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The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.

The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.

Here's an analysis of the acceptance criteria and study information based on the provided FDA 510(k) Clearance Letter for DISINTEK™ PA Test Strips:

Acceptance Criteria and Device Performance for DISINTEK™ PA Test Strips

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 numerical sample sizes (e.g., number of test strips, unique disinfectant solutions tested, or replicates) used for each test set within the "Dynamic Range," "Instructions for Use Validation," "Closed Bottle Shelf-Life Stability," "Open Bottle Use-Life Stability," "Analytic Specificity – Bioburden," or "Analytic Specificity – Other Disinfectants" studies.

For Comparative Sensitivity and Specificity, the document also does not specify the numerical sample size.

Data Provenance: The studies were conducted by Serim Research Corporation themselves, implying the data is generated internally from their own testing facilities. The data appears to be prospective, as it describes the testing performed on the new DISINTEK™ PA Test Strips to demonstrate their performance against defined criteria. No information regarding country of origin of the data beyond "Serim Research Corporation" is provided, but as an FDA submission, the testing would likely adhere to US regulatory 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. For chemical indicators like this, "ground truth" typically refers to the analytically determined concentration of PAA in the test solutions. This would be established by validated chemical testing methods (e.g., titration or spectroscopy) rather than expert consensus on visual interpretation. The document implies that the "ground truth" for FAIL/PASS results is based on a known PAA concentration (below/at 850 ppm MRC as FAIL, above as PASS), which would be determined analytically.

4. Adjudication Method for the Test Set

The document describes chemical indicator functionality (color change) and the interpretation of those changes (PASS/FAIL based on visual comparison to color blocks or a "solid black color" for the predicate). There is no indication of an adjudication method involving multiple human readers for interpreting the results of the DISINTEK™ PA Test Strips. The expectation is that the visual interpretation by a single user, following the provided instructions and color chart, is sufficient.

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 usually conducted for imaging diagnostics or devices where human interpretation directly impacts effectiveness and can be improved by AI assistance. This device is a chemical indicator with a direct visual interpretation, not a diagnostic imaging AI system.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are essentially standalone in terms of the device's chemical performance. The studies evaluate the chemical indicator's ability to accurately reflect the PAA concentration, independent of human variability in reading.

However, the "Instructions for Use Validation" section does implicitly involve human interaction, as it validates the device when used as directed by a human with a specific dip and read time. The "performance" being measured (100% FAIL below MRC, 100% PASS above MRC) is the device's inherent chemical reaction, and the human's role is to correctly perform the test and interpret the color chart. So, while it's not an algorithm only in the AI sense, the core data is about the chemical functionality.

7. Type of Ground Truth Used

The ground truth used is based on analytically determined peracetic acid (PAA) concentrations in the RAPICIDE™ PA HLD solutions. Solutions were prepared with known concentrations below, at, and above the 850 ppm PAA Minimum Recommended Concentration (MRC). The "FAIL" result would be correlated with PAA concentrations ≤ 850 ppm, and the "PASS" result with PAA concentrations > 850 ppm.

8. Sample Size for the Training Set

This information is not applicable/not provided. The DISINTEK™ PA Test Strips are a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm that learns from data.

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

This information is not applicable/not provided for the reasons stated in point 8.

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The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.

Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.

The provided FDA 510(k) clearance letter pertains to a chemical indicator device, "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118," not an AI/ML-enabled medical device. Therefore, the information regarding the acceptance criteria and study proving its performance is focused on the chemical and physical properties of the test strips, rather than AI model performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment relevant to AI/ML devices.

Based on the document, I can extract the following information relevant to the device's acceptance criteria and studies:

Device Description and Intended Use:

The Rapicide PA High-Level Disinfection Test Strips are chemical indicators used after the disinfection cycle to verify that the RAPICIDE™ PA High-Level Disinfectant solution has met the Minimum Recommended Concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning solid black when exposed to solutions at concentrations of 1100 ppm ± 20 ppm PAA. A "failure" (solution at or below MRC) is indicated if the pad turns dark grey, blue grey, violet grey, light grey, or white (no color change).

