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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Here's an analysis of the provided FDA 510(k) clearance letter, focusing on the acceptance criteria and the study proving the device meets them:

The VERIFY STEAM Integrating Indicator (K243876) is a chemical indicator designed to monitor steam sterilization cycles. It is intended to be placed within containment devices (packs, pouches, etc.) during sterilization to independently verify that critical parameters have been met. The device is considered to "pass" if a dark bar on the indicator enters the "ACCEPT (OK)" window.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical testing performed to evaluate the performance of the VERIFY STEAM Integrating Indicator and demonstrate its substantial equivalence to a predicate device (K213412).

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

• The document does not specify the exact sample sizes (number of indicators) used for each individual test (Stated Value, Simulated Use, Stability, Comparison with Biological Indicator).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission for a medical device, it is highly likely that these were prospective, laboratory-based studies conducted by the manufacturer (STERIS Corporation, Franklin Park, IL, USA) to evaluate the device's performance under controlled conditions.

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

• This device is a chemical indicator that produces a visual change (dark bar entering an "ACCEPT (OK)" window) based on exposure to sterilization parameters. The "ground truth" for these tests is established by the controlled sterilization cycle conditions (temperature, time, presence of steam) and the objective physical change of the indicator, rather than subjective expert interpretation.
• Therefore, no human experts were used to establish the ground truth for the test set in the way radiologists or pathologists would interpret an image. The performance is assessed against defined physical and chemical criteria.

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

• As the "ground truth" is determined by objective physical and chemical changes under controlled conditions, and the outcome (pass/fail) is a direct observation of the indicator's state, no adjudication method involving human experts was necessary for the test set.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VERIFY STEAM Integrating Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its primary function is to react chemically, not to be "read" in a complex interpretive sense by multiple human readers.

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

• This question is not applicable in the context of a chemical indicator. The device is entirely standalone in its function – it reacts chemically without any human intervention or an algorithm. Its "performance" is its physical color change, which is then observed by a human. There is no separate "algorithm" to evaluate.

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

• The ground truth for these tests is based on objective physical and chemical properties and predefined standards. Specifically:
  • Controlled Sterilization Parameters: The cycles are run at precisely defined temperatures and times, and the presence of steam is controlled. The "truth" is whether these parameters were met or not.
  • ANSI/AAMI/ISO 11140-1:2014: This international standard defines the performance requirements for chemical indicators, providing the objective benchmarks against which the device is evaluated.
  • Biological Indicator Inactivation: For comparison testing, the inactivation of a biological indicator (a highly resistant microorganism) serves as an objective "gold standard" for sterilization efficacy.

7. The sample size for the training set:

• The document does not mention a "training set" in the context of device development. This concept is typically associated with machine learning or AI models. For a chemical indicator, the "development" involves chemical formulation, material science, and engineering to achieve the desired reaction kinetics and visual endpoint. There isn't a "training set" in the computational sense.

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

• As there is no "training set" in the conventional sense for this type of device, this question is not applicable. The development of such an indicator would involve extensive research and development in chemistry and material science, where performance is iteratively optimized against the physical/chemical principles of sterilization and the requirements of relevant standards.

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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The VERIFY STEAM Integrating Indicator 5CM is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator 5CM is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The provided text is a 510(k) summary for a medical device (VERIFY STEAM Integrating Indicator and VERIFY STEAM Integrating Indicator 5CM), which focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data. It is not an AI/ML device, and therefore, the information requested in the prompt regarding AI/ML specific criteria (such as training set, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and stated device performance for this non-AI/ML medical device from the provided text.

Here's the relevant information presented in the format requested, with explicit notes about the inapplicability of AI/ML specific criteria:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The "reported device performance" is given as "PASS" in the document, indicating that the device successfully met the stated acceptance criteria for each test.

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

The document does not explicitly state the numerical sample size used for the test set experiments (Simulated Use Testing, Parallel performance as biological indicator). It only indicates "100% pass" and "100% fail" which implies that, for the tests conducted, all units observed performed as expected.

Regarding data provenance:

• The tests are described as "Simulated Use Testing" and "Parallel performance as biological indicator." This suggests the data was generated in a controlled laboratory or testing environment simulating real-world conditions.
• The document does not specify the country of origin of the data providers or if it was retrospective or prospective data, as these concepts are generally not applicable to the non-clinical testing of a chemical indicator device.

