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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 following Crosstex® Isofluid Plus Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. (non-sterile)

• Crosstex® Isofluid Plus Surgical Earloop Face Mask Blue .
• Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask Blue .
• Crosstex® Isofluid Plus FogFree Surgical Earloop Face Mask with Splash Visor Blue .

The Crosstex Isofluid Plus Surgical Masks are constructed of a cellulose inner facing, a 100% Spundonded porypropyitent elastic loops. The nose piece for the polypropyiene inter firedia, with non facil cae no fog strip (if applicable) is made of melt blow polypropylene.

The provided text describes the acceptance criteria and performance of Crosstex® Isofluid Plus Surgical Masks, focusing on non-clinical tests to demonstrate substantial equivalence to a predicate device.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Criteria" column is derived from the reported performance of the predicate device, as the submission states that the new device meets "all relevant requirements of the aforementioned test standards" and is "substantially equivalent." Typically, substantial equivalence is established by meeting or exceeding the performance of the predicate device for relevant parameters.

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

The document does not explicitly state a separate "test set" in the context of a dataset for an AI/ML device. Instead, the performance evaluation is based on bench testing of the physical masks.

• Fluid Resistance (ASTM 1862): "32 of 32 pass at 80mm Hg" for the new device, suggesting a sample size of 32 units tested. The predicate device had "30 of 32 pass at 80mm Hg," also implying 32 units tested for the predicate.
• Other tests (PFE, BFE, Flammability, Delta-P): Specific sample sizes are not explicitly stated for these tests within the provided text, but they would typically involve multiple samples to ensure statistical validity.
• Data Provenance: The data provenance is from non-clinical laboratory bench testing conducted to evaluate the physical and performance characteristics of the surgical masks. There is no information about the country of origin of the data beyond the submitter's identification in New York, USA. The nature of these tests makes them prospective in the sense that they are performed on manufactured products for regulatory submission.

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

This information is not applicable to this submission. The device is a physical surgical face mask, and its performance is evaluated through standardized bench tests (e.g., fluid resistance, particulate filtration). There is no "ground truth" in the context of expert consensus, pathology, or clinical outcomes that would require human experts to interpret data for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective, standardized physical performance tests rather than subjective 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

This information is not applicable. This submission is for a physical medical device (surgical face mask), not an AI/ML-driven diagnostic or image analysis system. Therefore, an MRMC study and the concept of "human readers improving with AI" are irrelevant to this device.

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

This information is not applicable. This is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these surgical masks is established by standardized laboratory test methods (e.g., ASTM 1862 for fluid resistance, ASTM F2299 for particulate filtration, ASTM F2101 for bacterial filtration, 16CFR1610 for flammability, and Mil M36954C for Delta-P). These methods define objective criteria and measurements to determine the performance against established industry standards and the predicate device's performance.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical device, not an AI/ML algorithm.

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

This information is not applicable. As there is no training set, there is no corresponding ground truth for it.

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The following Crosstex® Surgical Masks are intended for use in infection control practices to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.

• Crosstex® Surgical Earloop Mask White ●
• Crosstex® Surgical Earloop No Fog Mask White .
• Crosstex® Surgical Earloop No Fog Mask with Splash Visor White .

The Crosstex Surgical Masks are constructed of a cellulose inner facing, a 100% spunbonded polypropylene white outer facing, a 100% meltblown polypropylene filter media, with white non-latex elastic loops. The nose piece for the Crosstex Surgical Masks is aluminum wire while the no fog strip (if applicable) is made of melt blow polypropylene.

This document describes a 510(k) summary for Crosstex Surgical Masks, focusing on non-clinical performance tests rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI studies, ground truth, and expert adjudication are not applicable.

Here's an analysis 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

This information is not applicable as the study involves functional testing of a physical medical device (surgical masks), not an AI algorithm processing data. No "test set" in the context of data for an AI model is used. The testing would be performed on samples of the manufactured masks.

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

This information is not applicable. "Ground truth" in the context of AI models refers to definitively labeled data. For performance testing of a physical device like a mask, the "ground truth" is established by adherence to standardized testing protocols and measurements, not expert consensus on data points. The laboratories conducting these tests are assumed to be accredited and their personnel qualified to perform the specific tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in AI studies where multiple human readers interpret data to establish a consensus ground truth. For device performance testing, the results are typically quantitative measurements comparing against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance, which is outside the scope of this device (surgical masks).

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

This information is not applicable. The device is a surgical mask, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective measurements against recognized industry standards and test methods. For example, the Bacterial Filtration Efficiency (BFE) test produces a quantitative percentage that is compared to an accepted threshold. This is distinct from expert consensus, pathology, or outcomes data which are typically used for diagnostic devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI or machine learning device.

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

This information is not applicable. There is no "training set" for this device.

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