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The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization 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 Sterilizer 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 a 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 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 on the bottom shelf.

The STERRAD 100NX DUO Cycle is 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 1: 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.

• One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter.

Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens and 1 dual channel endoscope with ≥1 mm diameter x ≤670 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens

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

• Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of ≥1mm x ≤1500mm in length, and ≥2mm x ≤1630mm in length.
• One flexible endoscope per tray, and no more than two flexible endoscopes per cycle

Note1: 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 compatible duodenoscopes.

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, chemical indicator products and sterilant cassettes.

The STERRAD 100NX Sterilizer has five cleared sterilization cycles: STANDARD, FLEX, EXPRESS, DUO and ULTRA GI Cycles.

The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the DUO Cycle of the STERRAD 100NX Sterilizer to include one dual-channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter and with the weight of 3.4 kg (7.4 lbs). There are no other changes to the indications for use for the DUO cycle.

This document is a 510(k) clearance letter for a medical device (STERRAD® 100NX Sterilizer with ALLClear™ Technology). It is NOT a study describing the acceptance criteria and performance of an AI/ML-based device.

Therefore, the requested information regarding AI/ML-specific testing (e.g., sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document because it is irrelevant to a sterilization device clearance.

The document describes the acceptance criteria and test results for a physical medical device (a sterilizer), not a software or AI/ML diagnostic tool.

However, I can extract the information relevant to the sterilizer's performance and acceptance criteria as presented:

Acceptance Criteria and Device Performance for the STERRAD® 100NX Sterilizer with ALLClear™ Technology (DUO Cycle Claims Expansion)

This submission focuses on expanding the indications of the DUO Cycle of the STERRAD 100NX Sterilizer. The study demonstrates the safety and effectiveness of the device for sterilization of medical instruments.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the exact number of samples (e.g., number of sterilization cycles, number of instruments) used for each test. Instead, it refers to "test samples" and provides details on the type and dimensions of the medical devices tested.
  • DUO Cycle Validation Load: "The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and 2.2 mm diameter x 835 mm long PTFE/PE lumens, and 1 dual channel endoscope with 1 mm diameter x 670 mm long and 2.2 mm diameter x 845 mm long PTFE/PE lumens." This implies specific endoscopes were used for the validation tests.
  • Weight of Load: For the DUO Cycle, the validation load consisted of two flexible endoscopes with accessory devices weighing a total of 13.2 lbs.
• Data Provenance: The data provenance (e.g., country of origin) is not specified. The studies are described as "non-clinical testing" and are conducted to support a 510(k) submission to the U.S. FDA, implying they were conducted in a controlled lab setting, likely by the manufacturer. The tests are retrospective in the sense that they are completed prior to submission.

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

• Not applicable in the context of this device. Ground truth for sterilization efficacy is typically established through microbiological methods (e.g., spore kill, sterility assurance levels, no growth) following established sterilization standards and protocols (e.g., AAMI, ISO standards), rather than expert consensus on interpretation.

4. Adjudication method for the test set:

• Not applicable. Results are quantitative (e.g., growth/no growth, SAL calculation, functional specifications) and determined by laboratory testing, not human interpretation requiring 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:

• Not applicable. This is a sterilization device, not an AI/ML diagnostic tool used by human readers.

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

• Not applicable. This is a physical sterilizer. Its performance is evaluated in its designed operation, which is "standalone" in the sense that it performs the sterilization process automatically.

7. The type of ground truth used:

• The ground truth for sterilization efficacy is based on microbiological testing (sterility/no growth) and physical performance parameters of the device (e.g., maintenance of function of the processed instruments). This involves challenging the sterilizer with biological indicators (known number of resilient microorganisms) and assessing the complete kill, as well as verifying the endoscopes' functionality after processing.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires training data in the traditional sense. The "training" of the device is its design, engineering, and manufacturing in compliance with sterilization standards.

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

• Not applicable. As above, this is a physical device. The "ground truth" for its development would be established through engineering specifications, previous sterilizer designs, and compliance with relevant industry standards for sterilization processes and validation.

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