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The Sterilucent SCBI is intended to be used as a standard method for frequent monitoring of the Sterilucent HC 80TT Sterilizer Cycles, when incorporated into a test pack.

The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures.

Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent Self-Contained Biological Indicator (SCBI) is a sterilization process indicator that conforms to ANSI/AAMI/ISO 11138-1, and is intended for use only with the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer. The HC 80TT Hydrogen Peroxide Sterilizer has two pre-programmed sterilization cycles ("Lumen" and “Flexible") which both utilize vaporized hydrogen peroxide (VHP) to rapidly sterilize a variety of reusable medical devices.

The Sterilucent SCBI is to be used in a test pack configuration, with a different test pack (Process Challenge Device) used for each sterilization cycle. Each Process Challenge Device (PCD) is designed to have greater resistance than the worst-case sterilization load, allowing for survival beyond the sterilization half-cycle, but complete inactivation upon exposure to the full cycle.

The Sterilucent SCBI provides information on whether necessary conditions were met to kill a specified number of microorganisms upon exposure to either cycle of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer.

The document describes the acceptance criteria and study results for the Sterilucent Self-Contained Biological Indicator (SCBI) and Process Challenge Device (PCD).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. The provenance of the data is not explicitly stated in terms of country of origin, but the submission is for the U.S. Food and Drug Administration (FDA), implying the testing was conducted to meet U.S. regulatory standards. The testing appears to be prospective as it was conducted to demonstrate the functionality of the device.

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

This information is not applicable. The device is a biological indicator and process challenge device for sterilization. Its performance is evaluated through biological and physical tests based on established standards, not through expert interpretation of data like in diagnostic imaging.

4. Adjudication method for the test set

This information is not applicable for this type of device and testing. The evaluation relies on quantitative measurements and adherence to predefined performance metrics rather than expert consensus on subjective outcomes.

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

This information is not applicable. This device is a sterilization indicator, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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

This information is not applicable. The device itself is non-algorithmic and does not involve AI or human-in-the-loop performance in the conventional sense of software-as-a-medical-device. Its performance is inherent to its design and material properties.

7. The type of ground truth used

The ground truth for the SCBI and PCD testing is established by recognized international standards and methodologies for sterilization indicators. This includes:

• Biological inactivation: The absence or presence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Physical/chemical parameters: Measurements of D-value, survival/kill windows, spore population counts, pH changes, and color changes in chemical indicators.
• Compliance with standards: Adherence to ANSI/AAMI/ISO 11138-1, ANSI/AAMI/ISO 11140-1, and FDA Guidance documents.

8. The sample size for the training set

This information is not applicable. The Sterilucent SCBI and PCD are not AI/ML-based devices; therefore, there is no "training set" in the context of machine learning.

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

This information is not applicable as the device does not utilize a training set in the AI/ML sense.

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The Sterilucent Self-Contained Biological Indicator is for monitoring the efficacy of the hydrogen peroxide sterilization process in the Sterilizer Lumen and Non-Lumen cycles. It is intended for use solely in a test pack.

The Sterilucent Biological Indicator Monitoring System is intended for incubating and monitoring of the Sterilucent Self-Contained Biological Indicator.

The Sterilucent Self-Contained Biological Indicator is a self-contained biological indicator (SCBI) designed for use in monitoring the efficacy of the Sterilucent PSD-85 Sterilizer Lumen and Non-Lumen cycles. The SCBI consists of Geobacillus stearothermophilus bacterial spores, inoculated on a stainless steel carrier, and placed into a thermoplastic vial that serves as a culture tube. A small glass ampoule containing sterile culture medium (soybean casein digest formulation) and pH color indicator (Bromocresol Purple) is also contained in the vial.

The user places the Sterilucent SCBI into the Sterilucent PSD-85 sterilizer load and initiates a sterilization cycle appropriate for the particular type of load. After cycle completion, the SCBI is retrieved and activated by breaking the glass ampoule which contains a growth media. The activated SCBI is then incubated at 60°C ± 2°C for 18 hours and monitored for any color change. The appearance of a yellow color in the media indicates bacterial growth (a failing result); no color change indicates conditions for sterilization were achieved (a passing result).

The Sterilucent Biological Indicator Monitoring System is a biological indicator incubator which monitors for the presence and condition (growth [as indicated by a yellow color in the growth media] or no-growth [as indicated by purple growth media]) of Sterilucent SCBI. When an activated Sterilucent SCBI is placed into one of the incubation cavities, the LED in front of the cavity will illuminate amber. The incubator maintains the operating temperature specifications under all potential loading conditions over the recommended incubation time. It can incubate and monitor up to ten (10) Sterilucent SCBI plus one control unit.

The provided text describes the 510(k) summary for the Sterilucent Self-Contained Biological Indicator (K141238) and the Sterilucent Biological Indicator Monitoring System. While it outlines the non-clinical performance data and states that the results met established acceptance criteria, it does not provide explicit acceptance criteria in a table format with corresponding reported device performance, nor does it describe a study involving an "AI device" or human readers.

The document discusses a biological indicator for sterilizers, which functions very differently from a typical AI/ML-based medical device. Therefore, several of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," and "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set sample size," or "how ground truth for training set was established" are not applicable to this type of device.

However, I can extract the relevant information from the document to address the applicable parts of your request.

Acceptance Criteria and Study for Sterilucent Self-Contained Biological Indicator (K141238)

This submission pertains to a biological indicator and its monitoring system, not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study designs associated with AI/ML devices (e.g., MRMC studies, expert adjudication of AI output) are not relevant here. The studies described are performance tests for a biological indicator in a sterilization context.

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

The document states that "The results of all studies met the established acceptance criteria when applicable," but it does not explicitly list these criteria in a table format with precise performance numbers for each. Instead, it describes general compliance with "Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions (October 4, 2007)."

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

The document does not specify exact sample sizes for each test (e.g., "multiple lots" for population and D-value, "a series of sub-lethal exposures" for holding time).

• Sample Size: Not explicitly stated as numerical counts (e.g., N=X units). Described qualitatively (e.g., "multiple lots," "a series of sub-lethal exposures").
• Data Provenance: The studies were conducted by the manufacturer, Sterilucent, Inc., and the data refers to the performance of their device. The country of origin for the data is implicitly the USA, where the company is located. The studies are prospective performance characterization tests of the manufactured biological indicators.

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

Not applicable. Ground truth for a biological indicator is based on microbiological growth/no-growth, which is an objective biological outcome, not a subjective interpretation by experts like radiologists for image-based AI. The 'ground truth' is the objective determination of sterilization efficacy.

4. Adjudication method for the test set

Not applicable. The outcome of a biological indicator (color change indicating growth or no growth) is an objective, binary result that does not require expert adjudication in the way medical image interpretations might.

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 not an AI-assisted diagnostic device, and human reader performance is not a factor.

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

Not applicable. This is a physical biological indicator, not an algorithm. Its 'standalone' performance is its inherent microbiological and chemical response to sterilization.

7. The type of ground truth used

The ground truth used is the objective biological outcome of bacterial spore growth or inactivation after exposure to a sterilization process. This is determined by:

• The presence or absence of color change in the growth media within the biological indicator (yellow for growth/failure, purple for no-growth/pass).
• Microbiological assays (e.g., population counts, D-value determinations) to quantify resistance and viability.
• The efficacy of the sterilization process itself, which the BI is designed to monitor.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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