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510(k) Data Aggregation
(567 days)
Abaxis, Inc.
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium 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. Alternatively, the disc may also be used with serum.
The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.
The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied by CLIA goals or standard practices) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within Run %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 2.79% | |
| - Control 2 (6.19 mmol/L) | 1.38% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.31% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.58% | |
| Total %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 3.28% | |
| - Control 2 (6.19 mmol/L) | 1.65% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.89% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.89% | |
| Total %CV (Whole Blood, range 3.9-4.0 mmol/L) | Lower is better | 2.8% - 3.9% |
| Linearity | Deviation from linearity (DL) within ±0.5 mmol/L (per 42 CFR 493.931) | For all three matrices and various concentration ranges tested, the DL estimate was within +/- 0.31. R-square estimates were all > 0.98. RMSE estimates |
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(54 days)
ABAXIS, INC.
The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma in a clinical laboratory setting or point-of-care location.
Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.
The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. 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 sample 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 study information for the Piccolo® LAC Test System, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are generally inferred from the "Summary of Safety and Effectiveness" document, which aims to demonstrate substantial equivalence to a predicate device. For each performance characteristic, the "reported device performance" is the result demonstrated by the Piccolo Lactate Test System.
| Acceptance Criteria | Reported Device Performance (Piccolo Lactate Test System) | Study/Method Used |
|---|---|---|
| Linearity | Slope: 1.00 | Linearity Study |
| Intercept: 0.00 | ||
| Correlation Coefficient: 0.999 | ||
| Sensitivity | LOB (Limit of Blank): 0.02 mmol/L | CLSI EP17-A study |
| LOD (Limit of Detection): 0.07 mmol/L | ||
| LOQ (Limit of Quantitation): 0.11 mmol/L | ||
| Precision | Within-Run & Total Precision (Control & Plasma Pool Testing) | Precision Studies |
| Control Level 1: | Mean: 1.62 mmol/L, SD: 0.03 mmol/L, %CV: 1.8 (Within-Run) | |
| Mean: 1.62 mmol/L, SD: 0.04 mmol/L, %CV: 2.2 (Total) | ||
| Control Level 2: | Mean: 3.63 mmol/L, SD: 0.05 mmol/L, %CV: 1.5 (Within-Run) | |
| Mean: 3.63 mmol/L, SD: 0.08 mmol/L, %CV: 2.3 (Total) | ||
| Control Level 3: | Mean: 6.99 mmol/L, SD: 0.18 mmol/L, %CV: 2.6 (Within-Run) | |
| Mean: 6.99 mmol/L, SD: 0.36 mmol/L, %CV: 5.2 (Total) | ||
| Plasma Pool 1: | Mean: 0.86 mmol/L, SD: 0.02 mmol/L, %CV: 1.9 (Within-Run) | |
| Mean: 0.86 mmol/L, SD: 0.02 mmol/L, %CV: 1.9 (Total) | ||
| Plasma Pool 2: | Mean: 6.22 mmol/L, SD: 0.20 mmol/L, %CV: N/A (Within-Run) | |
| Precision (Fresh Whole Blood) - Internal | %CV ranges from 1.7% to 3.3% across 6 samples. | Inter-assay Precision Study |
| Precision (Fresh Whole Blood) - External | Site 1 Combined %CV: 2.0-3.5% | Whole Blood Precision Study at Three External Sites |
| Site 2 Combined %CV: 2.5-4.2% | ||
| Site 3 Combined %CV: 3.2-3.8% | ||
| Method Comparison with Predicate Device (i-STAT) | Slope (Linear Regression): 1.02 (95% CI: 1.01 to 1.04) | Method Comparison Study |
| Intercept (Linear Regression): 0.13 (95% CI: 0.07 to 0.19) | ||
| Correlation Coefficient, R: 0.996 | ||
| Slope (Deming Regression): 1.03 (95% CI: 0.99 to 1.06) | ||
| Intercept (Deming Regression): 0.06 (95% CI: -0.01 to 0.14) | ||
| Interference (Endogenous Substances) | Hemolysis: No interference up to 500 mg/dL | Interference Studies |
| Icterus: No interference up to 15 mg/dL | ||
| Lipemia: No interference up to 3,000 mg/dL | ||
| Interference (Exogenous Substances) | Dopamine: No interference at 0.52 mg/dL | Interference Studies |
| L-dopa: No interference at 0.5 mg/dL | ||
| Reference Interval | 0.53 - 2.10 mmol/L (95% of values) | Reference Interval Determination |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Linearity Study: Seven pools (including a saline blank and lowest non-zero calibrator and its dilutions). Each pool assayed 60 times.
