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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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