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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 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 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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STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology
• · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator (BI) /Process Challenge Device (PCD) is a selfcontained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRAD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2ºC.

The STERRAD VELOCITY BI/PCD can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.

The STERRAD VELOCITY BI/PCD consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.

The STERRAD VELOCITY BI/PCD has the same a-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K182404. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.

The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI/PCD and is used to distinguish between the positive and negative responses.

The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI/PCD to obtain the final fluorescence result in 15 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.

There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.

The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.

The STERRAD VELOCITY Reader of the subject device has the same hardware and uses same fundamental scientific technology as the predicate device cleared under K182404. Only the algorithm for fluorescence reading has been modified in the subject device to reduce the fluorescence readout time from 30 minutes to 15 minutes.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, based on the provided text:

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 specific sample sizes for the test sets in each study. It mentions that:

• For "Hydrogen Peroxide Dose Response and Sterilization Verification," "Design evaluation and Performance Qualification for Periodic Testing," "Verification of Reduced Incubation Time," and "Verification of BI Holding Time," the device's performance was evaluated by reanalyzing fluorescence results and data collected from previously submitted studies using the modified algorithm. No additional sterilization cycles were performed for these specific re-evaluations. This suggests the data provenance is retrospective, using previously gathered data.
• The original provenance of the data used for the reanalysis (e.g., country of origin) is not specified.

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

This information is not provided in the document. The studies primarily involve analytical testing against established biological and chemical indicators, rather than expert interpretation of medical images or other data requiring clinical expertise.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are based on analytical measurements (fluorescence readings, growth/no growth, chemical indicator changes) and adherence to set criteria. There is no mention of a human adjudication process for interpreting results.

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

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system used for monitoring sterilization, not a diagnostic AI system that assists human readers.

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

Yes, the studies described are essentially standalone performance evaluations of the STERRAD VELOCITY BI/PCD and Reader. The modified algorithm's ability to accurately read and interpret the biological indicator's fluorescence (without human intervention in the interpretation process) is the core of the verification. The reader automatically determines and displays the result ("Positive" or "Negative").

7. The type of Ground Truth Used:

The ground truth used in these studies is primarily biological/chemical reference standards and established scientific principles:

• Biological model: For periodic testing, the BI's resistance is compared to a "biological model," which represents the most difficult item routinely processed.
• Sterile BIs (growth and fluorescence): The "growth" outcome of the Geobacillus stearothermophilus spores (or lack thereof) after incubation, and the corresponding fluorescence, serve as the biological ground truth for assessing sterilization effectiveness.
• Chemical indicator changes: The color change of the chemical indicator (from red/pink to yellow/orange/brown dots) provides a chemical ground truth for exposure to hydrogen peroxide.
• 7-day incubation spore growth results: For verifying reduced incubation time, the rapid fluorescence results are compared against the longer, traditional 7-day visual assessment of spore growth, which is a well-established method for confirming biological indicator results.

8. The Sample Size for the Training Set:

This information is not provided. Given that the modification was an update to an existing algorithm based on reanalysis of previous data, and the device is a biological indicator reader rather than a deep learning AI, a distinct "training set" in the context of machine learning might not be applicable or explicitly documented in this way. The algorithm's development would have likely involved extensive testing and refinement, but the specific size or methodology for a formal "training set" is not detailed here.

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

As with the training set size, the specific methodology for establishing ground truth for any potential "training set" for algorithm development is not detailed. However, it can be inferred that the ground truth would have been established through controlled experiments involving the exposure of biological indicators to varying levels of hydrogen peroxide and subsequent traditional incubation and growth assessment (e.g., the 7-day incubation method mentioned). The previous K182404 submission would have contained details on the initial algorithm's development and associated ground truth.

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The ASP AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor is indicated for use with high-level disinfectant ASP AERO OPA™ ortho-Phthalaldehyde Solution to achieve high-level disinfection of flexible semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the AER.

