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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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Cross-Checks P chemical process indicator strips are designed to be used in the Sterrad sterilizer. Cross-Checks P Process Indicator Strips will exhibit a blue to red color change when exposed to hydrogen peroxide during the dillusion phase of the Sterrad cycle. When used as directed, the Cross Checks P strips give visible confirmation that the item has been exposed to hydrogen peroxide during the Sterrad Cycle.

SteriTec Cross-Checks P strips are 4" x 5/8" process indicators with indicator ink printed onto Tyvek plastic.

The SteriTec Cross-Checks P process indicator strips are designed to change color from blue to red when exposed to hydrogen peroxide during the diffusion phase of the Sterrad sterilizer cycle.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: 200 strips were used for each of the four different exposure timings (10 minutes, 15 minutes, 25 minutes, and 30 minutes), totaling 800 strips.
   • Data Provenance: The study was conducted using a Sterrad sterilizer, implying a controlled laboratory environment rather than a retrospective analysis of field data. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company.

2. Number of Experts and Qualifications: Not applicable. The assessment of color change for process indicators is typically objective and determined visually, often against a reference color chart, rather than through expert interpretation.

3. Adjudication Method: Not applicable. The color change is a direct physical observation.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed. This type of study is relevant for diagnostic devices requiring human interpretation.

5. Standalone Performance: Yes, a standalone performance study was conducted. The device's color change response was evaluated directly under controlled exposure times without human intervention influencing the outcome.

6. Type of Ground Truth: The ground truth was established by defining the expected color change (or lack thereof) at specific exposure durations to hydrogen peroxide within the Sterrad cycle. This is a direct measure of the device's functional response to the sterilizing agent.

7. Training Set Sample Size: The document does not specify a separate training set. The study appears to be a validation study of the final product with the reported 800 strips.

8. Ground Truth for Training Set: Not applicable, as a separate training set is not described. The performance criteria against which the device was evaluated are inherent to the intended function of a chemical process indicator.

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SteriTer CROSS-CHECKS sterilization chemical monitoring strips are designed to be utilized in steam sterilizers operating at 132" (270°F to 276°F to 276°F). When used as directed, the SteriToc Cross.Checks indicator strips give visible indication that sterilizing conditions were met. During steritization, the check mark at the end of the strip changes from white to black, becoming as dark or darker in intensity than the black reference arrow printed on the strip.

The basic formula and concept of black to white chemical steam sterilization indicators has not changed dramatically since they were invented in 1932.

Below is the information regarding the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "CROSS-CHECKS Steam Sterilization Indicator Strip" are primarily based on the visual color change of the strip from white to black, becoming as dark or darker than a reference arrow, indicating proper sterilization, and an incomplete color change for improper sterilization. This performance is validated against biological spore strips.

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

• Test 1 & 2 (Completed/Incomplete Sterilization Cycle): The text mentions "All indicator strips" and one "spore strip" per run. The exact number of SteriTec and ATI strips per run is not explicitly stated, but it implies a small, controlled sample for these specific tests.
  • Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
  • Retrospective/Prospective: Prospective (laboratory testing).
• Test 3 (Storage Tests): "SteriTec CROSS-CHECKS sterilization indicator strips" were used. The exact number is not stated, but the results are qualitative observations ("All strips appeared unchanged," "All indicator strips changed color").
  • Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
  • Retrospective/Prospective: Prospective (laboratory testing).
• Test 4 (Various Temperatures and Times):
  • Sample Size:
    • For each temperature range (124°C, 128°C, 130°C, 132°C, 134°C): Approximately 300 strips (SteriTec Cross-Checks CI 102 and CI 111 combined) along with 12 biological spore strips.
    • For each time duration (1 min, 2 min, 2.5 min, 3 min, 3.5 min at 132°C): Approximately 300 strips (SteriTec Cross-Checks CI 102 and CI 111 combined) along with 12 biological spore strips.
  • Provenance: Not explicitly stated, but implies laboratory testing performed by an "independent testing laboratory."
  • Retrospective/Prospective: Prospective (laboratory testing).

