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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 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 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 shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with

• An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●

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 a 59% aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and is vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.

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. Other major components of the system are constructed from passivated stainless steel. Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), and structural foam. 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 STERRAD NX cart.

The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction 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 pre-defined minimum concentration specification.

The modified STERRAD NX Sterilizer, which is the subject of this submission, incorporates a new vacuum pump and associated mounting components to improve the pump's durability. The new vacuum pump utilizes an oil warming element to maintain an optimum operating temperature range for the vacuum pump's oil during the periods of pump inactivation in-between reprocessing cycles. This modification will be implemented through hardware changes with no impact on the system software.

The technological characteristics associated with the sterilization process for the modified STERRAD NX Sterilizer are identical to those of the previously cleared STERRAD NX Sterilizer. In addition, the hardware changes associated with the described modification do not affect the cleared sterilization cycles or the manner by which the STERRAD NX Sterilizer is operated by the customer.

The provided document is a 510(k) premarket notification for a medical device: the STERRAD NX® Sterilizer with a new vacuum pump. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not for proving effectiveness of a new technology (like an AI algorithm) through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models is largely not applicable to this document.

The document describes a modification to an existing sterilizer (changing the vacuum pump) and focuses on demonstrating that this change does not negatively impact the device's existing performance or safety.

However, I can extract the closest analogous information from the document to answer your prompt, focusing on the verification testing conducted for the sterilizer's modification.

Summary of Device Performance and Acceptance Criteria (as applicable to a non-AI device modification):

This document describes a design modification (new vacuum pump) to an existing medical device, the STERRAD NX Sterilizer. The "acceptance criteria" here relate to demonstrating that the new component does not compromise the sterilizer's function or safety, and maintains the established efficacy of sterilization. Since this is not an AI device, concepts like "sensitivity," "specificity," or specific performance metrics for model predictions are not relevant. Instead, the acceptance criteria relate to functional performance and sterility assurance.

The studies conducted are primarily non-clinical design verification tests. There were no clinical studies submitted for this specific 510(k) notification.

Here's the breakdown of the information requested, adapting it to the content of the document:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criterion (Design Input Verified)	Reported Device Performance (Verification Testing Outcome)
   Vacuum Pump Performance:
   * Time to warm up across different power settings	Pass
   * Pump startup across different power settings	Pass
   * Pump current draw	Pass
   * Environmental specifications	Pass
   * Noise generation	Pass
   * Time to pump an enclosed space to a defined pressure	Pass
   * Fitment	Pass
   * Weight (impact on total device weight, mentioned in comparison table)	Modified device weighs 10 lb more, deemed acceptable
   * Qualitative verification of features (e.g., drain valve, liftable feature)	Pass
   Sterilization Efficacy (for STANDARD and ADVANCED Cycles with new pump):
   * Sterility Assurance Level (SAL) of 10⁻⁶ for Geobacillus stearothermophilus (Biological Indicators - BIs) with no growth observed. This demonstrates no impact to efficacy.	Pass (No growth observed on test BIs)
   Safety and Compatibility:
   * Biocompatibility (continued applicability of predicate data)	Applicable
   * Electromagnetic compatibility (EMC) (continued applicability of predicate data)	Applicable (no anticipated impact from notified body)
   * Electrical Safety (conformance to specific standards: CAN/CSA-C22.2 No. 61010-1, CAN/CSA-C22.2 No. 61010-2-040, UL 61010-1, IEC/EN 61010-1, IEC/EN 61010-2-40)	Conforms to applicable standards
   * Software Verification and Validation (continued applicability of predicate data - no software changes)	Applicable

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

   • Sample Size: The document does not specify the exact number of units or test runs for the vacuum pump verification tests. For the sterilization efficacy testing, it mentions "test BIs" (Biological Indicators) but doesn't quantify the number used. For lumen validation, specifies "a maximum of 10 lumens per load" and "only one flexible endoscope per sterilization cycle."
   • Data Provenance: The data is generated from non-clinical design verification testing performed by the manufacturer, Advanced Sterilization Products. The location or specific date of data generation isn't explicitly stated beyond the submission date (February 16, 2017). It is prospective with respect to the design modification.

