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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 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 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

Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 Ibs 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 1mm or larger and a length of 875mm 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 Ibs.

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 three previously cleared cycles (STANDARD, FLEX, EXPRESS) and the new optional additional DUO 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, and printer paper.

The provided document describes the STERRAD® 100NX® Sterilizer with DUO Cycle, a low-temperature hydrogen peroxide gas plasma sterilization system. The document focuses on the nonclinical validation testing performed to demonstrate its safety and effectiveness for sterilizing medical devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation of Acceptance Criteria: The acceptance criteria are implicitly performance-based, requiring the sterilizer to effectively sterilize various types of medical devices and demonstrate safety and reliability. The "Passed" result for each study indicates the device met these implicit performance expectations for sterilization. The overarching acceptance criterion is that the STERRAD® 100NX® DUO Cycle is "safe and effective for sterilization of medical devices within the indications for use" and establishes "equivalence...to the predicate devices."

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

The document does not explicitly state numerical sample sizes for each validation study beyond the following:

• Validation Load (General): "a validation load consisting of two instrument trays each weighing 10.7 lbs." (for Standard and Flex Scope cycles, excluding the 1x850mm endoscopes).
• 1 x 850 mm flexible endoscopes (Flex Scope cycle): "validated without any additional load."
• EXPRESS Cycle validation load: "a single instrument tray weighing 10.7 Ibs placed on the bottom shelf."
• DUO Cycle validation load: "two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs."
• 1 x 875 mm flexible endoscopes (DUO Cycle): This specific lumen type was used in several validation studies.
• Lumen counts: "A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle" and "A maximum of two flexible endoscopes, one per tray per sterilization cycle."

The data provenance is retrospective as the studies were performed specifically for regulatory submission of an existing device (STERRAD 100NX) with a new cycle (DUO Cycle). The country of origin of the data is not specified, but the applicant's address is Irvine, CA, suggesting studies conducted within the US or under US regulatory standards.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the testing (sterilization efficacy using biological indicators) typically relies on laboratory results and microbiological analysis rather than expert human interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as it relates to human review or consensus for the test set. The validation studies rely on objective criteria (e.g., elimination of G. stearothermophilus spores) for assessing sterilization effectiveness.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human interpretation is involved. The STERRAD® 100NX® Sterilizer is a sterilization device, not an AI-assisted diagnostic or interpretive system.

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

This question is not applicable to the STERRAD® 100NX® Sterilizer. The device itself is a standalone sterlization system. Its performance is evaluated directly through its ability to sterilize, not through an algorithm's performance separate from human interaction in an interpretive setting. The "standalone" performance here refers to the sterilizer's ability to achieve sterility without human intervention in the sterilization process, which is the core of its validation.

7. The Type of Ground Truth Used

The primary ground truth used for proving sterilization effectiveness is biological indicator (BI) testing using G. stearothermophilus spores. This is an industry-standard method where the complete elimination of these highly resistant spores indicates successful sterilization. The document refers to this as the "overkill" approach.
Other ground truths include:

• Material compatibility: Testing to ensure the sterilization process does not damage the treated devices.
• Toxicity testing: Ensuring no toxic residues are left.
• Functionality testing: Confirming devices remain functional after sterilization.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device (sterilizer) undergoing performance validation, not a machine learning or AI algorithm that requires training data. The devices tested in the validation studies (e.g., flexible endoscopes, instrument trays, lumens) represent the types of items the sterilizer is designed to process, but they are not a "training set" in the computational sense.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The "ground truth" for evaluating the sterilizer's performance was established through the rigorous, standardized microbiological and physical testing methods described (e.g., biological indicator kill, material integrity checks).

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This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:

• An inside diameter of 1 mm or larger and a length of 125 mm or shorter
• An inside diameter of 2 mm or larger and a length of 250 mm or shorter .

The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems 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 bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.

The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.