The AEROFLEX Automatic Endoscope Reprocessor (AER) with AUTOSURE MRC Monitor is designed to provide high-level disinfection for flexible, submersible endoscopes that have been manually cleaned. The AEROFLEX system consists of the software-driven AER, the AUTOSURE MRC reagent, AERO-OPA™ disinfectant solution, and AEROZYME™ enzymatic detergent.

The AEROFLEX AER with AUTOSURE MRC Monitor is indicated for use with high-level disinfectant ASP AERO-OPA ortho-Phthalaldehyde Solution to achieve high-level disintection of semi-critical endoscopes; high-level disinfection requires that the AER be used with the AERO-OPA Solution per its Instructions for Use.

Manual cleaning of endoscopes is required prior to placement in the AEROFLEX AER. After an endoscope is manually cleaned according to its manufacturer's recommended procedures, it is loaded into the AER. After starting the reprocessing cycle, the AER displays its progress during the cycle and signals that the cycle is complete on the control panel and with an audible tone.

The minimum recommended concentration (MRC) of ASP AERO-OPA ortho-Phthalaldehyde Solution is automatically checked and verified by the AER for every cycle using an integrated MRC monitor and reagent. The MRC monitor- tests the OPA concentration in every high-level disinfection cycle without the use of test strips; if the OPA concentration is below the MRC the system cancels the cycle and notifies the user.

To reduce user error and facilitate assurance of disinfection efficacy, the AEROFLEX System uses Radio Frequency Identification (RFID) technology to identify the ASP-branded consumables that are used with the system. Additionally, to enable electronic record-keeping by hospitals, the AEROFLEX system can be configured by users to transmit cycle printout information and/or print cycle records from the facility's network; the AEROFLEX System will also be compatible with ASP ACCESS™ Technology to allow automated record keeping.

This document describes the premarket notification (510(k)) for the AEROFLEX™ Automatic Endoscope Reprocessor (AER) with AUTOSURE™ MRC Monitor. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted and reports a "Pass" for each. The acceptance criteria are implicitly defined by the "Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (August 1993)" and the relevant electrical safety and EMC standards.

Here's a summary of the performance testing and their reported results:

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

The document does not explicitly state specific sample sizes for most of the performance tests (e.g., number of cycles for simulated use, number of endoscopes for in-use testing). It refers to "worst-case conditions" and "various OPA solution and MRC reagent conditions," implying a robust testing methodology but lacking numerical specifics.

• Provenance: The data provenance is internal testing conducted by Advanced Sterilization Products (ASP). The geographic location of the testing facility is not explicitly stated, but the company address is Irvine, California, USA, implying the testing was likely conducted in the US.
• Retrospective or Prospective: The testing would be considered prospective as it involves controlled experiments and data collection designed specifically to evaluate the performance of the device prior to marketing.

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

This document describes a medical device (automatic endoscope reprocessor) rather than an AI/ML clinical diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" often seen in AI/ML performance studies is not directly applicable in the same way.

• Ground Truth Establishment: The "ground truth" for this device's performance is established by physical and chemical measurements (e.g., OPA concentration, temperature, flow rates, microbial reduction for disinfection efficacy) and engineering validation against predefined specifications and regulatory guidance documents.
• Experts: While not explicitly stated as "experts establishing ground truth," the development and testing would have involved qualified engineers, microbiologists, and other scientific personnel with expertise in sterilization, disinfection, and medical device design and validation. Summative Usability Testing involved "representative end-user technicians and nurses," who can be considered "experts" in the context of device usability in a clinical setting.

4. Adjudication Method for the Test Set

Again, given that this isn't an AI-powered diagnostic device, there's no "adjudication method" in the sense of reconciling disagreements between expert readers. Performance is determined by quantitative measurements and validation against predefined technical specifications and regulatory (FDA) guidance.

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

No. This is not an AI/ML diagnostic device that provides interpretations that human readers would then review. The device discussed is an Automatic Endoscope Reprocessor, focused on disinfection efficacy and automated processes. MRMC studies are not applicable here.

