(21 days)
The Browne OPA Test Strip is a concentration monitor for use in ortho-phthalaldehydecontaining germicide solutions with a minimum effective concentration of 0.3%. The Browne OPA Test Strip is dedicated for use with Cidex™ OPA solution
The Browne OPA Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne OPA Test Strip has been developed to monitor the active OPA concentration of Cidex™ OPA solution that has a concentration greater than 0.3% by way of a color change from light blue to purple.
The provided text describes the Browne OPA Test Strip, a chemical indicator for monitoring the concentration of ortho-phthalaldehyde (OPA) in germicide solutions. Here's a breakdown of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum Effective Concentration (MEC): The device should indicate a concentration of OPA greater than or equal to 0.3%. | The Browne OPA Test Strip shows a color change from light blue to purple when the OPA concentration is greater than 0.3%. |
| Dip Time: 1 second | The proposed device has a 1-second dip time. |
| Read Time: 60 seconds | The proposed device has a 60-second read time. |
2. Sample Size Used for the Test Set and Data Provenance
The document provided does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only refers to a "summary of the technological characteristics of the new device in comparison to those of the predicate devices" in Section 12 of the premarket notification, which is not included in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The study described focuses on the chemical indicator's performance based on color change relative to chemical concentration, rather than human interpretation of results requiring expert consensus in the typical sense of a medical imaging study.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of a chemical indicator, the "ground truth" would likely be established by a quantitative chemical analysis of the OPA solution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The Browne OPA Test Strip is a chemical indicator, not a device that relies on human interpretation in the same way as, for example, a diagnostic imaging system. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not entirely applicable in the context of a chemical indicator strip. The "performance" of the device itself (the chemical reaction and color change) is inherently standalone. The human "in the loop" would be observing the color change and comparing it to a reference, not an algorithm. The study implicitly assesses the standalone performance of the chemical indicator.
7. The Type of Ground Truth Used
The ground truth used for this device would be the actual chemical concentration of OPA in the germicide solutions, most likely determined through a validated analytical method (e.g., titration or spectroscopy). The device's color change is then compared to this known concentration.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. As a chemical indicator, it's more likely to be calibrated and validated against known concentrations rather than "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for a "training set" was established. However, for devices like this, the ground truth would typically be established by preparing germicide solutions with precisely known OPA concentrations and then observing the corresponding color changes on the test strips. This would involve laboratory testing and chemical analysis to confirm the OPA concentrations.
§ 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).