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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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STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System.

The color of the STERRAD® SealSure™ Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen pcroxide and is intended to differentiate between processed and unprocessed loads. Reference the color comparator bars on the package box label.

STERRAD® SealSure™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD® Sterilization Systems. The STERRAD® Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low temperature sterilization of medical devices.

STERRAD® SealSure™ Chemical Indicator Tape is not intended to imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD® Sterilization Process, is present in the sterilization chamber.

STERRAD® SealSure™ Chemical Indicator Tape functions by means of a chemical reaction. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow. The gold (or lighter) STERRAD logos and chemical indicator square indicate that the load has been exposed to hydrogen peroxide.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The device is a chemical indicator tape, and the key performance aspects relate to its stability (shelf life) and adhesive properties. The document describes the acceptance criteria implicitly by stating what was tested and what the studies "support."

Study Information:

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

   • Sample Size: The document does not specify the exact number of samples (e.g., rolls of tape, individual pieces of tape) used for the stability or adhesion studies. It only refers to "samples of SealSure Chemical Indicator Tape."
   • Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc. The exact country of origin of the data is not explicitly stated, but the company address is Irvine, California, suggesting the studies were likely conducted in the US. The studies are prospective, as they involve testing the product over time (shelf-life studies) and assessing its properties under controlled conditions.

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

   • Not applicable for this type of device. The ground truth for chemical indicator tapes is typically established by physical/chemical properties (color change, adhesion strength) rather than expert interpretation of images or other subjective data. No experts are mentioned in this context.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods are typically used for subjective assessments (e.g., medical image interpretation) where multiple readers might have differing opinions. For physical/chemical properties like color change and adhesion, the assessment is typically objective and involves quantitative measurements against defined specifications.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for medical imaging AI systems where human readers interpret cases. The STERRAD® SealSure™ Chemical Indicator Tape is a physical chemical indicator, not an AI system or device requiring human interpretation in a comparative reader study.

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

   • Not applicable. This device is a physical chemical indicator, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.

6. The type of ground truth used:

   • The ground truth is based on physical and chemical properties of the tape:
     • Color and Functionality: The ability of the chemical indicator to undergo a recognizable color change from red to yellow (or gold/lighter) upon exposure to hydrogen peroxide. This is an objective, observable chemical reaction.
     • Adhesion Strength: Measured physical properties of the tape's adhesive, likely against predefined specifications for tack, peel strength, etc.

7. The sample size for the training set:

   • Not applicable. This device is a physical chemical indicator tape, not a machine learning or AI model. Therefore, there is no "training set" in the context of data used to train an algorithm. The product development process would have involved formulation and manufacturing process development, but not algorithm training.

8. 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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