Here's the breakdown of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information from the 510(k) Summary)

The provided document is a 510(k) clearance letter and an abbreviated 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, raw data, or comprehensive statistical analyses that would be found in a full study report or clinical trial documentation. Therefore, many of the requested details for AI/ML device studies (sample size, data provenance, expert adjudication, MRMC studies, training set details) are not applicable or not provided for this type of chemical indicator device.

Here's a breakdown of the requested information based on the provided text:

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

   • Sample Size: Not explicitly stated in the provided document. The 510(k) summary states that "Testing to assess and demonstrate performance of the subject device is summarized below," listing categories like "Dynamic Range," "Comparative Sensitivity and Specificity," etc., and concluding they "Met Acceptance Criteria." However, the exact number of test strips or solution samples used for each test is not disclosed.
   • Data Provenance: Not specified. It can be inferred that the testing was conducted internally by STERIS Corporation, likely in a laboratory setting, to evaluate the chemical performance of the test strips. Retrospective or prospective nature is not mentioned for this type of chemical performance testing.

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

   • Not Applicable / Not Provided: For a chemical indicator device, "ground truth" is typically established by precisely formulated chemical solutions (e.g., 850ppm PAA, 1100ppm PAA ± 20ppm PAA) with known concentrations, verified by analytical chemistry methods, rather than by human expert consensus or annotations as would be the case for medical imaging AI. The document does not mention the use of human experts for establishing ground truth.

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

   • Not Applicable / None: Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human expert annotations for complex data (e.g., medical images). For a chemical indicator, the output (color change) is objective and directly correlated with the chemical concentration. The "reading" of the strip is a visual interpretation of a chemical reaction against a defined color standard (solid black for pass, various greys for fail). Discrepancies would likely be addressed through re-testing or instrument calibration, not expert 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: MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation. This device is a chemical indicator test strip, not an AI-assisted diagnostic tool.

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

   • Not Applicable: This device is a physical chemical strip, not a software algorithm. Its performance is inherent in its chemical design.

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

   • Known Chemical Concentrations: The ground truth for this device is established by precisely prepared chemical solutions with known, verified concentrations of peracetic acid (e.g., 850ppm MRC, 1100ppm pass threshold). This is a direct physical or chemical measurement, not dependent on expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not Applicable: This device is a chemical indicator, not an AI/machine learning model that requires a training set. The "design" is based on chemistry and materials science, not data-driven learning.

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

   • Not Applicable: As there is no "training set" for a chemical indicator, this question is irrelevant. The "design" and "calibration" involve chemical engineering and materials science, where the components are selected and optimized to react predictably to specific chemical concentrations.

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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 Green Card Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 270°F (132°C) and 273°F (134°C) for 3.5 minutes. The indicator will demonstrate a uniform color change from purple to green when the proper sterilization conditions are met and no air is present. If enough air is present to create a 2°C or greater temperature difference in a standard Bowie-Dick test towel pack, the indicator will demonstrate a non-uniform color change.

The Green Card Bowie-Dick Test is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air as recommended by ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. The Green Card Bowie-Dick Test is a 3.5" X 1.91" card with the indicator ink printed on one side. Both sides of the card are laminated with a polyester film and an identification/record label is placed on the back side. The Green Card Bowie-Dick Test duplicates the resistance of a Bowie-Dick towel pack as described in ANSI/AAMI ST8 Hospital Steam Sterilizers.

The Green Card Bowie-Dick Test indicator areas will uniformly change color from purple to green when a passing Bowie-Dick test is performed. If a significant amount of air is present inside the sterilizer chamber during the sterilization cycle, it will be detected by the Green Card and displayed as a purple area on the indicator card, whereas the remainder of the indicator will have turned green. The non-uniform color change demonstrates the presence of air that would have created a 2°C temperature depression in a standard cloth Bowie-Dick pack.

The provided text describes the Green Card Bowie-Dick Test (BD115), a sterilization process indicator. The study detailed is a non-clinical performance test to verify the device meets applicable standards for Class 2 indicators for Bowie and Dick-type air removal tests.

