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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 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 cvcle:

· Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter*

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**

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.

• A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

The STERRAD 100NX Sterilizer 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 affect sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles.

An expansion of existing claims is being applied to the FLEX cycle without affecting the technology, software, or other physical features of the subject device.

The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the FLEX Cycle of the STERRAD 100NX Sterilizer to include single channel flexible endoscopes with extended dimensions from 850 mm in length to 1065 mm in length, when the inside diameter is ≥1 mm. There are no other changes to the indications for use for the FLEX Cycle. The FLEX Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter.

This document is a 510(k) Premarket Notification for the STERRAD 100NX Sterilizer with ALLClear Technology. The submission focuses on expanding the indications for use of its FLEX cycle. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below:

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 a specific "test set" in the context of an AI/algorithm-driven device, as this submission is for a medical device sterilizer. The "testing" refers to performance validation studies for the sterilizer's efficacy.

• Dose Response Study: The sample size is not explicitly stated in terms of number of endoscopes or individual tests, but the objective was to demonstrate a Sterility Assurance Level (SAL) of 10-6. This typically involves a statistically significant number of biological indicators and test devices to prove sterilization effectiveness.
• Simulated Use Study: The sample size is not explicitly stated. The study aims to demonstrate sterilization efficacy of the specified flexible endoscopes under simulated clinical use.
• Data Provenance: The studies were conducted by "Advanced Sterilization Products, Inc." This indicates the data is likely generated by the manufacturer and is prospective, as it's specifically for a claims expansion. No country of origin for the data is specified beyond the company's US address.

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

Not applicable. This is not an AI/algorithm-driven device requiring expert-established ground truth for image or data interpretation. The "ground truth" for a sterilizer's performance is the achievement of sterility, which is measured through microbiological methods (e.g., biological indicators, sterility tests), not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not an AI/algorithm submission that would involve expert adjudication of results.

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 device is a sterilizer, not an AI diagnostic or assistance tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This device is a sterilizer and does not operate as an algorithm-only system. Its primary function is to physically sterilize instruments.

7. The Type of Ground Truth Used

The ground truth used for the validation studies is sterility, as determined by standard microbiological methods. For sterilization processes, this involves demonstrating the inactivation of a specified number of highly resistant microorganisms (e.g., bacterial spores) to achieve a desired Sterility Assurance Level (SAL), typically 10-6 (meaning a one in a million chance of a non-sterile unit).

8. The Sample Size for the Training Set

Not applicable. This device is a sterilizer, not an AI/machine learning model that requires a training set. The "training" in the context of a sterilizer involves its design, engineering, and manufacturing to meet performance specifications.

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

Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth to be established in that sense. The product's performance specifications are established through industry standards, regulatory requirements, and internal research and development.

Ask a specific question about this device

The STERRAD 100NX Sterilizer 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* 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 850 mm or shorter**

Note: With the exception of the 1 x 850 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 850 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.

• A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

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

For the STANDARD and FLEX cycles, hydrogen peroxide (HoO2) vapor is generated by injecting aqueous hydrogen peroxide into an on-board vaporizer where the solution is heated and vaporized, thereby concentrating 59% H2O2 to 90% nominal H2O2. The H2O2 vapor is then introduced into the sterilization chamber under sub-ambient pressure and transformed 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 affect sterilization.

For the EXPRESS cycle, the onboard concentration process utilized for STANDARD and FLEX cycles is not used: the subsystem receives hydrogen peroxide solution from the delivery system. vaporizes the liquid and delivers it to the chamber.

For the DUO Cycle, hydrogen peroxide from the STERRAD 100NX Cassette follows a different flow path through the delivery module. The hydrogen peroxide, when withdrawn from the cassette, is temporarily held in the accumulators of the delivery module, and a smaller quantity (1.55 mL, nominal value) of hydrogen peroxide is dispensed or metered into the vaporizer during each of the two half-cycles of the DUO cycle. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel, Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), injection molding, and structural foam. The sterilizer also uses accessories such as reusable instrument trays, and printer paper.

