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Mesa Smart Read EZTest - Steam is a self-contained Biological Indicator intended for monitoring the efficacy of steam sterilization processes. The SCBI may be used in the following steam sterilization cycles:

*Unwrapped nonporous devices only

Mesa Smart Read EZTest has a validated reduced incubation time of 10 hours.

The biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 incculated onto a paper filter carrier and a small glass ampoule containing modified Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube. Smart Read EZTest - Steam is intended for use in monitoring the efficacy of steam sterilization processes with minimum exposure times of 20 minutes at 121 ℃ gravity displacement, 10 minutes at 132°C gravity displacement and 3 minutes at 132°C flash gravity displacement cycles.

Here's a breakdown of the acceptance criteria and study information for the Mesa Smart Read EZTest - Steam Biological Indicator, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Smart Read EZTest - Steam Biological Indicator are primarily based on its ability to demonstrate specific resistance characteristics (D-value, Z-value, Survival/Kill Window) and culture conditions for Geobacillus stearothermophilus ATCC #7953, matching those of its predicate devices. The performance is reported as meeting these criteria.

Study Information

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: "Three separate lots of product manufactured from three different primary spore crops" were tested.
• Data Provenance: Not explicitly stated, but based on the FDA submission, it would be considered US-based for regulatory purposes. The study appears to be prospective, specifically designed to validate the device's performance characteristics.

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)

• Not applicable. This device is a biological indicator, and its "ground truth" (i.e., whether sterilization was achieved or not) is determined by the growth or non-growth of Geobacillus stearothermophilus spores under controlled conditions, not by expert interpretation. The "truth" is an objective biological outcome based on the indicator's design and the sterilization process.

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

• Not applicable. The "adjudication" for a biological indicator is a direct observation of color change (purple to yellow) or turbidity indicating microbial growth (failure) or no change (success). This is an objective, binary outcome not requiring expert adjudication in the traditional sense of medical image interpretation.

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 self-contained biological indicator, not an AI-powered diagnostic tool for human readers. There is no human interpretation component in its fundamental operation that would necessitate an MRMC study.

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

• Yes, in a conceptual sense. The performance of the biological indicator is its standalone performance, as it objectively indicates sterilization efficacy based on spore viability and growth. There is no "human-in-the-loop" influencing its output. The device itself provides the result (color change/turbidity).

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

• The ground truth is the biological viability of Geobacillus stearothermophilus spores and their response to steam sterilization conditions. This is an objective biological outcome, determined by the presence or absence of growth (indicated by color change/turbidity) after incubation. This ground truth is established through standardized laboratory methods as per AAMI/ISO 11138-1:2006 and AAMI/ISO 11138-3:2006.

8. The sample size for the training set

• Not applicable in the context of an AI/machine learning training set. This device is not an AI algorithm but a physical biological indicator. The concept of a "training set" for AI does not directly apply here. However, the manufacturing process and quality control for biological indicators involve extensive testing and characterization of spore crops and finished products to ensure consistent performance, which could be considered analogous to "training" to ensure the device performs as expected.

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

• Not applicable for a biological indicator in the context of AI. For the development and validation of the biological indicator itself, the "ground truth" (i.e., the expected response of Geobacillus stearothermophilus spores to steam sterilization) is established through highly controlled laboratory experiments using standardized sterilization cycles and established methods for determining spore viability (e.g., direct plating, fractional experimentation) to derive D-values, Z-values, and survival/kill times. This ensures the spores in the BI have the known and consistent resistance characteristics necessary for monitoring sterilization.

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Smart-Read EZTest – Steam self-contained biological indicators (SCBI) are for monitoring the efficacy of saturated steam sterilization processes. Performance characteristics are established in accordance with USP 31 for the pre-vacuum 121°C steam process. Additional pre-vacuum saturated steam sterilization temperatures are also included in the Certificate of Analysis. Smart-Read EZTest – steam SCBIs are also appropriate for use in saturated steam processes of 132°C, 134°C and 135°C.

The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampoule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in USP 31 and ANSI/AAMI/ISO 11138-1.

