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

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

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

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

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

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

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

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

• It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors
• It can sterilize rigid and semi-rigid endoscopes without lumens.

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

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

• Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter
• Accessory devices that are normally connected to a flexible endoscope during use
• Flexible endoscopes without lumens

Note 1: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs.

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

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

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

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

Note1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf.

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication method for the test set:

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

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

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

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

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The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors,
• Medical devices with single stainless-steel lumen with:
  An inside diameter of 1mm or larger and a length of 125mm or shorter
  An inside diameter of 2mm or larger and a length of 250mm or shorter
  An inside diameter of 3mm or larger and a length of 400mm or shorter

• The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

• Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood.
• Intended user: trained nurse level or higher level of healthcare providers
  The validated maximum load conditions
  Total weight:
  The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs).
  Usage of sterilization pouch:
  The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant.
The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.

The provided text is a 510(k) summary for the LOWTEM Crystal 120, a low-temperature hydrogen peroxide sterilizer. It outlines the device's indications for use, its technical characteristics compared to predicate devices, and performance data. However, the document does NOT describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the format requested.

The "Performance Data" section (Page 10 and 11) lists various tests performed, their objectives, and an acceptance criterion of "Pass / Fail." It also states "Result: Pass" for all listed tests. This section generally confirms that the device passed general safety, electromagnetic compatibility, risk management, usability, sterilant potency, and sterilization efficacy tests. However, it does not provide the detailed quantitative acceptance criteria (e.g., specific thresholds for D-value or log reduction) beyond "Pass/Fail," nor does it elaborate on the methodology, sample sizes, or expert involvement for the individual tests.

Therefore, based on the provided text, I cannot complete the requested table and answer the detailed questions regarding acceptance criteria and the comprehensive study that proves the device meets specific performance criteria.

The document primarily focuses on regulatory approval based on equivalence to predicate devices, not on a detailed clinical study demonstrating device performance against specific acceptance metrics in a human-in-the-loop or standalone AI context, as might be expected for an AI/ML medical device. This device is a sterilizer, not typically an AI/ML-driven diagnostic or therapeutic device.

Here's what I can extract and what is missing, based on your prompt's structure:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• The document mentions "maximum of 20 lumens per load" for validation testing and "a total weight of 8.9kg(19.6lbs)" for validation loads. It also mentions "three lots of test accessories" for final process qualification. However, specific sample sizes (e.g., number of test cycles, number of devices/items tested for each specific test) are not detailed.
• Data provenance (country of origin, retrospective/prospective) is not mentioned.

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

• This information is not applicable and not mentioned, as the device is a sterilizer and its performance is measured by sterilization efficacy (e.g., bacterial kill, D-value) rather than expert interpretation of images or data.

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

• Not applicable/Not mentioned. The tests for a sterilizer are objective performance measures (e.g., spore kill, chemical residuals) rather than subjective assessments 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, as this device is a sterilizer, not an AI-assisted diagnostic tool.

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

• Not applicable. The "standalone" performance here refers to the sterilizer's ability to sterilize, which is inherent to its function and is what the various performance tests assess. There's no AI algorithm performing a separate task.

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

• For a sterilizer, the "ground truth" for sterilization efficacy is typically defined by standardized biological and chemical indicators, as well as validated physical parameters of the sterilization cycle. The document mentions "demonstration of >12 log reduction of Geobacillus stearothermophilus" and "test accessories (SCBI, CI strip and CI tape)" which are standard methods for assessing sterilization success.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device that requires a training set.

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

• Not applicable as this is not an AI/ML device that requires a training set.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

• Flexible endoscopes without lumens

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

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

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

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

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

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

• ULTRA GI™ Cycle

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

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

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

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

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

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

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

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

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

Here's an breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:

• ID of 1.0 mm or larger and a length of 3580 mm or shorter and .
• ID of 1.2 mm or larger and a length of 4095 mm or shorter .