Here's the breakdown of the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The testing was conducted on 3 manufactured lots of the Green Card Bowie-Dick Test.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective testing conducted by the manufacturer (SteriTec Products, Inc., located in Englewood, CO, USA).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided in the document. The ground truth for this type of device (a chemical indicator for sterilization) is established through physical measurements of temperature and air presence in a controlled sterilization environment, not through expert interpretation of images. The criteria refer to thermocouple graphs for temperature verification.

4. Adjudication Method for the Test Set:

• Not applicable or not specified. The performance of this device is assessed against objective physical and chemical changes (color change, temperature differences) based on defined ANSI/AAMI/ISO standards, rather than subjective human interpretation requiring adjudication.

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

• No. This type of study is not relevant for this device. An MRMC study is typically performed for AI/image analysis systems where human readers interpret medical images, and the AI assists in that interpretation. The Green Card Bowie-Dick Test is a chemical indicator that provides a direct visual result.

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

• Yes, effectively. The performance testing described is for the device itself to objectively meet specific physical and chemical criteria. The "algorithm" here is the chemical reaction of the indicator. The acceptance criteria are based on whether the indicator changes color as expected under specific sterilization conditions, without human interpretation influencing the measurement of those conditions (e.g., thermocouple readings). The visual interpretation of the color change by a human is the final step, but the "performance" of the device in demonstrating the condition is intrinsic to the device itself.

7. Type of Ground Truth Used:

• The ground truth is established through objective physical measurements in controlled sterilization environments, specifically:
  • Temperature measurements using thermocouples within a "Standard Test Pack" and at the drain, to verify specific temperature differences (e.g., no greater than 0.5°C difference for pass, 2°C or greater for fail).
  • Defined steam sterilization cycles (e.g., 270°F/132°C and 273°F/134°C for 3.5 minutes).
  • Absence or presence of residual air engineered into the test conditions.
  • Direct observation of color change (uniform green for pass, non-uniform with purple for fail) and color density as per ANSI/AAMI/ISO standards.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This is a physical chemical indicator, not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is inherent to its material composition and design, which is validated through a test set of manufactured lots.

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

• Not applicable. As explained above, there is no "training set" for this device in the context of an AI/ML algorithm. The device's inherent chemical and physical properties are designed to react to specific sterilization conditions, and its performance is validated against established industry standards for those reactions, not "trained" on data.

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The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 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, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;

Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.

Minimum Stated Values as determined in a resistometer:

SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).

The provided document describes the acceptance criteria and study results for the True Indicating Type 5 Integrating Indicator for Steam (CSPN-15). This device is a chemical indicator designed to monitor steam sterilization cycles.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Testing was performed for steam sterilization processes using multiple lots of True Indicating Chemical Indicator for Steam CSPN-15 over the range of the shelf-life". Specific numerical sample sizes for each test are not explicitly provided in this summary. The data provenance is derived from nonclinical tests conducted by or for True Indicating, LLC, following FDA and ISO guidelines. The context suggests prospective testing specific to the device's development and validation.

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

This device is not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for chemical indicators is established by objective physical and chemical measurements (e.g., specific temperatures, times, and presence/absence of steam for sterilization cycles, and color change observation). There is no mention of human experts being used to establish ground truth for this type of device.

4. Adjudication method for the test set

Not applicable. This device is a chemical indicator, and its performance is assessed by objective chemical/physical reactions and visual color changes, rather than subjective 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 not an AI/imaging device.

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

Yes, in a sense. The testing performed on the chemical indicator (Type 5 Integrating Indicator for Steam CSPN-15) is a standalone evaluation of its performance without human-in-the-loop interaction for interpretation, except for visual confirmation of the color change. The indicator itself is designed to provide a direct visual output.

