(79 days)
Steritec Cross-Checks EO Integrators are designed to provide an integrated response to EO gas sterilization in hospital sterilizers. Color change to brown is complete between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130 F and Relative Humidity at 45%.
The SteriTec CROSS-CHECKS EO Gas Sterilization Integrator is a chemical integrator.
The provided text describes the acceptance criteria and performance study for the SteriTec CROSS-CHECKS EO Gas Sterilization Integrator (K982547).
Here's an analysis of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, quantified table. Instead, the "Intended Use" defines the expected performance, and the "Performance Testing" section describes how the device met or surpassed the performance of predicate devices and biological indicators.
Inferred Acceptance Criteria / Intended Performance:
| Criteria | Reported Device Performance |
|---|---|
| Color Change for EO Gas Sterilization | |
| 1. Integrated Response | Designed to provide an integrated response to EO gas sterilization in hospital sterilizers. |
| 2. Time to Complete Color Change | Color change occurs between 30 and 45 minutes exposure to EO gas mixture of 88/12 with gas concentration of 600 mg/L, temperature at 130°F, and Relative Humidity at 45%. (Indications For Use specifies "Color change to brown is complete between 30 and 45 minutes...") |
| Comparison to Predicate Device (SURGICOT 2 EO Gas Indicator Strip) | Substantially equivalent in construction and performance. Performance data shows the Cross-Checks EO to be substantially equivalent. |
| Performance against Biological Indicators (EZTEST, ATTEST, STS Spore Strips) | Surpassed the performance of biological indicators for each of the four parameters used in ethylene oxide sterilization process. |
| Performance against other EO Integrators (Predicate and Sterigage EO Integrator) | Surpassed the performance of the Surgicot 2 EO Integrator (predicate) as well as the Sterigage EO indicator when tested on a side-by-side basis by an independent laboratory. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size (number of integrators/strips) used for the performance tests.
Data Provenance:
- Country of Origin: Not explicitly stated, but the testing was conducted by an "independent laboratory." The manufacturer is based in Castle Rock, CO, USA.
- Retrospective or Prospective: Not explicitly stated, but performance testing of a new device is typically prospective, involving controlled laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (chemical integrator) does not typically involve human expert interpretation for "ground truth" in the same way as an imaging AI. The "ground truth" is based on the physical and chemical response of the integrator to specific sterilization conditions. The assessment of whether it "surpassed the performance" of other indicators would be based on quantitative measurements of their responses under controlled conditions, not expert consensus on an image or clinical condition.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is determined by the physical/chemical response under controlled conditions, not by human interpretation requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a standalone chemical indicator, not an AI device designed to assist human readers.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is a standalone chemical integrator, meaning its performance is evaluated directly based on its color change response to sterilization conditions, independent of human interpretation for its primary function. Its performance is the "algorithm only" in the sense that it is a direct measurement of the device's output.
7. Type of Ground Truth Used
The ground truth is established by:
- Physical/Chemical Response: The inherent and expected color change response of the integrator material to specific concentrations, temperatures, humidity, and exposure times of ethylene oxide gas.
- Comparison to Established Biological Indicators: Biological indicators are the gold standard for sterilization efficacy, as they contain highly resistant bacterial spores. The performance of the chemical integrator is compared against these.
- Comparison to Predicate Devices: Performance is also compared to a legally marketed equivalent device (Surgicot 2 EO Gas Indicator Strip) operating under the same principles.
8. Sample Size for the Training Set
Not applicable. This is a chemical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).