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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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Lyme B. burgdorferi (IgM) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgM antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2-EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

The kit is an immunoblot method to detect IgM antibodies against B. burqdorferi antigens. The test kit contains:
. Nitrocellulose Test Strips with purified B. burgdorferi antigens (3) and quality control lines (3) present in specific positions
. Sample Diluent. Provided for specimen dilutions. Contains BSA and PBS
Positive Control derived from human serum positive for Lyme disease. Contains

The provided document describes the Lyme B. burgdorferi (IgM) MarStripe Test, an immunoblot assay for detecting IgM antibodies to Borrelia burgdorferi. The submission aims to establish substantial equivalence to a legally marketed predicate device, the MarDx B. burgdorferi IgM MarBlot Strip Test System (K951709).

Here's an analysis of the acceptance criteria and the study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the study aims to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" can be inferred as achieving comparable performance to the predicate device and demonstrating acceptable analytical characteristics.

2. Sample Sizes Used for the Test Set and Data Provenance

• Method Comparison: 676 specimens tested (those found positive or equivocal on an FDA-cleared first-step EIA). The study was a prospective study performed at three geographically distinct study sites. The country of origin for the data is not explicitly stated but implied to be the USA given the FDA context and reference to CDC.
• Analytical Specificity: 220 sera from normal individuals (blood bank donors) representing endemic geographic regions of the United States. Data provenance is from US blood bank donors, retrospective or prospective not specified but typical for such collections.
• Cross-reactivity: 246 potentially cross-reactive specimens from individuals with various other infectious conditions. Data provenance is not specified.
• Sensitivity: 87 well-characterized Lyme disease clinical specimens. Samples included early, early disseminated, and late phases. Data provenance is not specified but implied to be clinical.
• CDC Panels: 10 samples from the Lyme Disease Validation Panel and 32 samples from the Lyme Disease Basic Research Panel (Total 42 samples). These are reference panels from the Centers for Disease Control and Prevention (CDC).
• Precision: 8 specimens, each tested in 4 replicates, two runs per day over 12 days (total 96 tests per specimen).
• Reproducibility: 8 specimens, each tested in 4 replicates, two runs per day over 12 days, at each of three laboratory sites (total 192 tests per specimen per site, or 576 read-outs in total).
• Interference: 2 Lyme IgM negative and 3 IgM positive sera.
• Serum vs. Plasma Matrix Comparison: 20 pairs of sera/plasma (total 40 samples).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets.

• For the Method Comparison study, the ground truth was established by comparison to results from an "FDA cleared immunoblot results" (the predicate device) which followed "recommended criteria described by the Centers for Disease Control (CDC) and the Second National Conference on Serological Diagnosis of Lyme Disease". This implies standardized interpretation criteria rather than individual expert consensus.
• For the Sensitivity study, "87 well characterized Lyme disease clinical specimens" were used, implying their disease status was previously determined, likely through a combination of clinical diagnosis and laboratory testing, but specific expert involvement is not detailed.
• For the CDC Panels, the ground truth is the CDC's characterization of these reference panels.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set interpretation by human readers. For the reproducibility study, results were read by "2 human operators at each site," but it does not specify if or how discrepancies between these operators were resolved (e.g., 2+1, 3+1). The "ground truth" for the overall studies appears to be based on established reference methods or clinical characterization rather than adjudicated interpretations of the MarStripe test itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the context of human readers improving with AI vs. without AI assistance. The studies performed were primarily focused on the device's analytical performance and its agreement with a predicate device and established reference panels.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself (Lyme B. burgdorferi (IgM) MarStripe Test) is an immunoblot assay that requires visual reading. The results show "Positives", "Negatives", "Band Type" (Pos., Neg., Cut., Wpos.), implying visual interpretation by a human. For example, the reproducibility study explicitly mentions "Results were read by 2 human operators at each site". Therefore, this is not a standalone algorithm without human-in-the-loop performance; human visual interpretation is an integral part of the test.

7. The Type of Ground Truth Used

The ground truth varied depending on the study:

• Method Comparison: Ground truth was the results from an FDA-cleared predicate IgM Western blot device, interpreted according to CDC and Second National Conference on Serological Diagnosis of Lyme Disease criteria.
• Analytical Specificity: Implied ground truth is "normal individuals" from blood banks, presumed negative for Lyme disease.
• Cross-reactivity: Ground truth was the clinical diagnosis of other infectious conditions, with validation against the predicate IgM Western blot device for any MarStripe positive results.
• Sensitivity: "Well characterized Lyme disease clinical specimens," implying clinical diagnosis of Lyme disease stages.
• CDC Panels: Characterization provided by the CDC for their reference panels.
• Precision/Reproducibility/Interference/Serum vs. Plasma: The ground truth for these analytical studies was related to the known characteristics of the samples (e.g., known negative, known positive, spiked with interferents, paired serum/plasma) as determined by prior testing (e.g., FDA-cleared B. burgdorferi ELISA results).

