(386 days)
The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.
The Gambro DOM 200 measures the urea concentration in the dialysis solution leaving the waste outlet of a dialysis machine. Measurements obtained by this device are used in the treatment of certain renal diseases for patients on hemodialysis. The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.
Here's a breakdown of the acceptance criteria and the study information for the Gambro Dialysis Quality Monitor DQM 200, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device seeking clearance, not a detailed scientific study report. As such, it will not contain the in-depth information typically found in a full study publication, such as detailed sample sizes, expert qualifications, or specific statistical efficacy metrics. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In Vitro Performance: Device performs as intended and labeled. | "In Vitro testing demonstrated that the device performs as intended and labeled." |
| Clinical Performance: Device performs as intended and labeled. | "Clinical testing demonstrated that the device performs as intended and labeled." |
| Substantial Equivalence: Device is substantially equivalent to the predicate device (Baxter BioStat 1000 Urea Monitor) in composition, intended use, function, and labeling. | The FDA letter (K990039) confirms substantial equivalence to the legally marketed predicate device. |
Note: The document implies the acceptance criteria are that the device performs "as intended and labeled" and is "substantially equivalent" to the predicate. Specific numerical targets for accuracy, precision, or other performance metrics are not explicitly stated in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The text only states "In Vitro testing" and "Clinical testing" were performed.
- Data Provenance: Not specified. It is not mentioned where the data was collected (e.g., country of origin) or if the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a device measuring urea concentration, the ground truth would likely be established through a reference laboratory method rather than expert adjudication of images or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned as part of the submission. The device is a diagnostic tool (urea monitor), not an image interpretation or decision-support AI tool that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
- Effect size of human reader improvement: Not applicable, as no such study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, the "In Vitro testing" and "Clinical testing" describe the performance of the device itself (the "algorithm only," if we consider the device's measurement and calculation functions as an algorithm) in laboratory and clinical settings. These tests evaluate the device's ability to accurately measure urea and derive parameters. No human "in-the-loop" performance is described in these validation aspects, though the device aids a physician.
7. Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly state the specific methods used for ground truth. However, for a device measuring urea concentration, the ground truth would almost certainly be established by:
- Reference Laboratory Methods: During in-vitro and clinical testing, the DQM 200's measurements and calculated parameters would be compared against results obtained from established, highly accurate laboratory methods for urea concentration, such as enzymatic assays or isotope dilution mass spectrometry.
- Validated Formulas: The clinical parameters derived by the DQM 200 would be based on established and validated mathematical formulas (e.g., for urea kinetic modeling).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not detail any "training set" in the context of machine learning model development. This device appears to be based on established chemical principles and formulas rather than a data-driven machine learning model that requires a discrete training phase with a labeled dataset. Its "training" would likely refer to calibration and optimization during its development, not a separate data training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable in the context of a machine learning training set as described above. If "training set" refers to calibration or development data, the ground truth would have been established using precise chemical standards and reference measurement techniques to ensure the device's accuracy across its operational range.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.