(133 days)
CIDEX* OPA Solution Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of active ingredient in CIDEX* OPA Solution is above or below the minimum effective concentration of 0.3% OPA. CIDEX* OPA Solution Test Strips cannot be used to validate the sterilization or disinfection process.
The CIDEX® OPA Solution Test Strips consist of a 0.2-inch reagent-containing pad attached to one end of a 0.2 x 3.25-inch polystyrene handle. The indicator pad contains a color-forming reagent. It also contains an inhibiting compound that prevents visible reaction when the OPA concentration is at or below the MEC. When the OPA level is in sufficient excess of the MEC, the surplus reacts with the color-forming reagent. The sample is placed in a 12 x 75-mm glass test tube. The indicator pad is immersed in the sample for 30 seconds, removed and allowed to react for an additional two and one-half minutes at which time it is compared to a color standard. If the color of the entire pad is equal to or darker than the color standard, the concentration of ortho-phthalaldehyde (OPA) in CIDEX® OPA Solution is above the minimum effective concentration (MEC). If any part of the pad is lighter than the color standard, the CIDEX® OPA Solution should not be used.
The provided document describes the acceptance criteria and the study conducted for CIDEX® OPA Solution Test Strips.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specificity (no false PASS results) at MEC (0.30% OPA) | 1.00 (All 324 results were FAIL at 0.30% OPA, correctly indicating the solution is below the effective concentration) |
| Ability to detect OPA concentrations above MEC (0.40% OPA) | 322 out of 324 results were PASS (99.38% sensitivity) |
| Ability to detect OPA concentrations above MEC (0.45% OPA) | 324 out of 324 results were PASS (100% sensitivity) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 324 results were obtained with each standard (0.30% OPA, 0.40% OPA, and 0.45% OPA). This implies the test set comprised multiple samples (standards) evaluated multiple times. The document states "324 results were obtained with each standard," suggesting 324 individual tests for each OPA concentration.
- Data Provenance: The document does not explicitly state the country of origin. The study was conducted as "blind studies" using "CIDEX® OPA Solution standards." This suggests a controlled laboratory setting rather than data derived from real-world clinical use. The study is prospective as it involves controlled testing of the device.
3. Number of Experts and Qualifications
- Number of Readers: Eight individuals.
- Qualifications: "Three of the readers were inexperienced in laboratory techniques." The qualifications of the other five readers are not specified.
4. Adjudication Method
- The document implies that each of the eight individuals independently read the test strips, and their individual results were collected. It does not describe an adjudication method like 2+1 or 3+1 (where multiple experts independently interpret and then a tie-breaker or consensus is used). The results are presented as aggregated counts (e.g., "324 results were FAIL").
5. MRMC Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a chemical indicator test strip, not an AI-powered diagnostic tool.
6. Standalone Performance
- Yes, a standalone performance study was done. The study evaluated the performance of the CIDEX® OPA Solution Test Strips (the device itself) in detecting OPA concentrations in solution. There is no human-in-the-loop component beyond the visual interpretation of the color change on the strip, which is an inherent part of the device's function.
7. Type of Ground Truth Used
- Known Concentration Standards: The ground truth was established using "CIDEX® OPA Solution standards" with known concentrations of OPA (0.30%, 0.40%, and 0.45%). This is an objective ground truth based on chemically prepared solutions.
8. Sample Size for the Training Set
- The document describes performance testing for regulatory submission, not a machine learning model. Therefore, there is no explicit training set sample size as typically understood in AI/ML contexts. The description focuses solely on the validation/test phase of the device.
9. How Ground Truth for the Training Set was Established
- As concluded in point 8, there is no explicit training set for this device in the context of AI/ML. The device's mechanism is based on chemical reactions, and its design and formulation would have been developed through R&D, likely using internal experiments and optimization, rather than a formal "training set" with established ground truth as in supervised learning.
§ 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).