The STERRAD 100NX Sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.

The modified STERRAD 100NX Sterilizer with ALLClear Technology described within this submission incorporates enhancements and new features to improve reliability and usability. as briefly described following:

• Load Conditioning Feature: Available for use with the STANDARD, FLEX, and . EXPRESS cycles. Reduces canceled cycles by performing load and system checks and executing a load conditioning step prior to starting a sterilization cycle.
• . Enhanced Graphical User Interface (GUI): Added information to the error messages enabling users to take actions related to that error message. GUI enhancement also provides more intuitive navigation.
• Improved cassette insertion.
• New Touchscreen Display: Larger, higher resolution, and wider viewing angle.
• New External Panels: Enhance aesthetic appearance and accommodate the larger display.
• Capability for future "ecosystem" connectivity: Will allow communication and integration . with future ASP biological indicator reader(s), as well as other potential future communication features.

The technological characteristics associated with the sterilization process for the modified STERRAD 100NX Sterilizer ALLClear Technology are identical to those of the previously cleared STERRAD 100NX Sterilizer; the software and hardware changes associated with the described enhancements and new features do not modify the existing sterilization cycles.

This document describes the STERRAD® 100NX Sterilizer with ALLClear™ Technology, a low-temperature sterilization system using hydrogen peroxide gas plasma. The submission (K160903) concerns enhancements to reliability and usability of the previously cleared device, not changes to the core sterilization process.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative predefined "acceptance criteria" for the changes, but rather "Pass/Fail" results for various verification tests demonstrating compliance and functionality. The overall acceptance is implied by all tests yielding "Pass".

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

The document does not specify exact sample sizes for each verification test. It generally refers to "studies" or "testing" without detailing the number of units or cycles tested.
The data provenance is internal to Advanced Sterilization Products, as these are non-clinical verification tests conducted for regulatory submission. No information on country of origin of the data is provided beyond the submitting company's location (Irvine, CA, USA). The tests are prospective in nature, as they are specifically conducted to verify the changes in the device.

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

This information is not provided in the document. The tests seem to be objective engineering and scientific evaluations rather than expert-driven ground truth establishment. For example, sterilizer performance is evaluated against defined physical and biological parameters, and usability testing is conducted with users, but the "ground truth" for the device's function is its validated performance.

4. Adjudication Method for the Test Set

Not applicable. The tests are presented as objective measurements and verifications, not requiring an adjudication panel.

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 device is a sterilizer, not an AI-powered diagnostic system that involves human readers or interpretation of medical images.

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

Not applicable. This device is a physical sterilizer and does not involve AI algorithms in the context of diagnostic interpretation. Its performance is inherent to its mechanical, chemical, and software components operating in a standalone fashion.

7. The Type of Ground Truth Used

The ground truth for the performance of the sterilizer is based on established scientific principles of sterilization (e.g., microbial inactivation, hydrogen peroxide concentration, temperature, pressure), material compatibility, electrical safety standards, and software validation. For biological efficacy, this typically involves testing with biological indicators. For the improvements in this submission, the "ground truth" for the new features (e.g., load conditioning, new display) are that they perform their intended function (e.g., reduce out-gassing, display correctly) and do not compromise existing validated sterilization processes.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI models that require a "training set" in the conventional sense. The "training" for the device's operation is its design, engineering tolerances, and validated parameters.

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

Not applicable, as there is no "training set" in the AI sense for this device. The design and performance parameters are established through engineering specifications, regulatory standards, and scientific principles related to sterilization and medical device manufacturing.

Ask a specific question about this device

The STERRAD® NX® Sterilizer 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 affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

The STERRAD® 100NX® Sterilizer 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.

The STERRAD 100NX EXPRESS Cycle is an additional 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.

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.

