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510(k) Data Aggregation
(338 days)
Trinity Biotech (Primus Corporation, dba Trinity Biotech)
The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.
The Premier Resolution System is intended for Professional Laboratory Use only.
The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.
The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.
For In Vitro Diagnostic Use.
The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).
This document describes the performance data for the "Premier Resolution System," an automated High Performance Liquid Chromatography (HPLC) system for hemoglobin analysis. The study aims to demonstrate that the device is substantially equivalent to a predicate device, the Bio-Rad Variant II ß-thalassemia (K991127).
1. Acceptance Criteria and Reported Device Performance:
The document outlines comparative performance against a predicate device (Bio-Rad Variant II ß-thalassemia) and precision studies. The acceptance criteria are implicitly defined by demonstrating comparability and acceptable precision, rather than explicit thresholds for each metric. The reported device performance includes:
| Acceptance Criteria (Implicit) | Reported Premier Resolution System Performance (Quick Scan Assay) | Reported Premier Resolution System Performance (High Resolution Assay) |
|---|---|---|
| Correlation (Method Comparison) - Mean Bias vs. Predicate (Bio-Rad Variant II) | ||
| HbF comparability | -0.3 bias (1.1 to 48.9% interval) with 160 patient results | -0.4 bias (1.1 to 46.6% interval) with 158 patient results |
| HbA comparability | 0.7 bias (2.5 to 89.7% interval) with 682 patient results | 2.4 bias (3.5 to 90.5% interval) with 586 patient results |
| HbA2 comparability | 0.1 bias (1.6 to 6.1% interval) with 602 patient results | 0.1 bias (1.6 to 6.0% interval) with 598 patient results |
| HbS comparability | 0.3 bias (6.8 to 67.1% interval) with 106 patient samples | 1.3 bias (1.9 to 67.9% interval) with 110 patient samples |
| HbC comparability | -1.1 bias (9.5 to 82.8% interval) with 49 patient results | -1.0 bias (10.2 to 82.5% interval) with 49 patient results |
| HbD-LA comparability | 1.6 bias (11.6 to 82.7% interval) with 17 patient results | 2.7 bias (11.7 to 84.1% interval) with 17 patient results |
| HbE comparability | -3.0 bias (5.5 to 70.4% interval) with 25 patient results | -4.9 bias (5.3 to 66.7% interval) with 25 patient results |
| Precision (Single Site) - Within-Laboratory %CV | ||
| HbA (High) | 3.61% | 3.63% |
| HbA (Mid) | 0.89% | 1.37% |
| HbA2 (Mid) | 2.23% | 7.22% |
| HbA2 (Low) | 5.99% | 7.15% |
| HbF (High) | 1.05% | 3.49% |
| HbF (Mid) | 3.26% | 9.10% |
| HbS (High) | 0.89% | 1.33% |
| HbS (Mid) | 0.98% | 1.69% |
| HbC (High) | 0.78% | 1.15% |
| HbC (Mid) | 1.75% | 2.03% |
| HbD (High) | 1.88% | 2.20% |
| HbD (Mid) | 2.04% | 1.32% |
| HbE (High) | 2.84% | 4.63% |
| HbE (Mid) | 3.06% | 3.14% |
| LoD/LoQ (Quick Scan) | ||
| HbF LoD | 0.2% | 0.1% |
| HbF LoQ | 1.1% | 1.1% |
| HbA LoD | 0.1% | 0.7% |
| HbA LoQ | 2.3% | 2.2% |
| HbA2 LoD | 0.1% | 0.2% |
| HbA2 LoQ | 1.5% | 1.5% |
| HbS LoD | 0.1% | 0.3% |
| HbS LoQ | 1.0% | 0.9% |
| HbC LoD | 0.1% | 0.3% |
| HbC LoQ | 1.0% | 1.7% |
| HbD-LA LoD | 0.1% | 0.1% |
| HbD-LA LoQ | 1.5% | 1.4% |
| HbE LoD | 0.1% | 0.6% |
| HbE LoQ | 1.5% | 2.7% |
2. Sample Size and Data Provenance (Test Set):
- Correlation (Method Comparison): A total of 780 unique patient samples were collected and analyzed. The data provenance is described as being collected and analyzed at three (3) professional external laboratory sites. It is implicit that these were retrospective real-world samples, as they are referred to as "patient samples" used for method comparison against an existing device. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.
- Precision (Single Site): The sample size for each analyte was 80 data points, generated by a 20x2x2 study design over 20 days, with two runs per day and two replicates per run. These were "samples of varying concentrations" and not explicitly patient samples.
- Precision (Multisite): The sample size for each analyte was 75 data points (3x5x5 study design across three external sites, over five days with five replicates per day). These were "precision samples."
- Limits of Detection: 60 determinations of low-level samples for each hemoglobin type. These were "human whole blood samples" with varying levels of hemoglobins.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
This device is an in-vitro diagnostic (IVD) instrument for quantitative and qualitative analysis of hemoglobin species. The ground truth for such devices is typically established by well-characterized reference methods or by comparison to a legally marketed predicate device. In this submission, the primary method for establishing the device's performance is:
- Correlation (Method Comparison): Comparison against the Bio-Rad Variant II ß-thalassemia, which serves as the "ground truth" or reference for establishing substantial equivalence. No human experts are described as establishing ground truth for the test set, as the ground truth is the measurement from the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison of quantitative measurements from two analytical instruments (device under review vs. predicate device), and precision of the device itself. There is no subjective interpretation requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is an in-vitro diagnostic device that provides quantitative and qualitative measurements, not an image-based diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the entire study focuses on the standalone performance of the "Premier Resolution System" as an automated HPLC system. There is no human-in-the-loop component described for its routine operation or for the performance studies presented. The device performs the analysis and provides results independently.
