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The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator consists of a self-contained biological indicator inoculated with viable Bacillus atrophaeus bacterial spores that is placed in a dedicated biological indicator receptacle mounted on the purge probe in the sterilizer. It monitors the efficacy of the 6-hour gas exposure at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer.

The EOGas 4 Endo-SteriTest Rapid Readout Biological Indicator (RRBI) consists of a single-use self-contained biological indicator (SCBI) placed in a reusable biological indicator (BI) receptacle. It is designed for monitoring the efficacy of the 6-hour gas exposure at 50°C in an EOCas 4 Ethylene Oxide Gas Sterilizer.

The Bionova BT110 Rapid Readout Biological Indicator (K191021) consists of a plastic vial that serves as the culture tube and a cap including a filter material port to allow ethylene oxide to enter the vial. The plastic vial contains Bacillus atrophaeus spores inoculated onto a paper carrier, and a glass ampoule containing culture medium and a pH indicator. There is a chemical indicator printed on the unit label of the SCBI to indicate EO exposure by changing color from brown/red to green.

Following manufacturer's instructions, the operator inserts the Bionova BT110 Rapid Readout Biological Indicator into the reusable BI receptacle on the dedicated purge probe of the EOGas 4 Ethylene Oxide Gas Sterilizer, and initiates a 6-hour gas exposure at 50°C. After cycle completion, the SCBI is retrieved and activated by crushing the glass ampoule. The chemical indicator on the SCBI changes from brown/red to a green color after ethylene oxide exposure.

The activated SCBI and an unprocessed control are incubated in a Terragene Bionova IC10/20FR, IC10/20FRLCD or MiniBio Auto-Reader Incubator for 4 hours to detect fluorescent activity or 48 hours to detect color change. Evidence of microbial growth by presence of fluorescent activity or color change from blue to yellow must be interpreted as a failure to meet the conditions necessary for sterilization (cycle failed); no fluorescence or no color change indicates conditions for sterilization were achieved (cycle passed).

The provided document describes the EOGas 4 Endo-SteriTest RRBI, a rapid readout biological indicator for monitoring ethylene oxide sterilization cycles. The submission seeks to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The document explicitly lists "Functionality" and "Shelf Life" tests with their acceptance criteria and "Pass" results.
• For the individual studies performed for the Bionova BT110 Rapid Readout Biological Indicators (which is a component of the EOGas 4 Endo-SteriTest RRBI), the document states that "The results of all studies met the established acceptance criteria," without enumerating the specific criteria for each.

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

The document does not provide specific sample sizes (e.g., number of BIs or sterilization cycles) for the "test set" studies. It mentions that "The EOGas 4 Endo-SteriTest RRBI has been validated using applicable tests in FDA 2007 'Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions', and ANSI/AAMI/ISO 11138-1:2017 'Sterilization of health care products -Biological indicators - Part 1: General requirements'." These standards typically define the requirements for testing, including sample sizes, but the specific numbers used in this submission are not stated.

Data provenance is not explicitly mentioned but is assumed to be prospective bench testing conducted by the manufacturer as part of the validation process for regulatory submission. There is no mention of country of origin for data.

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

Not applicable. This device is a biological indicator designed to directly measure sterilization efficacy, not to be interpreted by human experts like medical images. The "ground truth" for a biological indicator is the direct observation of microbial growth (or lack thereof) after exposure to a sterilization process, relative to positive and negative controls.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the device's output (microbial growth/no growth, or fluorescent activity/no fluorescent activity) is a direct, objective measurement, not subject to subjective interpretation requiring 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

Not applicable. This is not an AI-assisted diagnostic or imaging interpretation device.

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

Not applicable. This is not an AI algorithm. The device itself (the biological indicator) is a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used for biological indicators is the viability of the Bacillus atrophaeus bacterial spores.

• Failed Sterilization: Indicated by observable fluorescent activity or a color change from blue to yellow in the culture medium, signifying spore survival and growth.
• Successful Sterilization: Indicated by no fluorescence and no color change, signifying spore inactivation.
• Positive controls (unprocessed BIs) are expected to show growth, and negative controls (processed BIs from a successful cycle) are expected to show no growth, confirming the validity of the test.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:

Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters

The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

Here's a summary of the acceptance criteria and study information for the EOGas 4 Ethylene Oxide Gas Sterilizer, based on the provided document:

Acceptance Criteria and Device Performance

Study Information:

1. Sample sizes used for the test set and data provenance:

   • Minimum Sterilization Parameters: Performed to define and validate the endoscope loads. The results indicate successful inactivation of 6-Log BIs for "two duodenoscopes, two colonoscopes, or one colonoscope and one duodenoscope in each load." The exact number of each type of load tested isn't specified, but implies multiple runs for different combinations.
   • Half Dose Validation: "Consecutive half dose cycles and full dose cycles were performed." No specific number of cycles or endoscopes is provided.
   • Simulated-Use Testing: "Inactivated biological indicators were obtained in all cycles for all duodenoscope and colonoscope loads tested." Again, the exact number of cycles or endoscopes is not specified.
   • In-Use Testing: "Duodenoscopes and colonoscopes, used on patients... processed using the 6-hour EO exposure." No specific number of patient-used scopes is provided.
   • EO Residuals: Tested on "Olympus TJF-Q180V, TJF-Q160VF, TJF-Q190V, PJF-160, CF-Q180AL, Pentax ED34-i10T2, ED-3490TK duodenoscopes and EC-3490Li colonoscopes" and "Fujifilm ED-530XT and EC-600HL." This indicates testing on a variety of endoscope models.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S., the testing would typically be conducted to U.S. regulatory standards. "In-Use Testing" mentions "used in routine endoscopic procedures in a hospital or clinic setting," suggesting prospective collection of real-world use data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This document describes performance testing of a sterilizer, where the "ground truth" is defined by the inactivation of biological indicators and the adherence to specified chemical and physical parameters. These are objective measures and do not typically involve human "experts" establishing a subjective ground truth, as would be the case for image interpretation or diagnosis. Therefore, no information on experts for ground truth is applicable or provided.

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

   • Not applicable. As noted above, the ground truth is based on objective laboratory measurements (biological indicator cultures, chemical concentrations, temperature, humidity, and residual levels), not a subjective human assessment requiring adjudication.

4. 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 document pertains to the validation of an ethylene oxide gas sterilizer, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • Not applicable. This device is a sterilizer, not an algorithm. Its performance is evaluated through its physical and biological sterilization capabilities.

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

   • The ground truth for the sterilization efficacy tests is primarily established by:
     • Biological Inactivation: The complete inactivation of 6-Log Bacillus atrophaeus biological indicators, confirmed by culture methods.
     • Physical Parameters: Measurement of critical process parameters (EO concentration, temperature, relative humidity, time) meeting defined specifications.
     • Chemical Residuals: Measurement of ethylene oxide residuals meeting ANSI/AAMI/ISO 10993-7 requirements.
     • Sterility Testing: For in-use testing, sterility was confirmed by a flush method per USP, indicating no microbial growth.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer and does not involve AI or machine learning models that require a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set is used for this type of device validation.

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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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