The STERRAD® NX® Sterilizer 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 STERRAD NX Sterilizer has two cleared sterilization cycles, the Standard and Advanced Cycles. The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before introducing into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the specification. The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable cart.

The STERRAD® 100NX® Sterilizer 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 STERRAD 100NX Sterilizer has four cleared sterilization cycles (Standard, Flex, EXPRESS, and DUO Cycles). The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. For the Standard and Flex Cycles, the hydrogen peroxide is concentrated before into the sterilizer chamber. For the EXPRESS and DUO Cycles, the concentration process is not used. For all four cycles, the hydrogen peroxide concentration is monitored during the cycle and the sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the specification. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays and printer paper.

The STERRAD NX and 100NX are controlled by software running on an onboard microprocessor. The software is designed to control the sterilizer and provide an interface for user interaction with the sterilizer. The software has the network connectivity feature that allows the Hospital IT Department to connect the STERRAD NX or STERRAD 100NX to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and then, if desired, to an Instrument Tracking System.

This document describes the regulatory submission for a software revision to the STERRAD NX and STERRAD 100NX Sterilizers, primarily enabling network connectivity. The core functionality of sterilization remains unchanged from the predicate device. Therefore, the "device performance" in this context refers to the performance of the software and the electrical safety and electromagnetic compatibility (EMC) of the overall system with the new software.

No human reader studies (MRMC) or standalone algorithm performance studies were conducted as this is not an AI/ML powered diagnostic device. The ground truth for the training set is not applicable as this is a software update for a sterilizer, not a machine learning model requiring training data.

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 distinct "test set" in the traditional sense of a dataset for algorithm evaluation. Instead, the testing pertains to the hardware and software functionality of the sterilizer.

• Electrical Safety and EMC Testing: Performed on the STERRAD NX and 100NX Sterilizers themselves. The sample size would be the units of sterilizers tested, which is typically a limited number of physical devices (e.g., one or a few units for compliance testing).
• Software Verification and Validation Testing: Implies testing performed on the software code and integrated system. The "sample size" here would be the extent of the test cases executed to verify software requirements.
• Data Provenance: Not applicable in the context of data used for algorithm training or evaluation, but rather for testing the manufacturing of the physical device and its updated software. This is likely internal testing by the manufacturer, Advanced Sterilization Products.

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

Not applicable. The ground truth for this device primarily pertains to engineering specifications, safety standards, and software requirements, not expert interpretation of outputs like images. The "ground truth" for electrical safety and EMC is defined by established international and national standards (e.g., CISPR, EN, CAN/CSA, UL, IEC).

4. Adjudication Method for the Test Set

Not applicable. This type of device testing relies on objective measurements against predefined engineering and regulatory standards, not subjective expert adjudication. For instance, an EMC test result is a "pass" or "fail" based on quantitative limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a sterilizer with a software update for network connectivity, not a diagnostic or screening tool that would involve human readers interpreting cases.

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

Yes, in essence, the software verification and validation testing, along with the electrical safety and EMC testing, represents a form of standalone performance evaluation for the updated system. The network connectivity feature itself operates without human intervention once configured, sending cycle parameters automatically. The "algorithm" here is the sterilizer's control software and the new networking software. Its performance is assessed against its functional requirements and regulatory standards.

7. The Type of Ground Truth Used

• For Electrical Safety and EMC: Regulatory and industry standards (e.g., CISPR 11, EN 60601-1-2, CAN/CSA-C22.2 No.: 61010-1, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-040, EN 55011). These standards define the acceptable limits for emissions and safety parameters.
• For Software Verification and Validation: Predetermined software requirements specifications and functional design documents. The "ground truth" is whether the software correctly implements its intended functions (e.g., network configuration, data transmission, error notifications) according to these documented specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a sterilizer system with a software update, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The STERRAD® NX® Sterilizer 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 affect sterilization. The STERRAD® NX® 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® NX® Sterilizer Standard cycle:
Single channel stainless steel lumens with