The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics: Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: · ID of 1.0 mm or larger and a length of 3580 mm or shorter and · ID of 1.2 mm or larger and a length of 4095 mm or shorter. The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.

The provided document is a 510(k) summary for the SteroScope® Sterilization Technology System. It outlines the non-clinical performance testing conducted to establish the device's safety and efficacy. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table (Table 3) listing various testing methods, their purpose, acceptance criteria, and results. All tests listed show a "Pass" result, indicating the device met the specified acceptance criteria.

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

The document describes non-clinical performance testing. It doesn't explicitly state sample sizes for each test in a numerical format that would typically be used for a clinical study (e.g., N=X patients). However, it mentions "multiple systems" for "Final Process Qualification," "multiple organisms" for "AOAC Sporicidal Test," "various flexible endoscopes" for "Endoscope Dose Response Curves," and "multiple flexible endoscopes" for "Functionality & Material Compatibility."

The data provenance is from non-clinical laboratory testing of the device, not from human subjects. The country of origin for the data is not specified, nor is whether the data is retrospective or prospective. Given it's non-clinical testing for a new device, it is inherently prospective data generation.

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

This information is not provided in the document. The tests performed are primarily performance-based tests against established standards and internal specifications, not expert-driven diagnostic interpretations. For example, for sterilization efficacy, the ground truth is "no growth" of specified microorganisms or a "6-log reduction," which are objective laboratory measurements, not expert consensus.

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

This information is not applicable as the tests are non-clinical performance evaluations, not human reader-based assessments requiring adjudication of interpretations.

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

This information is not applicable as this is a non-clinical 510(k) submission for a sterilization system, not a diagnostic imaging device utilizing AI that would involve human reader performance studies.

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

The device is a physical sterilization system, not an algorithm or AI. Therefore, standalone algorithm performance is not applicable. The tests performed are essentially "standalone" device performance evaluations in a controlled environment.

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

The ground truth for the non-clinical performance testing is based on established scientific and engineering principles, industry standards (e.g., ISO, IEC, AAMI, ASTM, AOAC, USP-NF, ISTA, OSHA), and internal specifications. For sterilization efficacy tests, the ground truth is a specific microbial reduction (e.g., 6-log reduction) or absence of microbial growth, which is a definitively measurable biological outcome. For other tests, it's adherence to specified physical, electrical, or chemical parameters.

8. The sample size for the training set:

This information is not applicable. The device is a physical sterilization system, not a machine learning model that requires a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.

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The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are > 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope accessories, mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

• Additional instruments may include non-lumened or lumened medical devices with the following configurations:

o Single, dual or triple channel stainless steel lumen that is

· ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• ≥ 0.77 mm ID and ≤ 527 mm in length

• ≥ 0.8 mm ID and ≤ 542 mm in length

• ≥ 0.48 mm ID and ≤ 100 mm in length
• · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
• Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
• ≥ 3 mm ID and ≤ 298 mm in length
• ≥ 4 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The five pre-programmed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below:

• V-PRO 1
• V-PRO 1 Plus ●
• V-PRO maX ●
• V-PRO maX 2 ●
• V-PRO 60
• V-PRO s2 ●

The provided text does not describe a study involving an AI/ML device for medical image analysis. Instead, it describes a 510(k) premarket notification for a V-PRO maX 2 Low Temperature Sterilization System, a device used for sterilizing medical instruments. The "acceptance criteria" and "study" described in the document relate to the performance of this sterilization system and its associated sterilant, not to an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML medical device based on the provided text. The document is about a sterilization system, not an AI product.

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The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

Additional instruments may include non-lumened or lumened medical devices with the following configurations: Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length

++ The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• 0.77 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The five preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

The provided text describes a 510(k) premarket notification for the STERIS V-PRO maX 2 Low Temperature Sterilization System. It focuses on the substantial equivalence of the proposed device to a predicate device, specifically regarding the addition of a "Specialty Cycle."

