., ISO 11138-1, ISO 11140-1), which would define the types and minimum numbers of samples required for such tests. The provenance of the data is implied to be from testing conducted by or for Plasmapp Co., Ltd. (South Korea) to support regulatory submission. It is by nature prospective testing for regulatory clearance.

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

Not applicable. This device does not involve expert interpretation of data or images to establish ground truth in the way an AI/ML device would. Ground truth for these sterilization indicators is established by physical/chemical measurements and biological assays (e.g., spore viability, color change under specific conditions) rather than expert consensus on complex diagnostic images.

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

Not applicable. No expert adjudication is involved.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

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

7. The type of ground truth used:

The ground truth for these devices is based on established scientific principles of sterilization, microbiology, and chemistry, as defined by the referenced standards:

• For the Biological Indicator: Viable spore population counts, D-value determination (time required to reduce spore population by 90% at a given temperature), survival time, and kill window studies using standard microbiological methods.
• For Chemical Indicators: Specific color changes occurring when exposed to defined concentrations and durations of sterilant agents, tested under controlled conditions.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% 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 the STERLINK™ FPS-15s Plus when operating in chamber mode.

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® IC10/20FR, 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 a 510(k) premarket notification for sterilization process indicators (biological and chemical) for use with a specific sterilizer. The study is a non-clinical performance test, and as such, several of the requested sections regarding AI/human reader performance, ground truth establishment, and training sets are not applicable.

Here's an analysis of the acceptance criteria and study as presented:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly defined by the "Pass" result, meaning the device met the requirements of the referenced standard or guidance document. The actual quantitative thresholds for "Pass" are not detailed in this summary but would be specified within the referenced standards (e.g., ANSI/AAMI/ISO 11138-1:2017).

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

The document does not explicitly state the sample sizes used for each specific test. However, the tests are non-clinical, laboratory-based studies rather than human subject trials. The data provenance would be the laboratory where these tests were conducted, likely in South Korea (Plasmapp Co., Ltd. is based there, and Terragene® S.A. is the manufacturer). These studies are inherently prospective in nature as they involve testing the devices against established standards.

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

Not applicable. This is a non-clinical performance study of sterilization indicators, not a study evaluating human interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by the physical or chemical standards and performance requirements outlined in the referenced ANSI/AAMI/ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method in this type of non-clinical performance testing. The tests yield objective, quantitative or qualitative results (e.g., spore kill, color change, D-value measurements) that are then compared against predefined criteria in the standards.

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

No, an MRMC study was not done. This is a non-clinical performance study of sterilization process indicators, not a diagnostic device that would involve human readers interpreting results.

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

This concept is not directly applicable. The device itself (the biological and chemical indicators) is not an "algorithm" in the typical sense of AI. The performance tests evaluate the physical and chemical characteristics of the indicators in a standalone manner against the specified standards, without human intervention in the measurement of their performance (though human technicians certainly perform the tests).

7. The Type of Ground Truth Used

The ground truth used for these performance studies is based on established industry standards and regulatory guidance documents. Specifically:

• ANSI/AAMI/ISO 11138-1:2017: Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements.
• ANSI/AAMI/ISO 11140-1:2014: Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements.
• FDA Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions.
• FDA Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators.

These standards define the expected performance characteristics (e.g., spore population, resistance, color change properties, stability) that the devices must meet.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical performance study of physical devices, not an AI model requiring a training set.

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

Not applicable. As this is not an AI model, there is no training set and therefore no ground truth established for one. The "ground truth" for the device's acceptable performance is defined by the rigorous specifications and testing protocols within the aforementioned international standards and FDA guidance documents.

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Terragene Chemdye® Bowie-Dick Test Pack (BD125X/1), Bowie-Dick Test Card (BD8948X/1) and Bowie-Dick Test Sheet (BDA4/1) are designed for testing air removal efficiency for cycles of 132ºC for 3.5 minutes in dynamicair-removal steam sterilizers.

Not Found

This document is a marketing authorization letter for a device and therefore does not contain the detailed information necessary to answer some of the questions. Specifically, it does not include information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

However, based on the provided text, here's what can be extracted:

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

This information is not available in the provided document. The document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.