- Precision (Control and Plasma Pool Testing): 80 replicates for each Control Level (N=80), 40 replicates for each Plasma Pool (N=40). Data provenance not specified directly but implied to be internal (Abaxis) based on the context.
- Precision (Fresh Whole Blood - Internal): 20 replicates for each of the 6 samples (N=20 for each). Data provenance is internal (Abaxis).
- Precision (Fresh Whole Blood - External): For each of the three external sites, 4 whole blood samples were tested. Each sample was tested by 2 operators (10 replicates each), totaling 20 replicates (N=20 combined) per sample per site. Total samples across 3 sites: 12. Total tests: over 240. Data provenance is implied to be external study sites but the country is not specified.
- Method Comparison with Predicate Device: 126 heparinized whole blood samples from 126 subjects. Data provenance is an external site, country not specified.
- Interference Studies: For endogenous substances, multiple test pools (at least 4) and a control pool were prepared for each of the two lactate levels. For exogenous substances, human plasma pools contained lactate at 0.70 and 2.60 mmol/L. "Two levels of lactate were used in all testing." Data provenance not specified.
- Reference Interval Determination: 130 heparinized whole blood samples from apparently healthy (self-reported) individuals. Data provenance not specified.
All studies appear to be prospective in nature, as they involve testing samples specifically for the purpose of validating the device. The country of origin of the data is not explicitly stated, but the company (Abaxis, Inc.) is based in Union City, CA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No "experts" in the traditional sense (e.g., radiologists, pathologists) were used to establish ground truth for the test set in this context. The studies involve analytical performance.
- For the Method Comparison Study, the "ground truth" or reference was the predicate device, the i-STAT Lactate test (Abbott). This device is an already legally marketed and established lactate testing system.
- For other studies (linearity, precision, sensitivity, interference), the "ground truth" is defined by the known concentrations of calibrators, controls, and spiked samples, or by established laboratory reference methods and protocols (e.g., CLSI guidelines).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None of the described studies utilize an adjudication method involving multiple human readers, as these are in vitro diagnostic device performance studies, not image interpretation or clinical decision-making studies. The performance is assessed against quantitative analytical targets or a reference 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
- No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that helps human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The entire submission describes the analytical performance of the Piccolo Lactate Test System, which is an automated instrument, functioning as a "standalone" device to measure lactate concentrations. The "human-in-the-loop" component primarily relates to sample collection, loading, and interpreting the final quantitative result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Known concentrations / Reference Method:
- Linearity, Sensitivity, Precision, Interference: Ground truth was established by using calibrators, controls, and spiked samples with known concentrations of lactate or interferents, according to industry standards (e.g., CLSI guidelines).
- Method Comparison: The predicate device, i-STAT Lactate test (Abbott), served as the reference method for comparison.
- Reference Interval Determination: The interval was determined by testing samples from a population of "apparently healthy" individuals, and the ground truth for their health status was based on "self-reported" information.
8. The sample size for the training set
- The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic device based on enzymatic colorimetric assay methodology.
- However, if by "training set" we consider the data used to initially develop and optimize the assay and its performance characteristics (e.g., establishing reagent concentrations, reaction kinetics, calibration algorithms), this information is not detailed in the 510(k) summary. The document focuses on the validation of the final device.
9. How the ground truth for the training set was established
- As noted above, a "training set" as understood in AI/ML is not applicable here. The development and optimization of such a diagnostic assay would typically involve extensive laboratory work to establish optimal reagent concentrations, reaction conditions, and calibration curves. The ground truth for this initial development would come from known standard solutions, reference methods, and clinical samples whose lactate concentrations are reliably determined by established laboratory techniques.
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(18 days)
ABAXIS, INC.