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

This question is not applicable as the device is a chemical indicator for sterilization. Its "ground truth" is established by physical and chemical properties and calibrated against known sterilization parameters and biological indicators, not by human expert interpretation of images or data. No human experts are involved in establishing the "ground truth" for the performance of this type of device in the context of the described tests.

4. Adjudication Method for the Test Set

This question is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this type of device testing. The results (pass/fail for the indicator's chemical reaction) are objective.

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

This question is not applicable. This is not an AI-assisted diagnostic or interpretive device. There are no human readers whose performance is being compared with or without AI assistance.

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

This question is not applicable. This is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its design and chemical properties.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established by:

• Pre-defined sterilization cycle parameters (temperature, time, pressure – i.e., "pass conditions").
• Pre-defined under-sterilization conditions (e.g., "stated value -15% time and/or -1°C" – i.e., "fail conditions").
• The performance of a biological indicator (BI), which is the gold standard for demonstrating sterilization efficacy by showing inactivation of highly resistant bacterial spores. The integrator's performance is compared to the BI's performance, ensuring the integrator does not "pass" before the BI is inactivated.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical chemical indicator, not an AI/ML device that requires a "training set." Its design and functionality are based on chemical engineering principles, not machine learning from data.

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

This question is not applicable for the same reasons as #8.

Ask a specific question about this device

The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• · 250°F/121°C, 30 minutes Gravity
• · 270°F/132°C, 4 minutes Dynamic Air Removal
• · 270°F/132°C, 15 minutes Gravity
• · 275°F/135°C, 3 minutes dynamic air removal
• · 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• · 270°F/132°C, 4 minutes Dynamic Air Removal
• · 270°F/132°C, 3 minutes Gravity
• · 270°F/132°C, 10 minutes Gravity
• · 275°F/135°C, 3 minutes dynamic air removal
• · 275°F/135°C, 3 minutes Gravity
• · 275°F/135°C, 10 minutes Gravity

The VERIFY® STEAM Integrating Indicator – Short is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator - Short is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) area of the viewing window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK) area of the viewing window, the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

This document describes the performance testing and acceptance criteria for the VERIFY® STEAM Integrating Indicator – Short, a chemical indicator used to monitor steam sterilization cycles.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions "Test of 3 Lots" for the BIER Vessel Testing. For Simulated Use Testing, it implies a sufficient number of tests to achieve "100% Pass result under pass conditions" and "100% Fail result under fail conditions." Specific numerical sample sizes for each test condition are not explicitly provided beyond the "3 lots" for BIER testing.
• Data Provenance: The studies were conducted as part of a premarket notification (510(k)) submission to the FDA. This indicates the data is prospective, generated specifically for regulatory approval. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying either U.S. or internationally generated data adhering to U.S. regulatory standards.

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

• This device is a chemical indicator that directly reacts to physical parameters (temperature and time) of a sterilization cycle. The "ground truth" for its performance is established by the controlled physical conditions of the sterilization cycles themselves (e.g., using an ISO 18472-conforming steam resistometer for BIER vessel testing).
• Therefore, the concept of "experts" establishing ground truth in the context of human interpretation of complex medical images (like radiology) does not apply here. The device's pass/fail outcome is based on a direct chemical reaction against predefined physical parameters, not subjective human assessment.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, the assessment of the device's performance is objective, based on its chemical reaction against controlled physical parameters, rather than requiring human interpretation and adjudication.

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

• Not applicable. This device is a chemical indicator, not an AI or imaging diagnostic tool that would be used by human readers for interpretation. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this product.

6. Standalone (Algorithm Only) Performance:

• This section describes the standalone performance of the chemical indicator itself. The device is designed to function independently by chemically reacting to sterilization conditions. Its "performance" refers to its ability to accurately reflect whether the critical parameters of a steam sterilization cycle have been met. The entire "Performance Testing" section (Table 5-2) details this standalone performance. For example, "Pass result at SV for each temperature claimed" demonstrates its performance when exposed to the specified sterilization parameters without human intervention for the primary assessment (though humans read the final indicator).

