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The DCA Vantage™ is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine.

The measurement of hemoglobin A1c concentration is recommended for monitoring the longterm glycemic control of persons with diabetes.

Testing for microalbuminuria (low concentration of albumin in urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). It is intended for use in both screening for, and monitoring treatment of, microalbuminuria.

Measurement of creatinine is used as a calculation basis to adjust the albumin/creatinine ratio result for varying urine concentrations.

The reporting of albumin/creatinine ratio is recommended for the early detection of kidney diseases.

The DCA Vantage system is for use in laboratories such as: physician office laboratories, clinics, and hospitals.

Tests performed using the DCA Vantage™ are intended for in vitro diagnostic use.

The DCA Vantage is a device modification to the previously cleared DCA 2000+. It is a semi-automated, benchtop analyzer designed to quantitatively measure the percent Hemoglobin A1c (HbA1c) in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine.

Identical to the DCA 2000+, all testing takes place at the analyzer. User steps to introduce the sample to the cartridge and the cartridge to the analyzer are unchanged. To perform a test, the user needs to collect test sample in the capillary holder, insert holder into the cartridge, scan cartridge into the barcode track, place cartridge in its compartment, remove the flexible tab and close the door to automatically start the test. Test results are displayed on screen and measurement is completed in 6-7 minutes.

Here's an analysis of the provided text regarding the DCA Vantage device, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The provided document describes a Special 510(k) submission for the DCA Vantage, a device modification of the DCA 2000+. The primary goal of the study was to demonstrate substantial equivalence to the predicate device (DCA 2000+), not necessarily to predefined "acceptance criteria" in the sense of absolute performance thresholds against a gold standard. Instead, the acceptance criteria are implicitly met if the DCA Vantage performs comparably to the DCA 2000+.

The study aimed to show that the DCA Vantage meets accuracy and precision requirements relative to the DCA 2000+.

Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific numerical ranges or statistical thresholds for "accuracy requirements" or "precision performance requirements." It states that these requirements were "met," implying that the statistical analysis (Linear Regression) confirmed a comparable performance to the predicate device.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size:
     • Fifty (50) whole blood specimens for HbA1c.
     • Fifty (50) urine specimens for microalbumin/creatinine.
   • Data Provenance: The study was an "internal study," suggesting it was conducted by the manufacturer (Siemens Medical Solutions Diagnostics). The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a device modification, it's likely prospective clinical samples collected for this specific validation, but this is not explicitly stated.

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

   • Not Applicable. The ground truth for this study was established using the predicate device (DCA 2000+) itself, not human expert consensus. The study aimed to show equivalence to an existing, legally marketed device.

3. Adjudication method for the test set:

   • Not Applicable. Since the predicate device served as the reference for comparison, there was no need for expert adjudication.

4. 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:

   • No. This was not an MRMC study. The device is a "semi-automated, benchtop analyzer" for quantitative measurements, not an imaging device that requires human interpretation or AI assistance for image analysis.

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

   • Yes. This was a standalone performance evaluation of the DCA Vantage device. While it is a "semi-automated" system requiring user interaction for sample introduction, its core function is independent measurement and reporting, not human-in-the-loop assistance for interpretation. The study directly compared the measurements produced by the DCA Vantage to those from the DCA 2000+.

6. The type of ground truth used:

   • The "ground truth" or reference standard in this equivalence study was the DCA 2000+ Analyzer. The performance of the modified device (DCA Vantage) was compared against the measurements obtained from the predicate device (DCA 2000+) using the same clinical specimens and quality controls.

7. The sample size for the training set:

   • Not Applicable / Not Specified. This device is a spectrophotometer that analyzes physical properties; it is not based on machine learning or AI that requires a "training set" in the traditional sense. The device's operation is based on established analytical principles and pre-programmed algorithms.

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

   • Not Applicable. As noted above, there is no "training set" for this type of device mentioned in the documentation.

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