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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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The Smart-Well incubator is intended for use with the Smart-Read EZTest selfcontained biological indicators (SCBI). The Smart-Read EZTest - steam SCBI is used for monitoring the efficacy of gravity or pre-vac saturated steam sterilization processes. This SCBI contains 105 spores of Geobacillus stearothermophilus derived from ATCC #7953. Performance characteristics were established in accordance with USP 32 and ISO 11138-1 for the 121°C steam process. Additional saturated steam sterilization conditions are also tested and appear on the Certificate of Analysis for Smart-Read EZTest - steam. These include 132°C, 134℃, and 135℃.

The Smart-Well microbiological incubator is specifically designed for the incubation of the SGM Smart-Read® EZTest steam self-contained biological indicator (SCBI). The Smart-Read EZTest biological indicator contains 10° spores of Geobacillus stearothermophilus derived from ATCC 7953 inoculated onto a paper carrier. The culture medium is a modified soybean casein digest broth containing bromcreso! purple and meets growth promotion requirements when inoculated with 100 spores or less (K930683 and K963841). This single temperature incubator uses a heated aluminum block to maintain the desired temperature of 60 + 2℃. The incubator has a specifically designed cavity in which to insert and activate the non-activated Smart-Read EZTest unit. The Smart-Read EZTest unit is inserted into this cavity and pulled forward to crush the glass media ampoule and activate the unit. This activated Smart-Read EZTest is removed from this cavity and placed into one of the eleven test cavities. Ten cavities are intended for use with exposed test units and one cavity is intended for use with a positive control. The unit is held in the test cavity for the desired duration of the incubation.

The incubator has telltale LED status lights in front of each test cavity. When a Smart-Read EZTest SCBI is placed into the test cavity, the LED is activated and illuminates amber. The LCD screen will display the particular cavity's test status. This message includes specific cavity number, test status and number of whole hours incubated.

The heated aluminum block provides the temperature desired to allow any surviving spores in the Smart-Read EZTest SCBI to germinate and grow. If viable spores are present in the Smart-Read EZTest SCBI, they will germinate and grow. When growth occurs the cells metabolize sugars and shift the pH of the culture medium to an acid pH. When the pH of the medium shifts to acid it will turn from its purple color to yellow. The monitoring of the color of the Smart-Read EZTest BI is accomplished by a very narrow band width LED. This light is absorbed by the purple color of the medium. However, when the media color shifts to yellow, light is transmitted through the sample and detected by a photo diode behind the sample. When a yellow color is present the photo diode is energized. These results are the same as those visually detected by the human eye under conventional incubation conditions. When the electronics in the cavity detect a yellow color (growth), the status LED will shift from amber to red. The LCD screen will indicate the cavity number, positive test status and the whole number of hours incubated when the test status changed.

If there are no viable spores in the Smart-Read EZTest BI, the incubation will be completed with no change in color status. The Smart-Read EZTest has been tested in accordance with the FDA CDRH protocol for reduced incubation time and meets a 10 hour incubation claim. Upon expiration of the setected incubation time and no cover change was detected (negative); the status LED in front of the cavity will shift from amber to green (no change in purple color). The LCD screen will indicate the cavity number, negative test status and the whole number of hours incubated which is the user selected incubation time duration.

When the test status LED changes from amber to either red or green, an audible prompt is communicated to the user to remove the Smart-Read EZTest SCBI from the cavity and visually observe its color either purple or yellow. The incubator is not making any decisions as to the acceptability of the test results; it is simply prompting the user to visually observe the samples and make appropriate decisions. The conditions detected by the incubator are 100% verifiable by the user. The results that the Smart-Well incubator vields can be achieved in any microbiological incubator that provides the same environment for the growth of viable spores required by the Smart-Read EZTest SCBI.

The Smart-Well incubator also has the provision to add a printer to document the testing events. The printer will document the change in status of the incubated Smart-Read EZTest unit. Information captured by the printer includes the incubator cell number, incubation start time and date, time of status change condition (positive or negative). The printer has the capability to print user pre-selected descriptions, as a convenience and if desired by the user, which include descriptions of the exposure conditions to which the Smart-Read EZTest SCBI was exposed. These options include the following: a) cycle temperature, b) cycle type (pre-vac/gravity), c) cycle exposure time, d) BI lot number, e) sterilizer number, f) user identification. If none of the above information is selected, the printer will leave blanks or print "?" mark to indicate that no information was selected.

