(176 days)
The STERIZONE® CI+ Chemical Indicator is a single-use process indicator intended to distinguish between processed and unprocessed packaged medical devices to be sterilized using the STERIZONE® VP4 Sterilizer. The device is intended for use only with the STERIZONE® VP4 Sterilizer, which has a single sterilization cycle ("Cycle 1"). Critical process parameters for Cycle 1 are summarized in Table 1.
The red stripe chemical indicator is located above the peach-colored stripe labeled as the "REFERENCE". After exposure to the Cycle 1 of the STERIZONE® VP4 Sterilizer, the chemical indicator color changes from red to peach-Reference color (or lighter).
The STERIZONE® CI+ Chemical Indicator (CI+) is a Class 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1: 2005(R)2010, and is intended to only be used with the STERIZONE® VP4 Sterilizer. The single pre-set cycle (Cycle 1) of the STERIZONE® VP4 Sterilizer utilizes vaporized hydrogen peroxide and ozone in a multiphase process, to rapidly sterilize a variety of reusable medical devices.
The CI+ chemical indicator consists of a polymeric material strip on which an indicator ink, a reference color and a varnish coating have been deposited. The CI+ provides a visual indication that a sterilization load has been exposed to the STERIZONE® VP4 Sterilizer Cycle 1. The indicator works by means of a chemical reaction, which results is a recognizable color change from red to peach (or lighter).
The provided text describes the STERIZONE® CI+ Chemical Indicator and its assessment for substantial equivalence to a predicate device. It explicitly states that "Performance testing was conducted to demonstrate the functionality of the STERIZONE® CI+ Chemical Indicator and general conformance with the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010."
However, the document does not describe a study involving an AI device or algorithm. The "device" in question is a chemical indicator that changes color. Therefore, most of the requested information regarding AI device-specific criteria (like sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or cannot be extracted from this text.
I will provide the acceptance criteria and performance as described for the chemical indicator, and note where the requested information is not relevant to this type of device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Requirement/Test from ANSI/AAMI/ISO 11140-1:2005(R)2010 | Acceptance Criteria (Implicit from "Passed") | Reported Device Performance |
|---|---|---|
| CI+ Functionality | Device functions as intended | Passed |
| Shelf-life | Maintains performance over shelf-life | Passed |
| Endpoint color stability | Sustains distinctive color change | Passed |
| ISO 11140-1 compliance | Meets all requirements of the standard | Passed |
| Biocompatibility | No adverse biological effects | Passed |
2. Sample Sizes and Data Provenance for Test Set:
The document does not specify specific sample sizes (e.g., number of indicators tested) for each non-clinical test.
Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests, which are laboratory-based functionality tests for a chemical indicator, not typically tied to patient data.
3. Number and Qualifications of Experts for Ground Truth (Test Set):
Not applicable. This device is a chemical indicator with a physical color change. Its performance is assessed by physical and chemical tests against a standard, not by human expert interpretation in the same way an AI diagnostic tool would be.
4. Adjudication Method for Test Set:
Not applicable for the reasons stated above. The "ground truth" for a chemical indicator is its physical response to sterilization parameters as defined by industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a chemical indicator, not an AI system. There are no "human readers" to improve with "AI assistance" in this context.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This device is a passive chemical indicator, not an algorithm.
7. Type of Ground Truth Used:
The ground truth used for evaluating the STERIZONE® CI+ Chemical Indicator is based on industry standards and physical/chemical properties. Specifically, performance is assessed against the requirements for Class 1 vaporized hydrogen peroxide sterilization indicators as detailed in ANSI/AAMI/ISO 11140-1:2005(R)2010. The color change (red to peach or lighter) triggered by exposure to the STERIZONE® VP4 Sterilizer's Cycle 1 is the intended functional ground truth.
8. Sample Size for Training Set:
Not applicable. This is a manufactured chemical indicator, not an AI model that requires a training set.
9. How Ground Truth for Training Set Was Established:
Not applicable. As above, no training set or AI model is involved.
§ 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).