(212 days)
The SPSmedical H2O2 Chemical Indicators are indicated for use as process indicators for all vaporized hydrogen peroxide cycles in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. They are intended to be used by health care providers with articles such as sterilization wraps, containers, cassettes, or pouches to distinguish between processed and unprocessed items. Indicators change to a signal color of Blue after exposure to vapor hydrogen peroxide.
SPSmedical Vaporized Hydrogen Peroxide (H2O2) Chemical Indicators are process indicators used to verify exposure to vapor hydrogen peroxide in the STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. Indicators will identify if an item has seen H2O2 during the sterilization process by changing to a Blue signal color. They provide a visual indication to help distinguish between processed and unprocessed items.
The provided document describes the SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators, a sterilization process chemical indicator. Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Verified exposure to vapor hydrogen peroxide in specified sterilizers. | Indicators change to a Blue signal color after exposure to vapor hydrogen peroxide. |
| Distinguish between processed and unprocessed items. | Provide a visual indication to help distinguish between processed and unprocessed items. |
| Compliance with AAMI/ANSI/ISO 11140:2005 requirements. | Testing included compliance with AAMI/ANSI/ISO 11140:2005 requirements for indicators run in vaporized hydrogen peroxide sterilization processes. |
| Acceptable results across multiple lots and shelf-life levels. | "All lots of SPSmedical Vaporized Hydrogen Peroxide Chemical Indicators gave acceptable results for all test performed." |
| Functional in STERRAD® 100S, 200, 100NX, NX and STERIS® V-Pro sterilization processes. | Testing included simulated use in these specified sterilization processes. |
Note: The document does not explicitly list quantitative acceptance criteria in a dedicated section. The acceptance criteria are inferred from the device's intended use, description, and the statement of compliance with standards and successful test outcomes. For example, the "blue signal color" is the performance outcome that meets the implicit acceptance criterion of "visual indication of exposure."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "Multiple lots of indicators with various levels of shelf life were included in testing." However, specific numerical sample sizes (e.g., number of indicators, number of runs) are not provided.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal verification and validation, as it was performed by SPSmedical Supply Corp. The testing is prospective in nature, as it involved performing tests designed to verify performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study described is a performance verification of a chemical indicator, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for a chemical indicator is whether it changes color as expected when exposed to the sterilant under specified conditions.
4. Adjudication Method for the Test Set
This information is not applicable/provided. As mentioned above, this is a chemical indicator performance study, not a study requiring expert adjudication of interpretations. The endpoint (color change) is a physical, observable phenomenon.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of AI on their performance. This document concerns a chemical indicator, which provides a direct visual signal that does not require "reading" in the clinical sense of a diagnostic image or complex output.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to this device. The device itself is a chemical indicator, which by definition has a "human-in-the-loop" component (a person observing the color change). There is no "algorithm" in the sense of a software-based system that operates independently. The device's performance stands alone in its chemical reaction.
7. The Type of Ground Truth Used
The ground truth used is the physical presence and concentration of vaporized hydrogen peroxide within the specified sterilization processes. The expectation is that the indicator will change color when adequately exposed to the sterilant and will not change color (or not change fully) if not adequately exposed. This is validated by running the indicators through controlled sterilization cycles in the specified STERRAD® and STERIS® V-Pro units.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is a chemical indicator, not a machine learning or AI-based system. Therefore, there is no "training set" in the context of algorithm development. The indicator's performance is based on its chemical properties, which are validated through testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reasons as 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).