(50 days)
The Piccolo Phosphorus Test System (presently contained on the Renal Function Panel Reagent disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of phosphorus in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Phosphorus The phosphorus assay is used for the quantitiation of phosphorus in human heparinized whole blood, heparinized plasma or serum. Phosphorus measurements are used in the diagnosis and treatment of renal insufficiency, hypoparathyroidism, vitamin D imbalance, a high calcium diet, hyperparathyroidism, and insulin treatment of diabetic ketacidosis.
The Piccolo Renal Function Panel Reagent Disc (which contains the Piccolo Phosphorus 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 summary of the acceptance criteria and the study details for the Abaxis Piccolo® Phosphorus Test System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but rather presents performance characteristics derived from linearity and precision studies. The implicit acceptance is that these results demonstrate the device performs "as well as the legally marketed device."
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | (Comparable to predicate & industry standards for a quantitative assay) | |
| Slope | (Close to 1.00) | 1.00 |
| Intercept | (Close to 0.00) | +0.2 |
| Corr. Coefficient | (Close to 1.00) | 0.999 |
| Sample Range | (Clinically relevant) | 2 - 17 mg/dL |
| Precision | (Clinically acceptable CV) | |
| Level 1 (3.1 mg/dL) | ||
| Within-Run CV | (Within acceptable limits) | 3.7% (n=80) |
| Total CV | (Within acceptable limits) | 4.7% (n=80) |
| Level 2 (7.3 mg/dL) | ||
| Within-Run CV | (Within acceptable limits) | 1.3% (n=80) |
| Total CV | (Within acceptable limits) | 2.0% (n=80) |
| Sample Type Comparison | (Comparability between sample types) | Phosphorous concentrations in serum are 0.3 mg/dL higher than in heparinized plasma and heparinized whole blood. (Comparability was established) |
2. Sample Size for the Test Set and Data Provenance
- Linearity Study: Sample range 2 - 17 mg/dL. The exact number of individual samples (data points) used to determine linearity properties (slope, intercept, correlation coefficient) is not explicitly stated, beyond the range.
- Precision Study:
n = 80for both within-run and total precision at each of the two levels tested. Thisnlikely refers to the number of replicates over time or runs to calculate precision. - Sample Type Comparison: The document does not specify the number of samples used for this comparison.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a clinical laboratory device, these studies are typically conducted under controlled laboratory conditions, which would be considered prospective for the purpose of device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No experts were used to establish ground truth in this type of study. These are analytical performance studies for an in vitro diagnostic device measuring a chemical analyte. The "ground truth" for linearity and precision is established by the reference methods or highly accurate control materials used to create the samples and by the inherent statistical calculations for precision.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an analytical performance study, not one requiring expert adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically associated with image-based diagnostic aids or clinical decision support systems where human interpretation is involved. This device is an automated chemistry analyzer, so human reader improvement is not a relevant metric.
6. Standalone Performance Study
Yes, the studies described (linearity, precision, sample type comparison) represent the standalone performance of the algorithm/device (Piccolo® Phosphorus Test System). These tests evaluate the inherent analytical capabilities of the system without human intervention in the result generation process itself, beyond operating the instrument.
7. Type of Ground Truth Used
- Linearity: The ground truth is established by the known concentrations of the samples used in the linearity study (e.g., diluted reference materials or spiked samples).
- Precision: The ground truth is the mean concentration of the control materials or samples tested, against which the variability (SD, CV) is measured.
- Sample Type Comparison: The ground truth is the measured values from the different sample types (serum, plasma, whole blood) compared against each other, presumably with one acting as a reference or a comparison of their inherent differences.
8. Sample Size for the Training Set
The document does not mention a "training set" or "training data." This is because the Piccolo® Phosphorus Test System is a quantitative chemical analyzer based on established enzymatic endpoint reaction methodology. Its performance is characterized analytically, rather than through machine learning models that require training data. The device likely uses factory-calibrated lot-specific data for calibration, as mentioned in Table 1, but this is not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the machine learning context) was described or used.
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(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 the limitations in § 862.9.