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The Piccolo Triglycerides - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of triglycerides in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location.

Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

The Piccolo® Lipid Panel - Capillary Reagent Disc (which contains the Piccolo® Triglycerides - Capillary 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.

Here's a breakdown of the acceptance criteria and the study details for the Piccolo® Triglycerides - Capillary Test System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in this summary. Instead, the summary presents the performance characteristics and implies that these results demonstrate substantial equivalence to predicate devices. For this table, I'll present the performance characteristics provided.

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

• Sample Size for Linearity: Not explicitly stated, but the "Summary of Linearity" implies sufficient samples were used to generate the reported slope, intercept, and correlation coefficient.
• Sample Size for Precision: 160 observations (n=160) for both within-run and total precision for each serum level.
• Sample Size for Method Comparison: 588 samples (N=588).
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is from "clinical and non-clinical tests performed using the Piccolo® Triglycerides Test System," implying it was generated specifically for this submission. It's prospective testing as the device underwent testing.

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

This information is not applicable to an in vitro diagnostic (IVD) device that measures a biomarker. The "ground truth" for these tests is typically established through reference methods or highly accurate laboratory analyzers, not expert interpretation. In this case, the Roche Triglycerides Test on the Cobas 6000 Analyzer serves as the comparator or reference method for the method comparison study.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Test results are quantitative measurements, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in vitro diagnostic device for quantitative blood analysis, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (linearity, precision, method comparison) represents the standalone performance of the Piccolo® Triglycerides - Capillary Test System. It measures triglyceride levels quantitatively without direct human interpretation of the primary result (beyond initiating the test and reading the numerical output).

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" (or reference method) was the Roche Triglycerides Test performed on the Cobas 6000 Analyzer, with results reported as the "Average of Duplicates."

8. The Sample Size for the Training Set

Not applicable. This device is a diagnostic test kit and analyzer, not a machine learning or AI algorithm that requires a "training set." Its calibration is based on "Bar code with factory calibrated lot specific data" (Table 1), implying chemical calibration and quality control rather than data-driven machine learning training.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The calibration of the device is factory-set and lot-specific using bar codes, as noted in Table 1.

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

Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders.

The Piccolo® Lipid Panel Reagent Disc (which contains the Piccolo® Triglycerides 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 analvzer. Alternately, the disc mav also be used with serum.

This document describes the regulatory submission for the Abaxis Piccolo® Triglycerides Test System. The device is a laboratory test system designed to measure triglyceride levels in blood samples.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance characteristics of the new device and compares them to those of a legally marketed predicate device (Bayer Triglycerides-RA Assay). The underlying acceptance criterion for regulatory approval in this context is "substantial equivalence" to the predicate device, meaning the new device performs as safely and effectively. The tests conducted (linearity, precision, sample type comparison, and method comparison) are standard ways to demonstrate this equivalence for in vitro diagnostic devices.

Below is a table summarizing the reported device performance and comparing it to the characteristics of the predicate device, which implicitly defines the 'acceptance' for a substantially equivalent device.

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

• Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples, but the results for slope, intercept, and correlation coefficient are provided.
• Precision Study:
  • Sample Size: n = 160 for both within-run and total precision for each serum level tested (Serum 1 and Serum 2). This appears to be 160 replicates per serum level, not 160 distinct patient samples.
  • Data Provenance: Not specified, but generally, such studies use commercially available control sera or pooled patient samples.
• Sample Type Comparison Study:
  • Sample Size: Samples from 20 different patients. Each sample type (serum, heparinized plasma, heparinized whole blood) was tested in quadruplicate.
  • Data Provenance: Not specified, presumed to be clinical samples.
• Method Comparison Study:
  • Sample Size: n = 172 data points. The document clarifies: "number of patient samples = n/2", meaning 86 unique patient samples were run in duplicate.
  • Data Provenance: Not specified, but these are patient samples tested against a predicate device, presumably from a clinical setting. Retrospective or prospective is not specified, but given the nature of the study, it's likely a mix or prospective collection for comparison purposes. No country of origin is mentioned.

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

This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for the test set (patient samples) is typically established by the reference method (the predicate device, in the case of method comparison) or by highly accurate laboratory methods, rather than by human expert consensus or adjudication.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are common in image-based diagnostic studies where human readers interpret results which are then reconciled. For quantitative laboratory tests, the result is a numerical value, and "adjudication" in the traditional sense is not performed on the test results themselves. Method comparison studies statistically compare the new device's numerical results to those of the predicate device.

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:

This information is not applicable and therefore not provided. MRMC studies are specific to diagnostic tools that involve human interpretation, often in imaging. The Abaxis Piccolo® Triglycerides Test System is an automated in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human reader interpretation for primary diagnosis.

6. 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) represent the standalone performance of the Abaxis Piccolo® Triglycerides Test System. The device is designed to operate as an automated system producing a quantitative result without direct human interpretation influencing the measurement itself (beyond sample collection and loading). The studies assess the device's inherent analytical performance.

7. The Type of Ground Truth Used:

For the method comparison study, the predicate device's measurement (Bayer Triglycerides-RA Assay) served as the de facto "ground truth" for comparison to establish substantial equivalence. For linearity, precision, and sample type comparison, the "ground truth" is typically established by the inherent analytical capabilities of the device itself and its ability to consistently and accurately measure known concentrations or produce reproducible results.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Abaxis Piccolo® Triglycerides Test System is a chemical analyzer, not a machine learning or AI-based system that requires a "training set" in the computational sense. Its reagents and methods are developed through biochemical and analytical chemistry principles, not by training an algorithm on a dataset.

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

This information is not applicable due to the nature of the device (see point 8).

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The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.

Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.

I am sorry but the provided text does not contain detailed information about acceptance criteria, study methodologies, or specific performance metrics that would allow me to populate the requested table and answer all the questions about a study proving device acceptance. The document primarily focuses on the 510(k) submission, intended use, device description, and a comparison to a predicate device for substantial equivalence. It does not include a clinical study report or performance data against specific acceptance criteria.

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