(67 days)
The Piccolo Lactate Dehydrogenase Test System (presently contained on the Piccolo Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.
Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; malignant diseases; and tissue alterations of the heart, kidney, liver, and muscle.
The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo Lactate Dehydrogenase Test System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples 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 an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, formatted as requested:
Device: Piccolo® Lactate Dehydrogenase Test System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance targets (e.g., "linearity must be >0.99"). Instead, it presents the results of linearity and precision studies. The implicit acceptance criteria would be for these results to demonstrate performance comparable to the predicate device and suitable for its intended use.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Piccolo System) | Predicate Device Information (Synchron LX20) |
|---|---|---|---|
| Linearity | Comparable to predicate/good clinical practice | Not explicitly stated for predicate | |
| - Slope | N/A | 1.012 | N/A |
| - Intercept | N/A | +0.253 | N/A |
| - Correlation Coefficient | N/A (implied >0.99 for good linearity) | 0.998 | N/A |
| Precision (Within-Run) | Comparable to predicate/good clinical practice | Not explicitly stated for predicate | |
| - Control Level 1 Mean | N/A | 87 U/L | N/A |
| - Control Level 1 SD | N/A | 3.0 | N/A |
| - Control Level 1 %CV | N/A (implied low %CV for good precision) | 3.4 | N/A |
| - Control Level 2 Mean | N/A | 350 U/L | N/A |
| - Control Level 2 SD | N/A | 3.8 | N/A |
| - Control Level 2 %CV | N/A (implied low %CV for good precision) | 1.1 | N/A |
| Precision (Total) | Comparable to predicate/good clinical practice | Not explicitly stated for predicate | |
| - Control Level 1 Mean | N/A | 87 U/L | N/A |
| - Control Level 1 SD | N/A | 4.4 | N/A |
| - Control Level 1 %CV | N/A (implied low %CV for good precision) | 5.0 | N/A |
| - Control Level 2 Mean | N/A | 350 U/L | N/A |
| - Control Level 2 SD | N/A | 7.0 | N/A |
| - Control Level 2 %CV | N/A (implied low %CV for good precision) | 2.0 | N/A |
| Sample Type Comparability | Heparinized plasma and serum results comparable | Established for Lactate Dehydrogenase | N/A |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity: Sample size not explicitly stated beyond the reported slope, intercept, and correlation coefficient.
- Precision:
- Sample Size: n = 80 for both within-run and total precision studies.
- Sample Type Comparison: Sample size not explicitly stated.
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. Given it's a 510(k) submission for a US market, studies would typically be conducted to meet US regulatory requirements. It is a non-clinical study since it involves comparing the device to a predicate device in a laboratory setting.
3. Number of Experts Used and Their Qualifications for Ground Truth
Not applicable. This is a non-clinical study evaluating the performance of a laboratory diagnostic device, not a diagnostic imaging or AI algorithm requiring expert interpretation for ground truth. The "ground truth" for linearity and precision would be derived from certified reference materials or established high-accuracy laboratory methods.
4. Adjudication Method for the Test Set
Not applicable, as this is a non-clinical laboratory device performance study, not a clinical trial or AI study involving human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance (linearity, precision) of a laboratory assay, not on the effectiveness of human readers with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Yes, the studies reported (Linearity, Precision, Sample Type Comparison) represent the standalone performance of the Piccolo® Lactate Dehydrogenase Test System. These are analytical studies of the device itself, without human interpretation as part of the performance metric.
7. Type of Ground Truth Used
- Linearity, Precision, and Sample Type Comparison: The ground truth would be established using reference methods or certified calibrators/control materials with known concentrations/activities of Lactate Dehydrogenase. For precision, the "true" value is the mean value obtained over multiple runs. For sample type comparison, the "true" value is derived from a comparative method or the predicate device if it's considered the reference.
8. Sample Size for the Training Set
Not applicable. This is a non-AI/ML medical device submission. Therefore, there is no "training set" in the context of machine learning. The device's calibration is based on "Bar code with factory calibrated lot specific data."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm. The device uses "factory calibrated lot specific data" for its calibration, which would be established during manufacturing and quality control processes using reference materials and established laboratory standards.
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.