(220 days)
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
The provided document describes the STERIS Celerity Incubator, a device designed to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Maintenance of Incubation Temperature | Temperature of BIs is maintained between 55°C - 60°C during incubation. Temperatures were observed over a 60min period and during a 1min loss of power. | PASS |
| Qualification Testing with intended Biological Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on reduced incubation time for intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators. | PASS |
| Human Factors | Typical users are capable of following the written instructions for use to correctly use the Celerity Incubators. | PASS |
| Electromagnetic Compatibility | IEC 60601-1-2:2014 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | PASS |
| Electrical Safety Conformance | IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of biological indicators in the "Qualification Testing with intended Biological Indicators". It mentions "intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators." No specific numbers are provided for these tests.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts or their qualifications for establishing ground truth for the biological indicator testing. The ground truth appears to be based on a "7-day grow out" method, which is a laboratory standard for sterility verification rather than expert human interpretation.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the validation process does not involve expert interpretation or subjective assessment that would require such a method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The Celerity Incubator is an automated device for reading biological indicators.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Qualification Testing with intended Biological Indicators" directly evaluates the automated fluorescent read of the device against a 7-day grow out method. This demonstrates the device's algorithmic performance in identifying viable organisms without human intervention in the result interpretation.
7. Type of Ground Truth Used
The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is 7-day grow out. This is a standard microbiological method to determine if a sterilization process has been successful by attempting to culture any surviving microorganisms over a 7-day period.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is because the Celerity Incubator is not an AI/machine learning model that requires a "training set" in the traditional sense. It's an automated device performing a specific detection function based on established scientific principles (fluorescence of enzymatic activity).
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set or an AI/machine learning model, the concept of establishing ground truth for a training set is not applicable to this device as described. The device's functionality relies on physical and chemical reactions and subsequent detection, rather than learning from a dataset.
§ 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).