(196 days)
The STERRAD® 100NX Test Pack is used for routine monitoring of the STERRAD® 100NX sterilization cycle and is also used for the periodic testing of a STERRAD® 100NX system using hospital-defined loads.
The STERRAD® 100NX Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle.
The provided text describes the STERRAD 100NX Test Pack, a biological indicator used for monitoring sterilization cycles. It details a non-clinical study conducted to evaluate its resistance compared to biological models.
Here's the information regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least as resistant to the sterilization process as the biological model (based on survival curves). | "With both cycles the Test Pack configuration was at least as resistant as the biological model." |
| At least as resistant to the sterilization process as the biological model (based on fraction negative data). | "fraction negative data collected using Test Pack containing three lots of CycleSure BI when exposed to increasing volumes of peroxide in both the Standard and Flex Scope Cycles indicate that the Test Pack configuration is at least as resistant as the biological models." |
| Indicative functionality of the chemical indicator (appropriate response for a chemical indicator). | "Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the response was determined to be appropriate for a chemical indicator." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text mentions "Test Packs containing three lots of CycleSure Biological Indictor" were exposed to various doses. No specific numerical sample size for the test set (number of individual test packs or repetitions) is provided.
- Data Provenance: Not explicitly stated, but the study is described as "non-clinical tests" and was conducted by the applicant, Advanced Sterilization Products. It does not mention country of origin or whether it was retrospective or prospective, although the nature of the testing implies a prospective, controlled laboratory study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device is based on the biological efficacy of sterilization (killing microorganisms) as measured by the response of the biological indicator and its comparison to a pre-defined "biological model," not on expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on biological efficacy and comparison to a model, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the physical and biological performance of a sterilization indicator, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not an AI/algorithm-based device in the context of image analysis or similar applications. The "standalone" performance here refers to the device's ability to accurately indicate sterilization, which is what the non-clinical tests assessed. The device itself (the biological indicator) is the "algorithm," and its performance was evaluated.
7. The Type of Ground Truth Used
The ground truth used is based on biological efficacy and a biological model. Specifically, the resistance of the Test Pack (containing biological indicators) to the sterilization process was compared to "biological models developed for both the Standard and Flex Scope Cycles." This involves:
* Survival curves (measuring organism survival at various sterilization doses).
* Fraction negative data (indicating the proportion of indicators that show growth vs. no growth).
* Chemical indicator response (appropriateness for detection).
Essentially, the ground truth for performance is the established efficacy requirements for a sterilization biological indicator.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set in the typical sense. The "training" for such a device would be its design and manufacturing process to consistently meet the biological resistance criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of machine learning. The "biological models" used for comparison are the reference points, which would have been established through prior biological efficacy studies of sterilization processes and the resistance of standard test organisms.
§ 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).