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The pre-vacuum steam sterilizer models 3870HSG and 3870HSG-WS are in hospitals and other healthcare facilities (e.g. hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices) for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.

The autoclave models 3870HSG-WS and the 3870HSG are dynamic-air-removal steam-heated sterilizers that are using steam as the sterilizing agent, which are suitable for large medical centers, dental clinics and operating rooms for the purpose of sterilizing heat stable medical devices: wrapped and unwrapped solids (IUSS), hollow and porous products.

The model 3870HSG-WS has an automatic door and is designed to be a fast cycle sterilizer that is mobile and can operate independent of building utilities due to its internal water reservoirs. The autoclave includes the option of water recycling, which allows the operator to manually fill the tap water reservoir with water that will be reused for 10 cycles, after which the reservoir is automatically drained and, in case the device is connected to a water inlet connection, be refilled automatically.

The model 3870HSG has an automatic door and is designed to be a fast cycle sterilizer. Contrary to the 3870HSG-WS, the 3870HSG need to be connected to the building utilities system (the water system). For both autoclave configurations (HSG/HSG-WS) a 9kW built-in steam generator is used to supply the steam for the sterilization process.

The autoclaves are Class B devices equipped with a vacuum system that allows:

• . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
• . Better steam penetration into the load; resulting in effective sterilization.
• . Better temperature uniformity.
• . Post sterilization drying phase - during the drying stage draws air through a HEPA filter (0.2um) and pushes that air through the heated chamber to remove moisture and facilitate the drying operation. Drying is performed with the door closed.

The autoclave models 3870HSG-WS and 3870HSG are stand-alone devices that do not need to interact with other devices or to interact with any person(s) or patient(s) besides the current device operator.

The provided text describes the acceptance criteria and the results of a study conducted for the Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS. This is a medical device (a sterilizer), and the study focuses on its performance in sterilizing medical devices.

Here's an breakdown of the information requested based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Device: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS

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

• Sample Size for Test Set: The document describes "tests" and "cycles" but does not explicitly state a quantitative sample size (e.g., number of sterilization runs) for each specific test. It implies multiple trials were conducted to meet each acceptance criterion, as performance tests like "Empty chamber tests" or "Biological performance" would typically involve multiple runs to demonstrate consistency and reliability. However, no specific quantitative sample size is provided in the document for the test set.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the U.S. Food & Drug Administration (FDA) by Tuttnauer LTD. based in Jerusalem, Israel, implying the tests were conducted by the manufacturer or a contracted lab. The tests are described as non-clinical tests, which means they are laboratory-based and simulated scenarios, not directly from patient data. The context suggests these were prospective tests performed specifically for this 510(k) submission, rather than retrospective analysis of existing data.

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

The document does not mention human expert involvement in establishing ground truth for the test set. The tests described are objective, quantitative performance measurements of a sterilizer (e.g., temperature, pressure, leak rate, biological indicator growth). Ground truth is established by physical measurements and the absence/presence of microbial growth, not by expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth is established by objective physical and biological measurements, not through human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is a steam sterilizer, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, the concepts of human readers, AI assistance, or MRMC studies are not relevant to this type of device and its performance evaluation as described.

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

• Yes, in essence, standalone performance was assessed. The device itself is an automated sterilizer. Its "performance" refers to its ability to achieve specific physical parameters (temperature, pressure, dry time) and biological outcomes (sterility assurance level, lack of growth). The tests described (e.g., Bowie & Dick test, air-leak-rate test, empty/full chamber load tests, biological performance tests) directly measure the sterilizer's function without human intervention during the cycle itself. Human operators set up and observe the results, but the "performance" being evaluated is the device's independent operation.

7. The type of ground truth used

The ground truth used for these tests is based on:

• Physical measurements: Temperature (within a specified range), pressure (leak rate), weight change (moisture retention). These are objectively measurable physical properties.
• Biological outcomes: The absence of microbial growth in biological indicators (BIs) or test turbines after sterilization, demonstrating a sterility assurance level (SAL) of 10⁻⁶. Positive controls are used to confirm test viability. This is an objective biological outcome.
• Visual inspection: Uniform color change for the Bowie-Dick test, absence of wet spots for moisture retention.

8. The sample size for the training set

This document describes the validation of a physical device (a steam sterilizer). It is not an AI/ML device, so there is no "training set" in the context of machine learning model development. The device operates based on preprogrammed cycles and physical principles, not on learned data.