The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood 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 - Capillary Reagent Disc (which contains the Piccolo® Total Cholesterol - 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 summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Piccolo® Total Cholesterol - Capillary Test System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|---|
| Linearity/Dynamic Range | Lower Limit | Not explicitly stated as an acceptance criterion, but established as 20 mg/dL | 20 mg/dL |
| Upper Limit | Not explicitly stated as an acceptance criterion, but established as 520 mg/dL | 520 mg/dL | |
| Slope (compared to reference method) | Not explicitly stated, but typically expected to be close to 1 | 0.989 | |
| Intercept (compared to reference method) | Not explicitly stated, but typically expected to be close to 0 | 19.7 | |
| Correlation Coefficient (r) | Not explicitly stated, but typically >0.99 for good linearity | 0.999 | |
| Precision | Within-Run %CV (Low Concentration e.g. Serum 1) | Not explicitly stated, but typically 0.95 or >0.98 for good correlation | Site 1: 0.991 (Linear & Deming), Site 2: 0.991 (Linear & Deming), Site 3: 0.987 (Linear & Deming), Combined: 0.989 (Linear & Deming). These very high R² values indicate excellent correlation. |
| Slope (Linear Regression) | Not explicitly stated, but expected to be close to 1 within a tight CI | Site 1: 0.97 (0.95 to 0.98 CI), Site 2: 0.96 (0.95 to 0.97 CI), Site 3: 0.96 (0.95 to 0.98 CI), Combined: 0.96 (0.95 to 0.97 CI). These are all very close to 1. | |
| Intercept (Linear Regression) | Not explicitly stated, but expected to be close to 0 within a tight CI | Site 1: 2.42 (-0.10 to 4.95 CI), Site 2: 2.83 (0.28 to 5.37 CI), Site 3: 1.30 (-1.73 to 4.33 CI), Combined: 2.20 (0.64 to 3.76 CI). These are all close to 0, often including 0 in their respective 95% CIs. | |
| Accuracy | CRMLN Certification | Certification by CRMLN (Cholesterol Reference Method Laboratory Network) | Accuracy was established by completing the certification process of the CRMLN. (This implies the device meets the accuracy standards required for CRMLN certification.) |
Note: The document implicitly defines successful performance by demonstrating strong correlation, linearity, and acceptable precision in comparison to the predicate device and established reference methods. Explicit numerical acceptance criteria (e.g., "R² must be >0.98") are not stated in this summary, but the reported results clearly meet the standards for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Test: Samples across the measuring range were used. The specific number of distinct samples isn't given, but testing was done on 20 Piccolo analyzers. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it would typically be prospective for device validation.
- Precision Test:
- Serum Samples for Within-Run and Total Precision: 160 measurements for each serum level (Serum 1 & Serum 2).
- Whole Blood Precision: 5 fresh whole blood samples were tested 7 times each on 4 analyzers over 3 hours. This means a total of 5 * 7 = 35 measurements per analyzer, and 35 * 4 = 140 measurements in total for whole blood precision (though the table states 28 for each sample). The document also states "a total of 20 analyzers were used" for this specific test, which introduces some ambiguity on the total number of data points if each sample was run on all 20 analyzers.
- The data provenance is not explicitly stated.
- Method Comparison Test:
- Site 1: 216 samples
- Site 2: 210 samples
- Site 3: 213 samples
- Combined Data: 639 samples
- The data provenance (e.g., country of origin, retrospective or prospective) for these clinical samples is not explicitly mentioned in the provided text. Based on the context of a 510(k) submission, these would typically be prospectively collected samples from a clinical laboratory or point-of-care setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the device's performance (specifically for method comparison) was established by comparison to the Roche Cholesterol Test on the Cobas 6000 Analyzer.
For accuracy, the device was certified by the CRMLN (Cholesterol Reference Method Laboratory Network). This implies adherence to established reference methods and standards, which are overseen by expert bodies but doesn't involve individual experts establishing ground truth for each test case in the same way as, for example, image interpretation. The "experts" are essentially the established reference methods and organizations that define accurate cholesterol measurement.
4. Adjudication Method for the Test Set
Not applicable. This device is an in-vitro diagnostic (IVD) quantitative test system, not an interpretive device like an AI-powered diagnostic imaging tool that would require human expert adjudication of results. The "ground truth" is analytical (e.g., reference assay results, certified reference materials).