7. The type of ground truth used

The ground truth used for this chemical indicator is based on:

• Physical and Chemical Parameters: Precisely controlled steam sterilization conditions (temperature, time, and steam presence) established in resistometers and hospital sterilizers.
• Biological Indicator Inactivation: For the "Side-by-Side Testing with a Biological Indicator," the ground truth for successful sterilization is the inactivation of biological indicators (BIs), which contain a known population of resistant bacterial spores. The chemical indicator's performance is compared against this biological standard.
• Color Change: The specific, objectively defined color change from pink to dark brown/black that indicates successful exposure to sterilization parameters.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not an AI model that requires a training set.

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

Not applicable. As noted above, this device does not utilize a training set in the way an AI model would.

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Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.

The Autoclave Indicator Tape can be used in the following steam sterilization cycles:

1. Gravity: 121°C, 30 minutes

2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes

EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.

The EO Indicator Tape can be used in the following EO sterilization cycle:

55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

1. Table of Acceptance Criteria and Reported Device Performance:

Autoclave Indicator Tape

EO Indicator Tape

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

The document does not explicitly state the sample sizes used for each specific test within the non-clinical testing. However, the tests are performed according to recognized international standards (ISO 11140-1:2014, ISO 10993 series) and FDA guidance, which typically involve specific sample sizes to ensure statistical validity.

The data provenance is not specified beyond "non-clinical testing" conducted by the applicant, Jiangmen New Era External Use Drug Co., Ltd. Given the nature of these tests (e.g., sterilization cycle performance, biocompatibility, adhesion), they are most likely conducted in a controlled laboratory environment. The document does not indicate if the data is retrospective or prospective, but performance testing for regulatory submission is typically prospective.

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

This section is not applicable. The tests performed are objective chemical and physical performance tests against established international standards and regulatory guidance, rather than subjective evaluations that would require expert human interpretation to establish ground truth.

4. Adjudication Method for the Test Set:

This section is not applicable. The tests performed are objective, with clearly defined pass/fail criteria based on physical and chemical reactions or measurements. There is no indication of an adjudication method being necessary for these types of tests.

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

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing of the sterilization indicators themselves, not on their use by human readers in a diagnostic capacity or with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done. The entirety of the "Summary of Non-Clinical Testing" section describes the standalone performance of the Autoclave Indicator Tape and EO Indicator Tape against established standards and criteria for their chemical indicator function. The device itself is the "algorithm" in this context, where it is designed to change color based on exposure to specific sterilization conditions. The tests evaluate this color change and other physical properties directly.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Established International Standards: ISO 11140-1:2014 for chemical indicators for sterilization.
• Regulatory Guidance: FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators."
• Defined Physical and Chemical Parameters: Specific temperature, time, and concentration parameters for steam and EO sterilization cycles that should induce a color change, and absence of color change under non-sterilizing conditions or dry heat.
• Biocompatibility Standards: ISO 10993-5, ISO 10993-10, and ISO 10993-23 for evaluating biological effects of medical devices.
• Material Science Specifications: Criteria for adhesion, offset/transference, and shelf-life.

8. Sample Size for the Training Set:

This information is not provided. The document describes premarket notification (510(k)) testing, which evaluates the final device product against performance criteria. It does not detail any "training set" in the context of machine learning, as these are chemical indicators, not AI/ML-based devices. The "training" for such devices is inherent in the chemical formulation and manufacturing process development.

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

This section is not applicable as the device is not an AI/ML-based system requiring a training set with established ground truth in that context. The "ground truth" for the development of these chemical indicators would have been established through extensive chemical research, formulation, and iterative testing to achieve the desired color change properties in response to specific sterilization parameters, guided by the ISO standards and regulatory requirements.

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The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.

Modification for Which Clearance is Being Sought: There were no physical changes to the device and are no new indications for use. The labeling was modified to include an additional pass reference color and a gradient between the original and new pass reference colors to improve user interpretation of chemical indicator.

