(462 days)
The Steritec Integraph is designed to provide an integrated response to steam sterilization at 132 C for sterilizers operating for 3 1/2 minutes or longer.
The Steritec Integraph CI 101 is a chemical indicator/integrator equivalent in construction and operation to the ATT Steam Close (predicate device).
This is a summary of the provided text regarding the 'SteriTec Integraph' device and its performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proper indication of sterilization conditions (Pass/Fail) | "In all cases they indicated properly whether the sterilization conditions had been met or not in the sterilizer chamber as verified by biological spore strips." |
| No false "PASS" indications when sterilization conditions were NOT met | "There were NO instances in which the SteriTec strips indicated that sterilization conditions were met when they were not (NO FAI SI PASS RESULTS)." |
| Margin of safety (no "PASS" result if biological spores survive) | "No SteriTec strip tested provided a "PASS" test result in tests when there were any biological spore survivors." |
| Stability after storage in high temperature | "Independent laboratory testing showed the SteriTec Integraph is stable after being subjected to extremes of heat..." |
| Stability after storage in high humidity | "...and high humidity." |
| Stability after 2.5 years of storage | "For stability after storage for two and one half years years." |
| Stability after being sterilized and then stored for 2 years | "For stability after being sterilized and then stored for two years." |
| Maintenance of original color (purple) during storage | "All strips maintained their purple color after storage testing." |
| Proper color change (purple to green) after sterilization | "After exposure to sterilization conditions, the indicators properly changed color from purple to green." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of Integraph strips) used for the performance testing. It refers to "tests" and "strips tested" in plural.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that "Independent laboratory testing" was conducted, but the location of these labs is not specified. The studies appear to be prospective, as the device was actively subjected to various sterilization conditions and storage studies.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the use of human experts to establish ground truth.
4. Adjudication Method for the Test Set
- No human adjudication method (e.g., 2+1, 3+1) was used. The performance was verified directly against "biological spore strips."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The device is a chemical indicator, not an AI system requiring human interpretation comparison.
6. Standalone Performance
- Yes, a standalone performance assessment was conducted. The SteriTec Integraph's performance was evaluated based on its own chemical reaction and color change in response to sterilization conditions, as verified by biological indicators. No human-in-the-loop performance is described.
7. Type of Ground Truth Used
- The primary ground truth used was biological indicators (biological spore strips). These strips are the accepted standard for verifying the effectiveness of sterilization processes. The device's color change was compared directly against the survival/kill of spores on these biological indicators.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as the SteriTec Integraph is a chemical indicator, not a machine learning or AI algorithm that requires training data. Its performance is based on its inherent chemical properties, not learned through data.
9. How Ground Truth for the Training Set Was Established
- This question is 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).