SteriTec Green Card Pack Bowie-Dick Test is a single designed to detect the presence of residusl air in pro-veauum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterlization conditions are met and no air is present to create a 2° C (+19-0° C) temperature difference between the center of the towel pack, as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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This document is a marketing authorization letter for a medical device (SteriTec Green Card Pack Bowie-Dick Test) and does not contain the detailed study information required to answer the prompt. The request asks for acceptance criteria and study details, including sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established. This marketing authorization letter, specifically pages 1-3, focuses on regulatory approval, substantial equivalence, and indications for use. It does not provide the technical details of a performance study demonstrating acceptance criteria.

Therefore, I cannot fulfill the request using only the provided text.

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SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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The provided document is a 510(k) clearance letter for the SteriTec Green Card Pack Bowie-Dick Test, Model BD 126. It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for a study or the results of such a study.

The letter mentions that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device likely underwent testing to demonstrate this equivalence. However, the specific design of that testing, including the acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies, is not included in this regulatory clearance letter.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need access to the actual 510(k) submission data, which would include the performance testing report.

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SteriTec Green Tape can be used in 121°C gravity sterilizers for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. Stripes turn black after exposure to steam sterlization conditions, thus providing identification of processed items.

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The provided document {0-2} describes the FDA 510(k) clearance for the SteriTec Green Tape, Model No: CI 159/1, CI 159/.5, CI 159/.75. This document focuses on the regulatory approval process and includes an "Indications for Use" section.

However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI/medical imaging device.

The SteriTec Green Tape is a sterilization process indicator, which is a chemical indicator designed to demonstrate that an item has been exposed to a sterilization process. It's not a diagnostic device involving complex algorithms, image analysis, or human reader interpretation in the way your questions are framed (e.g., radiologists, AI assistance).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the type of device you envision. The information you are requesting is typically found in pre-market submission summaries for more complex diagnostic devices, not for a chemical sterilization indicator.

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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.

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SteriTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270° F) or 135° C (275° F). When exposed to a steam sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green giving an integrated response and visible indication that sterilization conditions were met. If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.

Critical Parameters in a standard hospital pre-vacuum steam sterilizer

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This document is a 510(k) clearance letter for a medical device called the Emu-Graph Emulator, Model No. CI 131, which is a steam sterilization emulator. The letter states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested. It primarily focuses on the FDA's clearance of the device based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance from the provided text. The document only describes the intended use and the critical parameters for its function.

What is present in the document is a description of the device's function and expected visual indication related to sterilization conditions:

• Indications for Use: SteRiTec Emu-Graph is a steam sterilization emulator for use in a pre-vacuum steam sterilizer at 132°C (270°F) or 135°C (275°F).
• Expected Performance:
  • When exposed to sufficient sterilization process, the 2 MIN and 4 MIN indicator bars will turn from purple to green, giving an integrated response and visible indication that sterilization conditions were met.
  • If only the 2 MIN indicator bar turns green and the 4 MIN indicator bar displays an incomplete color change, insufficient sterilization conditions occurred.
• Critical Parameters:
  • Temperature: 132°C (270°F) - 4 MIN Indicator: 4 minutes
  • Temperature: 135°C (275°F) - 4 MIN Indicator: 3 minutes

This information describes what the device is designed to do and how it should visually respond, but it is not presented as formal acceptance criteria with corresponding study results in the structured way requested. The 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo clinical studies with detailed acceptance criteria as would be seen for a novel, high-risk device. The details you are asking for would typically be found in the 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.

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The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.

The Steri-Pak LF Bowie-Dick Test Pack is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air. The test pack is approximately 3%" x 5/4" x2/" in size consisting of a stack of 25 layers of porous blotter paper with a plastic laminated layer at the bottom. Embedded within the pack is an indicator sheet with steam sensitive ink printed on it. The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test.

The provided text describes a 510(k) submission for the Steri-Pak LF Bowie-Dick Test Pack. While it mentions "laboratory tests" for comparison to a predicate device, it does not explicitly detail acceptance criteria or a specific study that proves the device meets those criteria in a format that would allow for a direct fill-in of all your requested fields. The provided document is a summary for regulatory approval, not a detailed scientific study report.

However, I can extract the information that is present and indicate where information is not provided based on your specific questions:

Acceptance Criteria and Study Details for the Steri-Pak LF Bowie-Dick Test Pack

1. Table of Acceptance Criteria and 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)

• Sample Size: Not specified. The document only mentions "laboratory tests."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is implied to be internal testing by the manufacturer.