8. The Sample Size for the Training Set

The document describes performance studies for the Lyme B. burgdorferi (IgM) MarStripe Test. This device is a diagnostic assay, not an AI/ML model that requires a "training set" in the computational sense. The studies presented are validation studies of the finished device. There is no mention of an algorithm development phase with a dedicated training set.

9. How the Ground Truth for the Training Set Was Established

Since the device is a diagnostic assay (not an AI/ML model), there is no "training set" as understood in machine learning. Therefore, this question is not applicable to the information provided.

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Lyme B. burgdorferi (IgG) MarStripe Test is an immunoblot assay for the in vitro qualitative detection of human IgG antibody to individual proteins of Borrelia burgdorferi in human serum or plasma (K2- EDTA) in samples which have been found positive or equivocal using an EIA or IFA test procedure to provide supportive evidence of infection with B. burgdorferi.

The kit is an immunoblot method to detect IgG antibodies against B. burqdorferi antigens. The test kit contains: Nitrocellulose Test Strips with purified B. burgdorferi antigens (10) and quality control lines (3) present in specific positions, Sample Diluent, Positive Control, Negative Control, Conjugate (Antihuman IgG-HRP Conjugate), TMB Substrate, and PBS Wash Buffer concentrate. To perform the test, serum or plasma is added to individual B. burgdorferi Test Strips. In positive sera antibodies specifically bind to one or more of the test lines on the strips are washed according to the protocol, and then the pre-diuted, ready-to-use Conjugate is added to the test strips. After incubation and wash steps, the ready-to-use Substrate is added to the strips. During a 10 minute (±4 min) incubation, conjugate and substrate binding produces visible blue/purple lines for Serum Addition Control (SAC), Conjugate Addition Control (CAC) and Cut-Off Control lines. If the sample is positive for any of the antigen coated test lines, it will show a reaction more intense than the Cut-Off line. Reactions are read visually and reported as positive or equivocal (comparable to Cut-Off line). Strips which have 5 (or more) of the 10 test lines are considered positive for specific IgG antibody to B. burgdorferi.

Here's a breakdown of the acceptance criteria and study details for the Lyme B. burgdorferi (IgG) MarStripe Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics like sensitivity and specificity percentage targets. However, the reported performance against the predicate device and consensus can be considered the de-facto acceptance criteria for equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Reproducibility Test: 8 specimens (2 low negative, 2 high negative, 2 low positive, 2 moderate positive). Each specimen tested in 4 replicates, 2 runs per day, for a total of 72 tests per specimen at three laboratory sites.
• Analytical Specificity: 219 sera from healthy blood donors.
• Cross-reactivity: 136 potentially cross-reactive specimens from individuals with various other or infectious conditions.
• Interference: 5 sera (2 Lyme IgG negative, 3 Lyme IgG positive).
• Serum vs. Plasma Comparison: 10 pairs of native serum/plasma samples, plus 10 pooled serum/plasma samples (total 20 pairs).
• Method Comparison (Clinical Tests): 753 prospectively collected consecutive specimens, all initially positive on an FDA-cleared first-step EIA.
• Sensitivity (Clinical Specimens): 94 well-characterized Lyme disease clinical specimens (from the 753 specimens in Method Comparison).
• CDC Panels: 42 specimens from CDC (Lyme Disease Validation Panel n=10, Lyme Disease Basic Research Panel n=32).

Data Provenance:

• Healthy Blood Donors (Analytical Specificity): Representing endemic geographic regions of the United States.
• Clinical Specimens (Method Comparison & Sensitivity): Prospectively collected consecutive specimens tested at three sites. No further country of origin or specific demographic details are provided.
• CDC Panels: From the Center for Disease Control and Prevention.

Retrospective or Prospective:

• Method Comparison (Clinical Specimens): Explicitly stated as "prospectively collected consecutive specimens." The other studies do not explicitly state but generally, these types of validation studies are prospective or involve carefully selected retrospective samples to meet specific criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of external human experts establishing the ground truth for the test set in the conventional sense of, for example, radiologists interpreting images.

• Reproducibility: Results were read by 2 human operators at each of the 3 sites. No specific qualifications (e.g., years of experience) are provided for these operators, who are presumably laboratory personnel following a protocol.
• Method Comparison: The ground truth for comparing the device primarily relies on the predicate device (MarDx B. burgdorferi IgG MarBlot Strip Test System).
• Discrepant Analysis: For the 29 discrepant specimens, two additional commercially available B. burgdorferi IgG Western blot methods were used as comparators to establish a "consensus result." This implies laboratory methods rather than expert human interpretation.
• CDC Panels: Ground truth is established by the CDC's characterization of the panels.

