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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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SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.

The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SporView® Steam Self-Contained Biological Indicator:

This document describes a 510(k) premarket notification for a Class II medical device, a biological indicator used in sterilization. It focuses on demonstrating substantial equivalence to a predicate device, rather than a novel claim requiring extensive clinical trials or complex AI performance metrics. Therefore, many of the typical acceptance criteria and study details for AI/software devices (like expert adjudication, MRMC studies, or training set details) are not applicable here.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All test results met the defined acceptance criteria" generally, but does not provide specific numerical values for each criterion. The criteria listed above are inferred from the types of non-clinical testing performed to validate the device's label claims and performance characteristics.

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

The document does not explicitly state the numerical sample size for each specific test (e.g., number of indicators tested for resistance). It mentions "Multiple lots of indicators were tested."

• Sample Size: Not explicitly stated as a numerical value, but described as "Multiple lots of indicators."
• Data Provenance: The testing was "Non-Clinical Testing" performed by the manufacturer, SPSmedical Supply Corp., in the USA (Rush, NY). The document does not specify if the testing was retrospective or prospective, but given it's for a new product, it would inherently be prospective in nature.

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

Not applicable. This device is a biological indicator; its performance is measured against objective laboratory standards (e.g., spore count, resistance to sterilization, color change) rather than requiring expert interpretation like in image-based diagnostics.

4. Adjudication Method for the Test Set

Not applicable. The performance is determined by objective scientific measurements, not by human adjudication of ambiguous findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is not relevant for a biological indicator device. It is designed to demonstrate equivalence through non-clinical laboratory testing, not to compare human reader performance with or without AI assistance.

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

Yes, in essence. The documented testing (resistance, spore population, media recovery, etc.) is the standalone performance of the biological indicator itself, as it functions independently within the sterilization process. There is no "human-in-the-loop" component to its primary function or performance assessment.

7. The Type of Ground Truth Used

The ground truth for this device is based on established scientific principles and standards for biological indicators, including:

• Microbiological Standards: Known characteristics of Geobacillus stearothermophilus spores (e.g., population, D-value, Z-value).
• Sterilization Cycle Parameters: Objective measurements of temperature, pressure, and time in steam sterilization cycles.
• Chemical Indicators: The physical and chemical properties of the Tryptic Soy Broth with Bromnocresol Purple pH indicator, which changes color based on microbial growth.
• Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.2800) and consensus standards for biological indicators.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on biological and chemical reactions, not learned patterns from data.

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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