(195 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.
Here's an analysis of the provided text regarding the Celerity Incubator's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 Vaporized Hydrogen Peroxide Celerity 5 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 60101-1 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements | PASS |
| Software Validation per IEC 62304 | 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 provided document does not explicitly state the sample size used for the "Qualification Testing with intended Biological Indicators" which is the most relevant performance test described. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth. The acceptance criterion mentions "7-day grow out per FDA guidance," implying a standard microbiological method for determining growth, which typically doesn't involve "experts" in the sense of clinical reviewers.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The "7-day grow out" is a definitive biological outcome, not typically subject to adjudication in the same way clinical image reviews might be.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an incubator for biological indicators, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance test was done, referred to as "Qualification Testing with intended Biological Indicators." This test assesses the device's ability to accurately detect fluorescence in biological indicators, which is an automated process without human interpretation in the results pathway. The "human factors" test evaluates user interaction, but the core performance related to detecting BI growth is standalone.
7. The Type of Ground Truth Used
The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is biological growth/non-growth, as determined by a "7-day grow out" method. This is a functional, objective ground truth based on the viability of microorganisms.
8. The Sample Size for the Training Set
The document does not provide information on a training set sample size. This is because the Celerity Incubator is a hardware device with embedded software for interpreting biological indicator results based on a known biochemical reaction (fluorescence). It doesn't appear to be an AI/machine learning model in the typical sense that would require a separate training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a traditional training set for an AI/ML algorithm, the concept of establishing ground truth for a training set in this context is not applicable or described in the document. The device's operation is based on established principles of fluorescence detection for biological activity, 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).