4. Adjudication Method for the Test Set

• Reproducibility: No formal adjudication method like "2+1" is mentioned for individual band interpretation. The "Final positive or negative agreement was 100% for all specimens" suggests direct agreement between operators or that any differences were resolved internally to reach a unified result for each specimen.
• Discrepant Analysis (Method Comparison): A "2/3 comparator" consensus was used where the Lyme B. burgdorferi (IgG) MarStripe Test result was compared to results from two additional commercially available B. burgdorferi IgG Western blot methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This device is a diagnostic test kit (immunoblot assay) and not an AI-powered image analysis system that would typically involve human-in-the-loop performance evaluation. The "human operators" mentioned in reproducibility are interpreting the results of the kit, not an AI output.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire set of non-clinical and clinical tests (reproducibility batch, analytical specificity, cross-reactivity, interference, serum vs. plasma testing, and the initial method comparison against the predicate) represents the standalone performance of the device/kit itself. The "algorithm" here refers to the immunodetection process and interpretation rules inherent to the diagnostic kit, not a separate AI algorithm.

7. Type of Ground Truth Used

• Reproducibility: Based on prior FDA-cleared B. burgdorferi ELISA results (categorizing samples as low/high negative, low/moderate positive).
• Analytical Specificity: Healthy blood donors (presumed negative for Lyme).
• Cross-reactivity: Individuals with other infectious or autoimmune conditions (used to challenge specificity).
• Interference: Artificially spiked samples.
• Serum vs. Plasma Comparison: Comparison to results from an FDA-cleared Lyme EIA assay and subsequent Western blot IgG positivity/negativity.
• Method Comparison (Clinical Tests): The primary ground truth was the predicate device's result. For discrepant samples, a consensus of two additional commercial IgG Western blot methods served as the ground truth.
• Sensitivity (Clinical Specimens): "Well characterized Lyme disease clinical specimens" from the clinical study, with characterization across disease stages (early, early disseminated, late).
• CDC Panels: Characterized reference panels provided by the Center for Disease Control and Prevention.

8. Sample Size for the Training Set

No training set is explicitly mentioned or applicable in the context of this device. This is a diagnostic test kit that functions based on established biochemical reactions and interpretation algorithms, not a machine learning or AI model that requires a separate training phase. The described studies are validation studies for the finished product.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an AI/ML model, this question is not applicable. The device's "ground truth" (i.e., its intended performance characteristics) is established through the development and analytical/clinical validation studies presented.

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The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected of measles (rubeola) infection. This assay is intended for use as an aid in the diagnosis of a current or recent measles (rubeola) infection in conjunction with other clinical information and laboratory findings.

Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at a point of care. This test is not intended for use in screening blood and plasma donors.

The Trinity Biotech Captia™ Measles IgM test is an Enzyme-Linked Immunosorbent Assays (ELISA). When measles antigen (Edmonston strain) is bound to the solid phase and brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgM globulin conjugated with horseradish peroxidase which will bind to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4. The contents of the wells turn yellow. The color, which is indicative of the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

Here's an analysis of the acceptance criteria and the studies performed for the Trinity Biotech Captia™ Measles IgM ELISA Test Kit, presented in the requested format:

Acceptance Criteria and Device Performance for Trinity Biotech Captia™ Measles IgM ELISA

The provided document describes the performance characteristics and clinical studies of the Trinity Biotech Captia™ Measles IgM ELISA. The acceptance criteria are not explicitly stated as pass/fail thresholds in a dedicated table, but are inferred from the reported performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set (Clinical Studies 1 & 2): 188 samples from suspected measles infection cases.
  • Data Provenance: Retrospective, collected from individuals in whom a measles IgM test was ordered by the Texas Department of Health, Austin, Texas (66 samples) and the State Laboratory of Public Health in Raleigh, North Carolina (122 samples), USA.
• Test Set (Clinical Study 3): 8 samples.
  • Data Provenance: Retrospective, collected from submissions to the Kansas Department of Health and Environment Laboratory (KDHE), Topeka, Kansas, USA.
• Test Set (Specificity in a Normal Population): 200 random serum samples.
  • Data Provenance: Not explicitly stated, but implied to be from a general population (individuals between ages 18-65 with no known clinically apparent Measles infection). Location not specified.
• Test Set (Cross-Reactivity): 47 samples.
  • Data Provenance: Confirmed positive for other IgM antibodies (CMV, HSV1, HSV2, Rubella, VZV, Mumps, Parvo-B19) by Trinity Biotech Captia™ test kits. Location not specified.
• Test Set (Precision/Reproducibility): 6 blinded panel members (4 low-to-moderate positive, 2 negative).
  • Data Provenance: Not specified, likely internal or commercially sourced panels.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish the ground truth for the test sets in the clinical studies.
• The ground truth in Clinical Studies 1 & 2 was established using a "comparator testing algorithm" which consisted of "the results of other laboratory confirmation methods including comparator Measles IgM ELISA test kit, a comparator Measles IgM IFA test kit, Complement Fixation (CF), Hemagglutionation Inhibition (HI) and the Trinity Biotech Captia™ Measles ELISA IgG test kit." This implies multiple laboratory results were used to form a consensus or a defined algorithm, rather than individual expert adjudication of each case.
• Similarly, in Clinical Study 3, the "comparator algorithm included RNA polymerase chain reaction (PCR) on urine, nasopharyngeal swab (NPS) and/or throat swab (TS) samples."