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 design is typically used for interpretive diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance to measure the AI's impact on human performance. This device is an automated quantitative test system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Linearity, Precision, Method Comparison) represent the standalone performance of the Piccolo® Total Cholesterol - Capillary Test System as an algorithm/device-only system. Its output is a quantitative value, not an interpretation requiring human input for its direct result.
7. The Type of Ground Truth Used
- For Linearity, Precision, and Method Comparison: The ground truth was established by comparison to:
- Reference materials or samples of known concentration (for linearity, precision).
- A legally marketed predicate device: The Roche Cholesterol Test on the Cobas 6000 Analyzer (for method comparison).
- For Accuracy: The ground truth was established by "completing the certification process of the CRMLN" (Cholesterol Reference Method Laboratory Network). CRMLN certification signifies that the method is traceable to the Centers for Disease Control and Prevention (CDC) reference method for cholesterol.
8. The Sample Size for the Training Set
The provided document describes validation studies (linearity, precision, method comparison) for a predicate-based 510(k) submission for an IVD device. It does not mention any "training set" in the context of machine learning. The device is a chemical analyzer using enzymatic endpoint reactions, not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, the concept of a "training set" and its associated ground truth establishment is not applicable as described in the document. The device's operational parameters (e.g., reagent formulations, reaction conditions, calibration) would be developed and optimized through standard analytical chemistry and engineering practices, not machine learning training. Calibration is done via a barcode with factory-calibrated lot-specific data.
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(50 days)
ABAXIS, INC.
The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood 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 – Capillary Reagent Disc (which contains the Piccolo® HDL - 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 study information for the Abaxis Piccolo HDL - Capillary Test System, based on the provided text:
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state numerical "acceptance criteria" in a table format alongside the performance. Instead, it presents the results of various validation tests, implying that the device's performance within these studies was deemed acceptable for substantial equivalence. The predicate devices' specifications provide the implicit benchmarks for comparison.
Here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the comparisons and intended use:
| Test / Characteristic | Acceptance Criteria (Implicit, based on predicates & intended use) | Reported Device Performance (Piccolo® HDL - Capillary Test System) |
|---|---|---|
| Intended Use | Quantitative HDL determination in clinical/POC setting. | Quantitative HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. |
| Methodology | Enzymatic colorimetric end-point test. Similar to predicate. | Hybrid enzymatic colorimetric end-point test, making use of dextran/sulfate precipitation, centrifugation, and PEG-modified enzymes. |
| Sample Type | Appropriate for intended use (e.g., whole blood, plasma, serum). | Lithium heparinized capillary whole blood. |
| Dynamic Range | ≥ 15 mg/dL lower limit. | 15 mg/dL. |
| Assay Range | Similar to predicate, covering relevant clinical range. | 15 - 100 mg/dL. |
| Linearity (Slope) | Close to 1. | 0.983 |
| Linearity (Intercept) | Close to 0. | 0.5 |
| Linearity (Correlation Coefficient, r) | Close to 1. | 0.997 |
| Precision (Within-Run %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 2.6% |
| Serum 2 (Mean 38.0 mg/dL): 3.5% | ||
| Precision (Total %CV) | Acceptable for clinical use, comparable to predicate. | Serum 1 (Mean 55.3 mg/dL): 3.5% |
| Serum 2 (Mean 38.0 mg/dL): 4.3% | ||
| Method Comparison (Slope vs. Roche HDL Test) | Close to 1 (indicating agreement). | 0.99 (95% CI: 0.97 to 1.01) (Linear Regression) |
| 1.01 (95% CI: 0.99 to 1.03) (Deming Regression) | ||
| Method Comparison (Intercept vs. Roche HDL Test) | Close to 0 (indicating agreement). | -1.6 (95% CI: -2.4 to -0.8) (Linear Regression) |
| -2.6 (95% CI: -3.4 to -1.7) (Deming Regression) | ||
| Method Comparison (Correlation Coefficient, R²) | Close to 1 (indicating strong correlation). | 0.962 |
| Method Comparison (Std. Error of the Estimate, SEE) | Low (indicating good agreement). | 2.7 |
Study Details
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of unique patient samples, but the statistical results (Slope, Intercept, Correlation Coefficient) indicate multiple data points were analyzed across the dynamic range.
