(87 days)
A chemical indicator for monitoring all cycles within the Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer (Lumen & Flexible), STERRAD® 100S (Standard & Long), 200, 100NX (Standard, Flex & Express), NX (Standard & Advanced), STERIS® VPRO™ 1, V-PRO™ 1 Plus (Lumen & Non-Lumen), VPRO® maX (Flexible, Lumen & Non-Lumen) and Sterilucent PSD-85 (Lumen & Non-Lumen). The VH2O2 Indicators are intended to be used by health care providers with sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed units. Colors other than blue such as yellow/green should be treated as a process failure.
The Sterilucent VH2O2 Chemical Indicator is a Class 1/Type 1 process indicator that conforms to ANSI/AAMI/ISO 11140-1:2014, and is intended to be used with currently cleared hydrogen peroxide sterilizers (STERRAD® 100S, 200, 100NX, NX, STERIS® VPRO™ 1, V-PRO™ 1 Plus, VPRO® maX and the Sterilucent PSD-85) and 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 VH2O2 Chemical Indicator is provided in two different formats: Strip and Label. Both formats consist of a polymeric material on which indicator ink is deposited. A pressure-sensitive adhesive is provided on the back of the Label, which allows the process indicator to be adhered to various substrates including containers, pouches, tamper-proof arrows or locks, etc. The Sterilucent VH2O2 Chemical Indicator provides a visual indication that a sterilization load has been exposed to the VHP sterilization process. The indicator works by means of a chemical reaction, which results in a recognizable color change from red to blue.
The provided text is a 510(k) summary for a medical device (Sterilucent VH2O2 Chemical Indicator), but it does not describe a study involving an AI/ML-based medical device or comparative effectiveness with human readers. Therefore, many of the requested points, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable to this type of device (a chemical indicator).
However, I can extract the relevant information regarding the acceptance criteria and performance of this chemical indicator device.
Here's a breakdown of the information available in the provided document, addressing the closest applicable aspects of your request:
Device: Sterilucent VH2O2 Chemical Indicator (a non-AI, non-software device)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Goal) | Reported Device Performance (Result) |
|---|---|---|
| ISO 11140-1 compliance | Demonstrate compliance to ISO 11140-1 pass/fail criteria | Passed |
| Shelf-life | Demonstrate compliance to ISO 11140-1 pass/fail criteria on devices at the stated shelf life | Passed |
| Sterilucent VH2O2 Chemical Indicator Functionality | Demonstrate appropriate color change in applicable sterilizer | Passed |
| Endpoint Color Stability | Demonstrate processed indicator endpoint color stability | Passed |
| Biocompatibility | Demonstrate CI does not release any known toxic substances | Passed |
Color Change Specifics: The device is designed to change color from Red/Pink to Blue upon exposure to the VHP sterilization process. Colors other than blue (e.g., yellow/green) indicate a process failure.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test listed (e.g., how many indicators were tested for ISO compliance, shelf-life, etc.). It only states that "Performance testing was conducted to demonstrate the functionality..." and that the tests "Passed."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The tests were conducted to demonstrate compliance with the ANSI/AAMI/ISO 11140-1:2014 standard for vaporized hydrogen peroxide sterilization indicators. The testing is non-clinical performance testing of the physical device. Country of origin for testing is not specified, but the applicant is Sterilucent, Inc. in Minneapolis, Minnesota, USA. It is retrospective in the sense that the testing was performed and then summarized for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This concept is not applicable to this type of device. The ground truth for a chemical indicator's performance is established by whether it correctly changes color under specific chemical and physical sterilization conditions according to established international standards (ISO 11140-1). It's a binary chemical reaction/physical property, not an interpretation requiring human experts like in imaging.
4. Adjudication Method for the Test Set
This concept is not applicable. There is no "adjudication" in the sense of resolving disagreements among human readers or expert labelers for this type of device. The pass/fail criteria are based on objective physical/chemical changes and adherence to the ISO standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for AI/ML-based diagnostic devices where human readers' performance with and without AI assistance is being evaluated. This device is a chemical indicator, not an AI/ML diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This concept is not applicable. This is a physical chemical indicator, not an algorithm. Its "standalone performance" refers to its ability to react correctly to sterilization conditions, which is what the non-clinical tests (ISO 11140-1 compliance, functionality, etc.) evaluated.
7. The Type of Ground Truth Used
The ground truth is based on:
- International Consensus Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014, which defines the expected performance and pass/fail criteria for chemical indicators.
- Physical/Chemical Properties: The expected color change reaction when exposed to specific concentrations of hydrogen peroxide vapor and other parameters of the sterilization cycle.
- Absence of Toxicity: Biocompatibility testing to ensure the device does not release known toxic substances.
This is not a ground truth derived from expert consensus, pathology, or outcomes data in the medical imaging or diagnostic sense.
8. The Sample Size for the Training Set
This concept is not applicable. This device is a physical chemical indicator, not an AI/ML model that requires a training set. The device's "training" is its chemical formulation and manufacturing process, which are designed to react consistently.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the reason stated in point 8.
§ 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).