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

Since this is not an AI/ML device, there is no training set and therefore no ground truth established for a training set. The performance is assessed against established engineering and biological standards for sterilization.

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The Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices that are intended to provide sterilization of heat stable medical devices: wrapped (IUSS) solids, hollow and porous products.

The Tuttnauer horizontal autoclave series models 4472, 5596 and 6690 are dynamic-air-removal autoclaves that are designed for sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The autoclave operates in a temperature range of up to 137 C (279°F) and pressure up to 2.3 bar (34psi).

Each of the mentioned models differ from each other in chamber size and include different 1 or 2 door configurations. The models can come with onboard steam generation capability, but other configurations are used with external steam sources.

Here are the acceptance criteria and details of the study for the Tuttnauer Horizontal autoclave series, extracted and formatted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents acceptance criteria and reported performance (Pass/No Pass) directly within the "PERFORMANCE TESTING" section. No specific numerical results are provided beyond "Pass."

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

The document does not explicitly state the sample size (e.g., number of cycles performed) for each specific test or the "test set" in terms of physical units. However:

• The tests were conducted on the "Tuttnauer Horizontal autoclave series models: 4472, 5596, 6690, and 66120." It can be inferred that at least one of each model, or selected configurations, underwent these performance tests.
• The nature of sterilization validation studies typically involves multiple runs for each cycle type and load configuration to ensure reproducibility and meet sterility assurance levels.
• Data Provenance: Not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. However, given it's a 510(k) submission, these are typically prospective performance validation studies conducted by the manufacturer according to recognized standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the device is a steam sterilizer, and the "ground truth" for its performance is established by objective physical and biological indicators, not human expert consensus on images or diagnostics. The performance tests rely on meeting physical parameters (temperature, pressure, leak rates, dry weight) and biological sterilisation criteria (no growth of biological indicators).

4. Adjudication Method for the Test Set

This is not applicable. The performance tests for a steam sterilizer involve objective measurements and biological indicator results, not subjective interpretation requiring an adjudication process.

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

This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilizer.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. The device is a physical steam sterilizer, not an AI algorithm. Its performance is inherent to its physical operation and is tested directly. There is no "human-in-the-loop" component in its core sterilization function that would make this distinction relevant.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

• Physical Parameters: Measurements of temperature, pressure, time, and leak rates conforming to specific numerical thresholds (e.g., temperature not exceeding 3°C above sterilization temp, leak rate

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The T-Edge 10 & T-Edge 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices).

The T-Edge 10 & T-Edge 11 are validated for use in:

• · Sterilizing fabric packs / textiles
• · Sterilizing dental handpieces

The T-Edge 10 & T-Edge 11 are Table-Top steam sterilizers (autoclave) that use steam as the sterilizing agent. The autoclaves are fully automated device with a computerized control system, which is based on Linux Operating system. that ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle, including the ability of recording the sterilization parameters (with a built-in memory to store history of up-to 999 cycles). A graphical touchscreen is used for monitoring and control purposes.

The T-Edge 10 & T-Edge 11 are Class-B and Class-S devices. They are designed for repeated use of sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities.

The T-Edge 10 & T-Edge 11 are validated for use in:

• Sterilizing fabric packs / textiles
• . Sterilizing dental handpieces

The steam for the sterilization process is produced by warming up a controlled amount of demineralized water that is inserted into a pipe heating element and then flows into the chamber as steam. This technique is used as a way of reducing water consumption and saving energy. The autoclave is equipped with a heating element wrapped around the chamber to maintain the required temperatures and steam for the sterilization process. All of these processes are done via the computerized control system of the device.

The T-Edge 10 & T-Edge 11 autoclaves are equipped with a built-in vacuum pump used for fractionated pre-vacuum air removal at the first stage of the cycle, eliminating air pockets from all load types, including porous load and most kinds of tubes (rubber, plastic etc.). This is maximizing efficient steam penetration throughout the entire load, resulting in temperature uniformity and an effective sterilization. After the sterilization stage the vacuum pump is used for post-vacuum drying, performed with the door closed.

The door's locking mechanism is designed to allow closing/opening the door, easily, with one hand.