Based on the provided information, the device is a sterilizer, and the "acceptance criteria" and "study proving the device meets the acceptance criteria" refer to the sterilization efficacy and the validation studies conducted to demonstrate that the new Specialty Cycle effectively sterilizes the specified materials/devices.

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a sterilizer is to demonstrate the elimination of viable microorganisms. This is typically shown through achieving sterility with a certain Sterility Assurance Level (SAL), often by processing inoculated Biological Indicators (BIs). The effectiveness is demonstrated through "½ Cycle (Sterilization) Efficacy" and "Final Process Qualification."

Table of Acceptance Criteria and Reported Device Performance (Inferred from the document's validation summary):

Additional Requested Information:

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

• Test Set Sample Sizes:
  • Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
  • Fast Non Lumen Cycle: Validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
  • Flexible Cycle (Config 1): Two flexible endoscopes with a light cord and mat (no additional load).
  • Flexible Cycle (Config 2): One flexible endoscope with a light cord and mat, plus a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg). This configuration also included 5 stainless steel lumens.
  • Lumen Cycle: Validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg), with a maximum of 20 lumens per load.
  • Specialty Cycle (Non-lumened instruments): Validation load consisting of one pouched instrument tray or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).
  • Specialty Cycle (3D Printed Materials): Validation load consisting of pouched guide(s)/model(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
• Data Provenance: The document implies these are prospective validation studies conducted by STERIS Corporation for regulatory submission. The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This is a sterilization device, not an AI diagnostic tool. Ground truth for sterilizers is established through microbiological assays (e.g., biological indicators) and physical/chemical measurements (temperature, pressure, time, hydrogen peroxide concentration, etc.), not expert reader consensus like in imaging. Therefore, the concept of "experts establishing ground truth for the test set" in the context of human readers does not apply here. The expertise lies in microbiology, engineering, and quality assurance to design and execute the validation studies.

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

• Not applicable for a sterilization device validation study. Sterility is typically determined by the absence of growth in biological indicators, which is an objective measurement rather than a subjective human interpretation requiring adjudication.

4. 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 or diagnostic imaging system. There are no "human readers" involved in performing or interpreting the sterilization process in a way that would warrant an MRMC study.

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

• Not applicable. This is a physical device, a sterilizer, not an algorithm. The "performance" is the physical process of sterilization.

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

• The ground truth for sterilization efficacy is established through microbiological assays, specifically the 6-log reduction or complete kill of highly resistant bacterial spores (Geobacillus stearothermophilus) contained within biological indicators (BIs). This is an objective, quantitative measure of sterilization. Additional ground truth includes adherence to engineering specifications for process parameters and chemical validation.

7. The sample size for the training set:

• Not applicable. This is a medical device (sterilizer) and its validation, not an AI/machine learning model that requires a "training set." The performance data comes from experimental validations and engineering studies.

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

• Not applicable, as there is no "training set" in the context of an AI model. The validation studies demonstrate the device's capability to sterilize.

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The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK Plus can sterilize *:

• · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices with a single stainless steel lumen with:
• o An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 3 .97 lbs.

Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The materials compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).

The maximum load weight that can be placed in the Tyvek® roll is:

• · 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus
• 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer
• 1.54 pounds (0.7kg) for CHAMBER mode of STERLINK mini sterilizer

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1 :2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK sterilizer.

The Tyvek® Roll with CI for STERLINK Sterilizer is offered in the follow 1 type: · Sterilization roll. Flat

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.

Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterlization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

The self-contained biological indicator and chemical processing indicators are intended for use with.

• · CHAMBER mode of FPS-15s Plus sterilizer
• · CHAMBER mode of STERLink plus sterilizer
• · CHAMBER mode of STERLINK mini sterilizer

The STERLINK plus sterilizer with STERLOAD™ cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method.

This system consists of a main device connected pump module and cassette which are called the STERLINK plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant.