4. Adjudication Method for the Test Set

• For Clinical Studies 1 & 2, the ground truth was established by a "comparator algorithm" based on multiple laboratory confirmation methods (e.g., other ELISAs, IFA, CF, HI). The specific adjudication rule (e.g., 2 out of 3, 3 out of 4) is not explicitly detailed, but it generally implies a form of consensus derived from multiple test results rather than human expert adjudication.
• For Clinical Study 3, the ground truth was established by a "comparator algorithm" based on PCR results from various sample types. Again, the specific adjudication rules for discrepant PCR results (e.g., "NPS negative at two sites, urine positive at one site and urine indeterminate at one site") are not explicitly detailed for how the final "positive," "indeterminate," or "negative" comparator algorithm result was reached.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not performed. This device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is an automated or semi-automated laboratory test. It does not involve human readers interpreting images or data where AI assistance would be applicable in the traditional sense of an MRMC study for imaging diagnostics. The "readers" are the laboratory technicians operating the ELISA equipment.

6. Standalone Performance Study

• Yes, standalone performance was done for the device. All reported performance metrics (analytical performance, seroconversion, cross-reactivity, clinical agreement with comparator algorithms) represent the performance of the Captia™ Measles IgM ELISA as an algorithm/device only, without human "in-the-loop" assistance for interpreting the result of the ELISA itself. While humans perform the test and interpret the final ISR value against predefined cut-offs, the "algorithm" is determining the ISR.

7. Type of Ground Truth Used

• The ground truth used was a combination of other laboratory confirmation methods and algorithms.
  • For Clinical Studies 1 & 2: "comparator testing algorithm used at each institution to determine the presence of current or recent measles infection" which included "comparator Measles IgM ELISA test kit, a comparator Measles IgM IFA test kit, Complement Fixation (CF), Hemagglutionation Inhibition (HI) and the Trinity Biotech Captia™ Measles ELISA IgG test kit." This represents a form of expert-defined algorithm/consensus from multiple laboratory tests.
  • For Clinical Study 3: "comparator algorithm included RNA polymerase chain reaction (PCR) on urine, nasopharyngeal swab (NPS) and/or throat swab (TS) samples." This is essentially molecular pathology/laboratory results.
  • For Cross-Reactivity: Confirmed positive status based on other specific IgM ELISA tests.
  • For Seroconversion: A commercially available seroconversion panel.

8. Sample Size for the Training Set

• The document does not explicitly state a separate "training set" in the context of machine learning model development. This is an ELISA kit, not typically a machine learning algorithm that requires a distinct training phase in the same way. The development and optimization of the assay (e.g., antigen titration, calibrator development, component formulation) would be part of an iterative development process that could be considered analogous to "training," but not in the sense of a labeled dataset for an AI model.
• The cut-off determination study involved 228 Measles IgM negative sera, which were used to establish the positive threshold (mean + 4SD). This could be considered a form of "training" or "calibration" data for the assay's interpretive criteria.

9. How the Ground Truth for the Training Set Was Established

• As noted above, there isn't a traditional "training set" for a machine learning algorithm.
• For the cut-off determination, the 228 Measles IgM negative sera were explicitly described as "Measles IgM negative sera" and were used to calculate statistical parameters (mean and standard deviation of optical density readings) to define the initial positive threshold. Four samples were disqualified because they were in the equivocal range on Trinity IgM ELISA or indeterminate on a comparator Measles IFA test kit (due to non-specific staining). This implies an initial screening or pre-classification of these samples as "negative" before their use in cut-off calculation. The final cut-off was derived using these empirical observations.

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Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens.

The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

The Giardia Nitrocellulose Membrane Test Strip - above consist of

• A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip.
• B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip.
• C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone.

When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly.

The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.

The test concept:

Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region.

Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.

A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane.

Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.

Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.