The information that is sent to the printer can also be forwarded to a PC or data acquisition network.

The incubator functions exactly as described above if no printer is attached or no connection is made to a PC or data acquisition network.

The presented document is a 510(k) summary for the SGM Biotech Smart-Read EZTest SCBI (steam) and Smart-Well Incubator. This device is an accessory to Biological Sterilization Process Indicators. The document primarily focuses on the device's intended use, description, and substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested.

Therefore, many of the requested sections (1-9) cannot be fully populated with specific data from the provided text. The information below extracts what can be inferred or directly stated from the document, and notes where specific details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary primarily focused on substantial equivalence and device description, explicit "acceptance criteria" for performance metrics like sensitivity and specificity are not provided in the document. The performance described is qualitative, referring to detection of color change.

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

The document does not explicitly state the sample size used for a test set (e.g., number of SCBIs tested) or the data provenance (e.g., country of origin, retrospective/prospective) for the Smart-Well incubator's performance. It refers to the Smart-Read EZTest SCBI's testing.

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

Not applicable. The ground truth for biological indicators in this context is based on the visible color change of the media, which is a direct outcome of spore viability and metabolism. The incubator's function is to detect and report this change, not to interpret an image or complex medical data requiring expert consensus. The user is prompted to visually verify the change.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is a direct chemical reaction (pH change indicated by color), not a subjective assessment requiring adjudication. The device's electronic detection is presented as 100% verifiable by the user's visual observation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This device is an incubator for biological indicators, not an AI system assisting human readers in diagnostic tasks. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.

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

The device itself is essentially a "standalone" system that electronically detects the color change of the biological indicator and reports it. However, the document emphasizes the user's visual verification: "The incubator is not making any decisions as to the acceptability of the test results; it is simply prompting the user to visually observe the samples and make appropriate decisions. The conditions detected by the incubator are 100% verifiable by the user."

The statement "The Smart-Read EZTest has been tested in accordance with the FDA CDRH protocol for reduced incubation time and meets a 10 hour incubation claim" suggests a standalone performance evaluation of the SCBI (which the incubator is designed for), but not a specific "algorithm-only" study for the incubator's electronic detection performance separate from human verification.

7. The Type of Ground Truth Used

The ground truth used for determining positive or negative results of the biological indicator is based on visual color change of the culture medium (purple to yellow) due to a shift in pH caused by the metabolism of viable Geobacillus stearothermophilus spores. This is a direct biological and chemical outcome.

8. The Sample Size for the Training Set

The document does not provide a sample size for a "training set." This device is not described as utilizing a machine learning algorithm that requires a training set in the conventional sense. Its detection mechanism is based on optical sensors and pre-defined color spectrum changes.

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

Not applicable, as a training set for a machine learning algorithm is not indicated. The "ground truth" for the device's function (detecting color change) is based on the established scientific principle of the biological indicator's colorimetric response to spore growth.

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EZTest® - Gas self contained biological indicators are for monitoring the efficacy of ethylene oxide gas sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 600mg/l process.

The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule 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 the USP XXIII.

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The EZTest® - Gas biological indicator is designed to meet the performance characteristics described in the USP XXIII. The document outlines several characteristics that were evaluated.

The ultimate reported performance is that the EZTest® - Gas "meets the USP XXIII requirements" for the tested parameters.

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

• Sample Size: The document states that claims were evaluated using "at least three (3) spore lots using different spore crops and different media lots." This indicates that multiple units from these lots would have been tested for each characteristic. However, the exact number of individual biological indicators tested is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that it's a 510(k) submission to the FDA, the studies would likely have been conducted prospectively under controlled laboratory conditions, possibly in the USA, to generate the required performance data.

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

This type of device (biological indicator) does not typically involve human experts establishing a "ground truth" in the way an imaging AI algorithm would. The "ground truth" for a biological indicator is determined by the growth or non-growth of bacterial spores after exposure to a sterilization process and subsequent incubation. This is an objective biological outcome, not a subjective interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" is an objective biological outcome (spore growth/no growth), not a subjective assessment requiring adjudication by multiple experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI), not for biological indicators that assess the efficacy of sterilization directly through objective biological endpoints.

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. For a biological indicator, "standalone performance" refers to the device's ability to accurately reflect the presence or absence of viable spores after a sterilization cycle. The listed evaluations (D-values, survival/kill times, incubation readout, etc.) directly assess the device's inherent performance characteristics in a controlled laboratory setting, independent of human interpretation to determine the primary outcome. The reading of the color change is a direct function of the device's biological and chemical components, not a human reader's diagnostic skill.