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or Mini-Bio Auto-Readers Incubators.

Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper, and plastic.

This document describes the acceptance criteria and supporting study for the STERLINK™ plus Sterilizer with STERLOAD™ Cassette and associated components (Tyvek® Roll with CI for STERLINK™ Sterilizer, Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), and Terragene Cintape® (CT40)).

The document asserts substantial equivalence to a predicate device (STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, K212200), and therefore, the acceptance criteria are generally met by demonstrating compliance with recognized standards and establishing equivalence in performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission demonstrating substantial equivalence to a predicate, specific numerical "acceptance criteria" for novel performance metrics are not explicitly stated in the provided text as they would be for a de novo device. Instead, the acceptance criteria are implicitly that the device performs as well as or better than the predicate device and meets established standards for sterilization, packaging, and indicators. The reported device performance is presented as "Pass" for compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test or the country of origin/provenance of the data. It refers to various ISO and ASTM standards, which typically specify test methodologies and sample size requirements. The studies are non-clinical, likely laboratory-based evaluations to demonstrate performance against these standards. The submission originates from Plasmapp Co., Ltd. in South Korea, suggesting studies were likely conducted either internally or by contract research organizations, potentially in South Korea, in accordance with international standards. The studies would be prospective in nature, as they are tests performed on the device to prove its compliance with standards and equivalence.

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: Not explicitly stated (e.g., country of origin). The applicant is Plasmapp Co., Ltd., BVC-111, 125, Gwahak-ro, Yuseong-gu, Daejeon, 34141, Rep. of Korea (South Korea).
• Retrospective or Prospective: Implied to be prospective as the tests were conducted to demonstrate device performance against defined standards.

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

This submission is for a sterilization system and associated components, which are evaluated based on defined physical, chemical, and biological performance standards (e.g., sporicidal activity, material compatibility, chemical indicator color change) rather than interpretation of complex medical images or patient data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense (e.g., radiologists for an imaging device) is not directly applicable here. The "ground truth" is established by the well-defined parameters and pass/fail criteria of the referenced ISO and ASTM standards for sterility, material science, and indicator performance.
The experts involved would be laboratory technicians and engineers performing and verifying the tests, and potentially subject matter experts in sterilization science and engineering within Plasmapp and the regulatory body. Their qualifications are not specified but would be implicit in their roles and adherence to the testing standards.

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

Not applicable. This is a technical performance study against objective standards, not a diagnostic study requiring adjudication of expert interpretations.

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 sterilization system and its accessories, not an AI-based diagnostic device intended for use by human readers.

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

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

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

The "ground truth" for the performance evaluation of sterilization devices and accessories typically refers to:

• Biological inactivation: Complete kill of test microorganisms (e.g., Geobacillus stearothermophilus spores) for sterilizers and biological indicators, confirmed through culture methods.
• Physical and chemical parameters: Confirmation that specified physical conditions (temperature, pressure, time) were met and chemical indicators changed appropriately, as defined by industry standards and internal specifications.
• Material integrity: No degradation or adverse effects on device materials after sterilization, as per material compatibility tests.
• Packaging integrity: Maintenance of sterility barrier, confirmed by physical and microbial barrier tests.

These 'ground truths' are established through validated laboratory tests against international and national standards (ISO, ASTM, AOAC).

8. The sample size for the training set

Not applicable. This is a hardware device (sterilizer, packaging, indicators) and not an AI/machine learning model that requires a training set.

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

Not applicable. As this is not an AI/machine learning model, there is no training set and therefore no ground truth establishment for a training set.

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The STERLINK™ FPS-15s Plus sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A preprogrammed sterilization lumen cycle operates at low pressure and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK™ FPS-15s Plus can sterilize*:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices with a single stainless steel lumen with:
  • STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
  • STERLOAD™: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter

*The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively,

The STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments.