• An inside diameter of 1 mm or larger and a length of 150 mm or shorter
• An inside diameter of 2 mm or larger and a length of 400 mm or shorter

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD® NX® Sterilizer Advanced cycle:
Single channel stainless steel lumens with

• An inside diameter of 1 mm or larger and a length of 500 mm or shorter
  Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
• An inside diameter of 1 mm or larger and length of 850 mm or shorter

The STERRAD® 100NX® Sterilizer 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

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 850 mm or shorter

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

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

The STERRAD® NX® and 100NX® Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a hydrogen peroxide 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 and transforming the vapor into a gas plasma using electrical energy. The STERRAD® NX® and 100NX® are controlled by software running on an onboard microprocessor. The software is designed to control the sterilizer and provide an interface for user interaction with the sterilizer.

The network connectivity software revision that is the basis for this 510(k) premarket notification allows the Hospital IT Department to connect the STERRAD® NX® or STERRAD® 100NX® to a Hospital Local Area Network (LAN) for transfer of cycle parameters to a server and then, if desired, to an Instrument Tracking System. The software has been designed for ease of configuration using Dynamic Host Configuration Protocol (DHCP). The cycle information will be available in Portable Document Format (PDF) and Comma Separated Values (CSV) formats and transmitted using Transmission Control Protocol/Internet Protocol (TCP/IP). The network digital information will be identical to the existing cycle information printed out by the devices after each cycle (PDF file) and the existing electronic delimited data (CSV file) that can be downloaded through the USB port.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

It's important to note that this document is a 510(k) summary for a medical device (sterilizer), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against new, specific clinical acceptance criteria. The "acceptance criteria" here are primarily based on established standards for safety, electromagnetic compatibility, and software validation, aligning with regulatory requirements for demonstrating equivalence for a modification to an existing device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

Given the nature of this 510(k) submission, the "study" primarily consists of engineering and software testing to demonstrate that the modifications (software revision, upgraded CPU, and controller board) to the existing STERRAD® sterilizers do not negatively impact their performance and that the modified devices remain substantially equivalent to their predicates. This is not a typical clinical performance study of a diagnostic AI device.

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

• Test Set Sample Size: Not explicitly stated in terms of typical clinical "samples" (e.g., patients or images). For the electrical and EMC testing, entire STERRAD® NX® and 100NX® Sterilizer units with the upgraded CPU and controller board were tested. For software, the "test set" would refer to software validation test cases, which are not quantified here.
• Data Provenance: The testing was conducted by the manufacturer (Advanced Sterilization Products) or their designated testing facilities. This is internal testing, not external patient data.

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 submission. "Ground truth" in a clinical sense (e.g., expert labels on medical images or pathology reports) is not relevant for electrical, EMC, and software validation of a sterilizer. The "ground truth" for these tests are the specifications and requirements of the referenced standards.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert opinions. Here, the "truth" is determined by meeting objective engineering and software standards.

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:

• No MRMC or comparative effectiveness study was performed. This device is a sterilizer, not a diagnostic AI tool that assists human readers. The changes are to its internal computing and networking capabilities.

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

• Not directly applicable in the terms of a diagnostic algorithm. However, the electrical, EMC, and software validation tests are essentially "standalone" in that they evaluate the device's adherence to technical standards without human intervention in its primary operation during these tests. The software itself is a standalone component within the sterilizer, and its functionality (like network connectivity) was validated independently.

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

• For electrical safety and EMC, the ground truth is defined by the requirements of the referenced international and national standards (e.g., CISPR 11, EN 60601-1-2, UL 61010-1).
• For software validation, the ground truth is adherence to the software requirements specification and meeting safety and functionality expectations outlined in the FDA's guidance document for medical device software.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic imaging that requires a "training set" of data. The software is deterministic control software.

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

• Not applicable, as there is no "training set."

