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The Piccolo Total Cholesterol Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein disorders.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Total Cholesterol Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

Here's a breakdown of the acceptance criteria and study information for the Piccolo® Total Cholesterol Test System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, or correlation coefficient. Instead, it relies on demonstrating comparable performance to the predicate device. However, we can infer some performance metrics from the reported data.

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

• Linearity & Precision Test Sample Size:
  • Linearity: The document shows a slope, intercept, and correlation coefficient, but does not explicitly state the number of samples used for the linearity study.
  • Precision:
    • Within-Run: n = 160 (for each serum sample type, so likely 320 total measurements involving repetition)
    • Total: n = 160 (for each serum sample type, so likely 320 total measurements involving repetition)
• Sample Type Comparison Test Sample Size: Samples from 20 different patients. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
• Method Comparison Test Sample Size: 174 data points (n*) for both the Piccolo CHOL Test System and the Bayer Cholesterol Assay. Since patient samples were run in duplicate, this means approximately 87 patient samples were used (n/2).
• Data Provenance: Not explicitly stated (e.g., country of origin). However, given Abaxis, Inc. is in Union City, CA, and the FDA review is addressed to "Dr. Bleile, Ph.D. Director of Assay Development Abaxis, Inc. 3240 Whipple Road Union City, CA 94587," it is highly probable the studies were conducted in the United States. The studies appear to be prospective as they were specifically designed and conducted for the purpose of demonstrating substantial equivalence for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a diagnostic test for measuring total cholesterol, an objective biochemical marker. The "ground truth" for the test set is established by the reference method (Bayer Cholesterol-RA Assay) and the quantitative nature of the chemical reactions, rather than by expert readers or interpreters.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an objective quantitative assessment, not dependent on human interpretation requiring adjudication. Performance is compared to a predicate device and established linearity/precision targets.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic devices where human readers interpret images, and the AI's role is to assist or replace human interpretation. The Piccolo® Total Cholesterol Test System is an automated in vitro diagnostic device for quantitative chemical analysis.

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

Yes, the studies presented are for the standalone performance of the Piccolo® Total Cholesterol Test System. The device is designed for automated quantitative analysis, and its performance (linearity, precision, method comparison) is assessed as an algorithm-only measurement.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Piccolo® Total Cholesterol Test System is primarily established through:

• Comparison to a legally marketed predicate device: The Bayer Cholesterol-RA Assay, which serves as a clinical standard.
• Known concentrations: For linearity studies, a range of samples with known or precisely measured concentrations would be used to assess the device's ability to accurately measure across its assay range.
• Replicate measurements: For precision studies, repeated measurements of the same samples establish reproducibility.
• Clinical samples: Patient samples are used for method comparison to reflect real-world variability.

Essentially, the ground truth is reference method comparison and established analytical performance metrics (linearity, precision) rather than pathology, expert consensus, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or "test set" in the context of machine learning. This device is a biochemical analyzer, not
an AI/ML-based diagnostic algorithm that requires a training phase with a dedicated dataset. The device's calibration involves "Bar code with factory calibrated lot specific data" which is a form of calibration/initial setup, but not "training" in the AI sense.

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

Not applicable. As per point 8, there is no "training set" in the context of AI/ML for this device. The accuracy of the factory calibration would be established through laboratory reference methods and quality control procedures during manufacturing.

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