- Precision Study:
- Sample Size: n = 160 (for both within-run and total precision for each serum level). This likely refers to 160 individual measurements for each of the two serum levels or 160 replicates of each serum level.
- Data Provenance: Not explicitly stated, but the samples are referred to as "Serum 1" and "Serum 2," suggesting laboratory-prepared or pooled serum samples. No mention of country of origin or retrospective/prospective collection is provided for these particular samples.
- Method Comparison Study:
- Sample Size: N = 559.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. The samples are "analyzed by the Abaxis Piccolo HDL - Capillary Test System and the Roche HDL Test," suggesting human samples. The range of samples is 21 - 93 mg/dL for Piccolo and 23 - 92.5 mg/dL for Roche, indicating real-world patient samples covering a clinical range.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in-vitro diagnostic (IVD) chemistry analyzer for quantitative determination of HDL. For such devices, "ground truth" is typically established by:
- Reference laboratory methods,
- Predicate devices (clinically accepted and legally marketed), or
- NIST (National Institute of Standards and Technology) traceable standards.
In this case, the ground truth for the performance studies was established through comparison with a legally marketed predicate device (Roche HDL Test), which serves as the reference for method comparison. The precision and linearity studies use internal quality controls or characterized samples.
Therefore, the concept of "experts" establish ground truth in the same way as for imaging or clinical diagnosis is not directly applicable here. The "experts" would be the manufacturers and developers of the reference/predicate methods, and the laboratory professionals performing the analyses.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. Since this study concerns the performance of an automated IVD device comparing its results to a reference method (or itself for precision/linearity), no human adjudication method was employed or necessary. The quantitative results are compared statistically.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI). The Piccolo® HDL - Capillary Test System is an automated quantitative chemical analyzer, not a device requiring human interpretation in its output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, this was a standalone performance study in the context of an IVD device. The "algorithm" here is the device's integrated system of reagents, fluidic handling, and photometric detection, which automatically produces a quantitative HDL value. The performance metrics (linearity, precision, method comparison) evaluate the device's output without human intervention influencing the final analytical result. Human involvement is limited to sample collection, loading, and initiating the test.
7. Type of Ground Truth Used
- Linearity and Precision Studies: The ground truth for these studies relies on characterized samples or quality controls with known analyte concentrations. For linearity, serial dilutions of a high-concentration sample are used, with the expected values serving as the truth. For precision, control materials with specified concentrations are repeatedly measured.
- Method Comparison Study: The ground truth was established by comparison to a legally marketed predicate device: the Roche HDL Test (specifically, the "Roche HDL Test: Average of Duplicates"). The predicate device's results are considered the reference against which the new device's performance is measured.
8. Sample Size for the Training Set
No training set is explicitly mentioned or relevant in the context of this 510(k) submission. This device is a chemical analyzer based on established enzymatic calorimetric principles. It does not utilize machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device involves its internal calibration (factory calibrated lot-specific data via bar code) and manufacturing processes to ensure it accurately measures the analyte.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the AI/ML sense. The device's calibration and manufacturing are based on established chemical principles and metrology standards, ensuring the accuracy of its measurements across its assay range.
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(50 days)
ABAXIS, INC.
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.
| Performance Metric | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Piccolo® Triglycerides - Capillary Test System) |
|---|---|---|
| Linearity | Slope = 1, Intercept = 0, R = 1 | Slope: 1.000, Intercept: 3.0, Correlation Coefficient (r): 1.000 |
| Precision (Within-Run) | Low %CV for various concentration levels | Serum 1: Mean 206.8 mg/dL, SD 4.7, %CV 2.3 |
| Serum 2: Mean 163.7 mg/dL, SD 1.8, %CV 1.1 | ||
| Precision (Total) | Low %CV for various concentration levels | Serum 1: Mean 206.8 mg/dL, SD 5.5, %CV 2.6 |
| Serum 2: Mean 163.7 mg/dL, SD 2.4, %CV 1.5 | ||
| Method Comparison (vs. Roche Triglycerides Test) | Close agreement with predicate; Slope ~ 1, Intercept ~ 0, R² ~ 1 | N: 588 |
| Mean: 155.4 mg/dL | ||
| Std. Dev: 88.3 | ||
| Range: 36 - 496 mg/dL | ||
| Slope (95% CI): 0.96 (0.95 to 0.97) | ||
| Intercept (95% CI): 3.5 (2.1 to 4.9) | ||
| Correlation Coefficient (R²): 0.992 | ||
| Std. Error of the Estimate (SEE): 7.9 |
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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(277 days)
ABAXIS, INC.