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

   • Not applicable. This document describes engineering and sterility validation, not AI algorithm performance requiring expert human interpretation as ground truth. The "ground truth" for sterilization efficacy is the sterility assurance level (SAL) demonstrated by no growth of highly resistant biological indicators.

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

   • None applicable. This is not a human-in-the-loop diagnostic study requiring expert adjudication. The "adjudication" is based on objective measurements and established sterilization 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 study was done. This is not an AI-assisted diagnostic device, but a sterilizer. The document explicitly states: "No clinical data is being submitted in support of this Premarket Notification."

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

   • Not applicable. This is a physical sterilizer, not an algorithm. The "standalone" performance relates to the sterilizer's ability to achieve sterility on its own, which was tested.

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

   • The "ground truth" for sterilization efficacy is established by objective microbial biological indicator testing. Specifically, the absence of growth of Geobacillus stearothermophilus to demonstrate a Sterility Assurance Level (SAL) of 10⁻⁶. This is a universally accepted method for validating sterilization processes. Other "ground truths" were successful mechanical and electrical performance according to engineering specifications and safety standards.

8. The sample size for the training set:

   • Not applicable. This is not an AI device that uses a "training set." The device's operational parameters and design are based on engineering principles and previous validation, not machine learning.

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

   • Not applicable. As above, no training set was used.

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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® 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® 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 different sterilization cycles, the Standard cycle and the Advanced cycle.

The hardware for the STERRAD® NX 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 system and an optional movable cart. The STERRAD® NX Sterilizer can be placed directly on a table, counter top, or on the movable cart.

The document describes the validation testing for the STERRAD® NX Sterilizer. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each study type are implied as "Passed," meaning the sterilization process successfully rendered the tested items sterile. The document does not provide specific quantitative thresholds for passing (e.g., spore kill percentages), but "Passed" indicates the criteria were met.

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

• Sample Size: The document does not explicitly state a total number of samples for the entire test set. However, it provides details for specific validations:
  • 1 x 850mm flexible endoscope validation: Tested with only one flexible endoscope per sterilization cycle.
  • 1 mm diameter or larger and 500 mm or shorter lumens: Maximum of 10 lumens per load.
  • Other validations: The "Note" implies that with the exception of the 1 x 850mm flexible endoscopes, the validation studies were performed using a "validation load consisting of one instrument tray weighing 10.7 lbs." This suggests that for many tests, the sample size per cycle was consistent with a single instrument tray load.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission for a medical device cleared in the U.S. in 2005, it is highly likely that these were prospective validation studies conducted in a controlled laboratory environment to demonstrate the sterilizer's efficacy.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for sterilization efficacy studies is typically determined empirically through microbiological testing (e.g., culturing biological indicators or test organisms) rather than expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established objectively through microbiological methods, not through expert review and adjudication.

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

Not applicable. This device is a sterilizer, and its performance is evaluated in terms of its ability to kill microorganisms, not by human reader interpretation of images or other data. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

While "standalone" is often used in the context of AI algorithms, this refers to the performance of the sterilizer itself. The document comprehensively details numerous validation studies performed to demonstrate the sterilizer's standalone efficacy in achieving sterilization. The entire "SUMMARY OF NONCLINICAL TESTS" section (5.0) describes the standalone performance without human intervention during the sterilization cycle.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for these sterilization validation studies is primarily microbiological/biological evidence. Specifically, the "overkill" approach utilizes G. stearothermophilus spores, which are highly resistant biological indicators. The "Passed" result for each study indicates the complete inactivation of these spores and other tested microorganisms, demonstrating sterility.

8. Sample Size for the Training Set

Not applicable. This device is a physical sterilizer and not an AI or software device that relies on a "training set" in the machine learning sense. The validation studies demonstrate the sterilizer's inherent physical and chemical process efficacy.

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

Not applicable, as no training set (in the machine learning context) was used.

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