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The A,B . C Standards are intended for use in calibrating Nat, K., Cl. and TCO, analytes on the Dade Dimension Chemistry Systems.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation. The ALKO Standard Reagents are intended to serve as direct replacements to like named products manufactured by Dade Chemistry Systems Inc.(formally Dupont International). ALKO uses a similar composition, description and packaging design as that used by Dade Chemistry Systems Inc. in its products.

Here's an analysis of the provided 510(k) summary, structured to address your specific questions about acceptance criteria and study details:

Acceptance Criteria and Device Performance for ALKO Standards A, B, and C

This 510(k) submission describes ALKO Standards A, B, and C, intended for calibrating Na+, K+, Cl-, and TCO2 analytes on Dade Dimension Chemistry Systems with the MultiPLY™ Integrated Multisensor module. The study aims to demonstrate performance equivalence of ALKO products to Dade Chemistry Systems products.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria for the precision or accuracy studies in a tabular format. However, based on the presented data and the nature of calibration standards, implicit acceptance criteria can be inferred, primarily alignment with the performance of the predicate device (Dade Standards) and generally acceptable precision for diagnostic assays.

Implicit Acceptance Criteria and Reported Performance:

Note: The implicit criteria are based on standard expectations for clinical chemistry assays and the goal of demonstrating equivalence to a predicate device. Specific numerical targets for acceptance are not provided in the document.

2. Sample Size and Data Provenance

• Precision Study (Test Set):

  • Sample Size: For each analyte (Na+, K+, Cl-, TCO2) at each of the two levels of serum controls, data from 45 total observations (N=45) were used. This was derived from 3 runs per day, 3 times per run for 5 days (3 x 3 x 5 = 45). For "Run to Run" precision, N=15 for each analyte at each level (presumably representing the 5 days of testing with 3 runs per day as a unit).
  • Data Provenance: Not explicitly stated, but given the US manufacturer (ALKO Diagnostic Corporation, Holliston, MA) and the use of the Dade Dimension system, it's highly likely the data was collected in the United States. The study appears to be prospective for the purposes of this 510(k) submission, as it describes data collection for the specific purpose of demonstrating performance equivalence.

• Accuracy (Correlation) Study (Test Set):

  • Sample Size:
    • Na+, K+, Cl-: 156 patient serum samples and 12 control samples (Total N=168).
    • TCO2: 76 patient serum samples.
  • Data Provenance: Not explicitly stated, but likely United States (similar reasoning as above). The mention of "patient serum samples" suggests the data was collected for this study, making it prospective in nature.

3. Number of Experts and Qualifications for Ground Truth

• This submission describes calibration standards for an in vitro diagnostic chemistry system. The ground truth for such devices is typically established through:
  • Reference Methods: Highly accurate and precise analytical methods used to assign true values to calibrator and control materials.
  • Predicate Device Performance: The primary "ground truth" or reference for this 510(k) is the performance of the Dade MultiPLY™ Standard Reagents already cleared for use.
• There is no mention of human experts (like radiologists) being used to establish ground truth for this type of IVD device. The "ground truth" is analytical and comparative to a predicate device.

4. Adjudication Method for the Test Set

• Not applicable. This type of IVD submission, involving calibration standards and analytical performance, does not typically involve adjudication by human experts in the way clinical diagnostic imaging studies might. The comparison is objective, based on analytical values generated by the instruments with different calibrators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study focuses on human reader performance (e.g., radiologists interpreting images) with and without AI assistance. This 510(k) pertains to chemical calibration standards and analytical device performance, not human interpretation.

6. Standalone (Algorithm Only) Performance

• Essentially, yes, this is a standalone performance assessment in its context. The "device" in this case is the ALKO calibration standard. The studies assess the performance of the Dade Dimension instrument calibrated with ALKO standards (standalone performance of the calibrator-instrument system) against the same instrument calibrated with the predicate Dade standards. There is no human-in-the-loop component in the analytical measurements themselves.

7. Type of Ground Truth Used

• The ground truth in the context of this submission is effectively the performance of the predicate device (Dade MultiPLY™ Standard Reagents).
  • For the precision study, the ground truth is the inherent analytical variability of the system when calibrated with ALKO reagents (measured against itself).
  • For the accuracy (correlation) study, the ground truth for comparison is the values obtained when the Dade Dimension system is calibrated with Dade's own standards. The goal is to show that using ALKO standards yields comparable results.

8. Sample Size for the Training Set

• No separate training set is explicitly mentioned or relevant for this type of 510(k) submission. This device (calibration standard) is not an AI algorithm that "learns" from data. The studies performed are verification and validation studies (precision and accuracy) to demonstrate the product's performance against established benchmarks (the predicate device).

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

• Not applicable. As there is no "training set" in the AI sense, there is no ground truth established for a training set. The relevant ground truth (predicate device performance) is referenced directly for the test/comparison studies.

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