(245 days)
The STERRAD NX Test Pack is used for routine monitoring of the STERRAD® NX Sterilization cycle and is also used for the periodic testing of a STERRAD NX System using hospital-defined loads.
The STERRAD® NX 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 NX Test Pack and its evaluation, but it does not contain information suitable for a typical acceptance criteria table and study details as might be found for a medical diagnostic device's clinical performance study.
Instead, this document is a 510(k) summary for a sterilization process indicator (biological indicator test pack). The "performance" here refers to its ability to accurately challenge a sterilization cycle, not diagnose a condition in a patient.
Here's an attempt to interpret the request based on the provided text, focusing on the available information about the device's technical performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test Pack resistance to sterilization process (Standard Cycle) is at least as resistant as the biological model. | Survival curves and fraction negative data indicate the Test Pack configuration was at least as resistant as the biological model for the Standard Cycle. |
| Test Pack resistance to sterilization process (Advanced Cycle) is at least as resistant as the biological model. | Survival curves and fraction negative data indicate the Test Pack configuration was at least as resistant as the biological model for the Advanced Cycle. |
| Chemical Indicator in the Test Pack shows appropriate indicative functionality. | Response was determined to be appropriate for a chemical indicator when evaluated using half-cycle parameters of the Standard Cycle. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Three lots of CycleSure Biological Indicators were used within the Test Packs for exposure to various peroxide doses and increasing peroxide volumes for both Standard and Advanced Cycles. Specific numeric sample sizes (e.g., number of test packs per lot, number of exposures) are not provided.
- Data Provenance: The document does not specify the country of origin of the data. The study is non-clinical, involving laboratory testing of the device's resistance to sterilization. It is implied to be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this device. Ground truth for a sterilization indicator's performance is established by the known lethality of the sterilization agent (peroxide) and the resistance of the biological model (microorganisms), not by expert human interpretation.
4. Adjudication method for the test set
This section is not applicable. There's no human interpretation or decision-making that would require adjudication. Performance is assessed by objective measurements (survival curves, fraction negative data).
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
This section is not applicable. The device is a sterilization indicator, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable in the sense of an algorithm for diagnosis. However, if interpreted as a "device-only" performance evaluation, then yes, the entire study described is a standalone evaluation of the STERRAD NX Test Pack's physical and biological performance against established sterilization parameters, without human intervention in its function.
7. The type of ground truth used
The ground truth used is based on the biological model developed for the Standard and Advanced Sterilization Cycles. This model represents the expected resistance of microorganisms to the sterilization process. The Test Pack's performance (survival curves, fraction negative data) is compared directly to this established biological model to determine if it is "at least as resistant."
8. The sample size for the training set
This section is not applicable. The document describes the evaluation of a physical device against a biological model, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. (See point 8).
§ 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).