(87 days)
The Reprocessing Product Corporation (RPC) Total Chlorine Test Strips are indicated for detection of Free Chlorine and Total Chlorine in water. These Test Strips are indicated for testing water used to prepare dialysate (Free Chlorine and Chloramines) and for testing rinse water following dialysis equipment disinfection (Free Chlorine).
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Free Chlorine or Chloramines. The pad is attached to a plastic strip for handling. The color change is interpreted by the use of color blocks on two separate (ranges) color charts. Gradations for the Ultra-Low Total Chlorine (K100-0118) color chart include 0 ppm, 0.01 ppm, 0.02 ppm, 0.05ppm, 0.1ppm, 0.15ppm, 0.2 ppm. Gradations for the E-Z Chek® Sensitive Total Chlorine (K100-0106) color chart include 0 ppm, 0.1 ppm, 0.5 ppm and 3.0 ppm.
The provided document describes the Reprocessing Products Corporation (RPC) Total Chlorine Test Strips. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative pass/fail format with specific thresholds. Instead, it describes the intended performance and then presents data confirming that performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Detection of Chlorine Concentrations: | The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. |
| For water to prepare dialysate: | These data demonstrate accurate detection performance, below, equal to, and above the dialysis level of 0.1 ppm for Chloramines (measured as Total Chlorine). |
| Detection of Total Chlorine (Chloramines) at 0.1 ppm | |
| For dialysis equipment rinse water: | These data demonstrate accurate detection performance, below, equal to, and above the dialysis level of 0.5 ppm for Free Chlorine. |
| Detection of Free Chlorine at 0.5 ppm | |
| Consistency of Color Change and Correlation with Reference Solutions | The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine. These data demonstrate appropriate performance for use in testing dialysis equipment rinse water and for testing water for dialysate preparation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine." However, it does not specify the number of individual tests or measurements performed with these reference solutions. It does list the specific gradations for each test strip range (e.g., 0 ppm, 0.01 ppm, 0.02 ppm for Ultra-Low Total Chlorine).
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective. Given the nature of a 510(k) submission for a test strip, it's highly likely that the performance evaluation was conducted prospectively in a laboratory setting using prepared reference solutions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of testing for chemical reagent strips does not typically involve human experts establishing "ground truth" in the same way as medical imaging or clinical diagnoses. The "ground truth" is established by the known concentrations of the reference solutions themselves. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used when there's subjective interpretation or disagreement among human readers/experts. For these test strips, "ground truth" is determined by the precisely known concentrations of the reference solutions. The interpretation of the color change on the strip is then compared against a pre-defined color chart.
The document indicates: "The color change is interpreted by the use of color blocks on two separate (ranges) color charts." This suggests a direct comparison method rather than an adjudication process. Any discrepancies would likely point to a failure of the strip or the reading process, not an issue with establishing ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of device. MRMC studies are used to evaluate the impact of a device (often AI) on human reader performance in interpreting medical images or clinical data. This device is a semi-quantitative chemical test strip; its performance is assessed against known chemical concentrations, not through human diagnostic accuracy with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was performed. The entire performance section "The data confirm the product consistently generates color change which correlates with the color block for the Reference solution concentration. Reference solutions were used to evaluate performance between 0 and 10 ppm Chlorine..." describes the device's performance in isolation using reference solutions. It does not involve human readers interpreting results in a variable "human-in-the-loop" setting.
7. Type of Ground Truth Used
The type of ground truth used is known chemical concentrations (reference solutions). The performance of the test strips is validated by comparing the color change produced by the strip when exposed to these reference solutions against the expected color block for that known concentration.
8. Sample Size for the Training Set
The concept of a "training set" is primarily relevant for machine learning algorithms. Since this device is a chemical reagent test strip, it does not involve a machine learning algorithm and therefore does not have a "training set" in the conventional sense. The development of the chemical formulation and color chart would involve R&D and calibration, but not a dataset for algorithm training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for a machine learning algorithm, this question is not applicable. The ground truth for the performance evaluation (test set) was established by using precisely prepared reference solutions with known concentrations of chlorine.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.