Search Results

SteriTec Dry Heat Indicator Labels are designed to be utilized in dry heat (hot air) sterilizers operating at 160 C. The label provides clear identification of processed versus unprocessed items.

SteriTec Dry Heat Indicator Labels are process indicators that turn color from green to dark brown/black during dry heat processing at 160 C. The labels will usually complete their color change in less than 10 minutes at this temperature.

This 510(k) summary describes a basic sterilization indicator label, which operates differently from AI/ML-powered devices. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of medical device submission.

Here's an adaptation of your request to fit the information provided for the SteriTec Dry Heat Indicator Label:

Acceptance Criteria and Study for SteriTec Dry Heat Indicator Label

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, but generally, such testing for sterilization indicators would be conducted in a laboratory setting, likely in the US given the submission origin. This would be equivalent to a prospective lab test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. For a chemical indicator, "ground truth" is established by direct physical observation of color change in response to a defined temperature and time exposure, not by expert interpretation.

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

• Not Applicable. Adjudication is not relevant for this type of device. Performance is determined by direct observation of a physical/chemical change.

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 a chemical indicator, not an AI/ML device.

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

• Not Applicable. This is a chemical indicator, not an AI/ML device. Its "standalone performance" is its physical color change.

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

• Direct Physical/Chemical Observation: The "ground truth" is the visually confirmed color change of the indicator in response to exposure to dry heat at a specific temperature (160°C) for a specific duration (less than 10 minutes). This is a direct physical and chemical phenomenon, not dependent on expert consensus or pathology.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a passive chemical indicator. Its function is based on fixed chemical properties.

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

• Not Applicable. No training set is involved.

Summary of the Study Proving Device Meets Acceptance Criteria:

The 510(k) summary states: "Tests substantiated that the SteriTec Dry Heat Indicator Label performed safely and effectively as described and is equivalent to the predicate device."

This indicates that internal testing was conducted to demonstrate the device's ability to:

1. Change color from green to dark brown/black.
2. Perform this change usually in less than 10 minutes when exposed to 160°C in dry heat sterilization conditions.

The study's adequacy is further supported by the comparison to a legally marketed predicate device (ATI Dry Heat Indicator Labels), implying that the testing demonstrated similar performance characteristics to the already-cleared device. The specific details of the "tests" (e.g., number of indicators tested, specific temperature/time profiles, replicates) are not provided in this summary, but would have been part of the full 510(k) submission.

Ask a specific question about this device