(406 days)
Micro-X Residual Test Strips are intended for use as a semi-quantitative test of the residual presence of peracetic acid in dialyzers after reprocessing. This device may be used with all peroxyacetic/peracetic acid germicides used in the reprocessing of dialyzers, sanitation of water treatment systems and dialysis machine disinfection as part of an established quality assurance program.
Micro Xtm Residual Test Strips are approximately 0.25" x 4.75" packaged 100strips /container. The strips are labeled for use in Reprocessing Hemodialyzers. Micro X " Test Strips have a test pad, which is impregnated with peroxidase, which liberates oxygen from peracetic acid upon contact with the solution. The oxygen reacts with the chromophore, color indicator, which is also present on the test pad, resulting in a color change. The color change is compared to the color scale on the container and the result is read directly in mg/L.
The provided text focuses on the 510(k) summary for Micro X™ Residual Test Strips and the FDA's clearance letter. It describes the device, its intended use, and states that comparative testing was done. However, it does not contain enough information to fully describe the acceptance criteria and the study in the detail requested.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "Comparative testing between Micro Xtm Residual Strips" and states the device is "Substantially equivalent to Renalin Residual Test Strips." This implies the acceptance criterion was likely meeting or closely approximating the performance of the predicate device (Renalin Residual Test Strips). However, the specific metrics for comparison (e.g., sensitivity, specificity, accuracy, precision, detection limits, agreement percentage) and the actual numerical results are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance substantially equivalent to Renalin Residual Test Strips | Met (based on 510(k) clearance) |
| (Specific metrics and thresholds not provided in the document) | (Specific results not provided in the document) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document only states "Comparative testing." It does not specify the number of samples (e.g., how many tests were run, across what range of concentrations, or how many dialyzers/systems were tested).
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or from what country/locations the samples originated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The testing seems to be a chemical/analytical comparison rather than relying on human interpretation directly for primary ground truth.
4. Adjudication method for the test set:
- Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No. This type of study is not applicable as the device is a chemical test strip, not an imaging or diagnostic device requiring human interpretation of complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone, non-algorithmic chemical test strip. Its performance is inherent to its chemical reaction and color change. Users read the color change against a scale, but the core "algorithm" is the strip's chemistry. Therefore, its performance is its standalone performance.
7. The type of ground truth used:
- Implied Ground Truth: The ground truth for this type of device would typically be:
- Known concentrations of peracetic acid: prepared standards measured by analytical chemistry methods (e.g., titration, spectrophotometry) as the gold standard.
- Comparison to a predicate device: The performance of the Renalin Residual Test Strips would serve as a reference in this comparative study.
- The document doesn't explicitly state how the ground truth was established, but it would logically involve creating solutions with known peracetic acid concentrations.
8. The sample size for the training set:
- Not applicable/Not mentioned. Chemical test strips typically do not have "training sets" in the same way machine learning algorithms do. Their performance is based on their chemical composition, which is developed and optimized, but not "trained" with data.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned for the reasons above.
In summary: The provided text is a high-level 510(k) summary and FDA clearance letter. It confirms that comparative testing was done to establish substantial equivalence with a predicate device for Residual Test Strips, but it lacks the detailed technical specifications and study results that would describe specific acceptance criteria and performance data.
§ 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.