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

This information is not available in the provided document.

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

This information is not available in the provided document.

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

This information is not available in the provided document.

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 information is not available in the provided document. The device, Terragene Chemdye® Bowie-Dick Test Pack, Bowie-Dick Test Card, and Bowie-Dick Test Sheet, are chemical indicators for sterilization processes, not an AI-powered diagnostic tool that would typically involve human readers.

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

This information is not applicable/not available for this type of device. The devices are chemical indicators that change color to show air removal efficiency, and their performance is inherently standalone in their function (i.e., they indicate a condition without human interpretation of an algorithm's output).

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

This information is not available in the provided document. For Bowie-Dick tests, the "ground truth" would typically be established based on standardized test procedures and expected color changes under validated sterilization conditions.

8. The sample size for the training set:

This information is not applicable/not available in the provided document. The devices are chemical indicators, not machine learning algorithms that require a "training set."

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

This information is not applicable/not available for this type of device.

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Terragene Bionova® SCBI (BT224) is a self-contained biological indicator inoculated with viable 10 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

Terragene Bionova® PCD (PCD224-C, PCD224-2) and Integron® PCD (PCD26-C, PCD26-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification processes.

Terragene Bionova® Reader Incubators (10/20FRLCD, 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 Bionova® SCBI (BT110) is a self-contained biological indicator inoculated with viable 106 Bacillus atrophaeus bacterial spores and is intended for monitoring the efficacy of ethylene oxide sterilization processes.

The integrator Terragene Integron® IT12 is designed to chemically react over time with the critical parameters of ethylene oxide sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: 55°C for 240 minutes, 600 mg/l, RH 60 %, SV37°C/75 min., SV54°C/30 min, SV55°C/28 min.

Terragene Chemdye® CD16 is a chemical process indicator intended for monitoring the efficacy of ethylene oxide sterilization processes. The chemical indicator changes from purple/brown to green to indicate that the conditions of the cycle have been met.

Terragene Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT95 is Rapid Readout while BT96 is Super Rapid Readout. BT95 has Ranid readout at 2 hours at 60° C while BT96 has Super Rapid readout at 30 minutes at 60° C.

Terragene Chemdye® (CD40, CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from purple to green for CD40 and red to vellow for CD42 to indicate that the conditions of the cycle have been met.

The integrator Terragene Integron® TT26-1YS is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121° C for 30 minutes, 132° C for 25 minutes, 135° C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min.

The integrator Terragene Integron® IT26-C is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity Displacement: 121°C for 30 minutes, 132°C for 15 minutes, 135°C for 25 minutes, 135°C for 10 minutes; Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes. SV121° C/16.5 min., SV132° C/2.0 min, SV135° C/1.2 min..

Terragene Chemdye® CD29 is a chemical process indicator intended for monitoring the effication processes. The chemical indicator changes from yellow to dark brown/black to indicate that the conditions of the cycle have been met.

Terragene Cintape® CT22 is a chemical process indicator tape intended for monitoring the efficacy of steam sterilization processes. The indicating tape changes from yellow to dark brown/black when exposure to steam.

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.

Not Found

This document describes the FDA's acceptance of a premarket notification for sterilization process indicators, not an AI-powered medical device. Therefore, the provided text does not contain the information required to answer your request about acceptance criteria and a study proving an AI device meets those criteria.

The document discusses:

• Medical devices: Terragene Bionova® SCBI, Terragene Bionova® PCD, Terragene Bionova® Reader Incubators, Terragene Integron®, Terragene Chemdye®, Terragene Cintape®.
• Purpose: Monitoring the efficacy of various sterilization processes (steam, ethylene oxide, vaporized hydrogen peroxide).
• Regulatory status: Class II medical devices, subject to general controls.
• Indications for Use: Detailed descriptions of what each device monitors and how it indicates sterilization efficacy (e.g., color changes, fluorescence read times).

There is no mention of AI, algorithms, human readers, or expert consensus on AI performance, which are all key elements of your request.

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