(60 days)
The STERRAD® Sterilizer CycleSure® Test Pack is used for routine monitoring of the STERRAD 50, STERRAD 100S and STERRAD 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads.
The STERRAD® Sterilizer CycleSure® Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial (with an orifice) into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle. Two silicon mats are placed in the pouch during use to increase the resistance of the Test Pack, by acting as a reservoir for hydrogen peroxide.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
Acceptance Criteria and Study Details for STERRAD® Sterilizer CycleSure® Test Pack
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it describes the performance criterion in qualitative terms, primarily focusing on the device's resistance compared to a biological model.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Resistance to the Sterilization Process: The Test Pack must be more resistant to the sterilization process (hydrogen peroxide) in the STERRAD 50, STERRAD 100S, and STERRAD 200 Sterilizers than the biological model developed for each system. | "It was demonstrated that with all three STERRAD Sterilization systems, the Test Pack configuration [is] more resistant to the sterilization process than the biological model." (Page 2) |
| Indicative Functionality of the Chemical Indicator: The chemical indicator within the Test Pack must respond appropriately when in the Test Pack configuration using half-cycle parameters of the Standard Cycle. | "Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the data indicate that the chemical indicator responds appropriately when in the Test Pack configuration." (Page 2) |
| Substantial Equivalence: The STERRAD Sterilizer CycleSure Test Pack must be substantially equivalent to the predicate devices (STERRAD NX Test Pack). | "The STERRAD Sterilizer CycleSure Test Pack is substantially equivalent to the predicate devices, the STERRAD NX Test Pack." (Page 2) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the test set (e.g., number of test packs, number of sterilization cycles). It mentions "Test Packs containing CycleSure Biological Indictor were exposed to increasing doses of hydrogen peroxide in [each] of the STERRAD Sterilization systems." This implies multiple test packs and multiple exposures.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it's highly likely the data was generated in the US or in a manner compliant with US regulatory standards. The study appears to be prospective in nature, as it describes evaluations performed specifically to demonstrate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. The ground truth in this context is based on biological and chemical indicators' response to controlled sterilization parameters and comparison to a "biological model," which is an objective, mechanistic standard.
4. Adjudication Method for the Test Set
Not applicable. The study relies on objective measurements of biological inactivation and chemical indicator response, not subjective expert assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human interpretation is a key component. The STERRAD® Sterilizer CycleSure® Test Pack is an indicator device for a sterilization process, not a diagnostic tool requiring human interpretation comparison.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Yes, the study describes the standalone performance of the device itself without human intervention during the "reading" of the sterilization outcome, in the sense that the biological indicator either grows or does not grow, and the chemical indicator either changes color or does not. The evaluation focuses on the inherent biological resistance and chemical reactivity of the test pack.
7. Type of Ground Truth Used
The ground truth used is based on:
- Biological Inactivation/Survival Curves: Comparison of the Test Pack's resistance to a pre-established biological model for each STERRAD sterilizer system. This model represents a known, scientifically defined challenge to the sterilization process.
- Chemical Indicator Response: The chemical indicator's color change (or lack thereof) in response to "half cycle parameters" where appropriate. This is an objective chemical reaction.
8. Sample Size for the Training Set
Not applicable. This device is a physical indicator, not an AI/machine learning algorithm, so there is no "training set" in the conventional sense. The "training" of the device is its manufacturing and calibration to respond predictably to hydrogen peroxide.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The scientific and engineering principles behind biological indicators (e.g., D-value determination for Geobacillus stearothermophilus) and chemical indicators are well-established for assessing sterilization efficacy. The "ground truth" for the performance of the components themselves would have been established through prior characterization and validation during their development.
§ 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).