(90 days)
SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.
The device is made up of a 0.20 inch square faint-yellow reagent pad that has been chemically treated to detect peracetic acid in dialyzer reprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The provided text describes a 510(k) submission for a medical device called "SteriChek™ Peracetic Acid Reagent Strips." This device is a reagent strip designed to detect peracetic acid levels in dialyzer reprocessing. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with detailed acceptance criteria and performance metrics for a novel technology.
Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory document. This document is a premarket notification for a Class II device, where the primary goal is to show equivalence to an already marketed device, not to present a de novo study with strict performance criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided text. The document refers to "identical in performance" to the predicate device, but no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard) for the SteriChek device itself are given. The performance description is qualitative:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative Performance Equivalence to Predicate Device: The device should perform identically to the predicate device, "Serim™ Peracetic Acid Reagent Strips." | "ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device..." |
| Color development for peracetic acid detection: | "None or minimal color after 10 seconds indicates insufficient levels of peracetic acid and dark color (gray/purple) or black indicates acceptable levels of peracetic acid." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document does not describe a new clinical or laboratory study with a separate test set. The claim is based on manufacturing an identical product to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not available in the provided text. No specific ground truth establishment process for a new test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No adjudication method is mentioned as a new study was not conducted on this new device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/available. This device is a simple chemical reagent strip, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The device is a reagent strip that changes color, which is read by a human. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the SteriChek device, the "ground truth" implicitly relies on the established performance and chemical properties of the predicate device, Serim™ Peracetic Acid Reagent Strips. The underlying chemical reaction (iodide oxidation to iodine forming a color with starch) is the scientific basis. No new independent 'ground truth' study is discussed for this specific submission as it relies on equivalence.
8. The sample size for the training set
This information is not applicable/available. This is a chemical reagent strip, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/available. As explained above, there is no training set for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states: "The predicate device has been manufactured by Environmental Test Assessment of Performance: Systems, Inc. since its introduction by Serim Research Corporation. ETS will manufacture the SteriChek™ Peracetic Acid Strips using the same manufacturing and quality assurance procedures to produce a product identical in performance to the marketed device, but with a new name. The change in formulation provides for different color development but follow the same test principles as the predicate device."
Conclusion regarding the "study":
The "study" or justification for meeting acceptance criteria is essentially the claim of manufacturing identity and adherence to the same quality assurance procedures as the predicate device. The regulatory approach here is Substantial Equivalence (SE), meaning the device is considered safe and effective because it is essentially the same as a legally marketed predicate device. No new standalone performance study (as would be typical for novel devices or AI) is presented or required for this 510(k) submission. The "proof" is the assertion of identical manufacturing processes and shared underlying chemical principles with an already approved device.
§ 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.