(72 days)
The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems. MeterCare is an Over-the-Counter product and needs no prescription. The product is for In Vitro use only.
The "Conductivity Standard Solution – MeterCare" is a range of high accuracy conductivity standard solutions to calibrate conductivity meters used in dialysis to test the conductivity of dialysate of dialysis machines and water used in hemodialysis applications.
The information provided focuses on the regulatory submission for a medical device (a conductivity standard solution) and its substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria in a typical medical diagnostic or treatment context.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from the provided text for this type of device.
However, I can extract the relevant information regarding the acceptance criteria and the methods used to demonstrate the device's characteristics.
Here is the breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy (Uncertainty) | |
| Primary Solutions | ±0.10% |
| Secondary Solutions | ±0.15% |
| Composition | KCl, NaCl, 442 Natural Water (40% Sodium Sulfate, 40% Sodium Bicarbonate, 20% Sodium Chloride) |
| Intended Use | Used to calibrate conductivity meters for dialysate, dialysate concentrate, and water treatment systems in hemodialysis applications. |
| Safety and Effectiveness | Considered "safe and effective for the intended use and is substantially equivalent to the predicate device." |
Note: The "acceptance criteria" here are implied by the stated uncertainties for the solutions. The primary method of demonstrating performance is through adherence to established standards and substantial equivalence to a predicate device, as opposed to a direct measure against a performance goal in a clinical trial.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "test set" in this context refers to the batches of the Conductivity Standard Solution - MeterCare that were manufactured and tested according to various standards, not a patient cohort or a set of clinical cases. The document does not specify the number of batches or individual samples tested.
- Data Provenance: Not applicable in the context of clinical data. The device itself is a standard solution, and its performance is validated through metrological testing against recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for a conductivity standard solution is established by its chemical composition and precise manufacturing processes, which are then verified against metrological standards. There are no "experts" in the sense of clinical reviewers establishing a ground truth for diagnostic accuracy.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The performance is determined through standardized laboratory measurements and comparison to metrological standards, not through expert adjudication of ambiguous cases.
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
- MRMC Study: Not applicable. This device is a calibration standard, not an AI-powered diagnostic tool. There are no "human readers" in the context of interpreting results derived from this product in a diagnostic setting.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical chemical standard, not an algorithm or software device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the "Conductivity Standard Solution - MeterCare" is based on:
- Metrological Standards: Adherence to established scientific and industry standards for conductivity and calibration, such as NIST Special Publication 260-142, IUPAC Standards for Conductivity, OIML Standards for Conductivity, ASTM D 1125-91, and ISO 7888.
- Chemical Composition and Manufacturing Process: The precise formulation of the solutions (e.g., KCl, NaCl, 442 Natural Water composition) and their accurate preparation to yield specific conductivity values with defined uncertainties.
8. The sample size for the training set
- Sample Size: Not applicable. This is a manufactured product, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment: 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.