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The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a]] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.

The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.

Tina-quant Lipoprotein (a) Gen.2 Molarity assay quantifies lipoprotein (a) in human serum and plasma and reports the values in nmoVL with calibrator values traceable to the WHO/IFCC SRM2B reference material.

Reagents - working solutions
R1: Glycine buffer: 170 mmol/L. pH 7.0: stabilizers: BSA: rabbit serum 0.1 %, preservative
R3: Latex particles coated with polyclonal anti-human lipoprotein (a) antibodies (rabbit): 0.5 %; glycine buffer: 170 mmol/L, pH 7.3, BSA; preservative

Here's a breakdown of the acceptance criteria and study details for the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, based on the provided document:

This device is an in vitro diagnostic (IVD) assay, not an AI/ML-driven device. Therefore, the concepts of human readers, multi-reader multi-case (MRMC) studies, ground truth establishment by experts for images, training sets, and adjudication methods are not directly applicable in the typical sense as they would be for an AI model that interprets medical images. The "acceptance criteria" here refer to the predefined performance specifications for an analytical assay.

Device Name: Tina-quant Lipoprotein (a) Gen.2 Molarity

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "All acceptance criteria were met" for the non-clinical performance evaluation sections (Precision, Analytical Sensitivity, Linearity, Dilution, High Dose Hook Effect, Endogenous Interferences, Analytical Specificity/Cross-Reactivity, Sample Matrix Comparison, Method Comparison, and Stability). Specific pre-defined acceptance criteria are generally internal to the manufacturer's quality system and not explicitly listed in this 510(k) summary (which focuses on summarizing the results against those criteria). However, the reported device performance is provided, which demonstrates that the device met the manufacturer's internal criteria.

2. Sample Sizes and Data Provenance

• Precision (Repeatability): n = 84 (number of individual measurements per sample level).
• Precision (Intermediate Precision): 2 aliquots per run, 2 runs per day, 21 days.
• LoB: One analyte-free sample measured with three reagent lots, 6 runs, 10-fold determination per run, distributed over >3 days.
• LoD: 5 serum samples with low analyte concentrations measured with three reagent lots, 2-fold determination per run, 6 runs distributed over 5 days.
• LoQ: 5 serum samples measured with three reagent lots, 5 runs distributed over 5 days.
• Linearity: 1 run using 3 reagent lots and 5 replicates per sample. A dilution series prepared from human serum (sample High) and NaCl 0.9% (sample Blank) to obtain 16 levels.
• Method Comparison (to Lp(a) ELISA): n = 126 native human serum samples.
• Sample Matrix Comparison: ≥ 50 samples.
• Reference Range Study:
  • Caucasian/White: n = 425
  • African-American/Black: n = 111
  • Asian: n = 128
  • Hispanic/Latino (among Caucasian/White): n = 110
  • Non-Hispanic/Non-Latino (among Caucasian/White): n = 311
  • Data Provenance for Reference Range Study: Samples from apparently healthy adults in the United States, with equal representation of males and females. This suggests prospective collection for the purpose of establishing reference ranges. Other studies (e.g., method comparison, precision) would typically use laboratory samples which could be retrospective or specifically prepared for the study. The document does not specify "retrospective" or "prospective" for all tests, but the nature of these analytical performance studies often involves controlled, prepared, or collected samples without a specific patient encounter context. The "native human serum samples" for method comparison generally implies biological samples.

3. Number of Experts and Qualifications for Ground Truth

For this in vitro diagnostic device, "ground truth" is established by reference methods or validated analytical measurements, not by human expert interpretation in the way it would be for an AI image analysis tool.

• Not Applicable in the traditional sense for AI/ML image analysis. The "ground truth" for analytical performance tests like precision, linearity, or interference is an established analytical value or the characteristic of the sample itself (e.g., known concentration, presence/absence of interfering substance). For "method comparison," the ground truth is provided by the designated "Lp(a) ELISA reference method."

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense for AI/ML image analysis. Adjudication is usually performed by multiple human experts reviewing a case. For an IVD, the "adjudication" is inherent in the rigorous analytical protocols, statistical methods (e.g., CLSI guidelines), and the use of reference methods or certified reference materials for traceability.

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

• Not Applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Performance

• Yes, implicitly. The performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) evaluate the device (assay on the cobas c 503 analyzer) as a standalone system. There is no human intervention in the measurement or calculation of results once the sample is loaded. The device generates a quantitative value for Lp(a).