7. Type of Ground Truth Used:

• The ground truth used is based on controlled physical parameters of steam sterilization cycles, as defined by industry standards (e.g., ANSI/AAMI/ISO 11140-1:2014) and governmental guidance (FDA Guidance for Industry and FDA Staff: Premarket [510(k)] Submissions for Chemical Indicators).
• Specifically, this includes:
  • Stated Values (SV): Precise temperature and time combinations at which the sterilization is expected to be successful.
  • Sub-optimal Conditions: Conditions below the SV (e.g., 15% below SV or 1°C below SV, or "fail conditions" in simulated use testing) where sterilization is expected to fail.
  • Biological Indicator Inactivation: Comparison to the known performance of biological indicators which serve as the gold standard for sterilization efficacy.

8. Sample Size for the Training Set:

• This device is a physical/chemical indicator, not a machine learning or AI algorithm that requires a "training set." Its function is based on inherent chemical properties and design, not on learned patterns from data. Therefore, the concept of a "training set" is not applicable.

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

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• · 250°F/121°C, 30 minutes Gravity
• · 270°F/132°C, 4 minutes Dynamic Air Removal
• · 270°F/132°C, 15 minutes Gravity
• · 275°F/135°C, 3 minutes Dynamic Air Removal
• · 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• · 270°F/132°C, 4 minutes Dynamic Air Removal
• · 270°F/132°C, 3 minutes Gravity
• · 270°F/132°C, 10 minutes Gravity
• · 275°F/135°C, 3 minutes Dynamic Air Removal
• · 275°F/135°C, 3 minutes Gravity
• · 275°F/135°C, 10 minutes Gravity

The VERIFY® STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the Integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

The provided document details the acceptance criteria and the study that proves the VERIFY® STEAM Integrating Indicator device meets these criteria.

Here's the extracted information:

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 states that testing was performed on "3 Lots" for the BIER Vessel Testing. Specific numbers of individual devices tested within each lot are not provided.
   • Data Provenance: The study was conducted by STERIS Corporation for FDA submission. Details on the specific country of origin for the testing data are not explicitly stated, but the company is based in Mentor, Ohio, USA, and the documentation pertains to submissions to the U.S. FDA. The study appears to be prospective testing specifically for this 510(k) submission.

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

   • This is not applicable as the device is a chemical indicator for sterilization. The "ground truth" is established by the physical and chemical parameters of the sterilization cycles (time, temperature, steam presence) and the inactivation of biological indicators. It does not involve human expert interpretation in the way, for example, a diagnostic imaging device would.

4. Adjudication method for the test set

   • This is not applicable for a chemical indicator. The endpoint is a visual change (migration of a dark bar into an "ACCEPT (OK)" window) determined by the chemical reaction to physical parameters, 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

   • This is not applicable to this device. The VERIFY® STEAM Integrating Indicator is a standalone chemical indicator, not an AI-powered diagnostic tool requiring human interpretation.

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

   • Yes, essentially. The performance testing described (BIER Vessel Testing, Simulated Use Testing, Dry Heat Testing, BI growth-negative cycle, Offset/Bleeding) evaluates the device's inherent physical and chemical behavior in response to sterilization conditions, independent of active human intervention during its function. Its output (pass/fail indication) is then read by a human.

7. The type of ground truth used

   • The ground truth is based on the physical parameters of the steam sterilization cycles (time and temperature) and the inactivation of biological indicators (BIs). The device's chemical reaction indicates whether these critical parameters have been met sufficiently to achieve sterilization, which is then correlated with BI inactivation.

8. The sample size for the training set

   • This information is not explicitly provided. Chemical indicators are typically characterized and validated, but the concept of a "training set" as understood in machine learning/AI is not directly applicable here. The device's performance is based on its physical design and chemical formulation, which would have been developed and refined through R&D (implicitly "trained" on various conditions) rather than a formal machine learning training set. The approval document focuses on validation/verification testing.

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

   • As noted above, the concept of a "training set" in the context of AI is not applicable. The device's "ground truth" for its development would have been established through extensive laboratory characterization of its chemical reaction kinetics under varying steam sterilization conditions (temperature, time, steam presence) to ensure it correlates accurately with microbial inactivation (sterilization). This would involve controlled experiments in BIER vessels and other sterilization equipment across a range of conditions, using established sterilization principles and biological indicators as the ultimate arbiters of sterilization effectiveness.

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