Here's a breakdown of the acceptance criteria and the studies conducted for the STERRAD® 50 and STERRAD® 100S Sterilization Systems, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

                                                                   The In-Use testing demonstrated that the STERRAD® 50 and 100S Sterilization Systems were effective sterilizers of stainless steel lumen devices.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |

| No cytotoxicity or toxic residuals on processed materials | Cytotoxicity test results indicated that titanium materials processed did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals. |

Note: SAL of 10^-6 means there is a one in a million chance of a non-sterile unit. SLR values of 6.0 or higher indicate a 6-log reduction in microbial population, which is a common standard for sterilization.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Titanium Surface Sterilization: Not explicitly stated, but performed with "titanium materials representative of the materials commonly used in re-usable medical devices."
  • Lumen Sterilization: Not explicitly stated, but for the validation loads, a "maximum of 10 lumens per load" was used for the 1mm x 125mm and 2mm x 250mm lumens. The half-cycle validation tests used sufficient materials to demonstrate the SAL.
  • Tyvek-Mylar Pouched Device Sterilization: Not explicitly stated, but conducted with 1mm x 125mm and 2mm x 250mm stainless steel lumens in pouches.
  • Simulated Use Testing: Not explicitly stated how many devices, but used "devices representative of lumen claims."
  • In-Use Sterility Testing: Not explicitly stated how many devices, but used "Devices representative of lumen claims for the STERRAD® 50 Sterilization System" that were "used in routine surgeries at local hospitals."
• Data Provenance: Retrospective and prospective. The In-Use Sterility Testing involved devices "used in routine surgeries at local hospitals," suggesting data collected from real-world usage scenarios (retrospective element) which were then transported for prospective testing with the STERRAD systems. The other validation testing appears to be prospectively designed lab studies. No specific country of origin is mentioned beyond "local hospitals" for the in-use testing, implying a US-based context given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the summary. The ground truth for sterilization is typically established through microbiological testing (e.g., demonstrating the death of a highly resistant test organism), rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are primarily microbiological challenge tests for sterilization efficacy, not human interpretation tasks requiring adjudication.

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

• No MRMC comparative effectiveness study was mentioned or performed. The device is a sterilizer, meaning its performance is assessed by its ability to render medical devices sterile, not by human interpretation or diagnosis. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone Performance Study

• Yes, standalone performance studies were done. All the validation tests described (Surface Sterilization, Lumen Sterilization, Tyvek-Mylar Pouched Device Sterilization, Simulated Use Testing, In-Use Sterility Testing, Toxicity Testing) are assessing the algorithm/system-only performance of the STERRAD® 50 and 100S sterilizers without human intervention in the sterilization process itself. The "overkill" approach used in the validation testing directly assesses the system's ability to achieve a robust sterility assurance level.

7. Type of Ground Truth Used

• The primary ground truth used is microbiological evidence of sterility, specifically:
  • Inactivation of B. stearothermophilus endospores: This is a highly resistant bacterial spore used as a biological indicator to challenge sterilization processes. Its inactivation to a specific Sterility Assurance Level (SAL) (e.g., 10^-6) or log reduction (e.g., 6-log reduction) serves as the ground truth for effective sterilization.
  • Sterility Assessment: Direct assessment of the absence of viable microorganisms after processing.
  • Toxicity testing: Used to establish ground truth that no cytotoxic effects or toxic residuals remain.

8. Sample Size for the Training Set

• This information is not applicable. The STERRAD® Sterilization System is a physical-chemical sterilization device, not an AI/ML algorithm that is "trained" on data in the traditional sense. Its operation is based on pre-defined scientific principles of hydrogen peroxide gas plasma sterilization, not on learning from a dataset.

9. How Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated above. The system's "operating parameters" or "settings" are developed through scientific and engineering principles, not through a "training set" with established ground truth. The validation studies described in the summary are designed to prove the device meets performance criteria, not to train it.

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The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

Mirage FFM Series 2 is a respiratory mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bi-level devices.

