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The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

Please refer to the table below for program name, load description, sterilization temperature, exposure time, drying time and maximum load.

| Program
Name | Load Description | Sterilization
Temperature | Sterilization
Time | Drying
Time | Maximum
Load |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|----------------|--------------------|
| 134°C | solid objects, small porous objects, simple objects recessed,
narrow-clearance items, dental handpieces, and textiles;
wrapped and unwrapped | 134°C (273°F) | 4 minutes | 3 minutes | 0.5 Kg/
1.1 lbs |
| 121°C | solid objects, small porous objects, simple objects recessed,
narrow-clearance items, dental handpieces, textiles, and plastics;
wrapped and unwrapped | 121°C (250°F) | 30 minutes | 5 minutes | 0.5 Kg/
1.1 lbs |
| 134°C
FAST* | solid objects, non-porous objects, simple instruments (such as
scissors, handles, pliers, chisels, probes, etc.), and dental
handpieces;
unwrapped
*Immediate Use Steam Sterilization cycle | 134°C (273°F) | 4 minutes | N/A | 0.5 Kg/
1.1 lbs |

The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen. The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. Enbio S also features an additional sterilization cycle referred to as '134°C FAST' which is an immediate use steam sterilization cycle without drying. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.

The provided text is a 510(k) summary for the Enbio S steam sterilizer. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, particularly for the addition of a new sterilization cycle ('134°C FAST').

Here's the breakdown of acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and reported device performance:

The device performance is consistently reported as "Pass" for all tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the specific number of runs or samples used for each test (e.g., number of Vacuum Tests, Bowie & Dick Tests, or biological indicator challenge runs). It simply states that tests were "conducted per ANSI AAMI ST55:2016." This standard would typically specify the required test replicates.
• Data Provenance: The data comes from non-clinical bench testing. The country of origin for the testing itself is not specified, but the applicant, Enbio Group AG, is based in Oensingen, Switzerland. The testing is a component of a 510(k) submission to the U.S. FDA, implying it needs to meet U.S. regulatory standards. All tests are inherently "prospective" in the sense that they are conducted specifically for this submission to validate the device's performance.

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

This submission concerns a physical medical device (steam sterilizer) and its performance in achieving sterility, not an AI/ML-based diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of radiologists or similar clinical experts does not apply here. The "ground truth" for sterilization is established by well-defined physical and biological parameters and internationally recognized standards (ANSI AAMI ST55:2016) which dictate acceptable levels of microbial inactivation (Sterility Assurance Level - SAL).

4. Adjudication method for the test set:

Not applicable, as this is bench testing of a physical device against defined technical and biological standards, not an assessment requiring human interpretation and adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This submission pertains to a steam sterilizer, which is a therapeutic/sterilization device, not a diagnostic one.

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

Yes, in a sense. The performance testing evaluates the sterilizer's ability to achieve validated sterilization parameters independently of human intervention beyond operating the device. The device's efficacy is measured against objective criteria (temperature, pressure, leak rate, biological indicator kill) as outlined in the standards. There is no AI algorithm being evaluated in this specific FDA submission beyond the operational software/firmware of the sterilizer itself, which was validated using the same methodology as the predicate device.

7. The type of ground truth used:

The ground truth used for evaluating the Enbio S sterilizer is:

• Physical Parameters: Defined temperature and pressure ranges, and leak rates as specified by ANSI AAMI ST55:2016.
• Biological Inactivation: A 10^-6 Sterility Assurance Level (SAL), demonstrated through biological indicator challenges. This means that the probability of a single viable microorganism remaining on an item after sterilization is one in a million.

8. The sample size for the training set:

Not applicable. This is a physical device submission demonstrating performance based on engineering and biological testing, not an AI/Machine Learning model that requires a training set.

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

Not applicable, as there is no AI/Machine Learning training set.

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The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It has a hermetically sealed, heated chamber made from aluminum, with two heaters sink inside chamber walls. Inside this chamber, the sterilized load is placed on a special perforated tray. After closing the chamber, the user selects the appropriate sterilization program through the TFT touch screen. The actual sterilization phase starts after the pre-vacuum phase. The aluminum steam generator produces superheated steam and applies it inside the chamber. That steam penetrates the sterilized instruments. The set temperature is maintained inside the chamber depending on the selected sterilization cycle (121C° or 134°C), during a specified time (30 minutes or 4 minutes). After that time all the steam accumulated inside the chamber is pumped out and the drying cycle begins. When sterilization is finished, device displays to the user that process is completed, and that the load is sterile.

This document is a 510(k) summary for the Enbio S steam sterilizer. It outlines the acceptance criteria and the non-clinical bench testing conducted to prove that the device meets these criteria. Since this is a sterilizer, the relevant acceptance criteria and studies revolve around its ability to achieve sterilization.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical bench (performance) testing, not a test set in the sense of patient data or algorithm performance. Therefore, typical "sample size" and "data provenance" (country of origin, retrospective/prospective) don't directly apply here.

The tests conducted are physical performance tests on the sterilizer as a device. The "sample size" would refer to the number of sterilization cycles performed or units tested to demonstrate consistency and adherence to parameters. This specific detail is not provided in text, but it's implied that sufficient tests were run to determine a "Pass" for each criterion.

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

This information is not applicable for the given document. The "ground truth" for a steam sterilizer's performance is established by well-defined physical and biological standards (e.g., temperature/pressure tolerances, biological indicator kill rates). There isn't a need for human expert consensus in the same way there would be for a diagnostic imaging AI, for example.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., medical images). The tests performed on the sterilizer yield objective, measurable results (e.g., temperature readings, biological indicator color changes, leak rates) which do not require human adjudication in this context.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The submission does not contain any data from clinical testing." MRMC studies are typically for evaluating the impact of an AI on human reader performance for diagnostic tasks. This device is a mechanical sterilizer, not a diagnostic tool.

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

Yes, in a sense, a "standalone" evaluation was done. The tests performed are directly on the performance of the sterilizer itself, without human interaction impacting the sterilization efficacy. For example, the biological indicator tests verify the sterilizer's ability to kill microorganisms on its own. While a human initiates the cycle, the effectiveness of the sterilization process is tested independently.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on established scientific and regulatory standards for sterilization, specifically:

• Physical Parameters: Defined temperature and pressure ranges, leak rates, and cycle times as specified in ANSI AAMI ST55:2016.
• Biological Efficacy: The 10^-6 Sterility Assurance Level (SAL), verified using biological indicators (BIs) which contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). A successful sterilization run means the BIs show no growth, indicating a 1 in a million chance of a non-sterile item.
• Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards (IEC, CFR).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a traditional medical device (steam sterilizer), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This information is not applicable for the same reason as point 8.

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