This system consists of a main device and cassettes which are called the STERLINK™ FPS-15s Plus and STERPACK™ plus or STERLOAD™, respectively. The STERPACK™ plus and STERLOAD™ cassette contain 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

Based on the provided text, the device in question is the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette, a vaporized hydrogen peroxide sterilizer. The acceptance criteria and the study proving the device meets these criteria are primarily focused on the non-clinical performance of the sterilizer, specifically its ability to sterilize medical devices. The information provided is typical of a 510(k) summary for a medical device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass" for compliance with various standards and guidance documents. The reported device performance is that it "Passes" these tests.

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

The document does not explicitly state a specific "sample size" in terms of number of medical devices or test runs for each individual performance test (e.g., lumen sterilization). Instead, it states for lumen sizes: "The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load." It also mentions "a validation load with a total weight of 1 lb and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively."

• Sample Size for performance tests: For lumen sterilization, it mentions a maximum of five lumens per load. Other tests don't specify a detailed sample size breakdown within this document. The "Pass" results indicate that the testing met the minimum requirements for the specific standards.
• Data Provenance: The manufacturer is "Plasmapp Co., Ltd." in "Rep. of Korea (South Korea)." The document implies that the testing was conducted to meet the requirements of the U.S. FDA, but the location where the actual tests were performed is not explicitly stated. The nature of these tests (e.g., sterilization efficacy) strongly suggests they were performed as prospective validation studies to demonstrate the device's performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of information (number and qualifications of experts establishing ground truth for a test set) is generally relevant for AI/ML-driven diagnostic devices where human expert consensus forms the ground truth for image interpretation or diagnosis. For a sterilizer, the "ground truth" for its performance is typically established through objective, laboratory-based biological and physical testing using standardized methods and biological indicators (e.g., Geobacillus stearothermophilus). Therefore, the concept of "experts establishing ground truth for a test set" in the context of human interpretation of data is not applicable here. The "experts" would be the scientists and technicians conducting the validation tests according to the specified standards.

4. Adjudication Method for the Test Set

As the "ground truth" for a sterilizer's performance is objective (e.g., kill/no kill of microorganisms, meeting sensor specifications), adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not applicable. The device's performance is measured against established scientific and engineering standards.

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

No, an MRMC study was not done. MRMC studies are typically performed for diagnostic devices (especially those involving image interpretation) to evaluate the impact of a device (e.g., AI assistance) on human reader performance. This document is for a medical device sterilizer, which does not involve human interpretation of cases or AI assistance in that context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance tests described are standalone in the sense that they evaluate the sterilizer's ability to sterilize medical devices independently of human subjective assessment. The "algorithm" here is the sterilization cycle itself, and its effectiveness is measured directly through biological and chemical indicators. The results are based on the device's inherent design and operational parameters.

7. The Type of Ground Truth Used

The ground truth used for proving the sterilizer's efficacy is based on:

• Biological Activity: The ability to inactivate microorganisms (e.g., Geobacillus stearothermophilus spores) as measured by standard biological indicator tests (e.g., ISO 11138-1:2017, ISO 11737-1:2018, AOAC 966.04).
• Physical Parameters: Confirmation that the sterilizer operates within specified parameters (temperature, pressure, time) and that the sterilant is delivered effectively.
• Material Compatibility: Ensuring that the sterilization process does not degrade the materials of the medical devices being sterilized.
• Engineering Standards: Compliance with electrical safety, EMC, software validation, and other relevant engineering standards (e.g., IEC, EN, ASTM).

8. The Sample Size for the Training Set

This document does not refer to a "training set." The concept of training sets (and validation/test sets derived from them) is specific to machine learning or AI models that learn from data. This document is about a hardware device (sterilizer) whose performance is validated through defined physical and biological tests, not through training a model on a dataset.

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

As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The sterilizer's performance is established through controlled, laboratory-based validation studies against regulatory and industry standards for sterilization efficacy.

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The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.