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

The "standalone" performance here refers to the device operating independently to perform its intended function. The various "Performance Testing" categories listed in the tables (Process Parameter Physical Testing, Simulated Use Testing, In-Use Testing, Self-Disinfection Efficacy, System Verification Testing, MRC Monitor Testing, etc.) represent the standalone performance of the AEROFLEX system in achieving its disinfection and monitoring goals without direct human intervention during the cycle. Human interaction occurs before loading and after completion, but the process itself is automated and tested as such.

7. The Type of Ground Truth Used

The ground truth used is primarily based on:

• Physical and Chemical Measurements: Direct measurements of parameters like OPA concentration, temperature, flow, volume, and contact time.
• Microbiological Efficacy: Likely involves challenging the system with known levels of microorganisms (bioburden) and demonstrating a specified log reduction (e.g., "greater than 6-log10 reduction" mentioned in Flow Characteristic Evaluation). This would involve laboratory-based testing using culturing methods to determine viable microbial counts before and after reprocessing.
• Engineering Specifications and Design Requirements: The device's performance is validated against its pre-established technical specifications and the requirements outlined in relevant FDA guidance documents and international standards (e.g., for electrical safety, EMC).
• Usability Feedback: For summative usability testing, the "ground truth" would be direct observations and feedback from the intended users regarding the device's ease of use and safety in a simulated environment.

8. The Sample Size for the Training Set

This product is an automatic endoscope reprocessor, not a machine learning model developed with training data. Therefore, the concept of a "training set" for an algorithm's development is not applicable. The device's internal algorithms and control systems are likely developed through traditional software engineering principles and validated through the extensive non-clinical testing described.

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

As explained above, there is no "training set" for an AI/ML algorithm in this context. The "ground truth" against which the device's performance is validated is established through established scientific methods, engineering principles, and adherence to regulatory standards for disinfection and medical device functionality.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:

• · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and periodic testing of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2ºC.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple) if used for frequent monitoring purposes. When using this method, the biological indicator must be cultured in an incubator at 55-60℃ for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 100 Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow or yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device cleared under K170039. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4-methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (α-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of a-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth. the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.

The provided text describes the acceptance criteria and a study proving the device meets the acceptance criteria for the STERRAD VELOCITY™ Biological Indicator.

Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device, as outlined by the "Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, Section 10, Test Pack, issued on October 4, 2007," appears to be that the resistance of the subject device must be greater than or equal to the biological models for all claimed STERRAD Cycles. Additionally, all fluorescence-negative results during testing must be obtained in triplicate runs.

• Performance Study in STERRAD 100NX (STANDARD and FLEX Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (EXPRESS Cycle, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100NX (DUO Cycle): Pass
• Performance Study in STERRAD NX (STANDARD and ADVANCED Cycles, with/without ALLClear Technology): Pass
• Performance Study in STERRAD 100S Cycle: Pass |

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

• Sample Size: The document states that "all fluorescence-negative results were obtained in triplicate runs." This implies that for each performance study listed, testing was conducted in triplicate. The exact number of biological indicators (BIs) or runs per condition is not explicitly stated beyond "triplicate runs."
• Data Provenance: The data is from non-clinical performance testing conducted by Advanced Sterilization Products (ASP). There is no explicit mention of the country of origin of the data, but given ASP is based in Irvine, California, it's highly likely the testing was conducted in the United States. The study is inherently prospective as it involves new performance testing of the device for expanded indications.

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

This information is not provided in the document. For a biological indicator, the ground truth is typically established by the growth or non-growth of the microbial spores after exposure to a sterilization process, which is an objective measurement. It does not typically involve expert interpretation in the same way as, for example, reading medical images.

4. Adjudication Method for the Test Set

This information is not applicable in the context of biological indicator testing as described. The results (fluorescence-negative or positive, and spore growth/non-growth) are objective measurements based on the device's functionality and the viability of the spores. It does not involve human interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The STERRAD VELOCITY™ Biological Indicator is a standalone device for monitoring sterilization processes and its performance is assessed directly, not in conjunction with human interpretation in an MRMC setting.

