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Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.

The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator.

The provided text describes the acceptance criteria and performance study for the SteriTec CROSS-CHECKS EO Gas Sterilization Integrator (K982547).

Here's an analysis of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantified table. Instead, the "Intended Use" defines the expected performance, and the "Performance Testing" section describes how the device met or surpassed the performance of predicate devices and biological indicators.

Inferred Acceptance Criteria / Intended Performance:

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

The document does not specify the exact sample size (number of integrators/strips) used for the performance tests.

Data Provenance:

• Country of Origin: Not explicitly stated, but the testing was conducted by an "independent laboratory." The manufacturer is based in Castle Rock, CO, USA.
• Retrospective or Prospective: Not explicitly stated, but performance testing of a new device is typically prospective, involving controlled laboratory studies.

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

This type of device (chemical integrator) does not typically involve human expert interpretation for "ground truth" in the same way as an imaging AI. The "ground truth" is based on the physical and chemical response of the integrator to specific sterilization conditions. The assessment of whether it "surpassed the performance" of other indicators would be based on quantitative measurements of their responses under controlled conditions, not expert consensus on an image or clinical condition.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is determined by the physical/chemical response under controlled conditions, not by human interpretation requiring adjudication.

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

Not applicable. This is a standalone chemical indicator, not an AI device designed to assist human readers.

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

This is a standalone chemical integrator, meaning its performance is evaluated directly based on its color change response to sterilization conditions, independent of human interpretation for its primary function. Its performance is the "algorithm only" in the sense that it is a direct measurement of the device's output.

7. Type of Ground Truth Used

The ground truth is established by:

• Physical/Chemical Response: The inherent and expected color change response of the integrator material to specific concentrations, temperatures, humidity, and exposure times of ethylene oxide gas.
• Comparison to Established Biological Indicators: Biological indicators are the gold standard for sterilization efficacy, as they contain highly resistant bacterial spores. The performance of the chemical integrator is compared against these.
• Comparison to Predicate Devices: Performance is also compared to a legally marketed equivalent device (Surgicot 2 EO Gas Indicator Strip) operating under the same principles.

8. Sample Size for the Training Set

Not applicable. This is a chemical device, not a machine learning model, so there is no concept of 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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SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process. They are designed to be placed in each pack or package to be steam or chemical vapor sterilized, to indicate an item has been exposed to a steam or vapor process.

SteriTec CROSS-CHECKS Sterilization Process Indicators are a white to black chemical indicator strip that change color during steam or chemical vapor sterilization process.

This 510(k) submission (K955426) for the SteriTec CROSS-CHECKS chemical sterilization process indicator does not contain a detailed study proving the device meets specific acceptance criteria in the way a modern AI/software as a medical device (SaMD) submission would.

Instead, this submission relies entirely on a claim of substantial equivalence to a predicate device that was legally marketed prior to May 28, 1976. Therefore, many of the requested elements for a modern AI/SaMD study are not applicable or cannot be extracted from the provided text.

Here’s a breakdown based on the information provided and the nature of this type of submission:

Acceptance Criteria and Study for SteriTec CROSS-CHECKS (K955426)

Given the nature of a chemical process indicator and the age of this 510(k) submission, the "acceptance criteria" are implied by its function and comparison to a predicate device, rather than explicit performance metrics derived from a complex study as would be seen for AI/SaMD.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This submission relies on substantial equivalence and historical performance of the predicate. There is no mention of a specific test set or data collection for the SteriTec CROSS-CHECKS beyond its manufacturing and inherent chemical properties.

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

• Not Applicable / Not Provided. Ground truth, in the context of this device, is the visual color change indicating steam exposure, which is an inherent chemical property rather than an expert interpretation task.

4. Adjudication method for the test set

• Not Applicable / Not Provided. There is no mention of an adjudication process. The color change is a direct chemical reaction.

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 process indicator, not an AI/SaMD device. No MRMC study was performed as there's no "human reader" interpreting AI assistance.

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

• Not Applicable. This is a physical chemical indicator, not an algorithm.

7. The type of ground truth used

• The ground truth for this type of device is the actual exposure to sufficient steam/chemical vapor sterilization conditions, resulting in a visually observable chemical reaction (color change) on the indicator. This is an objective chemical phenomenon.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm. The device's performance is driven by its constant chemical formulation and manufacturing process.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for one. The device's efficacy is based on the established chemical reaction and its equivalence to a predicate device that has been marketed for decades.

Summary of the "Study" Proving Acceptance Criteria:

The "study" in this 510(k) submission is effectively a detailed comparison to a predicate device and a reliance on the existing scientific understanding of the chemical reaction involved.

• Predicate Device: ATI Division of PyMah Corporation Sterilometer Steam Strip® (marketed prior to May 28, 1976).
• Basis of Equivalence:
  • Similar Design, Composition, and Function: Explicitly stated as "similar in design, composition and function."
  • Shared Chemical Principle: The ink formulation for both devices is based on the lead sulfide reaction described in the Berman and Chaney patent (1938).
  • Minor Manufacturing Differences: The only noted differences are in the solvents used due to different printing processes (silk screen vs. rotogravure), but these solvents evaporate during manufacturing, leaving the active chemical components the same.
  • "Essentially Equivalent" Conclusion: The submission concludes that the SteriTec CROSS-CHECKS is "essentially equivalent in construction and operation" to the predicate, and therefore "will perform in the same safe and effective manner."

In essence, the "proof" is that the SteriTec CROSS-CHECKS is a direct descendent and near-identical chemical twin to a long-established, legally marketed device whose safety and effectiveness for indicating sterilization exposure were implicitly accepted for decades. No new primary efficacy study was required or performed for this type of submission.

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