The STERLINK mini can sterilize *:

• · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices with a single stainless-steel lumen with:
• o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter

*The validation testing was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs.

Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.

The materials compatible for use in the Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in Chamber mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HDPE), Polypropylene (PP), Polytetrafluoroethylene (PTFE) and Silicone (Hardness 50).

The maximum load weight that can be placed in the Tyvek® roll is:

• · 3.97 pounds (1.8 kg) for CHAMBER mode of FPS-15s Plus sterilizer
• · 1.54 pounds (0.7 kg) for CHAMBER mode of STERLINK mini sterilizer

The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140 1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat

Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.

Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.

Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.

Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

The self-contained biological indicator and chemical processing indicators are intended for use with:

• · CHAMBER mode of FPS-15s Plus sterilizer
• · CHAMBER mode of STERLINK mini sterilizer

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This system consists of a main device connected pump module and cassette which are called the STERLINK mini and STERLOAD™ mini cassette, respectively. The STERLOAD™ mini cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed medical devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINKIM Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).

Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or MiniBio Auto-Readers Incubators.

Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.

The provided text describes acceptance criteria and study results for medical sterilization devices (STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, and Sterilization Process Indicator for STERLINK Sterilizer).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: STERLINK mini Sterilizer with STERLOAD™ mini Cassette

• Test with gas inoculum: Only a maximum 15 colonies should grow out of a total of 10 bacterial permeability testers. The number of colonies in each bacterial permeability tester should not be greater than five. | Pass |
  | Residual sterilant on Tyvek® validation | To confirm the time required for the residual sterilant to be reduced to a safe amount after sterilization in accordance with the internal test standard. | ≤ 0.05 ppm | Pass |
  | Biocompatibility test | To confirm the biological safety after sterilization in accordance with ISO 10993-5. | ≤ Grade 2 | Pass |

Device: Sterilization Process Indicator for STERLINK™ Sterilizer (BT96, CD42, CT40)

Additional Study Information:

The provided text describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, not clinical studies involving human patients or complex AI algorithms requiring ground truth from experts. The devices are sterilizers and sterilization indicators, which are typically evaluated through microbiological and engineering performance testing.

Therefore, many of the specific questions about "test set," "ground truth," "experts," "adjudication," and "AI assistance" are not directly applicable to the type of device and testing described in this document.

For completeness, here's what can be extracted or inferred:

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

   • Sample size: Not explicitly stated as a single "test set" size. The text mentions "maximum of five (5) lumens per load" for lumen sterilization validation and "a validation load with a total weight of 1.54 lbs." for the sterilizer. For the Tyvek roll microbial barrier test, it mentions "a total of 10 bacterial permeability testers." Specific quantities for other tests are not provided.
   • Data provenance: Not specified. These are non-clinical engineering and microbiological tests, likely conducted in a laboratory setting by the manufacturer (Plasmapp Co., Ltd. and Terragene S.A.). The country of origin of the manufacturer is South Korea for Plasmapp and presumably Argentina for Terragene (as it's a known Argentinian company). The studies are "non-clinical tests," implying they were conducted in a controlled environment, not on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. The tests are laboratory-based and use established microbiological and engineering standards (e.g., ISO, ASTM, AOAC). "Ground truth" is determined by scientific measurements and observation of bacterial kill, physical properties, or chemical indicator changes, not by expert consensus on subjective interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., radiological reads) where multiple experts might disagree. These tests are objective measurements against defined 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: Not applicable. These devices do not involve "human readers" interpreting "cases" with or without "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm component to these devices described in the document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these sterilization and chemical indicator tests is based on:

   • Microbiological kill: Demonstrating the inactivation of a specified population of resistant spores (e.g., Geobacillus stearothermophilus) to a defined Sterility Assurance Level (SAL), typically 10^-6^. This is confirmed through laboratory culture methods.
   • Physical and chemical property measurements: Adherence to established engineering standards (e.g., tensile strength, burst pressure, color change properties of chemical indicators).
   • Safety standards: Compliance with international safety and electromagnetic compatibility standards.

