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The ALIBI biological indicator is used to monitor the efficacy of ethylene oxide sterilization cycles.

ALIBI is a biological indicator that complies with the USP XXV:2002 monograph Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier. The ALIBI biological indicator consists of a paper carrier inoculated with of Bacillus subtilis var. niger ATCC 9372 bacterial endospores, and a primary package made of glassine. After exposure to an ethylene oxide sterilization cycle, the biological indicator is incubated in soybean casein digest broth at 30-35°C for 7 days. Growth of biological indicator spores is evidenced by the presence of turbidity in the growth medium. If the sterilization cycle killed all of the biological indicator spores, the growth medium remains clear.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Stability studies on three lots manufactured from three different spore crops are in progress." This implies a test set of three lots (each from a different spore crop).
• Data Provenance: The study is described as "Real time data through the 12 months test interval." This indicates the data is prospective and collected over time during the stability study. The country of origin is not explicitly stated, but the company (Arden Laboratories, Inc.) is based in Willernie, Minnesota, USA.

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

This information is not applicable as the device is a biological indicator for sterilization, not a medical imaging or diagnostic device requiring expert interpretation. The ground truth is objective (presence or absence of microbial growth).

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The determination of growth or no growth is based on a clear, objective biological outcome (turbidity in the growth medium).

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 typically performed for diagnostic or screening devices where human interpretation is involved. The ALIBI Biological Indicator is a device to monitor sterilization efficacy, not for human interpretation of medical cases.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the evaluation of the ALIBI Biological Indicator is a standalone performance study. The device is used independently to indicate the efficacy of the sterilization cycle without direct human interpretation influencing the end result (turbidity development). The "algorithm" here is the biological process of spore inactivation and subsequent growth/no-growth, which is assessed objectively.

7. The Type of Ground Truth Used

The ground truth used is based on biological outcome:

• Presence of turbidity: Indicates survival of biological indicator spores (sterilization failure).
• Growth medium remains clear: Indicates all biological indicator spores were killed (successful sterilization).
  This is an objective, empirical ground truth based on microbial viability.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This device is a biological indicator validated against established standards. The "training" in a biological sense would be the development and optimization of the spore crop and manufacturing process to consistently meet the USP XXV criteria, which are not detailed as a distinct 'training set' of data.

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

Since a "training set" in the AI sense is not applicable, the establishment of ground truth for a training set is also not applicable. The underlying principles of what constitutes a "successful" or "failed" sterilization are predefined by the USP XXV monograph, which serves as the ultimate standard for the biological indicator's performance.

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