(164 days)
The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle.
The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterlizer Non-Lumen Cycle.
The Sterilucent PCD-L and PCD-NL are pre-assembled devices that consist of a Sterilucent Self-Contained Biological Indicator (SCBI), a vial, a vial cap containing a challenge tube, and a Chemical Indicator (CI) Label. The design of the PCD is such that it creates a challenge at least as challenging as the most difficult to sterilize item routinely processed in the PSD-85 sterilizer.
The PCDs are used by healthcare providers for qualification testing of the Sterilucent PSD-85 sterilizer and for routine monitoring of the PSD-85 sterilizer Lumen and Non-Lumen Cycles.
The user places the Sterilucent PCD into the Sterilucent PSD-85 along with a load and initiates a sterilization cycle. After cycle completion, the PCD is retrieved. The Cl is immediately accessed for a passing color change from pink to blue. If the CI is blue, the SCBI is removed from the PCD vial and activated by breaking the glass ampoule which contains a growth media. The 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 adequate sterilization (a passing result).
Here's a breakdown of the acceptance criteria and study information for the Sterilucent Process Challenge Device (PCD-L and PCD-NL), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Resistance to Sterilization Process | The PCDs must be "more resistant to the Sterilucent PSD-85 sterilization processes (Lumen and Non-Lumen Cycles) than is the biological model developed for validation of those sterilization cycles." | "The Sterilucent Process Challenge Device, PCD-L and PCD-NL, have been evaluated for resistance to the Sterilucent PSD-85 Lumen and Non-Lumen cycles respectively. These PCDs are at least as resistant to the sterilization process as the biological model used to validate the PSD-85 sterilizer." |
| PCD-L Suitability for Lumen Cycle | Suitable for performance qualification and routine monitoring of the Sterilucent PSD-85 sterilizer Lumen Cycle. | "The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification... and for routine monitoring of the PSD-85 Sterilizer Lumen Cycle." |
| PCD-NL Suitability for Non-Lumen Cycle | Suitable for performance qualification and routine monitoring of the Sterilucent PSD-85 sterilizer Non-Lumen Cycle. | "The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification... and for routine monitoring of the PSD-85 Sterilizer Non-Lumen Cycle." |
| Chemical Indicator Response (CI) | Chemical Indicator should demonstrate an "adequate" response (e.g., color change from pink to blue) during half-cycles with decreasing sterilant doses. | "The response of the PCDs chemical indicators during these exposures was also determined adequate." |
| Biological Indicator Organism | SCBI containing at least 10^6 spores of Geobacillus stearothermophilus. | "SCBI containing at least 10^6 spores of Geobacillus sterathermophilus" is a characteristic of the proposed device. |
| Chemical Indicator Class | Class 1 Chemical Indicator per ANSI/AAMI/ISO 11140-1. | "Class 1 Chemical Indicator per ANSI/AAMI/ISO 11140-1" is a characteristic of the proposed device. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: "PCDs from three separate manufacturing lots" were used for testing. The exact number of PCDs per lot is not specified.
- Data Provenance: The data is retrospective, generated from testing conducted by Sterilucent, Inc. The country of origin is not explicitly stated but can be inferred to be USA, where Sterilucent, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The ground truth for sterilization effectiveness is based on the biological indicator (absence or presence of bacterial growth) and the response of the chemical indicator, which are inherent properties of the device and the sterilization process being tested. This is a technical evaluation rather than an expert consensus interpretation.
4. Adjudication Method for the Test Set
Not applicable. The evaluation relies on objective measurements (biological indicator growth, chemical indicator color change) rather than subjective expert interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret output (e.g., images), and the goal is to assess reader performance with and without AI assistance. This device is a process challenge device for sterilizers, not a diagnostic tool requiring human interpretation comparison.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the study described is a standalone performance evaluation of the device itself. The device is designed to provide an objective indication of sterilization effectiveness without human-in-the-loop interpretation of complex data. The performance evaluation focuses on the device's inherent characteristics (resistance, indicator response) against established biological models and half-cycle exposures.
7. Type of Ground Truth Used
The ground truth used is based on:
- Biological Indicator Results: The presence or absence of Geobacillus stearothermophilus growth after incubation of the Self-Contained Biological Indicator (SCBI). A lack of growth indicates effective sterilization (passing result), while growth indicates a failure.
- Chemical Indicator Response: The color change of the Chemical Indicator (from pink to blue). This provides an immediate visual indication of sterilant exposure.
- Fraction-Negative Data: This method involves exposing biological indicators to varying sub-lethal sterilization doses and observing the proportion of indicators that fail to show growth. This helps establish the resistance characteristics.
- Biological Model for Sterilizer Validation: The PCD's resistance is compared against a pre-established biological model for the PSD-85 sterilizer, which represents the worst-case challenge.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI/machine learning model. The device itself is not an AI algorithm. The performance evaluation is based on direct testing with three manufacturing lots, as mentioned in point 2.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI model. The ground truth used for evaluating the device's performance (resistance, indicator response) is established through standardized microbiological and chemical indicator testing protocols.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).