7. Type of Ground Truth Used

The ground truth used is based on biological outcomes (growth or non-growth of Bacillus subtilis spores) and established industry standards as defined by the USP XXIII (United States Pharmacopoeia). This involves direct observation of microbial growth (manifested by a color change in the medium) after defined exposure to ethylene oxide and subsequent incubation.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a biological indicator, the development and manufacturing process doesn't typically involve machine learning training data. Instead, the "training" (or rather, development and validation) of such a device relies on extensive laboratory testing and adherence to established microbiological and sterilization science principles.

The description implies that the manufacturing process involves "a manufacturing in-process quality control system to specifications defining exacting parameters for production to assure a consistent product and good manufacturing procedures." This ongoing quality control and specification adherence serve a similar purpose to ensuring a consistent "learned" behavior in an AI model, but through traditional engineering and scientific validation.

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

Not applicable in the AI/ML sense. For this device, the "ground truth" for establishing its design and specifications (analogous to a training set for AI) would have been established through:

• Established microbiological principles: Understanding the resistance of Bacillus subtilis spores to ethylene oxide.
• USP XXIII guidelines: Adherence to defined performance characteristics for biological indicators.
• Historical data and scientific literature: Leveraging decades of knowledge related to sterilization processes and biological indicator design.
• Internal R&D and testing: SGM Biotech's own experimentation to develop their specific media formulation, spore carrier, and device configuration to meet the USP XXIII standards.

The "ground truth" for manufacturing quality assurance is established by testing each lot against the USP XXIII specifications for spore count, resistance, and purity.

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EZTest® - Steam self contained biological indicators are for monitoring the efficacy of saturated steam sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 121 C steam process. Additional saturated steam sterilization conditions are also included in the Certificate of Performance. EZTest® - Steam Bls are also appropriate for use in the high temperature 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 ampule 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 the USP XXIII.

Here's a breakdown of the acceptance criteria and study information for the EZTest® - Steam biological indicator, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The summary states that "A significant portion of the quality assurance specification is testing to the performance characteristics of biological indicators as outlined in USP XXIII." and that "Such compliance is required on each lot prior to release." This implies that the specific numeric acceptance criteria for D-values, survival/kill times, and Z-values, although not explicitly listed in the 510(k) summary, are derived from USP XXIII and are met by the device. The summary provides a list of evaluated characteristics rather than specific quantitative performance values.

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

• Sample Size: The summary states that "Claims were evaluated using at least three (3) spore lots using different spore crops and different media lots." This indicates a minimum of three distinct lots were used for testing resistance characteristics. The exact number of individual biological indicators tested within each lot is not specified.
• Data Provenance: The data is generated internally by SGM Biotech, Inc., as part of their "in-process quality control system" and "quality assurance specification." The summary does not provide information on the country of origin of the data or whether it was retrospective or prospective, but it implies a prospective testing approach as part of a release process for each lot.

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

This type of information is not applicable to this device. The ground truth for a biological indicator is inherent to its design and function: the presence or absence of viable spores after a sterilization cycle. The "ground truth" is established by direct microbiological methods (observing growth/color change), not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the output of a biological indicator (color change, turbidity) is a direct, objective observation of microbial growth or lack thereof, rather than something requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. This device is a biological indicator, not an AI-based diagnostic tool. It does not involve human readers interpreting data or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This is not applicable. This device is a biological indicator for monitoring sterilization, not an algorithm. Its "standalone" performance is its ability to accurately reflect sterilization efficacy based on spore survival.

7. The Type of Ground Truth Used

The ground truth used is based on microbiological growth/viability, specifically the survival and subsequent growth of Bacillus stearothermophilus spores. The change in the pH indicator (bromcresol purple changing from purple to yellow) is a direct, observable proxy for this microbiological activity. This is akin to a pathology/microbiology outcome.

8. The Sample Size for the Training Set

This is not applicable. As a biological indicator, the device does not employ a training set in the typical machine learning sense. Its performance is based on the inherent biological resistance of the spores and the chemical properties of the culture medium.

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

This is not applicable for the same reasons as point 8. The "ground truth" for its operation is the established science of microbial heat resistance and culture medium efficacy, which is a foundational scientific principle rather than a dataset requiring ground truth establishment.

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