Ask a specific question about this device

The STERRAD® 100NX™ Sterilizer 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 affect sterilization.

The STERRAD® 100NX™ Sterilizer can sterilize instruments which have diffusionrestricted 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*
  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 850 mm or shorter**
  Note: With the exception of the 1 x 850 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 850 mm flexible endoscopes were validated without any additional load.

*A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle.

** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No 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 diffusionrestricted spaces, such as the hinged portion of forceps and scissors

• It can sterilize rigid and semi-rigid endoscopes without lumens

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

The STERRAD® 100NX™ Sterilizer 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 STERRAD® 100NXTM Sterilizer has three different sterilization cycles, the Standard cycle, the Flex cycle, and the new optional additional EXPRESS cycle.

The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.

Here's a breakdown of the acceptance criteria and the study information for the STERRAD® 100NX™ Sterilizer with EXPRESS Cycle, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sterility assurance level of X"). Instead, it describes a "Passed" outcome for various validation studies, implying that the device met pre-defined success metrics for each study. The overarching acceptance criterion is achieving sterilization and demonstrating equivalence to predicate devices.

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

• Sample Size: The document does not explicitly state a total numerical sample size for the "test set" in terms of how many individual items were sterilized across all tests. However, it does provide specific load configurations used for validation studies:
  • Standard Cycle Validation Load: Two instrument trays, each weighing 10.7 lbs. (for 0.7 mm x 500 mm lumens). A maximum of ten single-channel stainless steel lumens (five per tray per cycle).
  • Flex Scope Cycle Validation Load: Two flexible endoscopes (one per tray per cycle) for 1 mm x 850 mm flexible endoscopes. For other flexible endoscopes, the load was two instrument trays, each weighing 10.7 lbs.
  • EXPRESS Cycle Validation Load: A single instrument tray weighing 10.7 lbs placed on the bottom shelf.
• Data Provenance: The document does not specify the country of origin of the data. It implies the studies were conducted by Advanced Sterilization Products (division of Ethicon, Inc.), based in Irvine, CA, USA.
• Retrospective or Prospective: The studies described ("Validation Testing") are inherently prospective, as they were conducted to validate the performance of the new EXPRESS cycle.

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

This information is not provided in the document. The document primarily focuses on microbiological "overkill" methods using G. stearothermophilus spores and physical testing, which don't typically involve human expert adjudication for ground truth in the same way as, for example, medical imaging diagnostics.

4. Adjudication Method for the Test Set:

This information is not provided as the ground truth establishment method (microbiological challenge and physical testing) does not involve adjudication by multiple experts. The "ground truth" for sterilization is typically measured by the inactivation of biological indicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human interpretation is involved. The STERRAD® 100NX™ Sterilizer is a sterilization device, and its effectiveness is determined by its ability to kill microorganisms, not by human interpretation of images or data.

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

The device itself is a standalone system (the sterilizer). The validation studies presented evaluate the performance of the sterilizer operating on its own; there is no "human-in-the-loop" performance being measured in the context of the device's primary function (sterilization). Therefore, in a sense, the evaluations are entirely of the "algorithm only" (the sterilization process) without human interpretive intervention.

7. The Type of Ground Truth Used:

The primary ground truth used is the inactivation of biological indicators, specifically G. stearothermophilus spores, using an "overkill" approach. This is a well-established and accepted method for demonstrating sterilization efficacy. Additional ground truth elements include:

• Physical/Chemical measurements: Ensuring appropriate levels of hydrogen peroxide and plasma are achieved.
• Bacteriostasis testing: Confirming that materials or residues do not inhibit microbial growth.
• Functionality and material compatibility assessments: Ensuring the devices being sterilized are not damaged and remain functional.