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

• Not provided. Bowie-Dick tests are physical/chemical indicators; their performance is assessed by color change under specific conditions, not typically by expert human interpretation in the same way an AI algorithm for medical imaging would be. The "ground truth" for a Bowie-Dick test is the successful removal of air in a sterilizer (resulting in a uniform color change) or the presence of residual air (resulting in an incomplete color change).

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

• Not applicable/Not provided. This is a physical/chemical indicator, not a diagnostic device requiring human interpretation and adjudication for "ground truth."

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 standalone chemical indicator, not an AI-assisted diagnostic tool for human readers.

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

• Yes, effectively. The device itself is the standalone "algorithm" (or chemical reaction) that produces a result (color change pattern) without human intervention in its function. The "performance" mentioned in the summary is the performance of this standalone indicator.

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

• The ground truth for a Bowie-Dick test is the physical conditions within the sterilizer, specifically the presence or absence of residual air. This is established by observing whether the indicator achieves a uniform color change (absence of air) or an incomplete color change (presence of air). This would be validated against calibrated sterilization equipment and known air leaks.

8. The sample size for the training set

• Not applicable/Not provided. This is a physical/chemical indicator, not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

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The Steritec Disposable EO Biological Test Pack is designed specifically for biological testing of EO gas sterilizers. The performance specifications for this product are 130 F, 45% to 60% Relative Humidity, 600 mg/L EO gas with all survivors at 15 minutes and all killed at 60 minutes.

SteriTec Disposable Biological Test Packs for EO Gas consist of a self-contained biological indicator containing B. Subtillis spores, placed inside a plastic canister and is covered with a closure cap containing a 5-100 micron porous plastic filter. This assembly is placed into a paper/plastic peel pouch along with a printed record card containing a chemical indicator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for SteriTec Disposable Biological Test Pack for EO Gas

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document provides performance data in a comparative context with the predicate device at 15, 25, 35, and 45 minutes, but does not explicitly state the SteriTec device's performance at the 60-minute mark, which is the "all killed" acceptance criterion. However, the FDA's clearance implies that this criterion was deemed acceptable.

2. Sample Size and Data Provenance

• Sample Size for the Test Set: Not explicitly stated. The text mentions "all test packs" and then percentages for "ATI Test Packs" and "SteriTec Test Packs" at different time points, implying a set of multiple packs for each test, but the exact number is not provided.
• Data Provenance: The performance tests were "conducted at NAMSA Laboratories," suggesting a third-party laboratory setting. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and NAMSA has labs globally, including in the US. The study appears to be prospective as it involves active testing of the device.

3. Number of Experts and their Qualifications for Ground Truth

• This device is a biological indicator for sterilization. The ground truth (whether bacteria are killed or survive) is determined by microbiological culture methods, not human interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI/imaging devices does not directly apply here. Instead, laboratory technicians following established microbiological protocols would have been responsible for determining survival/kill rates. Their specific qualifications are not mentioned, but it's implied they adhere to standard laboratory practices.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense. The "ground truth" for a biological indicator is a binary outcome (growth/no growth) determined by scientific culture methods, not by human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI devices where human readers provide interpretations and the AI system assists them. This submission is for a medical device (biological indicator) that functions independently to assess sterilization. The study performed was a comparison to a predicate device to demonstrate substantial equivalence, focusing on the device's inherent performance rather than human-AI interaction.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The "Performance Testing" section directly reports the survival rates of the SteriTec Disposable Biological Test Pack for EO Gas at various exposure times (15, 25, 35, and 45 minutes) without human-in-the-loop. This is the core of demonstrating the device's effectiveness as a biological indicator.

7. Type of Ground Truth Used

• The ground truth used is biological viability/non-viability (survival or kill) of B. Subtillis spores, determined through standard microbiological culture techniques. This is a form of direct, objective measurement of the intended biological outcome.

8. Sample Size for the Training Set

• Not applicable. This device is a biological test pack, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of algorithm development. The device itself is designed and manufactured based on scientific principles of microbial resistance and sterilization, not trained on data.

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

• Not applicable. As stated above, there is no training set for this type of device. The understanding of the resistance of B. subtilis spores to EO gas has been established over many years through scientific research and is a fundamental principle in sterilization efficacy testing.

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