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A chemical indicator for monitoring all cycles within the STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1 Plus (Lumen & Non-lumen), V-PRO® maX (Flexible, Lumen & Non-lumen) and Sterilucent™ PSD-85 (Lumen & Non-lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.

The Crosstex VH2O2 Chemical Indicators are intended for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX (Standard, Duo, Flex & Express), NX (Standard & Advanced), STERIS® V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and Sterilucent™ PSD-85 sterilization processes. The Crosstex VH2O2Chemical Indicators are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Chemical indicators change to a color of blue after exposure to vaporized hydrogen peroxide. Colors other than blue such as yellow/green should be treated as a process failure.

This document describes the Crosstex VH2O2 Chemical Indicators, a device designed to monitor vaporized hydrogen peroxide sterilization cycles. The information provided outlines the device's acceptance criteria and the studies conducted to prove its performance.

Acceptance Criteria and Reported Device Performance

Detailed Study Information:

1. Sample size used for the test set and the data provenance:
   The document does not specify a distinct "test set" sample size in terms of number of indicators. The testing involves subjecting the indicators to specific sterilization cycles (e.g., STERRAD® 100NX™ DUO) and then evaluating their performance, color change, and stability. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Crosstex International, Inc., a U.S. company. The studies appear to be prospective, laboratory-based tests designed to evaluate the physical and chemical properties of the indicators under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   This type of device (chemical indicator) does not typically involve human expert interpretation for "ground truth" establishment in the way an AI diagnostic algorithm would. The "ground truth" for these tests is based on objective, measurable changes in the indicator's color and stability following exposure to defined sterilization conditions, and compliance with established international standards (ISO 11140-1:2014). The assessment would likely be performed by trained laboratory personnel or quality control specialists rather than medical experts.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. The assessment criteria are objective (e.g., "Color change to blue," "No significant color change"). There is no mention of a subjective evaluation process requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Its function is to provide a direct visual indication of sterilization processing, not to interpret complex medical images or data.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This device is not an algorithm. Its performance is observed directly by human users (healthcare providers) who visually assess the color change of the indicator. The "standalone" performance here refers to the intrinsic chemical and physical response of the indicator itself, which is what the non-clinical tests evaluate.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The ground truth is based on the objective physical and chemical reaction of the indicator when exposed to vaporized hydrogen peroxide under specific, controlled sterilization conditions, as defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and verified by direct observation in laboratory settings.

7. The sample size for the training set:
   Not applicable. This device is a physical chemical indicator, not a machine learning or AI algorithm that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

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The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time.

The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle.

The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

The provided text describes the regulatory clearance for the "SporView Rapid Read Biological Indicator SteamPlus Test Pack." The document includes a summary of non-clinical performance data, which outlines the acceptance criteria and the results of the study conducted to demonstrate the device's performance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the sample size used for the test set or the country of origin of the data. It also does not specify if the data was retrospective or prospective. The "Summary of Non-Clinical Performance Data" implies prospective testing as it describes performance testing conducted to demonstrate compliance.

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

This information is not applicable to a biological indicator device. Biological indicators are evaluated based on their ability to show the presence or absence of viable microorganisms after a sterilization process, not on expert interpretation of images or other subjective assessments. The "ground truth" for a biological indicator is the objective determination of microbial growth or no growth.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation by multiple human readers (e.g., in medical image analysis). For a biological indicator, the outcome (growth or no growth) is an objective biological response.

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

This information is not applicable. This device is a biological indicator for sterilization monitoring, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

This information is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent in its design and biological response, not in an algorithm's output.

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

The ground truth for a biological indicator is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by observing microbial growth (or lack thereof) in a controlled incubation process. For the "complete kill" criteria, the ground truth is the absence of microbial growth, indicating a successful sterilization cycle. For resistance testing, the ground truth relates to the time/temperature exposure required to inactivate the spores.

8. The sample size for the training set

This information is not applicable. The device is a physical biological indicator, not a machine learning model that requires a training set.

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

This information is not applicable. As stated above, the device does not involve a training set.

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The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
• STERRAD® 100NX® (Standard Cycle)

The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units. Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.

The provided document describes the SporView® VH2O2 BI, a self-contained biological indicator designed to monitor hydrogen peroxide sterilization. The document presents performance data to demonstrate the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., spore population, D value, survival/kill response). However, it implies that sufficient samples were tested to demonstrate compliance with the defined acceptance criteria.

The data provenance is from nonclinical tests performed by the manufacturer, Crosstex/SPSmedical. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but given it's a submission to the FDA for a new device, the testing would generally be prospective and conducted under controlled laboratory conditions.

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. For biological indicators, the "ground truth" is typically established by the inherent biological and chemical properties of the spores and growth media, as measured by established laboratory standards and protocols, rather than expert human interpretation of results in the same way medical imaging might require. The "experts" would be the scientists and technicians conducting the tests according to standardized methods.

4. Adjudication method for the test set

This information is not applicable in the conventional sense. The "adjudication" is based on the objective measurement of biological and chemical parameters (e.g., spore count, D-value, color change) against predefined specifications. There is no mention of human-expert adjudication of results as would be found in diagnostic studies.

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

An MRMC comparative effectiveness study was not performed. This type of study is typically relevant for medical imaging or diagnostic devices where human readers (e.g., radiologists) interpret results, and the device might offer AI assistance. Biological indicators for sterilization assurance do not involve human "readers" interpreting complex results from the device itself in a clinical diagnostic setting.

