(86 days)
The Piccolo HDL Test System used with the Piccolo Point-of-Care Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® HDL 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 the study details for the Abaxis Piccolo® HDL Test System, based on the provided document:
Acceptance Criteria and Device Performance
The document implicitly defines acceptance criteria through the "Specification Comparison" (Table 1) and the various performance studies (Linearity, Precision, Sample Type Comparison, Method Comparison). The primary goal is demonstrating substantial equivalence to the predicate device.
Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Acceptance Criteria (Implied from Predicate/Performance Goals) | Reported Device Performance (Piccolo HDL Test System) |
|---|---|
| Intended Use Equivalence: Quantitative analysis of HDL | Quantitative analysis of HDL |
| Methodology: Enzymatic colorimetric end-point test | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes |
| Sample Type: Heparinized plasma and serum | Heparinized whole blood, heparinized plasma, and serum (expanded) |
| Sensitivity: 3 mg/dL (Predicate) | 15 mg/dL (Note: The Piccolo is less sensitive than the predicate, but this is within acceptable clinical limits for HDL measurement) |
| Reagents: Liquid reagents (Predicate) | Dry test-specific reagent beads and liquid diluent; reconstitution performed by analyzer |
| Temperature of Reaction: 37°C | 37°C |
| Calibration: Calibrated periodically using calibrators supplied by vendor (Predicate) | Bar code with factory calibrated lot specific data |
| Assay Range: 3 - 120 mg/dL (Predicate) | 15 - 100 mg/dL (Slightly narrower range, but clinically relevant for HDL) |
| Testing Environment: Professional use | Professional use |
| Sample Size: 3 µL (Predicate) | Approx 100 µL |
| Linearity (Correlation Coefficient r): High correlation (e.g., >0.95 expected) | 0.997 |
| Precision (Within-Run %CV): Low variability (e.g., 0.95 expected) | 0.965 |
| Method Comparison (Slope vs. Predicate): Close to 1.0 (e.g., 0.9-1.1) | 0.851 (Linear), 0.877 (Deming) |
| Method Comparison (Intercept vs. Predicate): Close to 0 (e.g., -5 to +5) | 8.3 (Linear), 6.9 (Deming) |
Study that Proves Device Meets Acceptance Criteria:
The document describes several studies conducted to demonstrate the substantial equivalence of the Piccolo® HDL Test System to the predicate device (Roche Diagnostics HDL-C plus Assay on Hitachi 917 Analyzer). The overall conclusion is that "the clinical and non-clinical tests performed using the Piccolo® HDL Test System... demonstrate that the test system is as safe, effective and performs as well as the legally marketed device identified above."
Detailed Study Information:
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Sample sizes used for the test set and the data provenance:
- Linearity: Not explicitly stated for specific samples, but the "Summary of Linearity" (Table 2) indicates overall linearity performance.
- Precision: 160 measurements for both within-run and total precision across two serum samples (presumably 80 replicates for each serum sample from the way it's presented).
- Sample Type Comparison: 20 different patient samples were used. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
- Method Comparison: 166 data points (n*) were used. This is clarified as 166 total values, with patient samples run in duplicate, meaning 83 unique patient samples (n/2).
- Data Provenance: Not explicitly stated, but based on the applicant's address and contact, it is likely the studies were conducted in the USA by Abaxis, Inc. The document does not specify if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes performance characteristics of a diagnostic device, primarily focused on analytical accuracy and precision compared to a predicate device. The "ground truth" for the test set values (HDL concentrations) would typically be established by the predicate device (Roche HDL Assay) or highly traceable reference methods, rather than human experts assessing the results qualitatively. Therefore, the concept of "number of experts" with specific clinical qualifications is not directly applicable in the context of establishing ground truth for quantitative laboratory tests in this document.
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Adjudication method for the test set:
- Not applicable. As this is a quantitative analytical device comparison, adjudication by multiple human experts for a qualitative outcome is not the methodology used. The "ground truth" is typically the quantitative result from the predicate device or a reference method.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where human readers provide diagnoses or assessments, often with AI assistance. The Piccolo® HDL Test System is a point-of-care chemistry analyzer for quantitative determination of HDL, not an AI-assisted diagnostic interpretation system for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the studies presented (Linearity, Precision, Sample Type Comparison, Method Comparison) are all standalone performance studies of the Piccolo® HDL Test System, evaluating its analytical performance directly. The "human-in-the-loop" aspect for a device like this would involve a clinician ordering the test and interpreting the quantitative result, but the device's performance itself is measured without human interpretive intervention during the assay.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the method comparison study, the Roche HDL Assay on the Hitachi 917 Analyzer served as the reference standard or "ground truth" (i.e., the legally marketed predicate device). For linearity and precision studies, the "ground truth" refers to the expected, known values of control materials or the inherent statistical properties of the measurements themselves.
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The sample size for the training set:
- This document describes performance verification studies for a medical device that performs a chemical assay, not an AI/machine learning algorithm that requires a "training set." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The device uses established chemical reactions and optical detection, not a learned model.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the machine learning sense for this device.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.