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The Canadian Technical Tape, Ltd. LF Process Indicator Steam Sterilization Tape is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121°C for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. The indicator stripes turn dark brown/black when exposed to steam sterilization conditions, thus providing an indication of processed items.

The process indicator tape distinguishes between items processed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with green indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.

This looks like a 510(k) summary for a medical device, specifically a steam sterilization tape. I will extract the requested information based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states, "The non-clinical testing that has been performed on multiple lots of indicators and each was found to meet all predetermined acceptance criteria." However, it does not provide specific numerical sample sizes for the test set or the provenance (country of origin, retrospective/prospective) of the data.

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

The document does not mention the use of experts to establish ground truth for the testing. The tests conducted are for a physical/chemical indicator, where the "ground truth" is determined by the physical/chemical reaction itself under controlled steam sterilization conditions, as defined by the referenced standards (ANSI/AAMI/ISO 11140-1 and FDA Guidance).

4. Adjudication Method for the Test Set:

Not applicable, as expert adjudication is not described or required for this type of device testing based on the provided document. The outcome is a binary "Pass" or "Fail" based on objective chemical/physical reaction, likely visually assessed against predefined color change criteria.

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

A MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic algorithms where human readers interpret medical images or data. The device here is a physical/chemical process indicator.

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

Yes, the testing described is a standalone performance evaluation of the device (the chemical indicator tape) itself. The "Perfomance Standard Testing" and "Summary of Nonclinical Testing" sections detail tests conducted directly on the tape samples in controlled environments (e.g., steam resistometer, cleared healthcare steam sterilizers) without human interpretation in the loop as part of the primary outcome measurement. The "indication of processed items" is a direct physical transformation of the tape.

7. Type of Ground Truth Used:

The ground truth used is based on defined physical/chemical conditions (e.g., exposure to specific temperatures and times in a steam sterilizer) as mandated by the referenced international standards (ANSI/AAMI/ISO 11140-1) and FDA guidance documents. The "trigger" for the indicator to turn dark brown/black is the achievement of specific moisture and temperature levels.

8. Sample Size for the Training Set:

Not applicable. This device is a physical/chemical indicator, not a machine learning or AI-based algorithm that requires a training set.

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 Process Indicator Tape for Steam Sterilization is indicated for use in holding sterilization packs together and can be used in gravity sterilizers operating at 121ºC for 30 minutes or pre-vacuum sterilizers operating at 132ºC for 4 minutes and 1359C for 3 minutes. The indicator stripes turn dark brown black when sterilization conditions, thus providing an indication of processed items.

The process indicator tape distinguishes between items processed and unprocessed in both gravity discharge and pre-vacuum steam sterilization cycles. The tape is made of a saturated crepe paper printed with white indicator lines that turn to dark brown/black when proper levels of moisture and temperature have been achieved. The tape adheres on contact and stays in place through live steam pressure.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This document is a 510(k) summary for a "Process Indicator Tape for Steam Sterilization" (K140940). It focuses on demonstrating substantial equivalence to a predicate device rather than a ground-up performance study for a novel device. Therefore, some of the requested information (like effect size of human readers with AI or training set details) is not applicable or provided.

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

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

• Sample Size: The document does not specify exact sample sizes for each test listed (e.g., number of tape strips tested for performance, number of sterilization cycles). It generally states "Testing was performed in accordance with..." and reports "Passed" for each category.
• Data Provenance: The document does not explicitly state the country of origin of the data. The submitting company, Canadian Technical Tape, Ltd., is located in Montreal, QC, Canada. The testing likely occurred in a laboratory setting. No information is provided on whether it was retrospective or prospective, but given the nature of product performance testing, it would be prospective.

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

Not applicable. This device is a chemical process indicator where the "ground truth" is determined by the physical/chemical reaction (color change) under specified sterilization conditions, as measured against established performance standards (ANSI/AAMI/ISO 11140-1). There is no mention of human expert interpretation being part of establishing the ground truth for the test results.

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

Not applicable. As noted above, the "ground truth" is based on objective chemical/physical reactions conforming to standards, not 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 document describes a chemical indicator, not an AI-powered diagnostic or assistive device for human readers. There is no AI involved.

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

Not applicable. This is a standalone device in the sense that its function (color change) is inherent to the product itself, not an algorithm. Its performance is purely standalone (tape changing color or not changing color).

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

The ground truth is established by the physical/chemical reaction of the indicator agent in response to specific sterilization conditions (temperature, time, steam presence), as defined by the performance standards (ANSI/AAMI/ISO 11140-1:2005(R) 2010). The endpoint specification (e.g., 121°C for 10 minutes) dictates the conditions under which the indicator is expected to change color, and the absence of these conditions where it should not.

8. The sample size for the training set

Not applicable. This is a manufactured product (chemical indicator tape), not an AI/machine learning model that requires a training set. The "training" in this context would be the product development and formulation to achieve the desired chemical reaction.

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

Not applicable, as there is no training set for an AI model. The chemical formulation and manufacturing process are developed to meet the established performance standards, where the ground truth is the chemical reaction under specified sterilization conditions.

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