8. The sample size for the training set: Not applicable. These devices do not involve machine learning or AI models that require a "training set."

9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

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The Steelco VS Series Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with twelve factory-programmed cycles, provided on the following page. At no time will there be patient contact with the subject device.

The Steelco VS Series Steam Sterilizers use saturated steam, generated from a house steam utility (e.g. boiler system) or from a steam generator, to sterilize heat-stable health care products. The sterilizer accomplishes this by removing the air in the chamber, exposing the load to saturated steam for a defined combination of time and temperature, and drying the load. Removal of air from the chamber occurs using either of two methods, gravity displacement or mechanical vacuum. Once the air removal phase is completed, the sterilizer progresses to the steam exposure phase. During the steam exposure phase, every surface of the load is exposed to saturated steam for a defined combination of time and temperature. Once the steam exposure phase is completed, steam is removed from the chamber and the load is dried using the latent heat in the load and the vacuum pump.

The provided text describes the non-clinical testing performed for the Steelco VS Series Steam Sterilizers (K213545) to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information based on the provided document:

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 the "sample size used for the test set" in terms of number of sterilization cycles or units tested. However, it mentions "ST8 Compliance Test Protocols for the individual machines" being documented for various performance criteria. This suggests that testing was conducted for the specific models of sterile, but the exact number of tests or cycles performed is not provided.

Regarding data provenance, the testing was non-clinical (laboratory/engineering testing) and focused on compliance with established standards (e.g., AAMI ST8, IEC/UL 61010, EN IEC 61326, ASME Boiler and Pressure Vessel Code). The document does not specify the country of origin of the testing data, but the manufacturer (Steelco S.P.A.) is based in Italy. The testing described is prospective in nature, as it was conducted to demonstrate compliance of the device before market introduction.

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

This section is not applicable as the described study is a non-clinical performance and safety validation study for a steam sterilizer, not an AI or diagnostic imaging device needing expert ground truth for interpretation. The "ground truth" here is defined by established engineering and medical device standards (AAMI ST8, IEC/UL 61010, etc.) and the physical performance of the machine.

4. Adjudication Method for the Test Set

This section is not applicable for a non-clinical performance and safety validation study of a steam sterilizer. The "adjudication" is met by demonstrating compliance with the specified technical standards and their criteria, not through consensus of human evaluators on specific cases.

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 typically performed for diagnostic or AI-assisted medical devices where human interpretation plays a role. The Steelco VS Series Steam Sterilizers are physical machines for sterilization, and their effectiveness is evaluated through engineering and microbiological performance testing against standards, not through human reader interpretation.

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

This question is not applicable in the context of this device. The device is a steam sterilizer, a physical machine designed to operate independently to achieve sterilization. It does not involve "algorithms" in the sense of AI-driven interpretation or diagnostic assistance where "human-in-the-loop" performance would be relevant. The software validation mentioned ensures the machine's control software functions correctly and safely.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria of the Steelco VS Series Steam Sterilizers is based on established industry standards and regulatory requirements. Specifically, this includes:

• ANSI/AAMI ST8:2013: For general performance, biological performance, mechanical air removal, and moisture retention.
• IEC/UL 61010-1 and 61010-2-040: For electrical safety.
• EN IEC 61326 part 1: For electromagnetic compatibility (EMC).
• ISO 62304: For software validation.
• ASME Boiler and Pressure Vessel Code, Section VIII (Division 1) and Section 1: For pressure vessel safety.

Compliance with these standards, as evidenced by testing and documentation, serves as the ground truth for the device's acceptable performance, safety, and effectiveness.

8. The Sample Size for the Training Set

This section is not applicable. The Steelco VS Series Steam Sterilizers are physical machines, not an AI model or a system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle standards, not machine learning model training.

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

This section is not applicable for the same reasons as #8. There is no training set for this type of device.

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