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Sterisheet Sterilization Wraps are single use non-woven sterilization wraps intended to enclose medical devices that are to be sterilized at a healthcare facility. They are used in the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Sterisheet Sterilization Wraps are single use, non-sterile sterilization wraps constructed from cellulose, synthetic fibers (polypropylene), and synthetic binders, with the addition of pigmentation. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer. Devices must be wrapped following manufacturer's instructions. After completion of the sterilization process, Sterisheet Sterilization Wraps maintain sterility of the enclosed medical devices for at least 3 months.

The provided document is a 510(k) premarket notification for a medical device called "Sterisheet Sterilization Wrap." It is not a document describing a study of an AI/ML powered device, nor does it contain information about acceptance criteria and performance data for such a device.

The product in question is a physical sterilization wrap, and the performance testing mentioned relates to its physical properties, material compatibility, biocompatibility, shelf life, and its ability to allow sterilant penetration and maintain sterility. The "study that proves the device meets acceptance criteria" refers to bench tests of a physical product, not a study of an AI/ML algorithm's performance.

Therefore, I cannot answer your request as it pertains to an AI/ML device study. The document does not contain any of the information you requested regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes for a test set (in the context of an algorithm).
• Data provenance (country, retrospective/prospective) for an algorithmic test set.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods for an algorithmic test set.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document is solely a regulatory submission for a traditional medical device.

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The Anprolene SteriTest consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated BI receptacle in the sterilizer. It monitors the efficacy of the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer. Critical process parameters for the cycle are summarized in Table 1.

The Anprolene® SteriTest consists of a single-use self-contained biological indicator (SCBI) placed in a reusable BI receptacle. It is designed for monitoring the efficacy of the 12 hour sterilization cycle at 20-29°C in an Anprolene AN75 Ethylene Oxide Gas Sterilizer.

The SCBI, the EZTest - Gas Biological Indicator, consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing modified soybean casein digest broth and phenol red acting as a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure.

Following manufacturer's instructions, the operator inserts the SCBI into the reusable BI receptacle on the purge probe of the Anprolene AN75 Ethylene Oxide Gas Sterilizer, and initiates a 12 hour cycle at 20-29°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from blue to a green/brown color depending on the duration of ethylene oxide exposure. The activated SCBI and an unprocessed control are incubated at 30-35℃ for 48 hours, and monitored for any color change and/or turbidity. Evidence of microbial growth by color change from red-orange to yellow and/or turbidity must be interpreted as a failure to meet the conditions necessary for sterilization (failed cycle); no color change or turbidity indicates conditions for sterilization were achieved (passed cycle).

This document describes the Anprolene SteriTest, AN7508.14, a self-contained biological indicator for monitoring ethylene oxide gas sterilization. The information provided focuses on the performance testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of biological indicators (sample size) used for each individual test (e.g., functionality, shelf life) in numerical terms for the test set. It mentions "each half dose cycle" and "each full dose cycle" and "each worst-case load," implying multiple tests were conducted under these conditions.

The data provenance is from laboratory bench tests conducted by Andersen Sterilizers, Inc. (the manufacturer). The text does not specify the country of origin of the data beyond implicitly being associated with the manufacturer. The studies are prospective in nature, as they are specifically conducted to validate the device's performance against defined criteria.

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

Not applicable. This is a biological indicator for sterilization, and the "ground truth" for its performance is established through microbiological testing (e.g., growth or no growth of spores) and physical measurements against established standards, not through human expert interpretation of images or data in the same way a diagnostic AI might require. The "experts" involved would be microbiologists and sterility assurance professionals conducting and interpreting the tests according to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from multiple human readers in diagnostic studies. For biological indicators, the outcome is determined by the objective results of microbiological assays (e.g., color change indicating growth or no growth) and adherence to established physical/chemical parameters for resistance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing how AI assistance impacts reader performance. The Anprolene SteriTest is a biological indicator, a device that provides an objective output (color change/turbidity) to monitor a sterilization process, not a diagnostic tool requiring human interpretation with or without AI.

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

Yes, the performance evaluation of the Anprolene SteriTest is inherently a "standalone" assessment of the device itself. The biological indicator (which can be considered the 'algorithm' in this context, albeit a physical/biological one) is placed in a sterilizer, and its output (color change upon incubation) directly indicates the success or failure of the sterilization cycle. Human involvement is for placement, retrieval, activation, and interpretation of the objective result, but the indicator's performance is intrinsic to its design and biological response, not a human-in-the-loop diagnostic process.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on microbiological viability (growth or no growth of Bacillus atrophaeus spores) and physical/chemical parameters of the sterilization cycle.