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

Yes, the performance study described is essentially a standalone (algorithm only) performance evaluation of the STERRAD VELOCITY™ Biological Indicator. The device, in conjunction with the STERRAD VELOCITY Reader, determines a "positive or negative result" based on the detected fluorescent signal, which is determined using an "algorithm developed for the STERRAD VELOCITY BI." The results presented ("Pass" or "Fail" for the performance studies and the resistance being "greater than" the biological model, and "fluorescence-negative results were obtained in triplicate runs") are indicative of the algorithm's direct performance in identifying effective sterilization.

7. The Type of Ground Truth Used

The ground truth for the biological indicator testing is based on the viability (growth or non-growth) of the Geobacillus stearothermophilus (ATCC 7953) spores after exposure to sterilization cycles, as well as the expected D-value (decimal reduction time) and and absence of growth in fully processed units. This is a biological/microbiological ground truth, directly tied to the primary function of a biological indicator. The "fluorescence-negative" result detected by the reader is directly correlated to the inactivation of spores. The document also mentions the optional visual pH-based color change result after 5-7 days of culture, which further confirms spore viability (or lack thereof).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This device is a biochemical indicator with an enzymatic detection system, rather than a machine learning or AI model that typically requires a large training dataset for learning patterns from data. The "algorithm developed for the STERRAD VELOCITY BI" likely refers to a pre-defined threshold or logic based on the biochemical reaction, rather than a machine-learned algorithm.

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

As no specific "training set" in the context of machine learning is indicated, the method of establishing ground truth for a training set is not applicable as described in the document. The foundational principles for the device's operation (α-glucosidase enzyme system, spore viability detection) are based on established microbiological and biochemical science. The development of the algorithm would have relied on understanding the relationship between enzyme activity, fluorescence, and spore inactivation, established through scientific studies and threshold determination rather than a traditional machine learning training process with a distinct training set.

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Tyvek® Pouches and Rolls with STERRAD® Chemical Indicator are intended to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2014 [Type I]) that changes from red to the color indicated on the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems.

The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1.

The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is constructed from Tyvek plastic films, with the STERRAD Chemical Indicator printed onto the Tyvek film. The self-seal pouch permits sealing of the pouch without need of heat-sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD Sterilization Systems.

The modified Tyvek Pouch/Roll with STERRAD Chemical Indicator is intended to enclose medical devices to be terminally sterilized in the STERRAD Sterilization Systems in a single or double pouch configuration. The medical devices are inserted into the pouch/roll, sealed, and then sterilized in the STERRAD Sterilization System.

The only difference between the modified device and the predicate device, is the increased post-processing shelf-life to 12 months.

The STERRAD Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. STERRAD Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to the color indicated by the comparator bar included on the shelf pack (or lighter) when exposed to hydrogen peroxide.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Tyvek® Pouch/Roll with STERRAD® Chemical Indicator with Extended Post-Processing Shelf-Life."

It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific publication of an efficacy study. Therefore, some of the requested information (like specific sample sizes for training sets, number of experts for ground truth, or MRMC studies) is typically not included in such summaries.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the modification is related to the shelf-life of the product.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of pouches/rolls tested for each condition) for the "Maintenance of Package Integrity" verification tests. It only lists the different STERRAD® systems and cycles that were tested to support the 12-month shelf-life.
• Data Provenance: The data appears to be prospective verification testing conducted by the manufacturer, Advanced Sterilization Products. The country of origin for the data is not specified, but given the FDA submission, it's typically conducted under US or international standards accepted by the FDA.

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

• This information is not provided in a 510(k) summary. The "ground truth" here is the objective measurement of sterility maintenance, likely performed by a microbiology lab, rather than an expert interpretation of data points.

4. Adjudication Method for the Test Set

• Not applicable as the "ground truth" is based on objective laboratory testing for sterility, not subjective expert assessment 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 device is a medical packaging with a chemical indicator, not an AI-powered diagnostic or assistive technology for human readers. There is no AI component or human reader involvement in interpreting its primary function (sterility maintenance).

