(15 days)
"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include the odilibrator of conduction to verify or calibrate conductivity or calibrate conductivity functions of dialysis related equipment.
These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.
H&S - Conductivity Standard Solution is salt-based liquid produced by dissolving reagent grade salt in treated water and equilibrated to atmospheric CO2. The salt concentration determines the conductivity value. The solution is packaged in various size polyethylene bottles and sealed with a taper indicator seal and cap. The product label is added, and the device is placed in a clear plastic bag The product label contains instructions for use, warnings, and other safety information. H&S - Conductivity Standard Solution is available in of a range sizes, values and accuracies.
No acceptance criteria or study information is available in the provided document for the "H&S - Conductivity Standard Solution". The document describes the device, its intended use, and states that verification and validation were performed, but it lacks specific details on quantitative acceptance criteria or the study methodology and results.
Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness studies.
Here's the table of acceptance criteria and reported device performance, however, it will be empty as the information is not present:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Based on the provided document, the following information is not available:
- Sample size used for the test set and the data provenance: Not mentioned. The document states "Verification and validation of the performance specifications of the device was performed on production lots and samples of the two predicate devices," but no sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a conductivity standard solution, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a conductivity standard solution, not an algorithm.
- The type of ground truth used: Not explicitly stated as "ground truth." The document mentions that the device is "traceable to NIST (National Institute of Standards and Technology)," implying that NIST standards serve as the reference for accuracy.
- The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.