7. The Type of Ground Truth Used

• Reference Method/Analytical Standards:
  • Precision, Sensitivity, Linearity, Interferences: Ground truth is based on known concentrations in control materials, spiked samples, or by using analyte-free samples, following standardized laboratory practices and CLSI guidelines (e.g., CLSI EP05-A3, EP17-A2, EP06-A-Ed2).
  • Method Comparison: The "ground truth" or reference values were derived from the Lp(a) ELISA reference method.
  • Traceability: The device's calibration values are traceable to the WHO/IFCC SRM2B reference material for nmol/L, indicating a standardized and accepted reference for accuracy.

8. The Sample Size for the Training Set

• Not applicable in the AI/ML sense. This is a traditional IVD assay, not an AI model that requires a "training set" to learn features. The assay is based on well-understood principles of immunoturbidimetry and does not involve machine learning training.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant to this device. The assay's "knowledge" is built into its chemical reagents, optical detection system, and pre-programmed algorithms for calculating concentration from turbidity measurements, based on established analytical principles and calibration to reference materials.

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ONLINE TDM Methotrexate is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

The ONLINE TDM Methotrexate assay is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

The ONLINE TDM MTX assay is a two-reagent system used for the detection of methotrexate in serum and plasma. In this technology drug hapten attached to the enzyme glucose 6 phosphate dehydrogenase (G6PDH) serves as the binding partner to anti-methotrexate antibody. A competitive reaction to a limited amount of specific anti-methotrexate antibody takes place between the enzyme bound hapten and free methotrexate in the sample. Enzyme activity is reduced with bound antibody. Only active enzymes reduce NAD+ to NADH. The rate of NADH formation during the reaction correlates to the methotrexate concentration and is measured photometrically.

The ONLINE TDM MTX assay is a homogeneous enzyme-immunoassay.

Reagents - working solutions

R1: Anti-methotrexate antibody (rabbit monoclonal), 3 µg/mL; NAD, G6P, bovine serum albumin in water, pH 6.3; preservative

R3: Methotrexate hapten conjugated to G6PDH, 0.3 µg/mL; bovine serum albumin in buffer, pH 7.8; preservative

The provided document describes the analytical performance evaluation of the "ONLINE TDM Methotrexate" assay. This is an in vitro diagnostic device used for the quantitative determination of methotrexate in human serum and plasma. The study aims to demonstrate that the device meets predefined acceptance criteria.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a comparative format for all tests. Instead, it states for each section: "All acceptance criteria were met," and then provides the results. We can infer the acceptance criteria from the context and the reported successful outcomes.

Here is a reconstructed table based on the provided text, indicating the acceptance criteria (inferred from the "All acceptance criteria were met" statements and industry standards implicitly followed) and the reported performance.

• Control 1 (0.0863 µmol/L): 4.4% CV
• Control 2 (0.485 µmol/L): 0.9% CV
• Control 3 (0.849 µmol/L): 0.7% CV
• Human Serum 1 (0.0872 µmol/L): 4.0% CV
• Human Serum 2 (0.526 µmol/L): 0.8% CV
• Human Serum 3 (0.889 µmol/L): 0.7% CV
• Human Serum 4 (4.85 µmol/L): 1.0% CV
• Human Serum 5 (44.2 µmol/L): 4.0% CV
• Human Serum 6 (449 µmol/L): 3.7% CV
• Human Serum 7 (1334 µmol/L): 3.1% CV

Intermediate Precision:

• Control 1 (0.0737 µmol/L): 10.9% CV
• Control 2 (0.487 µmol/L): 1.2% CV
• Control 3 (0.841 µmol/L): 0.8% CV
• Human Serum 1 (0.0752 µmol/L): 11.2% CV
• Human Serum 2 (0.526 µmol/L): 1.3% CV
• Human Serum 3 (0.889 µmol/L): 1.1% CV
• Human Serum 4 (4.91 µmol/L): 2.0% CV
• Human Serum 5 (44.2 µmol/L): 5.3% CV
• Human Serum 6 (449 µmol/L): 6.3% CV
• Human Serum 7 (1316 µmol/L): 5.1% CV
  All stated to have met acceptance criteria. |
  | Analytical Sensitivity | LoB, LoD, LoQ within predefined thresholds to ensure accurate measurement at low concentrations. | LoB: ≤ 0.0250 µmol/L (claim in labeling)
  LoD:

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The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or venous whole blood on the cobas c 503 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Tina-quant Hemoglobin A1cDx Gen.3 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the cobas c 503 clinical chemistry analyzer. The assay offers separate applications that are specific to the sample types whole blood and hemolysate. The Whole Blood Application differs from the Hemolysate Application in the hemolyzing step. For the Whole Blood Application, whole blood samples are placed on the analyzer and hemolysis occurs onboard the analyzer. For the Hemolysate Application, hemolyzed samples are placed on the analyzer and hemolysis occurs manually before placing the samples onboard the analyzer. The two applications yield the same results. Hemolyzing reagent is part of the test system and is either placed on board the analyzer for the Whole Blood Application or used manually for the Hemolysate Application. Anticoagulated whole blood is hemolyzed either manually or automatically prior to determination of HbAlc by a turbidimetric inhibition immunoassay. Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbAlc from the HbAlc/Hb ratio according to a user selected protocol, either IFCC or NGSP protocols.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Tina-quant Hemoglobin A1cDx Gen.3:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with pass/fail thresholds. Instead, it presents various performance studies and their results. The implicit acceptance criteria are that the device's performance metrics are acceptable for its intended use and comparable to or better than the predicate device.

Here’s a table summarizing the reported device performance for key metrics:

• Reproducibility (total CV%): Most samples/controls show CV% between 1.0% and 1.9%.
• Repeatability (CV%): Most samples/controls show CV% between 0.4% and 0.6%.
  Whole Blood Application:
• Reproducibility (total CV%): Most samples/controls show CV% between 1.2% and 1.6%.
• Repeatability (CV%): Most samples/controls show CV% between 0.4% and 0.8%. |
  | Limit of Blank (LoB) | Detection limit sensitive enough for clinical application. | Hb LoB: 0.0530 mmol/L (0.085 g/dL)
  HbA1c LoB: 0.0220 mmol/L (0.035 g/dL)
  This corresponds to 15 mmol/mol (IFCC) and 3.5% HbA1c (DCCT/NGSP) at 13.2 g/dL Hb. |
  | Limit of Detection (LoD) | Detection limit sensitive enough for clinical application. | Hb LoD: 0.119 mmol/L (0.192 g/dL)
  HbA1c LoD: 0.0437 mmol/L (0.07 g/dL)
  This corresponds to 22 mmol/mol (IFCC) and 4.2% HbA1c (DCCT/NGSP) at 13.2 g/dL Hb. |
  | Linearity/Reportable Range | Linear response across the claimed measuring range. | Hemoglobin (Hb): 4 – 40 g/dL (2.48 – 24.8 mmol/L)
  HbA1c: 0.3 – 2.6 g/dL (0.186 – 1.61 mmol/L)
  This corresponds to a measuring range of 23-196 mmol/mol HbA1c (IFCC) and 4.2-20.1% HbA1c (DCCT/NGSP).
  Empirical First Order Regression: Pearson's r for Hb = 0.9999, HbA1c = 0.9990. |
  | Endogenous Interferences | No significant interference from common endogenous substances at specified concentrations. | Demonstrated claimed maximum concentrations without interference for: Bilirubin (60 mg/dL), Ditaurobilirubin (60 mg/dL), Lipemia (400 mg/dL), Rheumatoid Factors (750 IU/mL), Total Protein (21 g/dL), Albumin (60 g/L), Immunoglobulin (IgG) (60 g/L), Glucose (1000 mg/dL), Triglycerides (1584 mg/dL). A percent deviation criteria was used (not explicitly stated but implied to be within acceptable limits). |
  | Cross-Reactivity | No significant cross-reactivity with specified hemoglobin fractions and glycated albumin. | Max Whole Blood Cross-Reactant Concentration with no Interference: HbA0 (120 g/dL), HbA1(a+b) (0.96 g/dL for Level 1, 1.6 g/dL for Level 2), Carbamylated Hb (2.0 g/dL), Acetylated Hb (2.0 g/dL), Glycated Albumin (10 g/dL), Labile HbA1c (1000 mg/dL).
  Note: Specimens with >7% HbF may yield lower than expected HbA1c values. |
  | Hemoglobin Variants | Accurate results for common hemoglobin variants (HbS, HbC, HbE, HbD, HbA2) within acceptable bias. | Relative % Bias from Reference Method at Low (around 6.5%) and High (around 9%) HbA1c:
• HbS: -2.5% (Low), -4.0% (High)
• HbC: -3.9% (Low), -6.0% (High)
• HbE: -0.1% (Low), -1.2% (High)
• HbD: -1.8% (Low), -2.6% (High)
• HbA2: -1.0% (Low), 0.4% (High)
  Note: Specimens with >7% HbF may yield lower than expected HbA1c values. |
  | Exogenous Interferences (Drugs) | No significant interference from a list of commonly used drugs at specified concentrations. | No significant interference reported for 18 listed drugs (N-Acetylcysteine, Acetylsalicylic acid, Ampicillin-Na, Ascorbic acid, Cefoxitin, Heparin, Levodopa, Methyldopa + 1.5, Metronidazole, Doxycyclin, Rifampicin, Gammagard, Cyclosporine, Phenylbutazone, Acetaminophen, Ibuprofen, Theophylline, Tolbutamide) at tested concentrations. |
  | Sample Matrix Comparison | Acceptable agreement across different anticoagulants and fill levels. | Mean Difference for K2-EDTA, K3-EDTA, Na Heparin, Li Heparin, NaF/Potassium oxalate, EDTA/Fluoride at full and half-full tubes indicate close agreement (e.g., -0.026 to 0.019). Upper and Lower 95% CIs are provided (e.g., -0.181 to 0.172). |
  | Method Comparison | Good agreement with the NGSP reference method (Tosoh Automated Glycohemoglobin Analyzer HLC-723G8). | Whole Blood Application: Mean bias vs. NGSP TOSOH = -0.046%.
  Hemolysate Application: Mean bias vs. NGSP TOSOH = 0.046%.
  Bias at concentrations: (e.g., 5% HbA1c: WB -2.4%, Hemolysate 0.6%; 12% HbA1c: WB 0.7%, Hemolysate 1.2%). |
  | Total Error (TE) | Total Error within clinical requirements, considering both bias and precision. | Hemolysate Application: TE ranging from 3.0% to 4.4% across HbA1c levels.
  Whole Blood Application: TE ranging from 3.1% to 5.2% across HbA1c levels. |

