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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:

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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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.

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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The Primus A1care Assay A1c test, for use with the TRI•stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

The Primus TRI•stat™ Instrument is a small (10"Wx11"Lx4"H), in vitro diagnostic instrument used with the Primus A1care Assay test to quantitate HbA1c using a patented two-phase optical method. The TRI•stat™ is capable of analyzing a total of 3 samples simultaneously.

The provided document is a 510(k) summary for the Primus TRI•stat™ Instrument and A1Care Assay, indicating substantial equivalence to a predicate device (K891235, Primus Boronate Affinity HPLC Method). However, it does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a comprehensive study report.

The document primarily focuses on establishing equivalent intended use, technology, and performance to the predicate device. It states: "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrate that the instrument and test substantially equivalent to the predicate device and are safe and effective for their intended use."

Without the actual study reports, the following information cannot be extracted:

Here's a table based on the information not available in the provided document, indicating what would typically be requested for such a description:

Acceptance Criteria and Device Performance (Not Provided in Document)

Here's a breakdown of the other requested information, indicating what is available and what is not:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size (Test Set): Not specified in the provided document. The document only mentions "comprehensive studies."
   • Data Provenance: Not specified.
   • Retrospective or Prospective: Not specified.

2. 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)

   • Not applicable as the device measures a quantitative biomarker (HbA1c). Ground truth for such devices is typically established through reference methods or certified reference materials, not expert consensus in the diagnostic imaging sense. The document implies comparison to the predicate device (Primus Boronate Affinity HPLC Method) and "known standards."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable for a quantitative diagnostic assay. Performance is assessed by statistical comparison to a reference method or certified values.

4. 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 is a standalone in-vitro diagnostic instrument for measuring a biomarker, not an AI-assisted diagnostic imaging device that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • The document describes the TRI•stat™ Instrument and A1Care Assay as standalone in-vitro diagnostic device. It quantifies HbA1c using a "patented two-phase optical method." While the instrument is "Partially Automated" and "Requires Sample Insertion and Tube Insertion," the measurement and result generation appear to be fully automated once the sample is loaded. Therefore, performance evaluation would be standalone. The document states "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • The document implies that performance is benchmarked against "known standards" and the predicate device (Primus Boronate Affinity HPLC Method). For HbA1c measurements, ground truth would typically be established by:
     • Reference methods: Such as HPLC methods (like the predicate device) or methods traceable to IFCC reference systems.
     • Certified reference materials: Samples with known, validated HbA1c concentrations.

7. The sample size for the training set

   • Not specified. The document does not describe the development or training of any machine learning model, only the evaluation of the full device. It mentions "factory calibrated" for optical measurements, which implies internal calibration data but not a distinct "training set" in the context of machine learning.

8. How the ground truth for the training set was established

   • Not applicable as no specific "training set" for a machine learning model is mentioned. Calibration and performance are likely based on reference materials and comparisons to established methods.

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NycoCard® CRP Test system is an in vitro diagnostic device for the quantification of Creactive protein (CRP) in human serum, plasma, and whole blood by a solid phase, sandwich-format, immunometric assay. The measurement of CRP aids in evaluation of sandwish inflammatory process induced by infectious microbial agents or by noninfectious inflammatory stimuli.

Not Found

This looks like a 510(k) clearance letter for the NycoCard® CRP device, which is an in vitro diagnostic device. This type of document typically declares the device substantially equivalent to a predicate device and allows it to be marketed. However, it does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria, nor does it typically discuss AI or ground truth in the context of device performance studies.

The information provided is primarily regulatory in nature (device name, regulation number, product code, substantial equivalence determination). There is no mention of specific performance metrics, sample sizes for studies, expert involvement, adjudication methods, or AI comparative effectiveness studies.

Therefore, I cannot extract the requested information from the provided text.

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The NycoCard® CRP Control is an assayed human serum control material intended to monitor and evaluate the precision and accuracy of quantitative C-reactive protein (CRP) assays. It is particularly recommended for use with the NycoCard® CRP point-ofcare test system for determination of C-reactive protein (510(k) submission date November 13. 2001, (K013787, Establishment Registration Number 1931251). Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "NycoCard® CRP Control" device. It is a control material used to monitor the precision and accuracy of C-reactive protein (CRP) assays, particularly with the NycoCard® CRP point-of-care test system.

The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot provide the requested information.

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In vitro diagnostic use to establish reference points for glycated hemoglobin test methods

Not Found

The provided text is a 510(k) clearance letter from the FDA for "Primus Liquid Calibrators for GHb/A1c Level 1 and Level 2." While it confirms the device is substantially equivalent to a predicate, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information from the given input. The document is solely an FDA clearance letter and does not detail the technical study data or acceptance criteria used for approval.

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Evaluate glycated hemoglobin test accuracy In vitro diagnostic use only

Not Found

I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer, indicating the clearance of a device. It does not contain information about the acceptance criteria, device performance, study design, or any of the specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document is a legal notification of substantial equivalence, not a summary of a clinical or performance study. Therefore, I cannot extract the requested information from this text.

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