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

• Not applicable. This device is not an algorithm or AI system. The "performance" being evaluated is the physical and chemical properties of the packaging and indicator.

7. The Type of Ground Truth Used

• The ground truth for the "Maintenance of Package Integrity" tests is objective laboratory measurements of sterility over time, specifically for 12 months after processing in various STERRAD® sterilization systems. This would involve microbial ingress testing or similar methods to confirm the sealed package prevents contamination. The chemical indicator's functionality (color change) is also objectively evaluated.

8. The Sample Size for the Training Set

• Not applicable. This product is a physical device being evaluated for its material properties and performance, not a machine learning model that requires a training set. The "testing" referred to in the document is verification testing.

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

• Not applicable, as there is no training set for a machine learning model.

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The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring STERRAD Sterilization Systems: · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S

The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.

Here's a breakdown of the acceptance criteria and study information for the STERRAD VELOCITY™ Biological Indicator and Reader based on the provided text:

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 specific sample sizes (number of biological indicators or test runs) used for each individual performance test (e.g., D-value determination, RIT study, performance in various sterilizers). However, it implies that the testing was rigorous enough to satisfy the requirements of ISO 11138-1:2006 and FDA guidance.

The data provenance is retrospective, as these are non-clinical lab performance tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is Advanced Sterilization Products (ASP), located in Irvine, California, USA, suggesting the studies were likely conducted in the US or in facilities compliant with US standards.

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

This information is not provided in the document. The "ground truth" for the biological indicator's performance is established by scientific methods for spore viability, resistance characteristics (D-value), enzyme activity, and growth inhibition, rather than expert interpretation of results. For electrical safety and EMC, the ground truth is established by adherence to recognized national and international standards by accredited testing bodies.

4. Adjudication Method for the Test Set

This information is not applicable/provided for these types of non-clinical laboratory performance studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of medical images/data, where discrepancies between readers need to be resolved. The "results" of these tests (e.g., Pass/Fail, numerical measurements) are objectively determined by the methodology described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and the AI's assistance to human readers is evaluated. The STERRAD VELOCITY™ Biological Indicator and Reader is a system for objectively monitoring sterilization processes, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone Performance

Yes, a standalone (algorithm only) performance was done. The entire suite of "Non-Clinical Data" presented details the performance of the STERRAD VELOCITY™ Biological Indicator and Reader system independently. The Reader's algorithm determines the final fluorescence result without human-in-the-loop interpretation for its primary function of determining BI positivity/negativity within 30 minutes. The BI's performance (spore population, D-value, RIT, etc.) is also evaluated systematically.

7. Type of Ground Truth Used

The ground truth used for the scientific performance testing of the Biological Indicator is based on objective scientific measurements and established microbiological and sterilization standards. This includes:

• Microbiological assays: For spore population determination, growth inhibition, and characterization of Geobacillus stearothermophilus.
• Sterilization kinetics: For D-value determination (using Holcomb-Spearman-Karber Procedure (HSKP) and Survivor Curve method as per ISO 11138-1).
• Enzymatic activity measurements: Fluorescence detection and its correlation to spore outgrowth.
• Physical and Chemical Testing: For chemical indicator functionality and real-time shelf life studies.
• Compliance with recognized standards: For electrical safety (e.g., IEC/EN 61010-1) and EMC (e.g., FCC Part 15, Subpart B).

8. Sample Size for the Training Set

The document does not contain information about a "training set" in the context of machine learning. The STERRAD VELOCITY™ Biological Indicator and Reader is not described as an AI/machine learning device that requires a training set in the conventional sense. Its "algorithm" is for fluorescence detection and conversion of voltage readings to positive/negative results, based on established biological and enzymatic principles, not necessarily learned from a large dataset. If there was any internal calibration or parameter setting, the details are not provided.

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

As there is no explicit mention of a "training set" for an AI/machine learning model as understood in typical AI device submissions, this information is not applicable and not provided in the document. The device's operational parameters and decision thresholds would have been established through a combination of scientific principles, engineering design, and empirical testing against known positive and negative controls.

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