7. Type of Ground Truth Used:
The ground truth for the device's performance is established mainly through:
- Comparison to a legally marketed predicate device: The Bio-Rad Variant II ß-thalassemia, for method comparison (correlation).
- Internal consistency and statistical measures: For precision (repeatability, within-laboratory, reproducibility) and limits of detection/quantitation. This relies on the inherent analytical capabilities and controls of the new device itself.
8. 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 automated HPLC system, where performance is based on chemical separation principles, not a learning algorithm that requires a separate training phase with labeled data in the AI sense. Its "training" or development would involve chemical and engineering optimization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this device. The development of an HPLC system involves instrument design, reagent formulation, and software development, which are validated through analytical performance studies like those presented (precision, linearity, method comparison, etc.).
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(132 days)
PRIMUS CORPORATION DBA TRINITY BIOTECH
The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.
The Premier Hb9210™ is an update of the predicate HPLC device, the Ultra2, which is the current model under K891235. The Premier Hb9210™ is a compact, integrated HPLC system and workstation with the Trinity Biotech AFFINITY Software for the quantitative determination of glycated hemoglobin using the patented boronate affinity chemistry with high performance liquid chromatography.
Here's an analysis of the provided information, addressing your requested points:
Device: Trinity Biotech Premier Hb9210™ HbA1c Analyzer
The Premier Hb9210™ is an automated High-Performance Liquid Chromatography (HPLC) system designed for the quantitative measurement of HbA1c in human capillary and venous whole blood. This device uses boronate affinity chemistry for HbA1c measurement, building upon the technology of its predicate device, the Ultra2 (K891235).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the performance metrics in a pass/fail format. Instead, it presents the results of performance tests aimed at demonstrating substantial equivalence to a predicate device. For the purpose of this response, I will interpret the reported performance from the precision and accuracy studies as the device's demonstrated performance.
Note: The document focuses on demonstrating substantial equivalence to a predicate device (Ultra2, K891235), not necessarily meeting specific pre-defined acceptance criteria for novel device approval.
| Performance Metric | Reported Device Performance (Premier Hb9210™) |
|---|---|
| Intra-run Precision (Hemolysate - All Sites) | |
| %HbA1c Concentration | 5.76% |
| Repeatability SD (Sr) | 0.07 |
| Repeatability %CV | 1.26 |
| Within-device Precision SD (ST) | 0.09 |
| Within-device Precision %CV | 1.62 |
| Accuracy (vs IFCC HbA1c Standards) | r = 0.9998 |
| Accuracy (vs Predicate Device Ultra2 - 51 samples) | r = 0.9976 |
| Linearity | 3.7% - 18.5% HbA1c |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Precision Test Set:
- Three hemolysate samples, each representing normal, decision point, and abnormal levels of %HbA1c.
- Each of these three samples was analyzed 80 times per site (2 analyses per run, 2 runs per day, over 20 non-consecutive days) across 3 sites.
- Total replicates: 240 replicates per HbA1c level (3 HbA1c levels * 80 replicates per site * 3 sites) if referring to individual measurements contributing to the overall analysis. The document states "a total of 80 replicates of each level per site, 240 replicates overall".
- Total observations for precision study: 1200 total observations (implicitly across the 3 HbA1c levels and 3 sites).
- Sample Size for Accuracy Test Set (vs. predicate): 51 samples.
- Data Provenance: Not explicitly stated, but the study was conducted at one internal and two external sites. The phrase "aliquotted and frozen whole blood" suggests controlled sample handling, but the origin country of the patient samples or whether they were retrospective or prospective samples is not specified. Given the context of a 510(k) submission, it's typically based on controlled laboratory studies rather than a full clinical trial with diverse patient populations and retrospective/prospective designations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic (IVD) for quantitative measurement, not an AI/ML-driven diagnostic requiring human expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or clinical diagnosis by human readers does not apply in this context.
- Ground truth for the HbA1c levels in the precision study samples would have been established by a highly accurate reference method or certified reference materials, not by human expert consensus or adjudication.
- For the accuracy study comparing to the predicate device, the predicate device itself served as the reference for comparison of the 51 samples.
- For the accuracy study against IFCC HbA1c Standards, the standards themselves provide the ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a quantitative measurement device, not one where human interpretation requires adjudication.
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
Not applicable. This device is an automated standalone in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described (precision, accuracy, linearity) are inherently standalone performance studies for the Premier Hb9210™ analyzer. The device performs the measurement and outputs the HbA1c value without human interpretative input in the measurement process itself.
7. The Type of Ground Truth Used
- Precision Study: Hemolysate samples representing different HbA1c levels. The "actual" concentrations were likely assigned using a reference method or certified values.
- Accuracy Study (IFCC HbA1c Standards): Certified IFCC HbA1c Standards. These are internationally recognized reference materials providing an agreed-upon "true" value for comparison.
- Accuracy Study (against predicate): The predicate device (Ultra2) results were used as the comparator for the 51 samples. While the predicate device itself is not "ground truth" in the strictest sense of a gold standard, it serves as the benchmark against which substantial equivalence is claimed.
8. The Sample Size for the Training Set
Not applicable. This document describes an in vitro diagnostic device using a well-established chemical and physical principle (boronate affinity HPLC). It is not an AI/ML device that requires a "training set" of data in the common sense of machine learning. The device's operational parameters are determined through engineering and chemical optimization, not through data-driven training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD device in the context of an AI/ML algorithm.
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