The provided text describes the Mirage Full Face Mask Series 2 and its substantial equivalence to the predicate device, Mirage FFM. The primary focus of this submission is to validate the addition of a new sterilization method (Sterrad 100S System) for multi-patient use.

Here's an analysis based on the information provided, keeping in mind that this document is a 510(k) submission, which focuses on substantial equivalence rather than detailed performance studies like those for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

• 3.4% glutaraldehyde solution (e.g., Cidex Plus)
• 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g., Cidex PA).
  Semi-critical mask components withstand 15 cycles of high-level disinfection. (The predicate Mirage FFM was already validated for these methods, and the new device maintains this.) |
  | For Sterilization (Sterrad 100S System): | Validation performed: Mirage FFM Series 2 was validated for multiple-patient use with sterilization using the Sterrad 100S System made by ASP (K991999).
  Semi-critical mask components withstand 15 cycles of sterilization. |
  | Functional Integrity after Disinfection/Sterilization (15 cycles): | Implied successful performance as the device is deemed "substantially equivalent" and the sterilization method "does not affect safety and effectiveness." |
  | Material Compatibility after Disinfection/Sterilization: | Implied successful performance, as the materials in air-path are identical to the predicate, and new materials (headgear, port caps) are deemed compatible with the cleaning/sterilization processes. |
  | Headgear (non-critical item) does not require high-level disinfection/sterilization: | The headgear is classified as a non-critical item and thus does not require high-level disinfection/sterilization, as stated. |
  | Valve membrane and air tubing replacement requirement (post-disinfection/sterilization for multi-patient use): | The user instructions highlight that the valve membrane and air tubing cannot be disinfected/sterilized and must be replaced before reusing on another patient. |

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

The document does not specify a "test set" in the context of clinical performance or a specific patient cohort for the sterilization validation. The validation is focused on the device's ability to withstand disinfection/sterilization processes.

• Sample Size: Not explicitly stated for number of units tested or patient data. The statement "15 cycles" refers to the number of disinfection/sterilization cycles the components were subjected to.
• Data Provenance: Not applicable in the context of country of origin for clinical data, as this is a device reprocessing validation, not a clinical trial. The validation was conducted to support the 510(k) submission to the FDA.

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

Not applicable. The ground truth for this submission relates to the efficacy of the disinfection/sterilization processes and the material integrity of the device components. This is typically established through laboratory testing and engineering analysis rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-reviewed "test set" 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 medical device for respiratory therapy, not an AI diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Performance Standards for Disinfection/Sterilization: The ability of the device components to withstand 15 cycles of specified high-level disinfection methods and the Sterrad 100S System sterilization method, while maintaining functionality and material integrity.
• Material Compatibility: Confirmation that the materials used are compatible with the reprocessing methods and maintain their intended properties.
• Predicate Device Equivalence: The foundation of the submission is demonstrating substantial equivalence to the predicate "Mirage FFM," which means its performance and safety characteristics, including its reprocessing capabilities, are comparable.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning for this device submission.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is generally referred to as "Performance Data" within the submission. It involves validation studies related to the reprocessing of the device for multi-patient use.

• The Mirage FFM Series 2 was subjected to 15 cycles of:
  • High-level disinfection with 3.4% glutaraldehyde solution.
  • High-level disinfection with 0.08% peroxyacetic acid and 1% hydrogen peroxide.
  • Sterilization with the Sterrad 100S System made by ASP.
• A "conditioning cycle" for each reprocessing method included disassembly, cleaning, disinfection/sterilization, and re-assembly.
• The acceptance criterion was that the "semi-critical mask components can withstand 15 cycles" of these processes. While the specific metrics of "withstanding" (e.g., burst pressure, leakage, material degradation assessment) are not detailed in this summary, they would have been part of the underlying validation reports.
• The "performance data" effectively demonstrates that the device's semi-critical components retain their integrity and functionality after repeated reprocessing, thus supporting its suitability for multiple-patient use with these methods. The conclusion of substantial equivalence further implies that this reprocessing does not compromise the device's safety or effectiveness compared to the predicate.

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