(200 days)
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:
| Cycle Type | Cycle Temp | Cycle Exposure Time |
|---|---|---|
| Gravity | 121°C | 30 Minutes |
| Gravity | 132°C | 10 Minutes |
| Flash Gravity | 132°C | 3 Minutes* |
| Pre-Vac | 132°C | 4 Minutes |
| Pre-Vac | 135°C | 3 Minutes |
*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.
| Acceptance Criteria Element | Description | Reported Device Performance (Smart Read EZTest - Steam, Subject Device) |
|---|---|---|
| Organism Type | Geobacillus stearothermophilus ATCC #7953 | Geobacillus stearothermophilus ATCC #7953 |
| Viable Spore Population | Minimum standard population 1.0 x 105 | Minimum standard population 1.0 x 105 |
| D-value @ 121°C | 1.5 - 3.0 minutes | 1.5 - 3.0 minutes |
| D-value @ 132°C | Not Less Than (NLT) 10 seconds | NLT 10 seconds |
| D-value @ 134°C | NLT 8 seconds | NLT 8 seconds |
| D-value @ 135°C | NLT 8 seconds | NLT 8 seconds |
| Z-value | Not Less Than 10°C | Not Less Than 10°C |
| Survival Time @ 121°C | NLT 5 minutes (Calculated per USP) | NLT 5 minutes (Calculated per USP) |
| Survival Time @ 132°C | NLT 1 minute (Calculated per USP) | NLT 1 minute (Calculated per USP) |
| Survival Time @ 134°C | NLT 40 seconds (Calculated per USP) | NLT 40 seconds (Calculated per USP) |
| Survival Time @ 135°C | NLT 40 seconds (Calculated per USP) | NLT 40 seconds (Calculated per USP) |
| Culture Conditions | 60°C +/- 2°C for 10 hours (for reduced incubation time validation) | 60°C +/- 2°C for 10 hours |
| Effectiveness Claim | Monitoring efficacy in various steam sterilization cycles (Expanded claims) | Demonstrated overall effectiveness in monitoring routine steam |
| sterilization cycles, including the expanded 121°C gravity, 132°C | ||
| gravity/flash gravity cycles. |
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.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).