Search Results
Found 1 results
510(k) Data Aggregation
(134 days)
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells and instruments. The Conductivity/TDS Calibrator Solutions may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the equipment, and do not come into contact with the patient.
The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles.
The provided text describes the 510(k) summary for the "Conductivity/TDS Calibrator Solution." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of specific numerical thresholds for conductivity or TDS. However, the implicit acceptance criterion is that the device demonstrates sufficient accuracy and reliability for its intended use as a calibrator solution. | "The test results demonstrated that the device exceeded the acceptance specifications by greater than one order of magnitude." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "production lots" were used for validation.
- Data Provenance: The validation was performed by the "Danish Institute of Fundamental Metrology." This indicates an international (Denmark) origin for the testing. The study was likely prospective as it was performed on "production lots" to validate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The validation was performed by an institute, not explicitly by individual experts establishing ground truth in a clinical context.
4. Adjudication Method for the Test Set
- This information is not provided in the document. The study does not appear to involve human interpretation requiring adjudication.
5. 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
- No, an MRMC comparative effectiveness study was not done. This device is a calibrator solution for instruments, not an AI-based diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The device itself is the "algorithm" (in the sense of a physical reference standard) and its performance was evaluated independently by the Danish Institute of Fundamental Metrology. There is no human-in-the-loop component for this type of device's primary function.
7. The Type of Ground Truth Used
- The ground truth for the performance validation was established by the "Danish Institute of Fundamental Metrology." This implies a metrological standard or reference measurement as the ground truth. They are an institute specializing in fundamental metrology, which concerns the scientific study of measurement.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The device is a calibrator solution, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided. As mentioned above, there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1