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Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
  The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.

Terragene® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.

Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advance cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the ground truth used for any of the Terragene products (Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)).

The document is an FDA 510(k) clearance letter, which confirms that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices for their stated indications. It outlines regulatory requirements and general information about FDA processes but does not detail the specific studies, testing methodologies, or results that demonstrate the devices meet performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:

• STERRAD 100S® Sterilization System
• STERRAD NX® Sterilization System (Standard and Advanced cycles)
• STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
• STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
• STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
• V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
• V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
• V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
• V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
• V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
• V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
• STERIZONE® VP4 Sterilizer (Cycle 1)

The 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue to pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

Here's a summary of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:

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 size (i.e., number of indicators) used for the sterile and incomplete cycles during the "Health Care Facility Simulated Use Testing." It broadly states "All Tri-Metric CIs tested met acceptance criteria," implying multiple indicators were used.

The data provenance is prospective, as the testing was conducted to evaluate the device's performance in a healthcare facility setting, specifically for the STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin for the data is not specified, but the submission is from a US-based company to the FDA.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for reading the chemical indicators. However, for a chemical indicator, the "ground truth" performance is typically based on the objective visual change of the indicator after exposure to defined sterilization conditions (complete vs. incomplete cycles). The acceptance criteria detail very specific visual outcomes ("blue toward pink in the ACCEPT region" for pass, and "blue toward pink only within the REJECT region" for fail), implying a relatively objective assessment rather than subjective expert interpretation, though standard operating procedures would likely be in place for reading.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. Given the objective nature of chemical indicator color change and defined "ACCEPT" and "REJECT" zones, it's likely that a single trained observer could determine the outcome, or multiple observers could independently read and have their results compared, without a formal adjudication process being explicitly detailed in this type of submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a chemical indicator, which is a standalone device that provides a visual reading, not an AI or diagnostic tool that assists human readers in interpreting complex data. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply here.

6. Standalone Performance Study

Yes, a standalone study was done. The "Health Care Facility Simulated Use Testing on STERIZONE® VP4 Sterilizer (Cycle 1)" was a standalone performance study. The chemical indicators were subjected to complete and incomplete sterilization cycles, and their performance (color change) was evaluated independently of any human intervention beyond the initial setup and final visual assessment. The results directly demonstrate the algorithm-only performance (e.g., the indicator's intrinsic ability to react to the sterilization process).

7. Type of Ground Truth Used

The ground truth used was based on the objective conditions of the sterilization cycles. This means:

• Complete Cycle: The indicator was exposed to the full, verified sterilization parameters (time, temperature, vaporized hydrogen peroxide concentration) of a successful STERIZONE® VP4 Cycle 1.
• Incomplete Cycle: The indicator was exposed to conditions known to be insufficient for sterilization (e.g., shorter time, lower temperature, insufficient sterilant).

The color change of the indicator was then compared against these known conditions.

8. Sample Size for the Training Set

This product is a chemical indicator, not a machine learning or AI-driven device. Therefore, there is no training set in the context of AI or machine learning algorithms. The device's performance is based on its chemical reaction properties, which are inherent to its design and manufacturing.

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

As explained above, there is no training set for this type of device. The chemical indicator's design and manufacturing are developed based on established scientific principles of chemical reactions to sterilants, rather than being "trained" on data.

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The Celerity™ HP Chemical Indicator is a vaporized hydrogen peroxide multivariable chemical indicator. It is designed for routine monitoring of the following cycles:

· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or

• Standard, Advanced, Express, Flex or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

The Celerity™ HP Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. If the critical variables are achieved, the color of the indicator ink changes from magenta to orange/yellow or lighter yellow when exposed to the V-PRO® Low Temperature Sterilization System cycles or ASP STERRAD® System cycles. The indicator is validated to function as a multiple variable indicator with increased resistance characteristics similar to ISO 11140-1:2014 end points for a Type 4 Vaporized Hydrogen Peroxide (VHP) Chemical Indicator (CI). No changes have been made to the device other than additional testing and updating the labeling for multivariable indicator claims.

The provided text describes the acceptance criteria and study results for the CELERITY HP Chemical Indicator, a medical device used to monitor sterilization cycles. Here's a breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of acceptance criteria and the reported device performance:

Regarding the other information, the provided text does NOT contain details about the following aspects, which are typically relevant for AI/ML-based medical devices or studies involving human readers:

2. Sample size used for the test set and the data provenance: This information is not explicitly stated. The study refers to "All CI" for the multivariable performance, implying a batch of Chemical Indicators were tested. The provenance (country of origin, retrospective/prospective) is also not detailed, though the manufacturing facility is in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and their qualifications: This device is a chemical indicator that shows a color change, not an AI/ML system requiring expert interpretation of images. Therefore, expert consensus on ground truth in that context is not applicable. The "ground truth" here is the physical reaction of the chemical indicator to specific sterilization parameters as defined by ISO standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a chemical indicator.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical chemical indicator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical chemical indicator.

