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The Chemical Indicator for Steam is intended for use with individual materials (i.e. pouches, packs, trays) to demonstrate the material has been exposed to a steam sterilization process to distinguish between processed goods.

The Chemical Indicator for Steam can transition from an initial color of yellow and turn to a dark brown/black color for Product Code: CSYN-US, pink to a dark brown/black color for Product Code: CSPN-US, and blue to a dark brown/black color for Product Code: CSBN-US when exposed to high temperature steam at the following time and temperature intervals as process indicators:

Gravity: 121°C/250 F - 30 minutes (wrapped/porous)

Pre-vacuum: 132℃/270 F - 3 minutes (unwrapped/nonporous)

Pre-vacuum: 132°C/270 F - 4 minutes (wrapped/porous)

Pre-vacuum: 134℃/273 F - 4 minutes (wrapped/porous)

Pre-vacuum: 135°C/275 F - 3 minutes (wrapped/porous and unwrapped/nonporous, mixed load)

The True Indicating Lead-Free Chemical Indicator for Steam product codes CSYN-US (yellow to dark), CSPN-US (pink to dark), and CSBN-US (blue to dark), all turn a permanent dark brown/black color when exposed to high temperature steam.

Paper Strip printed with Bismuth based chemical indicator ink with polyester overlaminate applied over the entire indicating ink strip

The provided text describes the acceptance criteria and the results of nonclinical tests for a chemical indicator for steam sterilization, not an AI/ML-based device. Therefore, many of the requested points, such as MRMC studies, number of expert readers, adjudication methods, and training set information, are not applicable.

Here's an analysis of the provided information concerning the acceptance criteria and performance of the Chemical Indicator for Steam (K220778):

Device: Chemical Indicator for Steam (K220778)
Type: Chemical Indicator
Purpose: To demonstrate that individual materials (pouches, packs, trays) have been exposed to a steam sterilization process, distinguishing between processed and unprocessed goods.

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

• 121°C for 10 minutes
• 134°C for 2 minutes
• 135°C for 2 minutes
  Fail result (signal color not achieved for all product codes) at the value for each temperature claimed:
• 121°C for 2 minutes
• 134°C for 0.3 minutes
• 135°C for 0.3 minutes | PASS |
  | Hospital Steam Sterilizer Testing | Determine if the chemical indicators reach specified endpoint color of dark brown/black when combined with a sterilization load and exposed to the sterilization cycle for which it is intended. | Pass result (signal color achieved for all product codes) at the value for each temperature claimed in combination of a sterilization load:
• Gravity: 121°C/250 F - 30 minutes (wrapped/porous)
• 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 and unwrapped/nonporous, mixed load) | PASS |
  | Dry Heat Testing | Demonstrate that the Chemical Indicator for Steam does not change color following a dry heat cycle. | Fail result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
  | End Point Stability | Determine the length of time that an exposed Chemical Indicator for Steam retains its post-exposure signal color. | 1 Month | PASS |
  | Offset/Transference | Demonstrate the chemical indicators do not bleed or offset to the substrate to which it's applied. | 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 |

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

• The document states that testing was performed using "multiple lots of True Indicating Chemical Indicator for Steam over the range of the shelf life."
• Specific numerical sample sizes for each test (e.g., number of indicators per lot, number of cycles) are not provided in the given text.
• The data provenance is from nonclinical laboratory testing following FDA guidance and relevant ISO standards (ISO 11140-1:2014) for the performance of chemical indicators. It is not patient data; rather, it is performance data of the physical device under controlled laboratory conditions simulating sterilization processes. The location of the testing is not explicitly stated as a country but is likely within the US given the FDA submission. The nature of the testing is experimental/prospective, as it involves putting the indicators through specific sterilization cycles and observing their color change.

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

• This question is not applicable as the device is a chemical indicator that undergoes a physical color change (yellow/pink/blue to dark brown/black) in response to steam exposure. The ground truth (whether the indicator changed color correctly) is determined by direct observation of the physical chemical reaction, not by expert interpretation of complex medical images or data. No human experts are involved in establishing the ground truth for the performance of the chemical indicator itself. The "experts" would be the laboratory technicians or scientists conducting the tests according to the defined protocols and visually confirming the color change.

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

• This question is not applicable. Adjudication methods are relevant for human interpretation tasks, especially in medical imaging where inter-reader variability exists. For a chemical indicator, the color change is a physical phenomenon intended to be unambiguous. The "ground truth" is the presence or absence of the expected color change based on exposure to the specified steam conditions.

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 question is not applicable. An MRMC study is relevant for AI/ML-based devices assisting human readers in diagnostic tasks. This device is a passive chemical indicator, not an AI system.

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

• This question is not applicable. This device is a chemical indicator, not an algorithm. Its performance is inherent to its chemical composition and design, observed directly as a color change.

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

• The ground truth is established by the physical and chemical properties of the indicator and the controlled steam sterilization conditions to which it is exposed.
  • For "pass" criteria, the ground truth is that the indicator was exposed to the required steam conditions (temperature, time) and should show the signal color change.
  • For "fail" criteria (e.g., inadequate exposure, dry heat), the ground truth is that the indicator was not exposed to the required conditions to trigger a full color change (or was exposed to conditions it should not react to) and should not show the signal color.
  • The "ground truth" for End Point Stability and Offset/Transference is the observable physical property of the indicator maintaining its color and not bleeding.

8. The sample size for the training set:

• This question is not applicable. This is a physical chemical indicator, not a machine learning model; therefore, it does not have "training data" in the sense of an AI algorithm. Its performance is based on its intrinsic chemical formulation and manufacturing quality.

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

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

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