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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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The SteriTec Disposable Biological Test Pack is a steam sterilization monitor designed specifically for biological testing of 121 "C (250" F) gravity or 132" ( (270°F) pre-vacuum steam sterilizers.

The pack consists of a self-contained biological indicator containing B. stearothermophilus spores inside a small package of porous and nonporous materials.

The provided document describes the SteriTec Disposable Biological Test Pack and its 510(k) submission. It focuses on demonstrating equivalence to a predicate device, the AAMI standard biological test pack, rather than establishing specific acceptance criteria for a new performance claim. Therefore, the device performance is reported in terms of equivalence to the predicate, not against specific numerical thresholds.

Here's an analysis based on the provided text, addressing the requested points:

K961721: SteriTec Disposable Biological Test Pack

1. Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance objective was to demonstrate equivalence to the AAMI standard biological test pack. The acceptance was based on the SteriTec pack "paralleling the results" of the AAMI pack.

• After 12 minutes exposure: Both packs experienced partial survivors.
• After 15 minutes and 20 minutes exposures: All biologicals were killed in both AAMI and SteriTec packs.
  Conclusion: SteriTec pack paralleled AAMI pack results. |
  | Prevacuum Sterilizer (132°C) | "Paralleled the results of the AAMI standard cloth biological test pack" for survival/kill at various exposure times. | - After 1 minute and 2 minute exposures: Both packs experienced partial survivors.
• After 3 minute exposure: All biologicals were killed in both AAMI and SteriTec packs.
  Conclusion: SteriTec pack paralleled AAMI pack results. |

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of devices or runs. The study involved multiple "sterilization runs" and "tests" at different exposure times in two types of sterilizers. For each condition (e.g., 10 min gravity, 1 min prevacuum), it implies at least one AAMI pack and one SteriTec pack were used, with the "biologicals" (presumably multiple biological indicators per pack) being assessed. The phrase "all the biologicals survived" or "all biologicals were killed" suggests individual biological indicators within the packs were sampled. However, the exact number of packs or biological indicators tested for each condition is not quantified.
• Data Provenance: The tests were conducted in a laboratory setting:
  • Gravity Sterilizer: "typical hospital gravity sterilizer" (AMSCO, Model 57CR, Type QDS-1624).
  • Prevacuum Sterilizer: "specially constructed laboratory prevacuum steam sterilizer built around an Amsco 20" x 20" x 40" chamber."
  • This indicates prospective, controlled laboratory testing. The country of origin is implicitly the US, given the FDA 510(k) submission context.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth in this study is objective biological growth or no growth of B. stearothermophilus spores, not an expert interpretation of data like imaging.

4. Adjudication Method for the Test Set

Not applicable. The ground truth (biological survival/kill) is determined by objective laboratory culturing methods, not by human adjudication of ambiguous results.

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

No, this type of study was not performed. MRMC studies are typically for diagnostic imaging or similar scenarios where human readers interpret cases, often with and without AI assistance. This submission describes a performance equivalence study for a sterilization indicator.

6. Standalone Performance Study

Yes, a standalone study was performed in the sense that the SteriTec Biological Test Pack's performance was evaluated independently in various sterilization conditions. Its performance was then compared to the AAMI standard pack. There is no human-in-the-loop interaction with the device's function itself; the device either indicates effective sterilization or it doesn't.

7. Type of Ground Truth Used

The ground truth used was biological outcome: survival (growth) or kill (no growth) of B. stearothermophilus spores. This is determined by standard microbiological culture techniques where the biological indicator is incubated after sterilization exposure to check for microbial viability.

8. Sample Size for the Training Set

Not applicable. This device is a passive indicator, not an AI/ML algorithm that requires a training set. The study describes physical performance testing.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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