(74 days)
Use the Celerity 20 Steam Incubator to incubate and automatically read Celerity 20 Steam Biological Indicators at 57 °C for a fluorescent result within 20 minutes.
The Celerity 20 Steam Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 Steam Biological Indicator (BI), subject of a concurrent 510(k) currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the BI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
The provided text describes the Celerity 20 Steam Incubator, which is an incubator/reader for biological indicators, not an AI-powered diagnostic device. Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission (510(k)). This document focuses on the incubator's performance in reading biological indicators, not on interpreting medical images or data.
However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Maintenance of Incubation Temperature | Maintain 55-60 °C for a minimum of 20 minutes (incubation time of Celerity 20 Steam BI) | PASS |
| Qualification testing with Celerity 20 Steam BI (Fluorescent Read Alignment) | 20-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time. | PASS |
| Qualification testing with Celerity 20 Steam BI (Full Cycle Exposure) | Pass testing with BI exposed to full cycle exposure and negative growth result in incubator. | PASS |
| Qualification testing with Celerity 20 Steam BI (Abbreviated Cycle Exposure) | Fail testing with BI exposed in abbreviated cycle exposure and positive result in incubator. | PASS |
| Alarm, LED and Print function Test | Demonstrate proper function of alarms, LED and print outputs. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of Biological Indicators or test runs) used for each qualification test. It generally refers to "testing" performed for "Qualification testing with Celerity 20 Steam BI".
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an incubator/reader for biological indicators. The "ground truth" for the biological indicators is established by their response to sterilization cycles and subsequent growth, determined by laboratory methods and compared to 7-day growth results. There are no human experts interpreting images or complex data in the way a radiologist would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a human-in-the-loop diagnostic device requiring adjudication of expert interpretations. The "ground truth" for the biological indicators is determined by objective biological growth or lack thereof.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device, and no human readers are involved in interpreting results from this incubator. Its function is to automatically read the fluorescent signal from a biological indicator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "standalone" in its reading function as it automatically detects fluorescence. The "Qualification testing with Celerity 20 Steam BI" section demonstrates its standalone performance in reading the biological indicators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the biological indicator (BI) performance is based on:
- 7-day growth results: For the "20-minute fluorescent read meets >97% alignment with 7-day growth results." This implies comparison to a gold standard biological growth assay over a longer incubation period.
- Biological response to sterilization cycles: BIs exposed to "full cycle exposure" should show negative growth (no fluorescence), and BIs exposed to "abbreviated cycle exposure" should show positive growth (fluorescence).
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. It is a hardware device with embedded logic for temperature control and fluorescence detection.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning algorithm for this device.
§ 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).