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

This concept is not directly applicable to this device. The SporView® VH2O2 BI is a physical biological indicator that provides a visual output (color change or turbidity). Its performance is inherently "standalone" in that it functions without a human actively making a diagnostic interpretation based on complex data. The human interaction is limited to observing the physical change and interpreting its meaning based on the device's design (purple = sterile, yellow = not sterile). There is no "algorithm" in the sense of software processing data for a diagnostic outcome.

7. The type of ground truth used

The ground truth used is primarily objective laboratory data derived from standardized biological and chemical assays. This includes:

• Spore population counts: Direct measurement of the number of viable spores.
• Survival/Kill Response: Observation of spore viability after exposure to specific sterilization parameters for defined periods (absence or presence of growth).
• D-value determination: A measure of the resistance of the spores to the sterilizing agent, calculated from experimental data.
• Growth media color change: A direct chemical indicator of metabolic activity (spore growth).
• Stability and material suitability testing: Physical chemistry and material science tests.

This ground truth is established through rigorous, controlled laboratory experiments adhering to industry standards for biological indicator testing.

8. The sample size for the training set

This information is not applicable as the SporView® VH2O2 BI is not an AI/machine learning device that requires a training set. Its performance is based on its inherent biological and chemical properties, not learned patterns from data.

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

This question is not applicable for the same reason as point 8.

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The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

The provided text describes the 510(k) premarket notification for the "EON Portable Reverse Osmosis Water Purification System." This document is a regulatory submission for a medical device and not a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic test.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Millenium HX) for a water purification system used in hemodialysis. The "acceptance criteria" and "study" described are related to the device's physical functions (water purification, heat disinfection) and regulatory compliance (electrical safety, biocompatibility), rather than performance characteristics of an AI/ML system.

Therefore, I cannot extract the information required by your prompt, such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets.
• Number of experts and their qualifications for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• MRMC comparative effectiveness studies for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The document is about a water purification system, not an AI/ML diagnostic or predictive device.

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The SporView® Rapid Read Biological Indicator is intended to be used with the 3M Attest Auto-Reader to monitor the effectiveness of dynamic-air-removal (prevacum) steam sterilization cycles of 4 minutes at 132°C. The SporView Rapid Read Biological Indicator provides a final fluorescent result in 3 hours. An optional pH color change is observed after 48 hours.

The SporView Rapid Read Biological Indicator is a self-contained biological indicator designed to be used with the 3M Attest 390 auto-reader to qualify or routinely challenge dynamic-airremoval (pre-vacuum) steam sterilization cycles of 4 minutes at 270°F (132°C). The SporView Rapid Read Biological Indicator is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap. Similar to the predicate device, 3M's 1292 Rapid Read-Out Biological Indicator cleared under 510(k)s K090569 and K926364, the subject device contains ≥ 105 viable spore population of G. stearothermophilus. It utilizes the a-glucosidase system, which is generated naturally within growing G. stearothermophilus. A successful steam sterilization cycle will result in no growth of G. stearothermophilus. A failure in the sterilization cycle creates a fluorescence change, which is detected upon incubation in the 3M 390 Attest Auto-reader. This provides an enzymatic result in 3 hours to indicate a steam sterilization process failure. The biological indicator will also detect the presence of G. stearothermophilus organism by a visual color change reaction. Biochemical activity of the orqanism will produce acid by-products that cause the media to change color after 48 hours. A visual pH color change after 48 hours also indicates a steam sterilization process failure.

This document describes the SporView Rapid Read Biological Indicator, a device designed to monitor the effectiveness of steam sterilization cycles.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test in the "Performance Characteristics Testing" section. However, the testing was conducted by Medivators in accordance with FDA Guidance on Biological Indicators to demonstrate that the device meets or exceeds acceptance criteria. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Medivators (Crosstex/SPSmedical). The type of data is non-clinical performance data. There is no information regarding country of origin or whether the data is retrospective or prospective, although typically, pre-market submissions involve prospective testing.

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 "ground truth" for a biological indicator would be based on the known state of sterilization (e.g., whether a sterilization cycle was effective or not) and the measurable biological response of the indicator (e.g., spore growth or no growth). This is determined by the experimental setup rather than expert consensus on individual results.

4. Adjudication method for the test set:

Not applicable. The "ground truth" for the performance of a biological indicator in these types of tests is typically objective (e.g., based on known sterilization parameters and direct observation of microbial growth/killing), rather than requiring adjudication among human experts.

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 biological indicator for sterilization monitoring, not an AI-assisted diagnostic or interpretation tool that would involve human readers.

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

Not applicable. The device is a biological indicator itself, which is then read by an auto-reader (3M Attest 390 Auto-Reader). The performance evaluated is the indicator's ability to accurately reflect sterilization efficacy, confirmed by its interaction with the auto-reader. There is no "algorithm only" performance reported in the sense of a software-based diagnostic.

7. The type of ground truth used:

The ground truth used for these tests is based on objective biological and physical measurements related to sterilization efficacy. This includes:

• Spore viability: Direct counts of viable spores.
• Resistance characteristics (D-value, Z-value, Survival Time): Determined by exposing the biological indicators to precisely controlled steam sterilization conditions and observing the killing kinetics of the spores.
• Growth promotion: Observing the ability of the media to support the growth of G. stearothermophilus.
• Fractional and full cycle inactivation: Observing partial kill after a fractional cycle and complete inactivation after a full cycle in a marketed sterilizer.

8. The sample size for the training set:

Not applicable as this is not an AI/machine learning device that requires a training set. The "training set" concept is traditionally associated with statistical models or machine learning algorithms that learn from data.

9. How the ground truth for the training set was established:
Not applicable for the reasons stated in point 8.

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