The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement.
C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.
The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium 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 sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
This document describes the Abaxis Piccolo C-Reactive Protein (CRP) Test System and demonstrates its substantial equivalence to a legally marketed predicate device (Beckman Synchron LX20 Chemistry System K070626). The information provided focuses on the performance characteristics of the Abaxis device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for linearity or precision in a numerical format that would represent target values. Instead, it presents the results of linearity and precision studies. The implicit acceptance is that these results demonstrate performance comparable to clinical expectations for such a device and are sufficient to prove substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Abaxis Piccolo CRP Test System) |
|---|---|---|
| Linearity | Demonstrate a strong linear relationship across the assay range. | Slope: 1.037 |
| Intercept: -0.764 | ||
| Correlation Coefficient: 0.997 | ||
| Precision (Within-Run & Total) | Demonstrate acceptable repeatability and reproducibility for different CRP levels in serum and plasma. | C-Reactive Protein (mg/L) |
| Serum Level 1 (n=80) | ||
| Mean: 8.3, SD: 0.70 (Within-Run), 0.81 (Total), %CV: 8.4 (Within-Run), 9.8 (Total) | ||
| Serum Level 2 (n=40) | ||
| Mean: 8.1, SD: 0.49 (Within-Run), 0.51 (Total), %CV: 6.1 (Within-Run), 6.3 (Total) | ||
| Serum Level 3 (n=40) | ||
| Mean: 8.8, SD: 0.54 (Within-Run), 0.54 (Total), %CV: 6.2 (Within-Run), 6.2 (Total) | ||
| Plasma 1 (n=40) | ||
| Mean: 34.5, SD: 1.04 (Within-Run), 1.09 (Total), %CV: 3.0 (Within-Run), 3.2 (Total) | ||
| Plasma 2 (n=40) | ||
| Mean: 105.5, SD: 2.06 (Within-Run), 2.30 (Total), %CV: 1.9 (Within-Run), 2.2 (Total) | ||
| Control Level 1 (n=80) | ||
| Mean: 33.0, SD: 1.21 (Within-Run), 2.12 (Total), %CV: 3.7 (Within-Run), 6.4 (Total) | ||
| Control Level 2 (n=80) | ||
| Mean: 108.0, SD: 1.88 (Within-Run), 3.14 (Total), %CV: 1.7 (Within-Run), 2.9 (Total) | ||
| Sample Type Comparability | Demonstrate comparable results across lithium heparinized whole blood, lithium heparinized plasma, and serum. | Comparability was established for CRP. |
Study Proving Device Meets Criteria:
The study conducted to prove the device meets these criteria is a series of clinical and non-clinical tests summarized in Tables 2 and 3 and described under Section 7: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: The sample size for the linearity study is not explicitly stated in terms of number of patient samples. It reports a slope, intercept, and correlation coefficient, which are derived from a series of measurements across a range of concentrations.
