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The Kem Medical Lead-free Chemical Indicators for Steam Sterilization are designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process, and to distinguish between processed and unprocessed units or loads. Use the Kem Medical Lead-free Chemical Indicators for Steam Sterilization in the validated steam sterilization processes described below:

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

*Gravity: 132 C/270 F - 3 minutes (unwrapped/nonporous)

*Gravity: 132 C/270 F - 15 minutes (wrapped/porous)

*Gravity: 135 C/275 F - 3 minutes (unwrapped/nonporous)

• Gravity: 135 C/275 F - 10 minutes (wrapped/porous or unwrapped/nonporous, mixed load)

• 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 or unwrapped/nonporous, mixed load)

The Kem Medical Lead-free Chemical Indicators for Steam Sterilization provide immediate confirmation of the sterilization process. The indicator ink is lead-free and can be printed onto suitable paper substrates. As an example, the ink is printed onto adhesive-coated paper for autoclave labels, or "dots", which are removed from a poly or paper backing for use.

The document describes the Kem Medical Lead-free Chemical Indicators for Steam Sterilization, a Class II medical device (Product Code JOJ) intended to demonstrate that a unit or load has been exposed to a steam sterilization process and to distinguish between processed and unprocessed units or loads.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this chemical indicator are based on the ISO 11140-1:2014 standard for sterilizer indicators. The performance is assessed by confirming a visual color change in response to specific steam sterilization conditions and maintaining that change over time.

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

The document does not explicitly state the numerical sample size (e.g., number of indicators) used for the independent study by Lexamed®. However, it implies testing was conducted across "all temperatures and times specified" for various steam sterilization cycles (Gravity and Pre-vacuum), which suggests a comprehensive set of test conditions.

The provenance of the data is prospective, as it involves a study specifically conducted to validate the performance of this new device against established standards. The geographical origin of the data is not specified, but given the FDA submission, it is likely that the testing was conducted in the US or in facilities compliant with US regulatory requirements.

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

This type of device (chemical indicator) relies on a clear, objective color change. The "ground truth" is established by the conditions of the sterilization cycle itself (e.g., whether the indicator was exposed to the correct temperature, pressure, and time). Therefore, the assessment of the chemical indicator's performance is typically based on visual observation of the color change against a defined "pass" color.

The document does not mention the use of human experts in a subjective interpretation sense (like radiologists interpreting images). Instead, the performance is assessed against the objective criteria of the ISO standard. The study was conducted by "Lexamed®" which is described as an "independent study." This suggests the use of qualified personnel experienced in laboratory testing of sterilization indicators, but specific number or qualifications of "experts" involved in establishing ground truth (beyond the objective standard) are not detailed.

4. Adjudication Method for the Test Set

There's no mention of an adjudication method in the traditional sense (e.g., 2+1 or 3+1 for human review of subjective data). For a chemical indicator, the endpoint (color change) is typically defined objectively. The determination of "pass" or "fail" is based on whether the indicator's color matches the specified post-exposure color (usually dark brown/black) after exposure to valid sterilization conditions and remains unchanged. This is an objective measurement rather than a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used for diagnostic or screening devices where human readers interpret complex data (like medical images) and the AI's role is to assist or replace human interpretation. This device is a simple chemical indicator with a direct visual output, not requiring complex human interpretation or AI assistance in decision-making.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone chemical indicator. Its performance is evaluated biochemically and visually, without an "algorithm" or "human-in-the-loop" in the way one would describe an AI-powered diagnostic tool. The "performance" being evaluated is the indicator's intrinsic ability to change color accurately under specific sterilization conditions. The tests performed verify this intrinsic performance.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is objective physical and chemical conditions established in a controlled laboratory setting (BIER Steam Sterilizer cycles, full autoclave cycles) and defined by the ISO 11140-1:2014 standard. The "truth" is whether the indicator was exposed to effective sterilization parameters, and the device is expected to accurately reflect that exposure via a color change.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set." It is a chemical indicator that operates based on a chemical reaction. Therefore, the concept of a "training set" is not applicable here.

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

As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set. The device's performance is driven by its inherent chemical properties, not by a learned algorithm from data.

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