Here's a summary of the acceptance criteria and the study details for the Uni-Gold™ Giardia device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity must be >90%"). However, based on the studies presented, the implicit acceptance criteria are 100% agreement/sensitivity/specificity in the evaluated studies.

2. Sample Sizes and Data Provenance

• Test Set for Agreement vs. Comparator Device:

  • Total Samples: 267 retrospective samples.
  • Matrix types: unpreserved frozen (42), C&S (15), SAF (139), and formalin (71).
  • Country of Origin: Not explicitly stated, but the studies were conducted at 3 external laboratories. Given the "US and Canada" mention for overall sample collection, it's likely from these regions.
  • Retrospective/Prospective: Retrospective.

• Test Set for Sensitivity/Specificity vs. DFA Microscopy (Retrospective):

  • Total Samples: 241 (91 positive, 150 negative).
  • Positive matrix types: formalin (48), SAF (13), unpreserved frozen (17), Cary Blair (3), and C&S (10).
  • Negative matrix types: formalin (42), SAF (70), unpreserved frozen (25), Cary Blair (3), and C&S (10).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Additional Retrospective Studies (Non-Fluorescent Microscopy):

  • Site 2 (Wheatley's Stain): 67 retrospective samples (22 positive, 45 negative).
  • Site 3 (Iron Hematoxylin Stain): 259 retrospective samples (60 positive, 199 negative).
  • Country of Origin: Not explicitly stated, but likely from "US and Canada."
  • Retrospective/Prospective: Retrospective.

• Test Set for Prospective Study (DFA Microscopy):

  • Total Samples: 378 negative samples.
  • Matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
  • Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
  • Retrospective/Prospective: Prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts" used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, the ground truth methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain) are laboratory diagnostic techniques typically performed by trained medical technologists or laboratory personnel. It implies that these established methods served as the expert-level reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by the reference methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain). In cases where the Uni-Gold device and the initial comparator device disagreed (e.g., in the "Agreement vs. Comparator Device" study), further resolution was sought through DFA microscopy or Iron Hematoxylin Stain, which effectively acted as an adjudicator to determine the true positive/negative status for those discrepant samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study compares the device performance to established laboratory methods or an existing comparator device, not the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was evaluated. The studies directly compare the Uni-Gold™ Giardia device's results (algorithm only, as it's a rapid immunoassay) against the chosen established ground truth methods (DFA microscopy, non-fluorescent microscopy, or a comparator device). There is no "human-in-the-loop" aspect to the device's reading mechanism described.

7. Type of Ground Truth Used

The types of ground truth used were primarily:

• DFA Microscopy: Direct Fluorescent Antibody microscopy.
• Non-Fluorescent Microscopy: Specifically, Wheatley's Stain and Iron Hematoxylin Stain.
• Comparator Device: Remel Xpect™ Giardia Lateral Flow Assay (510K #: K031942) for initial agreement studies, with discrepant results often adjudicated by DFA or Iron Hematoxylin Stain.

8. Sample Size for the Training Set

The document describes a rapid immunoassay device. It does not mention a "training set" in the context of machine learning. The device is a chemical/immunological test, not an algorithm that requires a training set in the AI sense. The development of the assay itself would have involved internal validation and optimization, but not a distinct "training set" as understood in AI studies.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI algorithm, this question is not applicable to the Uni-Gold™ Giardia immunoassay device.

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Trinity Biotech Uni-Gold™ Cryptosporidium is a single use rapid immunoassay for the qualitative detection of Cryptosporidium parvum (C. parvum) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Cryptosporidium gastrointestinal infections. As with other Cryptosporidium tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.

The Trinity Biotech Uni-Gold™ Cryptosporidium Test was designed as a single use, rapid, lateral flow immunoassay to detect the presence of Cryptosporidium parvum antigen in unpreserved (fresh & frozen), preserved, and media containing human stool specimens. The Trinity Biotech Uni-Gold™ Cryptosporidium test strip (5mm x 60mm) combines a nitrocellulose membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.