- Precision Studies:
- Serum Level 1: n = 80
- Serum Level 2: n = 40
- Serum Level 3: n = 40
- Plasma 1: n = 40
- Plasma 2: n = 40
- Control Level 1: n = 80
- Control Level 2: n = 80
- Sample Type Comparison Study: The document states "A study was conducted to examine and compare results for lithium heparinized whole blood, lithium heparinized plasma, and serum," but does not explicitly provide the number of samples used in this comparison.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a clinical laboratory test system, such studies are typically prospective analytical validation studies using prepared samples or patient samples collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an invitro diagnostic (IVD) device like a CRP test, "ground truth" is typically established by reference methods or validated comparative methods ("predicate device" in this case) rather than by expert consensus on qualitative interpretation. The "ground truth" for the test set is considered to be the quantitative values obtained from a reference method or the predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for this type of IVD device. Adjudication methods (like 2+1, 3+1) are common in studies involving expert interpretation of images or other subjective data. For a quantitative test like CRP, the "adjudication" is essentially the comparison of results against a reference method or the predicate device with predefined statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a MRMC comparative effectiveness study was not done. MRMC studies are typically performed for devices that involve human interpretation (e.g., radiologists reading images) to assess the impact of a device on reader performance. This document concerns a fully automated quantitative test system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done. The document focuses exclusively on the analytical performance of the "Piccolo C-Reactive Protein Test System" run on the "Piccolo xpress Chemistry Analyzer" (an automated system). The precision and linearity data presented directly reflect the performance of the device without human interpretation affecting the result. The comparison is between the new device and a predicate device, both being automated quantitative systems.
7. The Type of Ground Truth Used:
The ground truth used for this type of quantitative IVD device is generally based on:
- Comparison to a legally marketed predicate device: The document explicitly states the "Piccolo C-Reactive Protein Test System" is compared to the "Beckman Synchron LX20 Chemistry System K070626". The performance characteristics (e.g., linearity, precision) are evaluated using samples for which the CRP concentration is known or reliably determined by established methods or the predicate device.
- Reference materials/methods: Implicitly, the linearity and precision studies would rely on samples with known or traceable CRP concentrations, potentially established using reference materials or highly accurate reference methods, to assess the accuracy of the device across its measuring range.
8. The Sample Size for the Training Set:
The document does not provide information regarding a "training set" or its sample size. This is typical for analytical validation reports of IVD devices for 510(k) submissions, which focus on analytical performance testing rather than machine learning model development. The device itself is an immunoassay system, not an AI/ML algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The "ground truth" for the analytical performance studies (linearity, precision) would be established by reference methods or the performance of the predicate device, as mentioned in point 7.
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(98 days)
ABAXIS, INC.
The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Piccolo Magnesium Test System, which is an in vitro diagnostic device. This type of document typically does not contain detailed information about acceptance criteria, study designs, sample sizes, or ground truth establishment in the way that would apply to AI/ML or imaging devices.
The FDA 510(k) clearance process for in vitro diagnostics usually relies on demonstrating substantial equivalence to a predicate device, which involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than clinical outcome studies or expert-based ground truth for image interpretation.
Therefore, many of the specific details requested in your prompt (e.g., test set sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory document for an in vitro diagnostic test system.
However, I can extract what is explicitly stated or can be inferred:
1. A table of acceptance criteria and the reported device performance:
This information is typically found in the summary of safety and effectiveness, which is not fully included in this clearance letter. The letter confirms substantial equivalence without detailing the specific performance metrics used to establish that.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. Studies for IVDs are typically performed by the manufacturer, but country of origin isn't stated here.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable for an in vitro diagnostic magnesium test. Ground truth for an IVD refers to the correct concentration of the analyte, often determined by a reference method, not by human expert interpretation.
4. Adjudication method for the test set:
This is not applicable for an in vitro diagnostic magnesium test. Adjudication is relevant for subjective assessments, typically in imaging or clinical endpoints.
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 is not applicable as the Piccolo Magnesium Test System is an automated in vitro diagnostic device, not an AI-assisted imaging or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a "standalone" system in the sense that it performs the
quantitative determination of magnesium without human-in-the-loop interpretation of the result once the sample is loaded. However, this question's phrasing is more suited to AI/ML software. The device itself is the "algorithm," and its performance is determined directly.
7. The type of ground truth used:
For a quantitative diagnostic test like magnesium, the ground truth would typically be established by a reference method or a thoroughly validated, higher-accuracy method of measuring magnesium concentration (e.g., atomic absorption spectroscopy or another established/calibrated clinical chemistry analyzer). The document does not explicitly state the reference method used.
8. The sample size for the training set:
This is not applicable in the context of this device as it's an analytical instrument, not an AI/ML model that learns from a training set in the conventional sense. The "training" for such a device would be its calibration and validation based on chemical and electrical engineering principles, not a data-driven learning process.