2. Sample size used for the test set and the data provenance

• Precision (Repeatability and Intermediate Precision):

  • Sample Size: 10 samples (2 controls, 8 human samples) for each application (Hemolysate and Whole Blood). Measured for 21 days.
  • Data Provenance: Human samples and controls mentioned. No specific country of origin is stated, but implied to be laboratory-based testing. Prospective study design.

• Analytical Sensitivity (LoB, LoD):

  • Sample Size:
    • LoB: One analyte-free sample. 60 measurements per lot across 3 lots.
    • LoD: Five unique human samples with low-analyte concentrations. 60 measurements per lot across 3 lots.
  • Data Provenance: Human samples mentioned. Laboratory-based testing. Prospective study design.

• Linearity/Assay Reportable Range:

  • Sample Size: Separate dilution series (at least eleven levels) prepared from human hemolysate sample pools.
  • Data Provenance: Human hemolysate samples. Laboratory-based testing. Prospective study design.

• Endogenous Interferences:

  • Sample Size: Pooled whole blood samples at two HbA1c levels, spiked with 9 different interferents. 18 spiked samples + interferent-free pools. Each tested in ten-fold.
  • Data Provenance: Pooled whole blood samples. Laboratory-based testing. Prospective study design.

• Cross-Reactivity:

  • Sample Size: Not explicitly stated as a number of unique samples, but rather a "series of experiments" with specific cross-reactants. Ten replicates of each sample were analyzed for each dilution level.
  • Data Provenance: Laboratory-based testing using prepared samples to introduce cross-reactants. Prospective study design.

• Hemoglobin Variants:

  • Sample Size: 30 HbS, 30 HbC, 30 HbE, 29 HbD, 15 HbA2, 19 Elevated HbF. Total = 153 samples.
  • Data Provenance: Not specified, but implied to be characterized patient samples containing the variants. Laboratory-based testing. Prospective.

• Exogenous Interferences (Drugs):

  • Sample Size: Hemolysate samples at two HbA1c levels, spiked with 18 common drugs at two concentrations. Each drug/concentration combination tested in ten-fold.
  • Data Provenance: Hemolysate samples and spiked drugs. Laboratory-based testing. Prospective study design.

• Sample Matrix Comparison:

  • Sample Size: At least 40 samples of each anticoagulant type (e.g., K2-EDTA, K3-EDTA, Na Heparin, Li Heparin, NaF/Potassium oxalate, EDTA/Fluoride) at full and half-filled tubes. Samples from one donor for full/half-filled comparisons.
  • Data Provenance: Human donor samples. Laboratory-based testing. Prospective study design.