Here's an analysis of the acceptance criteria and study details for the Uni-Gold™ Cryptosporidium device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined "acceptance criteria" in terms of numerical thresholds for sensitivity and specificity. Instead, it presents the results of studies and aims to demonstrate substantial equivalence to a predicate device. For the purpose of this request, I will infer the implicit acceptance is achieving high sensitivity and specificity in comparison to gold standard methods and predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Comparator Device Study (Side-by-side with Remel Xpect®): 299 retrospective samples. Data provenance: United States (multiple external sites). Sample matrices included unpreserved frozen, Cary Blair, SAF, and formalin.
• Sensitivity/Specificity Study (vs. DFA Microscopy): 234 retrospective samples (77 positive, 157 negative). Data provenance: United States (2 external laboratories). Sample matrices included formalin, SAF, unpreserved frozen, Cary Blair, and C&S.
• Additional Retrospective Studies (vs. Non-fluorescent Microscopy):
  • Site 2: 47 retrospective samples (26 positive, 21 negative) vs. Modified Acid-Fast Stain.
  • Site 3: 281 retrospective SAF samples (60 positive, 221 negative) vs. Modified Kinyoun Stain.
• Prospective Study (vs. DFA Microscopy): 378 samples (all negative). Data provenance: one external laboratory in the US. Sample matrices included unpreserved fresh, unpreserved frozen, formalin, SAF, C&S, and Cary Blair.
• Overall Combined Test Set: 940 (prospective and retrospective) samples. Data provenance: Collected from Hospitals throughout the US and Canada.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of individual experts or their exact qualifications (e.g., number of years of experience, specific medical specialty) used to establish the ground truth for the test sets.

Instead, it refers to "DFA microscopy," "Modified Kinyoun Stain light microscopy," and "Modified Acid-Fast Stain" as the reference methods (ground truth). It is implied that these microscopy methods are performed and interpreted by trained laboratory professionals, but specific expert details are not provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1 reader consensus) for resolving discrepancies in the reference methods (DFA microscopy, Modified Kinyoun Stain, Modified Acid-Fast Stain).

In cases of discrepancy between the Uni-Gold™ device and the comparator/reference method within the studies, some retesting or re-evaluation against a "higher" ground truth was performed:

• Site 3 (Comparator Device Study): For the 51 samples positive by Uni-Gold™ but negative by comparator, 30 were positive by Modified Kinyoun Stain light microscopy and 3 by DFA microscopy (agreeing with Uni-Gold™). The one sample negative by Uni-Gold™ and positive by comparator was negative by Modified Kinyoun Stain microscopy (agreeing with Uni-Gold™). This indicates that microscopy was used as an adjudicator for samples where the test device and the comparator device disagreed.
• Site 3 (Non-fluorescent Microscopy Study): For the 23 negative samples (by Modified Kinyoun Stain) that tested positive on Uni-Gold™, three subsequently tested positive by DFA microscopy (agreeing with Uni-Gold™). This implies DFA microscopy acted as a higher-level adjudicator for certain discrepancies.

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 question is not applicable to the Uni-Gold™ Cryptosporidium device. The device is a rapid in vitro diagnostic immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not relevant to this type of device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is also not applicable. The Uni-Gold™ Cryptosporidium device is a standalone lateral flow immunoassay. Its performance is the "algorithm only" performance (the chemical reaction and visual readout) without human intervention in the detection process itself, beyond the initial sample preparation and result interpretation. There is no separate "algorithm without human-in-the-loop" performance as it is the test.

7. The Type of Ground Truth Used

The primary types of ground truth used for the test sets were:

• DFA Microscopy: Direct Fluorescent Antibody microscopy, considered a gold standard for Cryptosporidium detection.
• Modified Kinyoun Stain Light Microscopy: A non-fluorescent microscopy staining method.
• Modified Acid-Fast Stain: Another non-fluorescent microscopy staining method.
• Comparator Device Results: In some comparative studies, the results of the legally marketed predicate device (Remel Xpect® Cryptosporidium) were used for comparison. However, when discrepancies arose in these studies, microscopy methods (DFA or Modified Kinyoun) were often used to adjudicate.
• Clinical Evaluation and Medical History: The intended use statement notes that "results should be considered in conjunction with the clinical evaluation and medical history," implying that clinical context is part of the broader diagnostic process, but the technical ground truth for device performance was microscopy.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or any machine learning algorithm. This device is a biochemical immunoassay, not an AI or machine learning model that requires a discrete training set. The development of the assay's reagents and parameters would have involved internal validation and optimization, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an AI/ML algorithm in this context, this question is not applicable. The ground truth for developing and optimizing the immunoassay would have been established through standard laboratory practices using known positive and negative controls, and possibly characterized clinical samples, during the assay development process, prior to the formal validation studies presented here.

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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 Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

The Destiny Max instrument performs coagulation testing (clotting, chromogenic and immuno-turbidimetric) using human samples. The system is comprised of an instrument (Destiny Max Analyzer) that performs the tasks necessary to general an assay result together with a Personal Computer (PC) that receives the user's secueeds and provides the results. The assays used with the Destiny Max are generally requences detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations.

The Trinity Biotech Destiny MAX Coagulation Analyzer is a multipurpose system for in vitro coagulation studies. Its acceptance criteria and performance are detailed through a method comparison study and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the performance is reported through method comparison against a predicate device (AMAX Destiny) and precision data, implying an expectation of strong correlation (for method comparison) and low variability (for precision).