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

• Test 1, 2, 3 (Initial Interpretation): Implied that the "independent testing laboratory" personnel made the initial observations and recorded the results. Specific number and qualifications are not mentioned.
• Test 4 (Performance Data):
  • First Interpretation: A panel of three people selected by the independent laboratory were used to make the PASS/FAIL determinations. Their specific qualifications are not mentioned.
  • Second Interpretation: Another set of three interpreters were hired by SteriTec. Their qualifications are explicitly stated as nurses, who "generally have more experience in chemical indicator interpretations."

4. Adjudication Method for the Test Set

• Test 4 (Performance Data): The text indicates decisions were made by a panel of three for both rounds of interpretation, but it does not specify an adjudication method like 2+1 or 3+1. It simply states they were "used to make the PASS/FAIL determinations." The fact that a second panel was brought in due to a few results from the first set being "considered outside the product specifications" suggests a lack of consensus or issues with the first panel's interpretation, leading to a re-evaluation by the second panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly done in the way typically understood for comparing AI to human-assisted AI.
• The study involved panels of human readers interpreting the chemical indicators. There was a comparison between two sets of human interpreters (first panel vs. nurses) for Test 4, noting that the "interpretations of the second set of interpreters (Nurses) were more uniform." This focuses on inter-rater variability and expertise among human readers, not on AI assistance.

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

• No. The device is a physical chemical indicator strip that requires visual interpretation by a human. There is no algorithm or AI involved for standalone performance. The "performance" of the device itself (color change) is assessed by human observation.

7. The Type of Ground Truth Used

• For the indicator strips' performance: The primary ground truth for the effectiveness of the sterilization process itself (which the indicator is supposed to reflect) was established using biological spore strips. The indicator's color change was correlated directly with the kill/survival status of these biological indicators.
• For the interpretation of the color change: Expert consensus (from the panels of interpreters) was used to determine if the color change of the chemical indicator strip qualified as a "pass" or "fail."

8. The Sample Size for the Training Set

• Not applicable. This document describes the validation of a physical chemical indicator, not an AI or algorithm. Therefore, there is no "training set" in the context of machine learning. The "learning" for the product's design would have happened during its development, but this document focuses on its performance validation against established standards.

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

• Not applicable. As there is no training set mentioned for an AI/algorithm, there is no ground truth establishment for a training set.

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Sterilier CROSS-CHECKS EO gas process indicator monitoring strips are a yellow to brown chemical indicator strip that changes color during Ethylenc Oxide (EO) processing. They indicate that the item has been processed in Ethylene Oxide.

SteriTec CROSS-CHECKS EO process indicators are a pale yellow to brown chemical indicator strip that changes color during ethylene oxide processing.

The provided text describes a 510(k) application for a chemical process indicator and includes limited information about performance criteria and study details. Based on the available text, here's an attempt to answer the questions, highlighting what is present and what is missing.

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

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

• Sample Size for Test Set: Not specified. The document states "Laboratory tests were performed" but does not give a number of indicators tested.
• Data Provenance: Not explicitly stated, but the tests were performed by "an independent testing laboratory." The location of this laboratory and whether the data is retrospective or prospective is not mentioned.

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

This information is not provided. For a chemical indicator, ground truth would likely be established by exposure to EO gas under controlled conditions, not by expert interpretation.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of a chemical indicator, "adjudication" in the sense of human interpretation of complex outputs is not relevant. The "ground truth" for whether the indicator changed color would be directly observable.

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 device is a chemical process indicator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.

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

This concept is not directly applicable. The device itself is a "standalone" chemical indicator that changes color. There is no algorithm or human-in-the-loop interaction described beyond the observation of the color change. The "laboratory tests" inherently represent the standalone performance of the indicator.

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

The ground truth for this type of device would be whether the indicator was actually exposed to ethylene oxide gas under conditions that should trigger a color change, and conversely, whether it remained unchanged when not exposed. This would be established by controlled laboratory exposure to EO (or lack thereof) rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable. Chemical process indicators typically do not involve "training sets" in the machine learning sense. Their performance is based on chemical reactions.

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

Not applicable (see point 8).

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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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