(90 days)
The Steri-Dot Process Indicator for EO gas sterilization is designed for use by a health care provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed units or loads. The indicator dots turn from purple-red to green when exposed to EO gas sterilization conditions, thus providing an indication of processed items.
The Steri-Dot process indicator can be used in the following EO sterilization cycles:
- 37°C, 736 mg/l EO, ≥35% RH, 3 hours exposure
- 37°C, 759 mg/l EO, ≥35% RH, 3 hours exposure
- 54°C, 600 mg/l EO, 40-60% RH, 45 min or longer exposure
- 54°C, 736 mg/l EO, ≥35% RH, 1 hour exposure
- 55°C, 759 mg/l EO, ≥35% RH, l hour exposure
- 55°C, 600 mg/l EO, 40-60% RH, 4 hours exposure
The Steri-Dot Process Indicator is a single use chemical indicator designed for Ethylene Oxide (EO) sterilization monitoring. Each indicator consists of reactive EO indicator ink printed on a substrate paper circle, 3/4" or 1" in diameter, with adhesive backing. Individual indicators are printed with reactive ink only.
The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity and amount of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming a green compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve required level, the indicator ink chemistry changes color from purple-red to green. If the parameters do not achieve the required level, the indicator color will be brown or red.
The provided document describes the Steri-Dot® Process Indicator, a chemical indicator for Ethylene Oxide (EO) gas sterilization. The information primarily focuses on non-clinical testing to demonstrate its performance and substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Summary of Non-clinical Testing" table.
| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ANSI/AAMI/ISO 11140-1:2014 testing for Type 1 indicator. | To demonstrate conformance of Steri-Dot indicator to the requirements specified in ISO 11140-1:2014 for process indicators. | 37°C, RH 60%, EO 600mg/l, 3 min: no color change or color markedly different compared to green | |
| 37°C, RH 60%, EO 600mg/l, 25 min: green color | |||
| 54°C, RH 60%, EO 600mg/l, 2 min: no color change or color markedly different compared to green | |||
| 54°C, RH 60%, EO 600mg/l, 20 min: green color | |||
| 60°C, RH ≥85%, EO - none, 90 min: no change | Passed | ||
| Testing in EO cycles with parameters used in healthcare sterilization. | To demonstrate that Steri-Dot Process indicator achieves specified end color in typical cycles. | Color change from purple-red to green | Passed |
| Biocompatibility study and ink transfer test | To demonstrate that the indicator does not create biocompatibility issues to health care professionals and patients. The exposure to health care professional is minimal and well below any identified toxic thresholds for the compounds. | Evaluation of individual components for biocompatibility and indicators with similar formulation with long history of on the market. |
Testing according to ISO 11140-1:2014. Requirement: 6.2.2. No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
| End point stability and shelf-life study | To confirm that Steri-Dot process indicator has acceptable stability after processing when achieved and not achieved end point color (parameters when tested using real-time shelf-life exposure method). | Criteria not explicitly stated in the provided text for this row. | Implied Passed, as overall conclusion is positive. |
| Adhesive test – healthcare applications | The purpose of the test is to evaluate if the adhesive is suitable for its function and does not deteriorate during sterilization process. | The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after Steri processing. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing of a device rather than a study involving human data or a "test set" in the context of AI/machine learning. Therefore:
- Sample size: Not explicitly stated in terms of number of indicators tested for each condition. The testing is described as fulfilling the requirements of ISO standards and demonstrating performance.
- Data provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the Steri-Dot Process Indicator itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this document. The device is a chemical indicator that changes color. The "ground truth" for its performance is determined by the physical chemical reaction and visual observation based on established standards (e.g., ISO 11140-1:2014). There is no mention of expert readers or human interpretation of complex images/data to establish ground truth as would be the case for an AI medical device.
4. Adjudication Method for the Test Set
This section is not applicable. As it's a chemical indicator with a clear color change endpoint, there is no ambiguity requiring an adjudication method by multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
This section is not applicable. An MRMC study is relevant for AI devices where human readers interpret medical images or data. The Steri-Dot Process Indicator is a chemical indicator, not an AI-powered diagnostic tool. There are no human readers involved in its direct "performance" evaluation beyond visual confirmation of the chemical reaction.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This section is not applicable. The Steri-Dot Process Indicator is a physical chemical indicator, not an algorithm or software. Its performance is inherent to its material composition and chemical reaction, not a computational model.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on:
- Standardized Chemical Reaction: The chemical indicator's color change in response to specific sterilization parameters (temperature, humidity, EO concentration, exposure time).
- Compliance with International Standards: Specifically, ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators. This standard defines the expected color changes under various exposure and non-exposure conditions to ethylene oxide.
- Visual Observation: The "result" column in the table simply states "Passed," implying that the visual color change (or lack thereof) met the specified acceptance criteria.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as point 8.
In summary: The provided document is a 510(k) summary for a physical chemical indicator. It details the product's function, mechanism, and non-clinical performance testing against established ANSI/AAMI/ISO standards. Many of the questions you posed (e.g., sample size for AI test/training sets, expert consensus, MRMC studies) are primarily relevant for AI/software as a medical device (SaMD) rather than a simple chemical indicator. The "acceptance criteria" and "study proving device meets acceptance criteria" here refer to laboratory testing demonstrating compliance with performance standards for physical chemical indicators.
§ 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).