(99 days)
The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate.
The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with blood in dialysate. The pad is attached to a plastic strip for handling.
The provided document describes the Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips. Here's an analysis of the acceptance criteria and the study outlined:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative pass/fail format typical for medical device verification. Instead, it describes the intended performance and the study's findings regarding that performance.
| Acceptance Criteria (Implied from Intended Use) | Reported Device Performance |
|---|---|
| Indicate the presence or absence of blood in dialysate. | The product consistently generates color change which meets the color block for the reference solution concentration. |
| Measure equal to 0 mg HGB/dL (no blood). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Measure 0.25 mg HGB/dL (presence of blood at a specific detectable threshold). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Appropriate performance for use in hemodialysis dialysate during treatment. | These data demonstrate appropriate performance for use in hemodialysis dialysate used in treatment. |
| Technological characteristics: Detection based on pseudoperoxidative activity of hemoglobin and myoglobin, catalyzing oxidation of an indicator by an organic hydroperoxide, producing a color change consistent with color blocks. | Confirmed through the performance study where the device generates color change that meets the color block for reference solutions, implying the underlying technological principle is functional and produces the expected visual outcome. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Reference solutions" were used, and "data confirm the product consistently generates color change," but it doesn't quantify the number of tests performed or the sample size of distinct reference solutions/concentrations tested.
- Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance evaluation using reference solutions, rather than human clinical data from a specific country. It is almost certainly retrospective in the sense that the test strips were manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by the known concentrations of hemoglobin (HGB) in the prepared reference solutions, not by expert human interpretation. The "color block" comparison itself would be a visual assessment, but the ground truth is the chemical concentration.
4. Adjudication Method for the Test Set
Not applicable. The performance is evaluated by observing a color change and comparing it to a visual "color block" corresponding to known HGB concentrations. There is no mention of human adjudication for the results beyond this direct comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test strip where performance is assessed by comparison to reference color blocks, not by interpretation by multiple human readers. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this appears to be a standalone performance evaluation. The device's performance is determined by its inherent color-changing reaction to blood in dialysate, and its comparison to established color blocks. There is no "human-in-the-loop" aspect to its fundamental operation or the evaluation method described beyond visually comparing the strip's color to a reference.
7. The Type of Ground Truth Used
The ground truth used is known concentrations of hemoglobin (HGB) in prepared reference solutions. These solutions serve as the objective standard against which the test strip's color-changing reaction is evaluated.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent test strip, not an AI or machine learning algorithm that requires a "training set." Its chemical formulation dictates its performance, which is then verified.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.