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The TST Control Integrator for Steam Autoclave is a steam sterilization process indicator designed to indicate, through a yellow to blue color change, when a combination of parameters necessary for sterilization (270°F for 3 minutes) have been achieved.

Albert Browne Ltd. received clearance for a TST Control Integrator for Steam Autoclave, K902958, which monitored sterilization cycles with a holding temperature/time combinations of 250°F (121°C)/15 min. The purpose of this submission is to expand the process parameter combinations to include a cycle of 270°F/3 min.

Like the integrator described in K902958, the TST steam integrator discussed in this amendment changes color from yellow to blue when a specific set of process parameters required for steam sterilization to occur have been met. The parameters of the sterilization cycle monitored by the proposed integrator - time, temperature and the presence of steam - are equivalent to those monitored by the integrators described in K902958. Albert Browne Ltd. is amending K902958 in order to increase the combinations of parameters which produce a color change to include additional temperatures. The time-temperature combinations in sterilization cycles which will induce TST Control Integrators to change color from vellow to blue are presented in Table 1.

The TST steam integrator consists of a paper strip with the chemical indicator ink located on one end. The color change is pH based. The time and temperature required for the color change to occur is precisely controlled through manipulation of the chemical composition of the ink.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": "The TST Control Integrator for Steam Autoclave is designed to indicate, through a yellow to blue color change, when a combination of parameters (270°F for 3 minutes and the presence of steam) necessary for sterilization have been achieved.",
    "Reported Device Performance": {
      "Exposure in partial cycles": "The strips did NOT change color.",
      "Exposure in full cycles (270°F for 3 minutes, saturated steam)": "The strips changed color (yellow to blue).",
      "Safety margin": "The temperature/time required for color change to occur provides a wide safety margin over that necessary to kill spores on a biological indicator.",
      "Color change stability": "Color change was stable for at least 5 years after exposure.",
      "Expiration date validity": "Testing with strips ≥3 years from manufacture date demonstrated accurate, reproducible performance, confirming the 3-year expiration date is adequate."
    },
    "Table 1: Performance Characteristics for the TST Control Integrator for Steam Autoclave": {
      "Temperature": ["250°F", "270°F"],
      "Time (minutes)": ["15", "3"],
      "Presence of Steam": ["yes", "yes"],
      "Regulatory Status": ["[K902958](https://510k.innolitics.com/search/K902958)", "proposed"]
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not explicitly state the sample size used for the test set (number of strips tested). It mentions \"All strips used for testing were all ≥3 years from the date of manufacture,\" implying a prospective-like evaluation of aged product. The country of origin for the data is not specified beyond Albert Browne Ltd. being a UK company and the testing being conducted to U.S. standards (ANSI/AAMI ST45-1992).",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The ground truth for this device is based on physical/chemical properties and the efficacy of sterilization parameters against biological indicators, not on human expert interpretation of an image or signal. The performance is assessed against established sterilization standards (e.g., biological kill rates, specific temperature/time/steam combinations) rather than expert consensus.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The color change is a direct read-out of a chemical reaction, not subject to individual 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 is a physical/chemical sterilization process indicator, not an AI-based diagnostic or assistive device that would involve human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study is a standalone performance test of the device (integrator) itself. Its function is to perform a specific chemical reaction (color change) based on exposure to sterilization parameters, without human interpretation of complex outputs.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth is established by: \n- **Defined physical parameters:** Specific temperature (270°F), time (3 minutes), and presence of saturated steam, as required for sterilization. \n- **Biological kill rates:** Comparison to biological indicators (BIs) to ensure the conditions for color change provide a wide safety margin beyond what is necessary to kill spores.",
  "8. The sample size for the training set": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a physical/chemical device, not an AI/machine learning model that requires a training set."
}

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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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