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STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems:

The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems.

The color of the STERRAD® SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

The provided 510(k) summary describes a chemical indicator tape, not a software device or an AI/ML enabled device. Therefore, the typical acceptance criteria and study designs for AI/ML medical devices, such as those related to reader studies, ground truth establishment by experts, and training/test set details, are not applicable here.

However, I can extract the information relevant to the performance of this specific device based on the provided text.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, adapted to the context of a chemical indicator tape:

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study for the Chemical Indicator Tape:

• Device Under Test: STERRAD® SEALSURE® Chemical Indicator Tape
• Purpose of the Device: To function as a process indicator, changing color from red to gold (or lighter) when exposed to hydrogen peroxide within specific STERRAD® Sterilization Systems, differentiating between processed and unprocessed loads.

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

• The document does not specify sample sizes for the individual tests (e.g., how many tapes were tested for adhesion, how many cycles for functionality).
• Data Provenance: The studies were conducted internally by Advanced Sterilization Products ("Performance testing was conducted to demonstrate the functionality..."). No information on geographical origin of data or retrospective/prospective nature is provided, though given it's a new product, it would inherently be prospective testing.

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

• This is not applicable as the "ground truth" for a chemical indicator is based on physical and chemical reactions (color change indicating exposure to sterilant, adhesion properties, stability) which are objectively measured, not subject to expert interpretation in the way medical images are.

4. Adjudication Method for the Test Set:

• Not applicable. The "results" are objective measurements (e.g., color change, adhesion strength), not subjective human interpretations requiring adjudication.

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

• Not applicable. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical data. This device is a physical indicator.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is not an algorithm. Its "standalone" performance is its intrinsic physical and chemical properties as a process indicator. The nonclinical tests ("Chemical Indicator Functionality," "Tape Adhesion Strength," etc.) essentially describe its standalone performance.

7. Type of Ground Truth Used:

• The ground truth is based on the physical and chemical properties of the indicator tape:
  • Functionality: Successful color change from red to gold (or lighter) upon exposure to hydrogen peroxide in specific STERRAD® sterilization cycles.
  • Adhesion: The tape maintaining its adhesive properties.
  • Stability: The color change remaining stable post-processing.
  • Biocompatibility: The material being safe for its intended use (no adverse biological reactions).
  • Shelf Life: The device maintaining its properties over time.
  • These are verified through laboratory testing against established physical and chemical standards/expectations for such indicators.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML model that requires a training set.

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

• Not applicable.

Overall Conclusion from the Provided Text:

The STERRAD® SEALSURE® Chemical Indicator Tape underwent a series of nonclinical tests to demonstrate its functionality, adhesion, color stability, biocompatibility, and shelf life. All tests "Passed," indicating that the device met its pre-defined performance requirements. The results support the claim that the device is "as safe and as effective for differentiating processed from unprocessed packages" as its predicate devices, leading to a finding of substantial equivalence.

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