(28 days)
The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:
- · Dynamic Air Removal 270°F (132°C) 4 minutes
- · Dynamic Air Removal 275°F (135°C) 3 minutes
- · Gravity 250°F (121°C) 30 minutes
- · Gravity 270°F (132°C) 15 minutes.
When used in conjunction with the Celerity™ Steam Incubator, the Incubator provides a fluorescent result within 20 minutes.
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
Here's an analysis of the provided information to answer your questions about acceptance criteria and the study that proves the device meets them:
Device: Celerity 20 Steam Biological Indicator
1. A table of acceptance criteria and the reported device performance
Based on the document, only one performance test is explicitly mentioned with an acceptance criterion and conclusion:
| Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Simulated Use | Demonstrate no growth when exposed to a full cycle | Full cycle - no growth |
The document also lists several technical characteristics for the Celerity 20 Steam Biological Indicator (modified) and compares them to the predicate device. While these aren't explicitly stated as "acceptance criteria" in the same way as the "Simulated Use" test, they represent performance parameters that the device is expected to meet and does meet, often being "Identical" to the predicate.
For completeness, here's a combined table including those technical characteristics as implicit acceptance criteria if one assumes they must match the predicate:
| Feature | Acceptance Criteria (typically matching predicate) | Reported Device Performance |
|---|---|---|
| Simulated Use | Demonstrate no growth when exposed to a full cycle | Full cycle - no growth |
| Indicator organism | > 90% similarity to ATCC 7953 Geobacillus stearothermophilus | > 90% similarity to ATCC 7953 Geobacillus stearothermophilus (Identical to predicate) |
| Mechanism of action | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety | An enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety (Identical to predicate) |
| Accessories | Automated incubator / reader | Automated incubator / reader (Identical to predicate) |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | 1.0 - 4.0 x 10^6 spore/SCBI (Identical to predicate) |
| Resistance | D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s | D121 ≥ 1.5 min D132 ≥ 10 s D135 ≥ 8 s (Identical to predicate) |
| Survival Time | Meets the longer of FDA and ISO 11138-3 requirements | Meets the longer of FDA and ISO 11138-3 requirements (Identical to predicate) |
| Kill Time | Meets the shorter of FDA and ISO 11138-3 requirements | Meets the shorter of FDA and ISO 11138-3 requirements (Identical to predicate) |
| Hold time | Up to 72 h | Up to 72 h (Identical to predicate) |
| Carrier growth inhibition / media growth | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure | Positive growth of less than 100 spores after primary packaging and media are subject to worst case steam exposure (Identical to predicate) |
| Culture Conditions | 55- 59 °C, media included in SCBI, 20-minute incubation time. | 55- 59 °C, media included in SCBI, 20-minute incubation time. (Identical to predicate) |
| Primary Packaging | Direct inoculum on plastic vial, cap with recovery media. | Direct inoculum on plastic vial, cap with recovery media. (Identical to predicate, though the cap label changed, this refers to the fundamental structure) |
| Shelf Life | 10 months (predicate) | 10 months (Identical to predicate, but the note states "Shelf-life testing is ongoing", implying this is the target or current demonstrated shelf life, not necessarily a completed test definitively proving the full 10 months for the modified device if testing is still ongoing at the time of submission) |
| Cap label | Single-ply label on cap edge, Process indicator on label | Single-ply label on cap edge, Process indicator on label (Differs from predicate, which had a two-ply label on cap top. This is a design change, not a performance criterion in the same way, but noted for comparison.) |
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 explicitly state the sample size used for the "Simulated Use" test or any other specific test. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective nature).
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)
This type of information is not applicable to a biological indicator device. The "ground truth" for a biological indicator is determined by the presence or absence of microbial growth, which is an objective biological outcome rather than an expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, the determination of microbial growth is objective, not requiring human adjudication.
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 device is a biological indicator, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biological indicator, not an algorithm. Its performance is inherent to its biological and chemical properties. The Celerity™ Steam Incubator provides an automated fluorescent result, which could be considered a "standalone" reading, but it's not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for relevant tests (like viability, resistance, survival, kill time, and simulated use) is based on the presence or absence of microbial growth (Geobacillus stearothermophilus), which is an objective biological outcome. This is determined through standard microbiological techniques.
8. The sample size for the training set
Not applicable. This device is a biological indicator, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this type of 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).