8. The Sample Size for the Training Set:

This document does not refer to a "training set" in the context of an algorithm or AI. The STERRAD® 100NX™ Sterilizer is a physical device with a defined process, not a machine learning model that undergoes a training phase. The validation studies demonstrate the performance of the finalized device.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The device's design and parameters would have been developed based on scientific principles of sterilization and iterative testing, not by training an algorithm on a dataset with pre-established ground truth.

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The STERRAD® 100NX™ Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase medical "devices" at 2011" withing a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization.

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. *

Medical devices, including most flexible endoscopes, with the following materials and Modical as nocessed 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 850 mm or shorter. **

Note: With the exception of the 1 x 850 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 Ibs. The 1 x 850 mm flexible endoscopes were validated without any additional load.

• A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle. ** A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load.

The STERRAD® 100NXTM Sterilizer 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 STERRAD® 100NX™ Sterilizer has two different sterilization cycles, the Standard cycle and the Flex cycle.

The hardware for the STERRAD® 100NX™ Sterilizer consists of a sterilization chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer system also uses accessories such as a disposable sterilant cassette, reusable instrument trays, printer paper, and an optional movable cart. The STERRAD® 100NXTM Sterilizer can be placed directly on a table, counter top, or on the movable cart.

The provided text is a 510(k) summary for the STERRAD® 100NX™ Sterilizer. It describes the device's indications for use, its predicate device, a general description, and a summary of nonclinical tests. However, the document does not contain specific acceptance criteria, reported device performance metrics in a table format, sample sizes or provenance for test sets, details on ground truth establishment (number of experts, qualifications, adjudication methods), information about MRMC studies, or standalone algorithm performance.

The text focuses on the validation testing performed, which used an "overkill" approach with G. stearothermophilus spores to demonstrate the sterilizer's effectiveness.

Based only on the provided input, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria:
  • The primary acceptance criterion for a sterilizer is usually the complete inactivation of a specified biological indicator (e.g., G. stearothermophilus spores). The "overkill" approach implies demonstrating sterility under challenging conditions (e.g., high spore populations). The document states "Testing was performed using the 'overkill' approach utilizing G. stearothermophilus spores."
  • Specific performance metrics (e.g., Sterility Assurance Level (SAL) of 10^-6 or better) are implied by the overkill method but not explicitly stated as quantitative acceptance criteria in this document.
  • The ability to sterilize specific types of lumens and endoscopes of certain dimensions is also an implicit acceptance criterion.
• Reported Device Performance: The document only states "Table 8-1 on the following page identifies the validation studies performed and the results obtained." This table is not provided in the given text, so specific performance results are unavailable.

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

• Sample Size: The document mentions "a validation load consisting of two instrument trays each weighing 10.7 lbs" for most studies. For the 1 x 850 mm flexible endoscopes, they "were validated without any additional load." It also specifies "A maximum of ten lumens, five per tray" and "A maximum of two flexible endoscopes, one per tray." These describe the loading configurations for the tests, but not the total 'sample size' in terms of the number of sterilization cycles or the total number of biological indicators tested.
• Data Provenance: Not specified. This is a nonclinical, device performance study, not a clinical study on human data.

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

• Not Applicable. This is not a study involving human interpretation of data where expert ground truth would be established. The "ground truth" for a sterilizer is the proven inactivation of biological indicators, which is a laboratory measurement.

4. Adjudication method for the test set:

• Not Applicable. There is no human adjudication component for this type of device performance study.

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-powered diagnostic or interpretive tool.

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

• Not Applicable. This is a hardware and software system for sterilization, not an algorithm being tested for standalone performance. The sterilizer operates autonomously to perform the sterilization cycle.

7. The type of ground truth used:

• The ground truth for the sterilization efficacy tests was the inactivation of G. stearothermophilus spores. This is a biological indicator common in sterilization validation, typically confirmed by culture methods to ensure no viable spores remain after processing.

8. The sample size for the training set:

• Not Applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The "training" for a sterilizer system is its design and engineering parameters.

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

• Not Applicable. As above, no training set in this context.

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