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SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text is a 510(k) clearance letter from the FDA for the SteriTec Smart-Read Biological Test Pack. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• The device name and model number.
• The regulation number and name.
• The regulatory class.
• The product code.
• The date of the submission and receipt.
• The determination of substantial equivalence to a legally marketed predicate device.
• General controls provisions of the Act that apply to the device.
• Contact information for various FDA divisions.
• The intended indications for use of the device, which is a biological test pack for steam sterilizers.

This biological test pack is a physical device used to verify sterilization conditions, not an AI/ML algorithm or software. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/ML devices is not present in this document.

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SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79.

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about specific acceptance criteria or the study used to prove the device met those criteria. The letter acknowledges the submission and declares the device substantially equivalent to a predicate device based on the information provided by the applicant.

Therefore, I cannot extract the requested information from the provided text.

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SteriTec Smart-Read® Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 minutes or longer at 132°C (270°F) in pre-vacuum steam sterilizers. The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by ANSI/AAMI ST79. When used as directed, the Chemical Integrator Record Card gives visible indication that sterilizing conditions were met.

The provided text is a 510(k) premarket notification FDA letter for a sterilization process indicator. It is not an AI/ML device and therefore does not contain the information required to answer the prompt.

The document discusses the regulatory approval of the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: BI 108" and confirms its substantial equivalence to predicate devices. It outlines the general controls provisions of the Act that apply to the device and provides contact information for further inquiries. The "Indications for Use" section specifies that the device is designed for testing pre-vacuum steam sterilizers at particular temperatures and durations and visually indicates if sterilizing conditions were met.

Since this is a traditional medical device (a biological test pack for sterilization) and not an AI/ML powered device, the concepts of acceptance criteria in the context of AI/ML model performance (e.g., sensitivity, specificity, AUC), sample size for test sets/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable here.

Ask a specific question about this device