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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

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.

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CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, and when used according to the Directions for Use.

High Level Disinfectant: CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, at 20° C (68° F) with an immersion time of at least 12 minutes for a reuse period not to exceed 14 days.

Minimum Effective Concentration (MEC): 0.3%.

CIDEX® OPA Solution is formulated to contain 0.55% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, chelating agents, and a dye in a phosphate buffer. ortho-Phthalaldehyde is chemically related to glutaraldehyde in that they are both aldehydes. The mechanism of action of ortho-phthalaldehyde is postulated to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

Device Name: CIDEX® OPA Solution (0.55% ortho-phthalaldehyde Solution)
Intended Use: High level disinfectant for reprocessing heat-sensitive medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Simulated Use (Tuberculocidal): Specific sample size for this test is not explicitly stated, but it involved efficacy against Mycobacterium terrae in artificial soil.
• In Use Testing: One hundred endoscopes were studied.
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective in nature, designed to test the performance of the CIDEX® OPA Solution under controlled and simulated-use conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document describes laboratory efficacy tests and clinical "in use" testing. For these types of studies involving disinfection and sterilization, "ground truth" is typically established by standardized laboratory protocols and microbiological cultures, rather than expert medical consensus in the diagnostic sense.
• The "In Use Testing" on 100 endoscopes would have involved microbiologists or laboratory personnel responsible for culturing and determining the presence/absence of microorganisms, and potentially clinicians handling the endoscopes. No specific number or qualifications for "experts" establishing ground truth are provided in the context of consensus interpretation, as this is not an image-based or qualitative diagnostic assessment. The "ground truth" is typically objective microbiological growth or lack thereof.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments (e.g., interpreting medical images).
• For the types of tests described (microbiological efficacy, biocompatibility, material compatibility), adjudication by consensus of multiple human readers is not typically involved. Results are usually objective measurements (e.g., colony counts, toxicity levels, material degradation) performed according to established protocols. Therefore, the adjudication method would effectively be none in the traditional sense, relying instead on the established scientific reproducibility of the tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are typically used to evaluate the diagnostic performance of human readers, with and without the assistance of AI, usually in the context of medical imaging or pathology. This submission is for a chemical disinfectant, which is evaluated based on objective laboratory and in-use efficacy against microorganisms, not human diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable to this device. CIDEX® OPA Solution is a chemical disinfectant, not an algorithm or an AI software device. Its performance is inherent to its chemical properties and formulation.

7. The Type of Ground Truth Used

The "ground truth" for the studies described is primarily:

• Microbiological Culture Results: For efficacy testing (sporicidal, bactericidal, fungicidal, tuberculocidal, virucidal, and in-use testing), the ground truth is the presence or absence of viable microorganisms after exposure to the disinfectant, as determined by standard microbiological culture and enumeration techniques.
• Toxicological Endpoints: For biocompatibility, the ground truth is based on observed biological responses in in vitro and in vivo animal models (e.g., acute toxicity, sensitization, genetic toxicity, developmental toxicity).
• Material Integrity Assessments: For material compatibility, the ground truth is based on visual inspection, mechanical property testing, or other methods to assess degradation or changes to medical device materials.

8. The Sample Size for the Training Set

• This question is not applicable as CIDEX® OPA Solution is a chemical disinfectant, not a machine learning or AI-based device that requires a "training set" in the computational sense. The formulation of the disinfectant is based on chemical principles and experimental optimization, not on a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as point 8.

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