Method Comparison (Slope, Intercept, R/R² values):
The device performance is reported across various assays (TriniCLOT PT HTF, TriniCLOT Excel S, TriniCLOT APTT S, TriniCLOT Thrombin Time, TriniCLOT Fibrinogen, TriniCLOT FVII, TriniCLOT FIX, TriniCHROM Antithrombin IIa, TriniLIA D-Dimer) in both optical and mechanical modes (where applicable). The reported R or R² values are consistently high, ranging from 0.88 to 1.00. Slopes are generally close to 1 and intercepts close to 0, indicating strong correlation and agreement with the predicate device.

Linearity (R values):
For linearity, the reported R values are all very high, ranging from 0.993 to 1.000.

Precision (%CV values):
Precision is assessed at different levels for each assay and mode, with "Within Run" and "Total" %CVs reported. The %CV values generally range from 0.6% to 24.2%, depending on the assay, level, and mode. For most clotting assays (PT, APTT, Thrombin Time), the %CVs are often below 5%. For Fibrinogen, FVII, FIX, Antithrombin, and D-Dimer, some %CVs are higher, particularly at lower concentrations or for “Total” precision.

Since specific acceptance criteria were not explicitly stated (e.g., "R² must be > 0.95" or "%CV must be

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The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 1 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performanace in these populations and with automated equipment

The Captia™ HSV 1 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assav (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 1 antigen. The Captia™ HSV 1 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection.

For In Vitro Diagnostic Use Only.

The Captia™ HSV 1 IgG Type Specific test is an Enzyme-Linked Immunosorbent assay to detect IgG antibodies to Herpes simplex 1 antigen. Purified recombinant HSV gG1 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Here's a breakdown of the acceptance criteria and study information for the Captia™ HSV 1 IgG Type Specific ELISA Test Kit, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics presented in the study. The device is deemed acceptable if its agreement with the predicate device (Western Blot or other ELISA) falls within certain confidence intervals, demonstrated across various patient populations.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Expectant Mothers: n = 210 sera. Data provenance: Consented, coded, unselected, banked, and masked sera. Country of Origin: Not specified beyond "Pacific Northwest university" which references the Western Blot. Retrospective (banked sera).
   • Sexually Active Adults: n = 198 sera. Data provenance: Consented, unselected, and masked sera. Country of Origin: Not specified beyond "Pacific Northwest university". Retrospective (masked sera implies pre-collected).
   • Low Prevalence Population: n = 184 sera. Data provenance: Unselected, banked, and masked sera. Country of Origin: Not specified beyond "Pacific Northwest university". Retrospective (banked sera).
   • Culture Positives: n = 53 sera. Data provenance: Unselected, retrospective, and masked sera from patients at least six weeks but not more than one year post clinical presentation and culture. Country of Origin: Not specified beyond "Pacific Northwest university". Retrospective.
   • Alternate HSV 1 Type Specific IgG ELISA Comparison: n = 200 specimens. Data provenance: Prospective, unselected, sequentially submitted specimens. Country of Origin: Not specified beyond "Pacific Northwest University".
   • Type Specificity with HSV 2 Western Blot Positives: n = 56 sera. Data provenance: Samples from the "above described populations" (expectant mothers, sexually active adults, low prevalence persons, and HSV 2 culture positives) that were HSV 2 Western Blot positive and HSV 1 Western Blot negative. Country of Origin: Not specified beyond "Pacific Northwest University". Retrospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not explicitly state the number or qualifications of experts used to establish the ground truth. The ground truth (reference method) was established by an "HSV 1 Western Blot (WB) from a Pacific Northwest university" or "culture" for some cases. While Western Blot interpretation requires expertise, no details about the experts are provided.

3. Adjudication method for the test set:
   The document does not mention an adjudication method for the test set. Results from the Trinity ELISA were compared directly against the Western Blot or culture reference method. For the expectant mothers and low prevalence population studies, "equivocal" results from the Trinity ELISA were excluded from the percentage agreement calculations but reported in the raw counts.

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:
   No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic ELISA kit, not an AI-assisted diagnostic tool that would involve human readers interpreting results with or without AI. The evaluation is solely on the performance of the assay itself compared to a reference method.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, the studies presented are all standalone performance evaluations of the Captia™ HSV 1 IgG Type Specific ELISA kit. The performance metrics (e.g., % agreement positive, % agreement negative) are direct comparisons between the ELISA results and the reference method (Western Blot or culture) without human interpretation being factored in beyond the initial reading of the ELISA and the reference method itself.

6. The type of ground truth used:
   The primary type of ground truth used was:

   • Expert Consensus / Established Reference Method: Western Blot (HSV 1 Western Blot, HSV 2 Western Blot). The Western Blot is considered a gold standard for type-specific HSV serology.
   • Pathology / Outcomes Data: Culture (for the "Culture Positives" study), indicating active infection.

