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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

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.

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HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.

Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.

This reagent is intended for professional use only.

HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.

Here's a breakdown of the acceptance criteria and study details for the HiChem® BUN Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implied by the comparison to the predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit). The study's goal was to demonstrate similar performance. The quantitative acceptance criteria are not explicitly stated as numerical thresholds (e.g., "within X% difference"), but rather through statistical comparisons like correlation coefficients (r) and differences in regression equations.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision Study:
  • Serum/Urine Samples (non-ORDAC): For each of the 5 samples (3 serum, 2 urine), n = 60 (This represents 60 individual measurements for each sample type, collected over 10 days, assayed twice per day in triplicate).
  • ORDAC Samples: For each of the 2 spiked serum samples, n = 60 (This represents 60 individual measurements for each sample type).
  • Data Provenance: Not explicitly stated, but clinical laboratory studies often use control materials and patient samples from the country where the manufacturer is based (USA in this case, based on FDA submission). The study design (assaying twice per day over 30 days) suggests prospective data collection for the precision aspect.
• Patient Comparison (Method Comparison) Study:
  • Serum/Plasma: n = 160
  • Urine: n = 79
  • Data Provenance: "collected from adult patients" - implies prospective collection of patient samples. Likely from the US, given the FDA submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of submission for a diagnostic reagent does not typically involve experts establishing a "ground truth" in the way an imaging or diagnostic AI model would. In in-vitro diagnostics, the "ground truth" is typically the quantitative result obtained from a reference method or the predicate device itself, which is assumed to be accurate.

Therefore, this section is not applicable for this device. The "ground truth" for comparison is the performance of the established, legally marketed predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit).

4. Adjudication Method for the Test Set

Not applicable. There's no subjective interpretation requiring adjudication in a quantitative diagnostic assay comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is a study comparing the performance of two quantitative diagnostic reagents, not a study involving human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in the sense that the device (reagent) performance itself is being evaluated and compared to a predicate, independent of human interpretation of the results. The "algorithm" here is the chemical reaction and analytical measurement process on the SYNCHRON CX® and CX® DELTA Systems. The reported performance metrics are purely analytical measurements of the reagent's characteristics.

7. The Type of Ground Truth Used

The ground truth or reference standard for comparison is the Beckman® SYNCHRON® CX® Systems BUN Reagent Kit. This is a well-established, legally marketed predicate device, and its performance is assumed to be the "gold standard" against which the new HiChem® BUN Reagent is evaluated for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a diagnostic reagent, not an AI/ML model that requires a "training set." The development of the reagent itself would involve R&D and formulation, but not a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

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The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea. BUN determination, therefore, has become the most widely used screening procedure for evaluating kidney function. Increased BUN levels occur in cases of impaired kidney function such as chronic nephritis, acute glomerulonephritis, polycystic disease of the kidney, nephrosclerosis and tubular necrosis. BUN levels are also elevated due to urinary tract obstruction and during the terminal stage of liver disease. Decrease in BUN levels often accompany primary hepatic insufficiency and acute hepatitis.

The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.

This document describes a diagnostic reagent, the Sigma Diagnostics BUN Reagent, and its performance in measuring blood urea nitrogen (BUN) levels. It is not an AI/ML device, and therefore several of the requested categories are not applicable. I will provide information for the relevant categories based on the provided text.

Acceptance Criteria and Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a number of samples. The text mentions "serum samples" were used for the comparison study and precision evaluations.
• Data Provenance: Not specified, but implied to be from clinical laboratory testing given the nature of the device (BUN reagent). Retrospective or prospective is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a chemical reagent, not an AI/ML device relying on human interpretation of images or other subjective data. The "ground truth" for this device would be established by reference methods or validated comparative methods.

4. Adjudication method for the test set:

• Not applicable. There is no subjective interpretation involved that would require adjudication.

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:

• Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a chemical reagent, not an algorithm. Its performance is measured directly on laboratory analyzers. The "standalone" performance here refers to its ability to accurately measure BUN concentrations.

7. The type of ground truth used:

• The "ground truth" for evaluating the Sigma Diagnostics BUN Reagent's performance was its comparison against the Beckman BUN Reagent Kit, Part No. 443350, which served as the reference or comparative method for establishing substantial equivalency. Reference methods and established clinical chemistry principles form the basis of ground truth for chemical assays.

8. The sample size for the training set:

• Not applicable. Reagents do not have "training sets" in the AI/ML sense. Their formulation and performance are optimized through chemical and analytical development.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set in the AI/ML context for this device.

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