9. How the ground truth for the training set was established:
This is not applicable as explained in point 8. The "ground truth" for calibration would be based on certified reference materials or highly accurate standards.
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(67 days)
ABAXIS, INC.
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.
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(10 days)
ABAXIS, INC.
The Piccolo Magnesium Test System (presently contained on the Renal Function 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 magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
The Piccolo Renal Function Panel Plus Reagent Disc (which contains the Piccolo Magnesium 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.
The provided document describes the safety and effectiveness of the Piccolo® Magnesium Test System. The device is intended for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum.
Here's an analysis of the acceptance criteria and the study performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with pass/fail thresholds for each metric. Instead, it presents performance data (linearity, precision) and draws a conclusion of substantial equivalence to a predicate device. For the purpose of this analysis, we will infer the "acceptance criteria" through comparison to the predicate device's characteristics and general expectations for clinical laboratory devices.
| Performance Metric | Predicate Device (Vitros 950 Magnesium Slides) | Piccolo Magnesium Test System Reported Performance | Implied Acceptance Criteria (Based on Substantial Equivalence) | Met? |
|---|---|---|---|---|
| Linearity | Not explicitly stated (implied to be acceptable) | Slope: 0.992, Intercept: -0.05, Corr. Coefficient: 0.999 | Correlation Coefficient ≥ 0.99 (or comparable to predicate) | Yes |
| Sensitivity | 0.2 mg/dL | 0.1 mg/dL | Equal to or better than predicate (≤ 0.2 mg/dL) | Yes |
| Assay Range | 0.2 - 10.0 mg/dL | 0.1 - 8.0 mg/dL | Comparable to predicate's clinical relevance Range | Yes* |
| Within-Run Precision (CV) | Not explicitly stated | Level 1: 1.7%, Level 2: 1.0% | CVs typically |
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(86 days)
ABAXIS, INC.
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.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Piccolo® Triglycerides Test System) |
|---|---|---|
| Intended Use | Quantitative analysis of triglycerides | Quantitative analysis of triglycerides |
| Methodology | Enzymatic endpoint reaction | Enzymatic endpoint reaction |
| Sample Type | Heparinized plasma and serum | Heparinized whole blood, heparinized plasma, and serum |
| Sensitivity | 0.99 mA per mg/dL or 0.088 A per mmol/L | 3.82 mA per mg/dL or 0.338 A per mmol/L; 20 mg/dL |
| Reagents | Dry reagents (reconstituted by user prior to use) and liquid reagents | 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 | Bar code with factory calibrated lot specific data |
| Assay Range | 0 - 500 mg/dL | 20 - 500 mg/dL |
| Testing Environment | Professional use | Professional use |
| Sample Size | 2 µL | Approx 100 µL |
| Linearity (Slope) | (Implied to be close to 1) | 1.000 |
| Linearity (Intercept) | (Implied to be close to 0) | 3.0 |
| Linearity (Correlation Coefficient 'r') | (Implied to be close to 1) | 1.000 |
| Precision (Serum 1, Mean) | (Not specified as a target, but precision is expected) | 206.8 mg/dL (Within-Run & Total) |
| Precision (Serum 1, SD) | (Not specified as a target, but precision is expected) | 4.7 (Within-Run), 5.5 (Total) |
| Precision (Serum 1, %CV) | (Not specified as a target, but precision is expected) | 2.3 (Within-Run), 2.6 (Total) |
| Precision (Serum 2, Mean) | (Not specified as a target, but precision is expected) | 163.7 mg/dL (Within-Run & Total) |
| Precision (Serum 2, SD) | (Not specified as a target, but precision is expected) | 1.8 (Within-Run), 2.4 (Total) |
| Precision (Serum 2, %CV) | (Not specified as a target, but precision is expected) | 1.1 (Within-Run), 1.5 (Total) |
| Method Comparison (Correlation Coefficient 'r') | (Implied to be close to 1 for substantial equivalence) | 0.999 |
| Method Comparison (Slope) | (Implied to be close to 1 for substantial equivalence) | 0.983 (Linear), 0.984 (Deming) |
| Method Comparison (Intercept) | (Implied to be close to 0 for substantial equivalence) | 8.2 (Linear), 8.1 (Deming) |
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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