The chamber door has the following features protecting personnel from hazards:

• . Two door micro-switches that indicate that the door is closed and locked. Without this indication steam is not introduced into the chamber. These micro-switches prevent opening the door while the chamber is pressurized and at the end of cycle until chamber pressure equalizes to room pressure.
• An electrical door locking pin that blocks door opening during operation. .

In addition, the following safety devices are installed in the autoclave to optimize its safe operation:

• A safety thermostat to prevent over-heating of the chamber heating elements. .
• . A safety cut-off switch to prevent over heating of the pipe heating element.
• . A pressure safety valve to prevent over-pressurizing of the chamber.

The T-Edge 10 & T-Edge 11 autoclaves have two optional configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The demineralized water overflow outlet is located on the rear cover, demineralized water overflow, and wastewater outlet on the rear cover. Built-in system for checking water quality Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water.

The T-Edge 10 & T-Edge 11 feature a built-in memory to record up to 999 sterilization cycles. The T-Edge 10 & T-Edge 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC.

The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine. The device also has a built-in network port (LAN) for use with optional Tuttnauer's R.PC.R software.

The chamber is made of a corrosion-resistant 316L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.

The provided document outlines the acceptance criteria and performance data for the Tuttnauer T-Edge 10 & T-Edge 11 steam sterilizers, as submitted for FDA 510(k) clearance.

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 does not explicitly state the specific sample sizes (number of tests/runs) conducted for each performance test. It only provides a summary of the test purpose, acceptance criteria, and whether the device "Passed" or "No Pass."

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It generally refers to "non-clinical tests conducted."

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

This information is not provided in the document. The tests performed are primarily engineering and microbiology validation tests against established standards (e.g., ANSI/AAMI ST-55, IEC 61010, ASME). These types of tests typically rely on objective measurements and adherence to specified protocols rather than expert consensus on ground truth in the way an imaging AI algorithm might.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective performance validations against technical standards, not subjective assessments requiring adjudication by multiple readers or experts.

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

No. This document describes the validation of a steam sterilizer, which is a medical device for sterilizing instruments, not an AI/imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or included.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI algorithm but a physical device. The performance tests evaluate the device's ability to sterilize effectively according to pre-defined parameters and standards.

7. Type of Ground Truth Used

The "ground truth" for the performance tests outlined is based on:

• Established Industry Standards: Such as ANSI/AAMI ST-55 for sterilization performance, IEC 61010 for electrical safety, ASME for pressure vessel codes, and EN/IEC 61326 for EMC.
• Physical Measurements/Observations: Including temperature readings, leak rates, color changes on indicators, and the absence/presence of microbial growth (for biological performance tests).
• Pre-defined Parameters: Sterilization temperature, time, and dry time, against which the device's actual performance is measured.

For biological performance tests, the "ground truth" for sterility is the absence of microbial growth (i.e., a 10-6 SAL or greater assurance of sterility), as determined by biological indicators (BIs) and process challenge devices (PCDs).

8. Sample Size for the Training Set

Not applicable. This is a medical device (steam sterilizer), not an AI/machine learning model that requires a training set. The device's operation is based on established physical principles and pre-programmed sterilization cycles, not on learned patterns from a data 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 Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves that are intended for use by a health care r no rathant nealized products by means of pressurized steam. The devices are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products.

Tuttnauer Horizontal Models: 4472, 5596, 6690, 66120, 69120 and 69180 autoclaves

This document is a 510(k) premarket notification for Tuttnauer Horizontal Autoclaves and details their intended use and preprogrammed sterilization cycles. It is not a study proving a device meets acceptance criteria, nor does it contain information about AI/ML device performance. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Device Name: Tuttnauer Horizontal Models: 4472, 5596, 6690, 6990, 66120, 69120 and 69180 autoclaves
• Regulation Name: Steam Sterilizer (21 CFR 880.6880)
• Intended Use: Sterilization of heat-stable medical devices (wrapped solids, hollow, and porous products) by means of pressurized steam in a healthcare setting.
• Preprogrammed Cycles: Details sterilization temperature, sterilization time, dry time, and maximum load for various cycles (IUSS, Wrapped, IUSS delicate, Wrapped delicate, Bowie and Dick, Vacuum test) across different models.

To answer your request, I would need a document specifically detailing an acceptance study for a device, including performance metrics, sample sizes, ground truth establishment, and if applicable, AI/ML study details. This document is a regulatory approval notification.

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