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The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterlization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue.

The STERRAD 100NX Sterilize can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle:

· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer FLEX Scope cycle:

• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

Note: With the exception of the 1 x 1065 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 1065 mm flexible endoscopes were validated without any additional load.

The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures.

• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors

· It can sterilize rigid and semi-rigid endoscopes without lumens.

Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf.

The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions:

• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter

· Accessory devices that are normally connected to a flexible endoscope during use

• Flexible endoscopes without lumens

Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following:

• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.

· One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Notel : The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI Cycle compatible duodenoscopes.

The APTIMAX™ Tray for ULTRA GI™ Cycle is designed to encase surgical instruments for sterilization in STERRAD™ 100NX Sterilization System with ALLCLEAR™ Technology:

• ULTRA GI™ Cycle

The STERRAD 100NX Sterilization System with ALLClear Technology is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to achieve sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, biological indicator products and sterilant cassettes. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.

The STERRAD 100NX Sterilizer described within this submission introduces the new ULTRA GI Cycle along with the new APTIMAX Instrument Tray for ULTRA GI Cycle.

The STERRAD 100NX Sterilizer ULTRA GI Cycle is an additional cycle designed for sterilization of the following:

• Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more ● than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length.
• . One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle

Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.

Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes.

The APTIMAX Instrument Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLClear Technology:

• ULTRA GI Cycle .
  This cycle is designed to run on STERRAD 100NX System with ALLClear Technology with the DUO Module enabled. ALLClear Technology features of Load Check, System Check, and Load Conditioning are integrated into the ULTRA GI cycle.

The provided text describes the acceptance criteria and study results for the STERRAD™ 100NX Sterilizer with ALLClear™ Technology, specifically for the new ULTRA GI™ Cycle, and the APTIMAX™ Instrument Tray for ULTRA GI Cycle.

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides two tables: Table 3 for the STERRAD 100NX Sterilizer and Table 4 for the APTIMAX Instrument Tray.

Table 3. Performance Test Results - STERRAD 100NX Sterilizer (ULTRA GI Cycle)

Table 4. Performance Test Results - APTIMAX Instrument Tray for ULTRA GI Cycle

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

The document does not explicitly state the numerical sample size for the test sets. However, it mentions procedures like "validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs" for existing cycles and similar descriptions for the ULTRA GI cycle (e.g., "validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf"). These refer to the type and weight of the sterilization load, not the statistical sample size for performance validation.

The data provenance is from non-clinical testing conducted by Advanced Sterilization Products, Inc., likely within the United States (given it's an FDA submission for a US company). These are prospective tests performed specifically for this submission to demonstrate the device's efficacy and safety.

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

This information is not provided in the document. The testing described is for a sterilization device, which typically relies on laboratory microbiologists and engineers to establish ground truth through direct measurement of sterilization efficacy (e.g., elimination of spores, microbial growth inhibition) and material compatibility, rather than clinical experts like radiologists interpreting images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/not provided. Adjudication methods like '2+1' or '3+1' are typical for studies involving human interpretation of medical images or data where expert consensus is needed. For a sterilization device, the "ground truth" (e.g., sterility, material integrity) is established through objective, quantifiable laboratory performance tests, not through expert consensus or adjudication.

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

This is not applicable. The device is a sterilizer, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, no MRMC study was conducted or is relevant.

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

This is not applicable. The device is a physical sterilizer system with hardware and software controlling the sterilization process. Its performance is inherent to the system itself, not an algorithm that performs a standalone task in isolation from human input or a physical process, in the way a diagnostic algorithm would. The tests aim to demonstrate the sterilizer's ability to achieve sterility without human intervention in the sterilization process, only the loading and unloading of instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the sterilization efficacy tests is microbiological validation (e.g., demonstration of a Sterility Assurance Level (SAL) of 10-6, absence of microbial growth). For material compatibility, the ground truth is the maintenance of manufacturer's functional specifications for the processed endoscopes and the biological safety of materials post-sterilization. For the tray, it's the mechanical and physical integrity and cleaning efficacy. These are objective, empirically measured outcomes.

8. The sample size for the training set:

This is not applicable. The document describes a physical medical device (sterilizer) and its accessory tray. It's not an AI/ML device that requires a training set of data. The "training" for such a device occurs during its design and development, through engineering principles, material science, and iterative testing, not through a data-driven training set in the AI sense.

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

This is not applicable, as it's not an AI/ML device requiring a training set. The "ground truth" for the device's design and functionality would be established through established engineering standards, sterilization guidelines (e.g., AAMI standards), and internal R&D validation processes.

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