The provided FDA 510(k) Premarket Notification summary describes a Chemical Indicator for the enspire CLCSPS (LCC015). The device is substantially equivalent to a predicate device (K240032). The key difference is a modification to the labeling to include an additional pass reference color and a gradient to improve user interpretation.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Users performed all critical tasks successfully" as the acceptance criteria for the Human Factors Study, and the result was "PASS". However, the sample size for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions a "Human Factors Study" but does not specify the number of experts (users) involved in this study or their qualifications. The nature of the device (a chemical indicator for sterilization monitoring) suggests that "experts" in this context would likely be healthcare professionals or sterilization technicians who would use such indicators.

4. Adjudication Method for the Test Set

The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1). For a human factors study, this would typically involve observing user performance and possibly qualitative feedback, rather than formal expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. The study described is a Human Factors Study related to user interpretation of the chemical indicator's color change, not a comparative effectiveness study with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is a physical chemical indicator, not an algorithm or AI. Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The device's function inherently involves human interpretation of a chemical reaction (color change).

7. Type of Ground Truth Used

For the Human Factors Study, the "ground truth" would implicitly be the correct interpretation of the chemical indicator's color change according to the established visual reference provided by the manufacturer. The acceptance criteria suggest that the ground truth was that users could correctly identify the "pass" condition based on the newly designed labeling.

8. Sample Size for the Training Set

Not applicable. This device is a physical chemical indicator, and there is no "training set" in the context of machine learning or algorithms. The device itself is designed based on known chemical reactions and visual communication principles. The human factors study evaluates the effectiveness of the labeling in conveying the correct interpretation to human users.

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

Not applicable. As there is no training set mentioned for the device itself (it's a physical indicator), this question is not relevant. The ground truth for the performance evaluation (Human Factors Study) is the correct interpretation of the indicator's state as defined by the manufacturer's specified color reference for a "pass" condition.

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The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container 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, 10 minutes Dynamic Air Removal
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 3 minutes Dynamic Air Removal
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 Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS
270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS

Stated values (as determined in a steam resistometer):

30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
2.4 minutes at 134°C
1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.

It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.

The information provided describes the acceptance criteria and study proving the Getinge Assured MI Steam Migrating Integrator meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study involved "3 manufactured lots" of the Integrator for performance testing. The document does not specify the exact number of units or individual indicators tested within each lot for each distinct test. The data provenance is not explicitly stated as originating from a specific country, but the submission is to the U.S. FDA by a U.S.-based company (SteriTec Products Manufacturing CO INC, 74 Inverness Drive East Englewood, CO 80112 U.S.). The studies are prospective in nature, as they involve active testing of the device to verify performance.

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

This type of device (chemical integrator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The performance is based on physical and chemical reactions (e.g., color change, migration) under controlled conditions, compared against established standards. Therefore, information about the number or qualifications of human experts establishing ground truth for the test set is not applicable and not provided in the document.

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

Not applicable. The "ground truth" for chemical indicators like this is determined by objective physical/chemical changes against defined parameters (temperature, time, steam presence). It does not involve 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:

Not applicable. This device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers interpreting output.

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

Not applicable. This is a passive chemical indicator, not an algorithm or software. Its performance is inherent in its physical and chemical properties.

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

The ground truth for this device's performance is established by objective criteria based on physical and chemical reactions under controlled steam sterilization conditions, defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. This includes:

• Temperature and time exposure in a steam resistometer (BIER vessel).
• Observation of indicator agent migration/color change.
• Confirmation of lack of reaction under sub-lethal conditions (e.g., 15% less time, 1°C less, dry heat).
• Comparison with biological indicators in terms of inactivation.

8. The sample size for the training set:

Not applicable. This is a physical/chemical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.

9. 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 Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below:

*Gravity: 121 C/250 F - 30 minutes (wrapped/porous)
*Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous)
*Gravity: 132 C/270 F - 15 minutes (wrapped/porous)
*Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous)

• Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load)
• Vacuum assisted (prevacuum): 132 C/270 F - 3 minutes (unwrapped/nonporous)
• Vacuum assisted (prevacuum): 132 C/270 F - 4 minutes (wrapped/porous)
• Vacuum assisted (prevacuum): 134 C/273 F - 4 minutes (wrapped/porous)
  *Vacuum assisted (prevacuum): 135 C/275 F - 3 minutes (wrapped/porous or unwrapped/nonporous, mixed load)

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads.

