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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.

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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 maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).

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

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 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 STERLINK™ 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).

The provided text describes the regulatory clearance of a medical device, the Tyvek® Roll with CI for STERLINK™ Sterilizer, by the FDA. It outlines the device's intended use, its technical characteristics compared to a predicate device, and the non-clinical testing performed to establish its substantial equivalence.

However, the request asks for specific details related to the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/Machine Learning (ML) device, including information like sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, and human reader improvement with AI.

The provided document does not describe an AI/ML device. It describes a physical medical device (sterilization wrap) and its chemical indicator. Therefore, the information requested about AI/ML specific study design elements (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI, ground truth establishment for AI models) is not present in the provided text.

The document focuses on non-clinical performance and safety testing of the physical sterilization wrap and its chemical indicator based on established ISO and ASTM standards.

Below is a summary of the acceptance criteria and performance as presented in the document for the physical medical device, acknowledging that it does not pertain to an AI/ML system.

Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)

The document details performance and safety tests for the "Tyvek® Roll with CI for STERLINK™ Sterilizer" against various standards. The acceptance criteria are implicit in the "Pass" result for each test against the specified standard.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

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

• The document does not specify the exact sample sizes (number of units tested) for each of the performance and safety tests listed. It only indicates that testing was "evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode."
• Data Provenance: The testing was conducted by Plasmapp Co., Ltd. (Applicant/Submitter based in South Korea) or their designated testing facilities. The specific geographical origin of the data (e.g., country) beyond the company's location is not further specified. The studies described are non-clinical (laboratory-based) performance and safety tests, not clinical studies on human subjects, so the "retrospective or prospective" designation as it applies to patient data is not applicable here.

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

• This question is not applicable as the device is a physical sterilization wrap and chemical indicator, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance is determined by adherence to established, quantitative engineering and biological standards (e.g., presence of sterilant, barrier integrity, physical strength).

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

• This question is not applicable as the device is a physical product and the testing involves adherence to quantitative standards, not subjective expert review or 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 question is not applicable as the device is a physical product (sterilization wrap) and its chemical indicator, not an AI-assisted diagnostic or interpretative tool for human readers.

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

• This question is not applicable as the device is a physical product, not an algorithm.

7. The type of ground truth used:

• The ground truth for the performance of the sterilization wrap and its chemical indicator is based on established standard specifications and laboratory testing protocols for material properties, sterilization efficacy, barrier integrity, and chemical indicator function (e.g., color change upon exposure to hydrogen peroxide). This is not expert consensus, pathology, or outcomes data in the context of diagnostic AI.

8. The sample size for the training set:

• This question is not applicable as there is no mention of a training set for an AI/ML model. The device underwent non-clinical performance and safety testing.

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

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

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The STERLINK™ FPS-15s 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™ FPS-15s 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.

The STERLINK™ FPS-15s 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 and cassette which are called the STERLINK™ and STERLOAD™, respectively. The STERLOAD™ cassette contains 59% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

Here's a breakdown of the acceptance criteria and study information for the STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical device sterilization submissions, the acceptance criteria are generally defined by adherence to recognized national and international standards. The "Reported Device Performance" in this context is the statement of "Pass" for each test, indicating that the device met the requirements of the specified standard.

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

The document does not explicitly state the specific number of "samples" in a general sense for each test. However, it does provide some details related to test conditions:

• Lumen Sterilization: Validation testing for lumen sizes was conducted using a maximum of five (5) lumens per load.
• Validation Studies (General): Validation studies were performed using a validation load with a total weight of 3.97 lbs.
• Data Provenance: The document generally refers to "non-clinical tests" performed using listed standards. There is no specific mention of country of origin for the data or whether the studies were retrospective or prospective. Given the nature of device validation, these tests are typically performed in a laboratory setting as prospective experiments.

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

This type of information (number and qualifications of experts) is generally not applicable to the validation of a sterilization device. The "ground truth" for sterilization efficacy is established through standardized microbiological testing using biological indicators and adherence to defined Sterility Assurance Levels (SALs). These are objective biological endpoints, not subjective expert interpretations.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The results are typically objective (e.g., growth or no growth of biological indicators, direct measurements of physical parameters) and do not require expert adjudication in the same way clinical image interpretation might.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a sterilization device, not an AI-powered diagnostic tool that relies on human readers or AI assistance.

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

Not applicable. This is a physical sterilizer and sterilant system, not an algorithm. Its performance is inherent to its design and chemical process, independent of human real-time interaction beyond operation.

7. The Type of Ground Truth Used

The ground truth used for sterilization efficacy is primarily microbiological endpoints, specifically:

• Sterility Assurance Level (SAL): Demonstrated by the inactivation of biological indicators (Geobacillus stearothermophilus) to a specified probability (e.g., 10^-6), as required by standards like ISO 14937.
• Sporicidal activity: Confirmed through tests like AOAC 966.04.
• Material compatibility: Assessed through various ASTM and ISO standards to ensure the device does not damage materials or leave harmful residues.
• Physical and Chemical Parameters: The ground truth for operational aspects (temperature, pressure, sterilant concentration, shelf-life, etc.) is based on established scientific principles and measured values.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." Its validation involves traditional engineering, chemistry, and microbiology testing.

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

Not applicable, as there is no training set for this device.

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