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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 STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

• · STERRAD™ 100S Sterilization System
• · STERRAD NXTM Sterilization System
  o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
  The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

• . STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
  o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
• . STERRAD NX™ Sterilization System
  o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD™ 100S Sterilization System

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

The provided document describes the acceptance criteria and the studies conducted for several sterilization process indicators and related devices (Chemical Indicator Strip, Chemical Indicator Tape, Biological Indicator, Biological Indicator Reader, and Process Challenge Device Vial). The studies aim to demonstrate the substantial equivalence of these devices to their legally marketed predicates, particularly with the inclusion of the new ULTRA GI Cycle.

Here's a breakdown of the requested information for each device where available:

1. STERRAD™ Chemical Indicator (CI) Strip (14100)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for chemical indicators.

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

• Yes, the studies described are standalone performance tests of the chemical indicator strip itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

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

• Not applicable.

2. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for chemical indicators.

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

• Yes, the studies described are standalone performance tests of the chemical indicator tape itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) and physical properties (adhesion strength) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

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

• Not applicable.

3. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader (43210, 43210-30, 43220)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable. Ground truth for biological indicators is based on microbiological growth/no growth and fluorescence detection, which are objective measures.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for biological indicators and their readers.

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

• Yes, the studies described are for the standalone performance of the biological indicator and the reader. The reader's "algorithm" interprets the fluorescence, but it's not described as an AI/ML system requiring typical training/test sets.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus ATCC 7953) and fluorescence detection, which correlates to enzymatic activity of the organism.

8. Sample size for the training set:

• Not applicable. While the reader processes data, it's not described as an AI/ML system with a separate training set.

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

• Not applicable.

4. ULTRA GI™ Process Challenge Device (PCD) Vial (43400)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable. Ground truth for PCDs is based on the resistance they provide to the sterilization process, measured using biological indicator growth/no growth and fluorescence detection.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not applicable for PCDs.

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

• Yes, the studies described are for the standalone performance of the PCD vial in conjunction with the biological indicator and reader.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus) and fluorescence detection, demonstrating the designed resistance to the sterilization process.

8. Sample size for the training set:

• Not applicable.

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

• Not applicable.

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The STERRAD NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD Sterilization Process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.

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

· Single-channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 150 mm or shorter. ↑

· Single-channel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 400 mm or shorter. ↑ 7 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not

exceed the maximum number of lumens validated by this testing.

Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED Cycle:

· Single-channel stainless steel lumens with an inside diameter of 1 mm or larger and a length of 500 mm or shorter. ↑

· Single-channel PE/PTFE flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter.*

Note: With the exception of the flexible endoscopes, the validation studies were performed using a validation load consisting of devices in one instrument tray weighing 10.7 lbs (4.9 kg). The flexible endoscopes were validated without any additional load. **

f The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Your loads should not exceed the maximum number of lumens validated by this testing.

• Only one flexible endoscope up to 1065 mm long with or without APTIMAX Instrument Tray Holders can be used per cycle, or only one flexible endoscope up to 850 mm long per cycle with or without a STERRAD Instrument Tray Mat. No additional load. Check the medical device manufacturer's instructions for use prior to processing any scope in the STERRAD NX Sterilizer; and check if Instrument tray mats or only tray holders are validated for use with flexible endoscopes longer than 850 mm.

** The validation testing for flexible endoscopes up to 850 mm long was conducted with one endoscope per cycle using a STERRAD Instrument Tray Mat to help protect the endoscope no additional load. The validation testing for flexible endoscopes longer that 850 mm was conducted with one endoscope per cycle using APTIMAX Instrument Tray Holders to assist with device placement and help protect the endoscope: no additional load.

The STERRAD NX Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles.

The sterilizer uses a disposable sterilant cassette that contains the 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. The hydrogen peroxide is concentrated before into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the specification.

The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, countertop, or on the movable cart.

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

The STERRAD NX Sterilizer with ALLClear Technology described within this submission expands the indications of the ADVANCED Cycle of the Sterilizer to include single channel flexible endoscopes with extended dimensions of 1065mm in length when the inside diameter is ≥1mm. The previously cleared dimensions of the predicate device are 850mm in length when the inside diameter is ≥1mm. There are no other changes to the indications for use of the ADVANCED Cycle. The ADVANCED Cycle is compatible with single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1mm or larger and length of 1065mm or shorter2

The provided document is a 510(k) summary for the STERRAD® NX Sterilizer with ALLClear™ Technology, specifically for an ADVANCED Cycle Claims Expansion. This device is a sterilizer and the document describes its performance in achieving sterility of medical devices, not an AI/ML-enabled diagnostic or treatment device. Therefore, many of the requested categories in the prompt, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone performance," "training set," and "ground truth for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and performance studies for the sterilization function.

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 numerical sample sizes for each test in terms of the number of endoscopes or biological indicators (BIs) used. However, it indicates:

• Dose Response: "BI Samples from 1.5mL of 53% hydrogen peroxide in half cycles" and "total kill of BIs in the half cycle condition at 1.5 mL of 53% hydrogen peroxide injected." This implies multiple BI samples were used at different hydrogen peroxide injection volumes.
• Simulated Use: "flexible endoscopes with proposed claims expansion of ≥1 mm diameter x ≤1065 mm in length" and "all test devices." This suggests multiple endoscopes were tested.
• Data Provenance: The studies were conducted by Advanced Sterilization Products, Inc. (ASP), located in Irvine, CA. The document does not specify whether the data is retrospective or prospective, but given it's for a claims expansion and performance testing, it would inherently be prospective testing specifically performed to support this submission.

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

Not applicable. This is a sterilization device, not a diagnostic device requiring expert interpretation for ground truth. Sterility is determined by microbiological testing (absence of microbial growth).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). Sterilization efficacy is determined objectively through microbiological testing.

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-enabled diagnostic or treatment device involving human readers.

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

Not applicable. This device is a sterilizer, not an algorithm, and its performance is evaluated based on its ability to sterilize medical instruments.

7. The Type of Ground Truth Used

The ground truth used for these studies is microbiological sterility, defined by:

• Absence of microbial growth in biological indicators (Dose Response and Simulated Use tests).
• A sterility assurance level (SAL) of 10^-6 (Dose Response).
• A spore log reduction greater than 6 (Simulated Use).
• Presence of growth in positive controls to confirm viability of microorganisms (Dose Response and Simulated Use).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it's not an AI/ML device.

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

Not applicable. No training set for an AI/ML device.

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

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

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

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

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

· Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter**

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

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

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

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

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

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

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

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

· Flexible endoscopes without lumens

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" in the context of an AI/algorithm-driven device, as this submission is for a medical device sterilizer. The "testing" refers to performance validation studies for the sterilizer's efficacy.

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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