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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 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene-vinyl acetate copolymer film. The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider in 3-hour and 6-hour gas exposures at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heatsealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85 EO Indicators, when placed on the outside of the sterilization pouches. indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for 6 months.

The provided document is a 510(k) premarket notification for a medical device (Tyvek Sterilization Pouches with Chevron Seal), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML-driven device.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this document.

This submission is for a physical product (sterilization pouches) and details non-clinical performance testing related to its material properties, sterilization efficacy, and shelf life, not an AI/ML algorithm.

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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 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Tyvek Sterilization Pouches with Chevron Seal are constructed from an uncoated Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylenevinylacetate copolymer film. The pouches 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. Following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed. The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle. Andersen Sterilizers' AN85/AN86 EO Indicators, when placed on the outside of the sterilization pouches, indicate EO exposure and offer a convenient way to differentiate pouches that have been processed in EO sterilization cycles from unprocessed units. The color of the AN85/AN86 EO Indicators changes from yellow-green to blue after exposure to EO. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least 3 months (90 days).

The provided text describes the acceptance criteria and the study proving the device meets these criteria for Tyvek Sterilization Pouches with Chevron Seal (K170429), when used with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

Here's the breakdown of the requested information:

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

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 specific sample sizes for each test (e.g., number of pouches tested for seal strength, microbial barrier, etc.). It refers to "performance testing" and "studies" but doesn't quantify the number of units/samples used in these tests.

• Data Provenance: The context of the document (FDA 510(k) submission) implies these studies were conducted by the manufacturer, Andersen Sterilizers, Inc., likely in the United States (their address is Haw River, North Carolina). The studies appear to be prospective in nature, designed to demonstrate the safety and effectiveness of the device for the specific new indication (use with Anprolene AN75).

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 provided in the document. The studies described are primarily bench tests and performance testing against industry standards (ISO, ASTM) and internal validation. They do not involve expert human interpretation of data in the same way a diagnostic AI device would. "Ground truth" here is established through scientific testing methods (e.g., biological indicator inactivation for sterility, physical property measurements for package integrity).

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

This is not applicable as the evaluation of this device is based on objective physical and microbiological test results, not on human interpretation or consensus. Therefore, no adjudication method was used or needed.

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, not an AI or diagnostic imaging device. Therefore, MRMC studies involving human readers are not relevant.

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

Not applicable. This device is a medical device product, not a software algorithm. The "performance" described is purely the physical and biological efficacy of the pouch itself in the sterilization process, independent of human interpretation or automated algorithms.

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

The ground truth for this device's performance is established through objective scientific measurements and standardized testing methodologies, including:

• Microbiological testing: Such as microbial aerosol challenge tests and biological indicator inactivation assays to demonstrate sterility assurance levels.
• Physical property testing: Measurements of seal strength, burst strength, and peel open characteristics to assess package integrity.
• Chemical/Material analysis: To confirm material compatibility and biocompatibility against established standards (e.g., ISO 11607-1).
• Time-based stability testing: To demonstrate shelf life and maintenance of sterility over time.

8. The sample size for the training set

Not applicable. This device is a physical product (sterilization pouch), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML development.

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

Not applicable for the same reason as point 8.

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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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