• Method Comparison:

  • Sample Size: 171 whole blood samples and 173 hemolysate samples.
  • Data Provenance: Samples from a "secondary NGSP reference laboratory." This suggests these are clinical samples that have been previously characterized by a gold standard (NGSP certified) method. The nature (retrospective/prospective clinical samples) is not explicitly stated but is consistent with a clinical validation using real patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not describe the use of human experts to establish ground truth in the way one would for image-based diagnostic AI. This device is an in vitro diagnostic (IVD) reagent system for quantifying a biomarker (HbA1c).

• Ground truth for the performance studies (e.g., precision, linearity, interferences) is established through:
  • Reference materials (e.g., controls like PreciControl HbA1c norm/path).
  • Dilution series from characterized sample pools.
  • Spiking experiments with known concentrations of interferents or cross-reactants.
• For Hemoglobin Variants and Method Comparison:
  • The "ground truth" or reference method is the NGSP Tosoh HPLC system. This system undergoes certification by the National Glycohemoglobin Standardization Program (NGSP) and is considered a highly accurate laboratory assay method, not dependent on human expert interpretation of a result. No individual human expert counts or qualifications are reported for establishing these reference values.

4. Adjudication method for the test set

Not applicable. This is an IVD device, not an AI or imaging diagnostic device that typically requires expert adjudication for ground truth establishment. The performance is assessed by comparing results to established reference methods, spiked concentrations, or statistical analysis of replicates.

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. The Tina-quant Hemoglobin A1cDx Gen.3 assay is an in vitro diagnostic (IVD) device for quantitative determination of HbA1c. It does not involve human readers interpreting images or data with or without AI assistance. It provides a numerical result.

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

Yes, the studies described are all standalone (algorithm only) performance evaluations. The device autonomously measures HbA1c and Hb concentrations, calculates the ratio, and reports the final HbA1c result. There is no human intervention in the result generation process once the sample is loaded onto the analyzer.

7. The type of ground truth used

The ground truth used in various parts of the study consists of:

• Reference Methods: The NGSP Tosoh HPLC system for method comparison, which is a recognized standardized method for HbA1c determination.
• Certified Reference Materials/Controls: PreciControl HbA1c norm and path with assigned values.
• Known Concentrations: For linearity, LoB, LoD studies, the "truth" is derived from preparing samples with known concentrations or by statistical analysis of repeat measurements of low/negative samples.
• Spiked Samples: For interference and cross-reactivity studies, the "truth" is the un-spiked sample value, and the effect is measured by deviation after adding a known amount of interferent.
• Characterized Patient Samples: For hemoglobin variant testing, samples from patients known to carry specific hemoglobin variants were used.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI. The Tina-quant Hemoglobin A1cDx Gen.3 is a reagent system for a well-established immunoassay technique. Its development involved chemical and assay optimization, not machine learning model training.

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

Not applicable, as there is no mention or indication of a machine learning "training set" for this IVD device. The assay's analytical principles are based on turbidimetric inhibition immunoassay (TINIA) and bichromatic photometric determination, which are traditional chemical analysis methods, not AI-driven algorithms requiring training data.

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Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems.

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

The Tina-quant® C-Reactive Protein IV reagent will be a liquid ready to use 2 component particle enhanced immunoturbidimetric assay.

Reagents - working solutions

R1: TRIS* buffer with bovine serum albumin; preservatives

R2 Latex particles coated with anti-CRP (mouse) in glycine buffer; immunoglobulins (mouse); preservative

• TRIS= Tris(hydroxymethyl)-aminomethane

The Tina-quant® C-Reactive Protein IV assay will be based on the DUREL technology (dual radius enhanced latex - technology) which is also used in C-Reactive Protein Gen.3 predicate method. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The aggregates are determined turbidimetrically.

The document describes the non-clinical performance evaluation of the Tina-quant® C-Reactive Protein IV device. Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Study Details:

The performance studies were designed in accordance with CLSI guidelines (EP5-A3, EP17-A2, EP6-A) and FDA guidance for CRP assays.