They are Type 1 Process Indicators per ISO 11140-1:2014 Sterilization of healthcare products-Chemical Indicators - Part 1 General Requirements, consisting of chemical indicator ink and paper substrate with a visual color change from light color (white/off-white) to dark color (cocoa/black) when exposed to a steam sterilization process.

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization consist of indicator ink printed on a paper substrate with or without adhesive. The indicator ink is lead free. An example of this indicator is the ink printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use.

Kem Medical manufactures in various shapes and sizes printed on paper substrates with and without adhesive on the underside, and with or without labeling on each individual indicator.

The provided text is a 510(k) summary for a medical device called "Kem Medical Lead-free Chemical Indicators for Steam Sterilization". It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text, while also noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Endpoints color not reached when exposed to failing conditions in autoclave cycles. | Pass |
  | Dry heat | Verify device requires the presence of saturated steam to turn to reach endpoint | - 30 min at 140 °C: No change | Pass |
  | Transference ISO 11140-1:2014 | Demonstrate the chemical indicators do not bleed or offset to substrate which it's applied according to ISO 11140-1:2014 | - The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | Pass |
  | Endpoint color stability | Endpoint color maintained | - Endpoint color remained unchanged for 8 months | Pass |
  | Shelf Life (Implicitly tied to test results) | Demonstrate long-term performance | Device performance meets ISO 11140-1:2014 requirements at 0, 1, 2, and 3 years real time. (This is an overall stated goal of the qualification, rather than a specific test with a single acceptance criterion in the table, but it's crucial for the 3-year shelf life claim.) | Met (supported by qualification testing at various time points) |

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 indicators tested per condition). It mentions "All indicators exposed to..." for BIER vessel tests and implies multiple indicators were tested for autoclave cycles.
• Data Provenance: The testing was performed by "True Indicating LLC". The country of origin is not explicitly stated, but the submission is to the US FDA, implying testing relevant to US regulatory standards. The testing appears to be prospective as it's part of a formal qualification process for the device.

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

• This information is not applicable to this type of device and study. Chemical indicators demonstrate a visible color change based on chemical reaction to sterilization conditions. The "ground truth" is the physical state of the indicator after exposure to specified conditions, which is objectively measurable (color change) against the predefined pass/fail criteria. Human expert interpretation of complex images or signals is not the primary mechanism of operation or evaluation here.

4. Adjudication Method for the Test Set:

• Not applicable. As above, the assessment is based on a measurable color change against a defined endpoint, not subjective interpretation requiring multi-expert adjudication. The document states "showed a dark color change" or "showed either no color change or a slight color change," which implies a direct observation against a known endpoint.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement:

• No. This is not an AI/Software as a Medical Device (SaMD) study. The device is a physical chemical indicator. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is not a software device. The "performance" is the chemical indicator's physical change.

7. The Type of Ground Truth Used:

• The ground truth is objective physical/chemical reaction to predefined sterilization parameters. The "pass" conditions are known levels of steam sterilization exposure, and the "fail" conditions are sub-optimal or non-sterilizing exposures (e.g., lower temperature, shorter time, or dry heat). The color change (or lack thereof) is then compared against the expected outcome for these conditions.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Not applicable. See point 8.

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The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALL Clear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾'' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The provided document is a 510(k) premarket notification for a medical device called "CELERITY HP Indicator Tape (PCC077)". It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document states, "No testing was required to verify the labeling change," and clarifies that "The revised labeling is in accordance with recommendations in 'User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry'' April 1, 2003." This implies that the current submission (K242189) is for a labeling change on an existing device, and therefore, no new performance testing was conducted for this specific submission.

The document also refers to the predicate device, K240760, and states that the proposed and predicate devices have "Identical" technological characteristics and performance limitations. This suggests that the performance criteria and related studies would have been established and demonstrated for the predicate device, and since the current device is identical in these aspects (apart from labeling), no new studies are needed.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document, as this submission primarily addresses a labeling change.

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