(108 days)
The CELERITY 20 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.
The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of the V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the sterilizers.
The CELERITY 20 HP Challenge Pack (pack), is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems. The pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The user places the pack into the V-PRO Sterilizer and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the CELERITY 20 HP Biological Indicator* (BI) contained in the pack are retrieved. The CI is assessed for a passing color change immediately and the BI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The BI is activated by sealing the vial and thus puncturing the cap to release the contained media.
The activated SCBI is incubated at 55-60 ℃ in the CELERITY HP Incubator** for a final determination of viability within 20 minutes of incubation.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Demonstrate the pack shows passing results in worst-case load under worst-case sterilization conditions | PASS |
| Cycle-Specific Testing | The pack provides an equivalent or greater challenge to the claimed cycle than the biological model under worst-case conditions. | 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 or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing... has been completed" and implies that these tests were conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests seem to be laboratory-based performance evaluations against specific criteria rather than expert-based assessments.
4. Adjudication Method for the Test Set
This information is not provided as the tests appear to be objective performance evaluations (pass/fail) rather than requiring adjudication for subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size
An MRMC comparative effectiveness study was not performed or reported in this document. The device is a sterilization process indicator, not an 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
The device itself is a "Biological Indicator Challenge Pack" which is a physical product, not a software algorithm. The "performance" being tested is its ability to accurately indicate sterilization conditions. Therefore, a standalone algorithm-only performance study is not applicable in this context. The "incubation" part involves a device (CELERITY HP Incubator) that reads the biological indicator, which is a form of automated assessment, but not an "algorithm only" study in the typical sense of AI.
7. The Type of Ground Truth Used
The ground truth for the "Simulated Use" and "Cycle-Specific Testing" appears to be established through:
- Worst-case sterilization conditions: This refers to the scientific and engineering parameters that define a minimal challenge for sterilization.
- Biological model: This likely refers to the known and established resistance of the biological indicator organism (e.g., bacterial spores) to the sterilization process. The acceptance criteria imply a biochemical or microbiological ground truth (i.e., whether the biological indicator's spores are killed or not under defined conditions).
8. The Sample Size for the Training Set
This product is a physical device (sterilization indicator), not an AI model that requires a training set. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set was Established
As explained above, a training set is not applicable 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).