Acceptance Criteria and Device Performance Study for Smart-Read™ EZTest® - Steam Biological Indicator

This report describes the acceptance criteria and the study that proves the Smart-Read™ EZTest® - Steam biological indicator meets those criteria for reduced incubation time.

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the reduced incubation time (RIT) study is that 97% of growth results observed at 7 days should be available at the RIT of 10 hours for the biological indicator (BI) that have been exposed to a partial sterilization cycle.

Overall, all partial cycles meet or exceed the 97% concordance requirement at 10 hours compared to 7 days, demonstrating the device's ability to achieve reduced incubation time. |

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

• Sample Size for Test Set: The study involved multiple partial sterilization cycles, each using a varying number of biological indicators (BIs).

  • Partial Cycle #1: 44 BIs
  • Partial Cycle #2: 45 BIs
  • Partial Cycle #3: 73 BIs
  • Partial Cycle #4: 80 BIs
  • Partial Cycle #5: 52 BIs
  • Partial Cycle #6: 53 BIs
  • Partial Cycle #7: 73 BIs
  • Partial Cycle #8: 48 BIs
  • Partial Cycle #9: 46 BIs
  • Partial Cycle #10: 60 BIs
  • Partial Cycle #11: 61 BIs
  • Partial Cycle #12: 80 BIs
    The total number of BIs tested across all partial cycles is 715.

• Data Provenance: The document does not explicitly state the country of origin but implies laboratory testing conducted by SGM Biotech, Inc., located in Bozeman, MT, USA. The study design is prospective as it involves controlled exposure of BIs to partial sterilization cycles. The report indicates that the test was performed with "four different spore crops and multiple lots of product from each crop", suggesting multiple batches of the device were evaluated.

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

The ground truth for this device is established through microbiological growth assessment. This does not typically involve interpretation by human "experts" in the same way clinical imaging studies do. The assessment of growth (yellow color change) or no growth (clear and purple) is an objective, binary outcome. Therefore, there were no "experts" with specific qualifications like radiologists establishing the ground truth in this context. The results are based on direct observation of the color change in the culture medium, which is an intrinsic characteristic of the biological indicator's function.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations. For the Smart-Read EZTest, the outcome (growth or no growth as indicated by color change) is a direct, objective result. There is no indication of an adjudication method being used because the results are determined by the biological reaction rather than human interpretation requiring consensus.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's role is to assist in that interpretation. The Smart-Read EZTest is a biological indicator designed for a direct chemical and biological reaction, not requiring human interpretation beyond observing a color change. Therefore, assessing how human readers improve with AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The data presented demonstrates the performance of the biological indicator itself in detecting sterilization failure (survival of spores). The "device performance" refers to the BI's ability to accurately show growth within the reduced incubation time, independent of any human intervention beyond activating and incubating the device and observing the final color change.

7. Type of Ground Truth Used

The ground truth used is a biological outcome (microbial growth of Geobacillus stearothermophilus spores) directly observed through a color change in the culture medium. For the purpose of establishing reduced incubation time, the 7-day incubation period serves as the gold standard ground truth, against which the 10-hour incubation results are compared. The 7-day result is considered the definitive indicator of spore survival or death.

8. Sample Size for the Training Set

The document does not explicitly state a separate "training set" for the reduced incubation time study. The study describes the methodology for establishing the reduced incubation time, which implies a development and testing process (i.e., the presented data acts as the validation that the 10-hour time is effective). The "test was performed with four different spore crops and multiple lots of product from each crop," suggesting robust testing across various manufacturing iterations and spore batches.

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

As noted above, a distinct "training set" in the context of an AI/algorithm is not directly applicable here. However, the process for establishing the ground truth (7-day incubation) for the development and validation of the 10-hour reduced incubation time is as follows:

The ground truth for spore survival or death (growth or no growth) is established by incubation for 7 days at 60 ± 2°C. This extended incubation period ensures the maximum opportunity for any surviving spores to proliferate and cause a color change. This 7-day incubation serves as the reference standard against which the performance of the shorter (10-hour) incubation time is evaluated. The principle is that if spores survive, they will show growth within 7 days. The study then aimed to demonstrate that the same growth would be observable reliably at 10 hours.

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