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The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple complex under strong alkaline conditions.

The provided 510(k) summary describes the acceptance criteria and the study that proves the device meets those criteria for the S-Test CA Reagent cartridge, used for quantitative determination of calcium in serum or heparin plasma.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The summary does not explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it presents performance data for precision, accuracy, and sensitivity, which are implicitly the criteria for demonstrating substantial equivalence.

• Within-run CV: 1.1 to 1.2% (3 CA levels)
• Total CV: 1.6 to 2.2% |
  | | | POL Sites (5 days):
• Within-run CV: 0.4 to 3.9%
• Total CV: 0.7 to 4.3% |
  | Accuracy | High correlation with comparison method; low error | Correlation Study (181 samples):
• Correlation Coefficient: 0.978
• Standard Error Estimate: 0.4
• Confidence Interval Slope: 0.950 to 1.003
• Confidence Interval Intercept: -0.30 to 0.17 |
  | | | Patient Correlation (4 POL sites):
• Correlation Coefficients: 0.929 to 0.965
• Standard Error Estimates: 0.49 to 0.68
• Confidence Interval Slopes: 0.833 to 1.048
• Confidence Interval Intercepts: -0.62 to 1.54 |
  | Sensitivity | Low detection limit | Detection Limit: 2.3 mg/dL |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: For accuracy/correlation studies, 181 samples were used in the main correlation study, ranging from 2.4 to 14.5 mg/dL CA values.
• Data Provenance: The document does not explicitly state the country of origin. It mentions studies conducted "at three separate Physician Office Laboratory (POL) sites and in-house" as well as "four separate POL sites," suggesting these were conducted within the US, where the applicant (Alfa Wassermann Diagnostic Technology, LLC) is located. The studies appear to be prospective as they involve assaying samples on the S40 Clinical Analyzer and a comparison method for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a clinical chemistry device for quantitative measurement. The "ground truth" is established by a comparison method, which is another established clinical analyzer or laboratory method for measuring calcium. Experts are not typically used to establish ground truth in this context; rather, the accuracy of the new device is validated against the results of a recognized, validated reference method. The document does not specify details about the "comparison method" used, such as its specific identity or the qualifications of those operating it beyond being a "comparison method."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Adjudication methods are typically employed in studies where human interpretation of results is involved (e.g., radiology image interpretation). For quantitative chemistry assays, the comparison is made directly between the numerical output of the new device and the comparison method.

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

N/A. This is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable.

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

This device is a standalone diagnostic test system (reagent cartridge + analyzer). The performance data presented (precision, accuracy, sensitivity) directly reflects the performance of the "algorithm" and instrument without human interpretive subjectivity in the measurement itself. Human action involves operating the instrument and interpreting the numerical output, but the measurement itself is automated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the accuracy studies was established by a comparison method (another clinical analyzer or laboratory assay) that is presumably already clinically validated and accepted.

8. The sample size for the training set

N/A. This 510(k) summary describes a traditional in vitro diagnostic device, not a machine learning model that requires a "training set." The device's performance is based on its chemical and photometric principles and calibration, not on data-driven training.

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

N/A. (See point 8).

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