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The T-Top 10 & T-Top 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 & dental offices).

The T-Top 10 and T-Top 11 devices are validated for use in:

• · Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
• · Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The steam is produced by warming up a controlled amount of water inserted to a pipe heating element, and then to the chamber. This technique saves energy and water consumption.

The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber.

The autoclave is equipped with a vacuum system, which supports and improves:

• . 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.
• . Steam penetration into the load; resulting in effective sterilization.
• . Temperature uniformity.
• . Post sterilization drying phase

A touchscreen is used for monitoring and control purposes.

The device has 2 built -in USB ports to enable the operation of an external optional barcode printer:

• The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates
• . One barcode printer can be connected to the machine.
• The printer connection to the machine, by using a USB socket, with a dedicated cable .
• Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket).
• . A barcode printer is an optional addition to the autoclave

The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC.

The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two 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 T-Top 10 has a manually filled reservoir of demineralized water only.

There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front.

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-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 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.

There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option - see software reports in the 510(k) file.

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

The provided text describes the regulatory clearance of a steam sterilizer (T-Top 10 & T-Top 11) and its performance testing against established standards. It does not contain information about an AI/ML-driven medical device, nor does it detail a clinical study involving human readers or the establishment of ground truth by multiple experts. Therefore, many of the requested categories are not applicable to the provided document.

However, I can extract and present the information regarding the device's acceptance criteria and the study that proves it meets those criteria, based on the provided text.

Here's the relevant information:

Acceptance Criteria and Device Performance Study for T-Top 10 & T-Top 11 Steam Sterilizer

The T-Top 10 & T-Top 11 are steam sterilizers, and their performance is evaluated based on their ability to consistently achieve sterilization parameters and operate safely according to recognized standards. The "study" proving this involves various performance tests, not a clinical trial in the sense of AI/ML device evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "sample size" in the conventional sense of a clinical trial (e.g., number of patients/images). Instead, performance testing of a sterilizer involves a series of runs or cycles under specific conditions. The provenance is internal laboratory testing against established standards, not necessarily geographical (e.g., country of origin of data). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission.

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

Not applicable. The "ground truth" for a steam sterilizer's performance is objective and defined by established physical and biological parameters (temperature, pressure, time, sterility assurance level) as per industry standards (e.g., ANSI/AAMI ST-55). It does not involve expert interpretation or consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on objective measurements and predefined pass/fail criteria, not subjective human judgment requiring adjudication.

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

Not applicable. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. A steam sterilizer does not involve human reading or AI assistance in its primary function.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical sterilizer and not an algorithm in the context of AI/ML. Its performance is inherent to its physical operation and design conforming to engineering and sterilization standards.

7. Type of Ground Truth Used

The ground truth used for this device is based on pre-established industry standards and scientific principles for sterilization, including:

• Physical parameters: Temperature, pressure, and exposure time, measured by calibrated instruments.
• Biological indicators (BIs): Spore strips containing highly resistant microorganisms (e.g., Geobacillus stearothermophilus) which, when inactivated, demonstrate a required sterility assurance level (SAL) (usually 10^-6^).
• Chemical indicators (CIs): Devices (like Bowie-Dick test sheets) that react to specific sterilization conditions (e.g., steam penetration, air removal) with a visible color change.
• Engineering specifications: Electrical safety, electromagnetic compatibility, pressure vessel integrity.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning. The device's design and operation are based on engineering principles and validated through the performance tests outlined above.

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

Not applicable. There is no training set or ground truth in the AI/ML sense. The "training" for such a device is its design and manufacturing process to meet the specified performance metrics.

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