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510(k) Data Aggregation
(72 days)
CONDUCTIVITY STANDARD SOLUTION-METERCARE
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.
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