(497 days)
The STERRAD® 100NX® DUO Cycle Test Pack is used for routine monitoring of the STERRAD® 100NX® DUO Sterilization Cycle and is also used for the periodic testing of a STERRAD® 100NX® System DUO Cycle, using hospital-defined loads containing devices that do not exceed claims of the cycle. The STERRAD® 100NX® DUO Cycle Test Pack consists of a STERRAD® CYCLESURE® 24 Biological Indicator, vial and cap to hold the BI.
The STERRAD® 100NX® DUO Test Pack consists of a CYCLESURE® 24 Biological Indicator (BI) and a STERRAD® NX® Test Vial with cap for holding the BI during the sterilization cycle.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resistive Equivalence to Biological Model: The Test Pack must be at least as resistant to the sterilization process as the biological model developed for the DUO Cycle. | Passed. Based on both survival curves and fraction negative data as a function of dose, the Test Pack configuration was found to be at least as resistant as the biological model. |
| Functionality of Chemical Indicator Disc: The chemical indicator in a DUO Test Pack configuration must show appropriate response in half-cycle parameters of the DUO Cycle. | Passed. The response was determined to be appropriate for a chemical indicator. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "DUO Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI)" were used for the resistance evaluation.
- Data Provenance: Not explicitly stated, but given that the applicant is Advanced Sterilization Products, a division of Ethicon, Inc. located in Irvine, CA, it is highly likely the testing was conducted prospectively and in the United States. The study description implies a laboratory or controlled setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of human experts being used to establish the "ground truth" for this device. The ground truth is intrinsically defined by the biological model and the chemical indicator's expected behavior within the sterilization process. The "ground truth" here is the scientific measurement of biological indicator survival and chemical indicator color change.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication as the assessment was based on objective biological and chemical responses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation is a key component, and the AI's impact on human performance is being measured. This device is a biological indicator for sterilization monitoring, not a diagnostic tool requiring human interpretation for its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The entire evaluation focuses on the performance of the STERRAD® 100NX® DUO Cycle Test Pack product itself, which functions as a standalone indicator of sterilization effectiveness. Its performance is measured directly against established biological models and chemical indicator specifications, without human interaction influencing the core function it is designed to evaluate (i.e., whether sterilization occurred). The "algorithm" here isn't a complex AI, but rather the intrinsic biological and chemical response mechanisms of the test pack.
7. The Type of Ground Truth Used
The ground truth used is based on:
- Biological Model: The established and validated "biological model developed for the DUO Cycle" represents the benchmark for resistance to the sterilization process. This model likely involves characterized microorganisms and their known inactivation kinetics.
- Expected Chemical Indicator Response: The predetermined, appropriate response of the chemical indicator to the sterilization conditions (specifically half-cycle parameters).
8. The Sample Size for the Training Set
There is no explicit mention of a "training set" in the context of an AI/ML algorithm. This device is not an AI/ML product. The testing involves physical devices (biological indicators) rather than training data for an algorithm. The "training" in this context would be the historical data and scientific principles used to develop the biological model itself, but that's not described here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no explicitly defined "training set" for an AI/ML algorithm. The "ground truth" for the device's functional evaluation (as described in point 7) is established through scientific validation of the biological model and the chemical indicator's properties, likely using established standards and lab procedures.
§ 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).