7. The type of ground truth used: The ground truth for this device's performance is established by ISO 11140-1:2014 standards for chemical indicators and verified by subjecting the indicators to controlled sterilization conditions with specified time, temperature, and sterilant concentration. The "complete color change" and "incomplete color change" are the physical manifestations defining the ground truth.

8. The sample size for the training set: Not applicable. This is an engineered chemical product, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

Here's an analysis of the acceptance criteria and study proving device performance 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 provided text does not explicitly state the sample size used for the simulated use testing. It mentions "All Tri-Metric CIs tested," but the specific number is not given.

The data provenance is prospective as it describes testing conducted for the purpose of demonstrating performance of the device in new sterilizer cycles (specifically the STERIS V-PRO s2). The country of origin of the data is not specified, but the applicant (3M Company) is based in St. Paul, Minnesota, USA.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. However, for a chemical indicator (CI), the "ground truth" is typically the objective color change against a predefined standard (e.g., a "REJECT" or "ACCEPT" zone on the indicator itself), rather than subjective expert interpretation. The acceptance criteria clearly define what constitutes a "PASS" or "FAIL" based on the visible color change within specific regions of the indicator.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For this type of device (chemical indicator), the assessment of "PASS" or "FAIL" is based on the objective color change relative to the marked "REJECT" and "ACCEPT" zones on the indicator, as defined in the acceptance criteria. It is implied that the assessment is a direct comparison to these internal standards.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation needs to be evaluated. The 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is an objective chemical indicator, not a device requiring human interpretation for its primary function. The evaluation focuses on the chemical reaction and color change.

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

This is effectively a standalone study in the context of a chemical indicator. The "device performance" refers to the intrinsic chemical reaction and color change of the indicator itself when exposed to the sterilization conditions. There is no "human-in-the-loop performance" being evaluated in terms of a diagnostic interpretation, and no AI algorithm is involved. The indicator functions mechanically/chemically to provide a visual result.

7. The Type of Ground Truth Used:

The ground truth used is based on defined physical/chemical properties and objective observation of color change against established reference points (the "REJECT" and "ACCEPT" regions on the indicator). This is directly tied to the efficacy of the sterilization cycle itself as the true determinant of whether the conditions were met. The indicator is designed to reflect this physical reality.

8. The Sample Size for the Training Set:

The provided document does not mention a training set as this device is a chemical indicator and does not employ machine learning or AI algorithms that would require a training set. The performance is based on the chemical formulation and design of the indicator.

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

As there is no training set for this chemical indicator device, this question is not applicable.

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Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.

The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.

Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.

Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, based on the provided document:

Acceptance Criteria and Device Performance

Note on "Acceptance Criteria": The document lists "Stated Values" for the chemical indicator, which represent the minimum conditions at which the indicator is designed to reach its endpoint (change color to "ACCEPT"). These are:

• VH2O2: 5.1 mg/L
• Exposure Time: 1 minute
• Temperature: 50°C

The general acceptance criteria for the nonclinical testing seem to be 'Pass' for each test, indicating that the device performed as expected under the tested conditions.

Study Details

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

   • The document does not specify the exact sample size for the test set (e.g., how many individual indicators were tested for each sterilizer type or condition). It mentions "chemical indicator samples" for endpoint color stability and shelf life testing.
   • Data Provenance: The document implies the testing was conducted by the manufacturer, 3M Company, as part of their premarket notification. The location of the testing is not explicitly stated (e.g., country of origin), but it's likely internal to 3M's development and validation processes. The study is prospective as it's part of the premarket submission for a new device.

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

   • The document does not mention the use of human experts to establish ground truth for reading the chemical indicator's color change. Chemical indicators are typically designed for objective visual interpretation, where the "ground truth" is defined by the physical/chemical properties of the indicator and its response to specific sterilization parameters, as determined by laboratory measurements of those parameters.
   • Therefore, this question is not directly applicable in the context of this device and study.

3. Adjudication method for the test set:

   • None specified. As mentioned above, the assessment of a chemical indicator's color change against defined "ACCEPT" or "REJECT" zones is generally a direct visual interpretation, not requiring expert adjudication in the same way, for example, a medical imaging diagnosis might. The endpoint specifications are based on the physical chemistry of the indicator.

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:

   • No. This is a chemical indicator, not an AI-powered diagnostic device or a system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant to this submission.

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

   • Not applicable. This is a physical chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical interaction with the sterilant.

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

   • The ground truth for this device is based on the defined physical/chemical parameters of the sterilization process (VH2O2 concentration, exposure time, and temperature) and the indicator's designed response to these parameters. The "Stated Values" (SV) in Table 1 define the minimum conditions for a successful ("ACCEPT") outcome. The "Health Care Facility Simulated Use Testing" and "Worst Case Sterilant Exposure Testing" would have used calibrated sterilization equipment to establish these ground truth conditions.

7. The sample size for the training set:

   • Not applicable. This device is a passive chemical indicator, not a machine learning model, so there is no "training set." Its design and performance are based on chemical engineering and empirical testing rather than iterative learning from data.

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

   • Not applicable. As there is no training set, this question is not relevant.

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