7. The sample size for the training set:
   The document does not provide information on a training set. The presented studies are performance evaluations of the final device, implying that any training and development would have occurred prior to these validation studies. Therefore, the sample sizes mentioned are for the test sets.

8. How the ground truth for the training set was established:
   Since no training set details are provided, the method for establishing its ground truth is also not mentioned.

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The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) I Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performance in these populations and with automated equipment.

The CaptiaTM HSV 2 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 2 antigen. The Captia™ HSV 2 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection. Purified recombinant HSV gG2 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The provided document details the performance characteristics of the Captia™ HSV 2 IgG Type Specific ELISA Test Kit. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, it presents the performance of the device against a predicate device (Western Blot) and an alternate ELISA. The reported performance is summarized below from different study populations. The predicate device used for comparison is the Western Blot (WB) from a Pacific Northwest university.

2. Sample Size Used for the Test Set and Data Provenance

The document describes several distinct test sets:

• Expectant Mothers:
  • Sample Size: n = 210
  • Data Provenance: Consented, coded, unselected, banked, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Sexually Active Adults:
  • Sample Size: n = 198
  • Data Provenance: Consented, unselected, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Low Prevalence Population:
  • Sample Size: n = 184
  • Data Provenance: Unselected, banked, and masked sera. The reference method (Western Blot) was from a Pacific Northwest university. This suggests retrospective data.
• Culture Positives:
  • Sample Size: n = 56
  • Data Provenance: Unselected, retrospective, and masked sera from patients at least six weeks but not more than one year post clinical presentation and culture HSV 2 positive. Reference methods (culture and Western Blot) were from a Pacific Northwest university.
• Prospectively Collected, Sequential Sera (vs. Alternate ELISA):
  • Sample Size: n = 200
  • Data Provenance: Prospective, unselected, sequentially submitted specimens. Collected by an outside investigator at a Pacific Northwest University.
• Type Specificity with HSV 1 Western Blot Positives:
  • Sample Size: n = 292
  • Data Provenance: HSV 1 Western Blot positive and HSV 2 Western Blot negative sera from the above described populations (expectant mothers, sexually active adults, low prevalence persons, and HSV 1 culture positives). Collected by an outside investigator at a Pacific Northwest University. This is a retrospective analysis of previously collected samples.

In general, the data seems to be from the United States (Pacific Northwest university) and is predominantly retrospective (banked, unselected, masked, retrospective sera), with one prospective study for comparison against an alternate ELISA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly mention "experts" in the context of establishing ground truth. The ground truth for comparative studies is established by reference methods, primarily:

• Western Blot (WB): From a "Pacific Northwest university." No specific detail on the qualifications of the individuals performing or interpreting the Western Blot.
• Culture (for Culture Positives set): Implies standard laboratory procedure for viral culture, not explicitly associated with "experts" in this context.

Therefore, the specific number and qualifications of experts beyond the unspecified standard practices of a university lab for performing Western Blots and cultures are not detailed in the provided information.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1). The comparisons are directly between the Captia™ ELISA and the reference method results. There's no mention of a process where multiple readers or experts review discordant results to reach a consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA test kit) and does not involve human readers interpreting images or results, nor does it incorporate AI. Its performance is measured directly against laboratory reference standards.

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

Yes, the studies presented describe the standalone performance of the Captia™ HSV 2 IgG Type Specific ELISA Test Kit. This is an enzymatic immunoassay (ELISA) performed in a laboratory setting, and its efficacy is measured by comparing its outputs directly against established reference methods (Western Blot, culture, or another ELISA). There is no "human-in-the-loop" component in the performance evaluation described, beyond the technical execution of the tests themselves.

7. The type of ground truth used

The primary type of ground truth used across the various studies is:

• Reference Standard (Western Blot): The Western Blot (WB) method from a Pacific Northwest university served as the gold standard for serological detection of HSV 2 IgG antibodies in most studies.
• Culture: For the "Culture Positives" group, the ground truth for actual infection was established by HSV 2 culture positivity.
• Alternate ELISA: In one study, another commercially available HSV 2 type-specific IgG ELISA was used as a comparative reference.

8. The sample size for the training set

The document provides performance data based on comparative studies with clinical samples. It does not mention a "training set" in the context of machine learning or algorithm development. This is a traditional IVD device, not an AI-driven algorithm. The performance evaluation focuses on the device's accuracy against established reference methods using specific test populations.

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

As there is no explicit "training set" described for the development of a machine learning algorithm, this question is not applicable. The device's underlying mechanism is a biochemical ELISA, not an algorithm that learns from data. Its "ground truth" for development would relate to the antigen/antibody interactions it's designed to detect.

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