• Microbiological Ground Truth: This is established by observing whether the Bacillus atrophaeus spores on the indicator survive (indicated by growth and color change) or are killed (no growth, no color change) under defined sterilization conditions (full dose, half dose).
• Performance Standards Ground Truth: The tests adhere to established regulatory and consensus standards such as FDA 2007 "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions" and AAMI/ANSI/ISO 11138-1 "Sterilization of health care products – Biological indicators - Part 1: General requirements." These standards define the expected response characteristics (e.g., specific D-value equivalent, partial kills, full kills).

8. The Sample Size for the Training Set

Not applicable. Biological indicators like the Anprolene SteriTest are not "trained" in the way an AI algorithm learns from a training set. Their performance is inherent to their design, the number of spores, and their resistance characteristics. The tests described are for validation, not training.

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

Not applicable, as there is no "training set" for this type of device. The device's performance is based on established scientific principles of microbiology and sterilization, and tested against those principles.

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AN85/AN86 EO Indicators are single-use Type 1 process indicators used to distinguish between processed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.

AN85/AN86 EO Indicators are adhesive-backed Type 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.

AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.

The provided document describes the acceptance criteria and a study demonstrating that the AN85/AN86 EO Indicators meet these criteria.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in terms of number of actual indicators used. The testing was described as "Performance testing" characterized in a Chemical Indicator Evaluator Resistometer (CIER) and an Anprolene AN75 Ethylene Oxide Gas Sterilizer.

• Sample size: Not explicitly quantified. The document states "AN85/AN86 EO Indicators" or "subject AN85/AN86 EO Indicators" were tested, implying a sufficient number for the experiments, but a specific count is not given.
• Data provenance: Prospective. The performance testing was conducted specifically to demonstrate the safety and effectiveness of the AN85/AN86 EO Indicators for their intended use with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

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

Not applicable. This device is a chemical indicator, not a diagnostic device requiring human expert interpretation in the traditional sense for establishing ground truth. The "ground truth" for its performance is determined by its chemical reaction to ethylene oxide under controlled conditions, producing a visible color change.

4. Adjudication method for the test set

Not applicable. As noted above, the performance of a chemical indicator is based on its visible color change response to chemical exposure, rather than a subjective interpretation requiring adjudication. The "Pass" results in the summary table indicate that the indicators successfully met the predefined chemical and physical criteria for each test.

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 chemical indicator, not an AI-powered diagnostic device. No human reader studies (MRMC or otherwise) were conducted or are relevant.

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

Not applicable. This is a chemical indicator; there is no algorithm involved. The "standalone" performance means the indicator itself (the physical device) was tested.

7. The type of ground truth used

The ground truth for the AN85/AN86 EO Indicators is based on:

• Controlled chemical and physical exposure: The indicators are exposed to precisely defined ethylene oxide sterilization cycle parameters (temperature, time, gas concentration, humidity) in a Chemical Indicator Evaluator Resistometer (CIER) and the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
• Observable color change: The ground truth is the predictable and consistent color change from "yellow-green to blue" when exposed to these parameters, and no color change when not exposed.
• Compliance with standards: Adherence to ISO 11140-1 for Type 1 process indicators.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not a machine learning model that requires a training set.

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

Not applicable. This is a chemical indicator, not a machine learning model.

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The Tyvek Sterilization Pouches with Chevron Seal are intended to enclose medical devices that are to be sterilized in a single pouch configuration at a healthcare facility. They are used in the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous high-density polyethylene (HDPE) fibers, with front material consisting of a clear, laminated polyethylene terephthalate (PET) / low density polyethylene (LDPE) or LDPE-ethylene-vinylacetate copolymers (EVA) film. They are used to enclose medical devices that are to be sterilized by a healthcare provider in the 3 hour sterilization cycle at 50°C in an EOGas 4 Ethylene Oxide Gas Sterilizer. Devices are inserted into the pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, while the heat sealed pouches are heat sealed prior to the cycle. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days) or until used.

This document describes the Andersen Sterilizers, Inc. Tyvek Sterilization Pouches with Chevron Seal (K152058).

The acceptance criteria and related study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes for each specific test mentioned (e.g., number of pouches tested for seal strength, microbial barrier, etc.).
• The data provenance is not specified beyond indicating that "Performance testing was conducted." It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not provided in the document. The document describes performance testing against established standards (ISO, ASTM) and internal criteria, rather than relying on human expert assessment for ground truth.

4. Adjudication method for the test set:

• Not applicable. The tests are objective and based on established technical standards and measurements, not subjective human assessment 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:

• Not applicable. This device is a sterilization pouch and not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is not an algorithm. The performance testing described is for the physical and functional characteristics of the sterilization pouch itself.

7. The type of ground truth used:

• The ground truth for the performance tests is based on established industry standards and regulatory requirements, such as ISO 11607-1, ASTM standards, FDA compliance for materials, and specific biological indicator inactivation levels (e.g., 6-Log reduction for sterility assurance).

8. The sample size for the training set:

• Not applicable. This device is not a machine learning model, so there is no training set.

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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