2. Sample sized used for the test set and the data provenance:

• Precision (Repeatability & Intermediate Precision):
  • Controls: Precinorm Protein and Precipath Protein.
  • Human Serum Samples: 4 human serum samples were used to evaluate repeatability and intermediate precision, plus 6 human serum samples for the specific results documented in the table. Each sample/control was analyzed with multiple aliquots (e.g., 2 aliquots for 21 days for precision).
  • Data Provenance: Not explicitly stated (e.g., country of origin), but it's noted as "human serum samples." The studies are prospective for the device evaluation.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: Ten aliquots of analyte-free saline (N=60 determinations per lot).
  • LoD: Five samples of low analyte level human serum (N=60 determinations per lot).
  • LoQ: Nine low concentration human serum samples (N=25 determinations per sample per lot).
  • Data Provenance: Not explicitly stated for specific origin, but uses "analyte free saline" and "human serum."
• Linearity/Assay Reportable Range:
  • Samples: Dilution series prepared from native unmodified human serum sample pools, resulting in 15 levels. Each level measured in triplicate (n ≥ 3).
  • Data Provenance: "native unmodified human serum sample pools."
• Endogenous Interference:
  • Samples: Effects determined at 2 CRP levels (5-10 mg/L and 35-100 mg/L) utilizing 11-level serial dilution sets of interfering substances. Each level measured in triplicate.
  • Data Provenance: Not explicitly stated, likely lab-prepared samples with added interferents.
• Exogenous Interference (Drugs):
  • Samples: Effects determined at 2 CRP levels (5-10 mg/L and 35-100 mg/L) using pooled samples spiked with drugs. N=5 results per drug.
  • Data Provenance: Lab-prepared samples with added drugs.
• Sample Matrix Comparison:
  • Samples: Native samples from single donors drawn into serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma primary tubes.
  • Range Tested: 3.34 to 344 mg/L.
  • Data Provenance: "native samples (single donors)."
• Method Comparison to Predicate:
  • Samples: One hundred ten (N=110) native, unaltered serum samples.
  • Data Provenance: "native, unaltered serum samples."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This device is an in-vitro diagnostic (IVD) assay for quantitative determination of C-Reactive Protein (CRP). The "ground truth" for such devices is established by reference methods, certified reference materials, and accepted analytical techniques, not by expert interpretation in the same way imaging studies might use radiologists. The measurements for the test set samples (e.g., CRP concentrations) are determined by the analytical methods themselves, often verified against established standards or predicate devices. There is no mention of human experts establishing ground truth for the test set in the context of interpretation.

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

For IVD assays, ground truth is typically analytical, not based on expert adjudication of observations. The "truth" is the measured concentration, often confirmed by multiple replicates or comparative methods, as opposed to a consensus reading process found in clinical imaging studies. Therefore, no adjudication method (like 2+1 or 3+1) is applicable or described here.

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, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic instrument for measuring a biomarker (CRP). It does not involve human readers interpreting images or results that would be "assisted" by AI. The device directly produces quantitative results.

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

Yes, the performance studies described are for the device (Tina-quant® C-Reactive Protein IV on a cobas c 501 analyzer) operating in a standalone capacity. It measures CRP in samples without human intervention in the interpretive output. The studies evaluate the analytical performance of the instrument and reagents themselves.

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

The ground truth for this IVD device is based on:

• Analytical Standards: For LoB, LoD, LoQ, and Linearity, ground truth is established through statistical derivation from measurements of samples with known low or varying concentrations, or through the use of analyte-free samples or reference materials.
• Predicate Device Comparison: The "Method Comparison to Predicate" establishes the ground truth by comparing the device's results against a legally marketed and established predicate device (Roche Diagnostics C-Reactive Protein Gen.3), assuming the predicate provides the accepted reference values.
• Spiked Samples/Known Concentrations: For interference studies (endogenous and exogenous), ground truth is established by adding known amounts of interfering substances or drugs to samples with known CRP concentrations and observing the recovery of the expected CRP value.
• Certified Reference Materials (CRM): The "Traceability/Standardization" indicates that the candidate device is standardized against the certified reference material of IRMM (Institute for Reference Materials and Measurements) ERM-DA474/IFCC. This is a primary source of analytical ground truth.

8. The sample size for the training set

This document describes a premarket notification (510(k)) submission for a medical device. The "training set" concept is typically associated with machine learning or AI models. This device is an immunoturbidimetric assay, which is a traditional analytical chemistry method, not an AI/ML system. Therefore, there is no "training set" in the context of machine learning. The studies described are performance evaluations to demonstrate that the device meets its analytical specifications.

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

As there is no "training set" for an AI/ML model for this traditional IVD assay, this question is not applicable. The device's performance is validated against analytical performance criteria as described above in point 7.

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The Ammonia II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems.

Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

The Ammonia II (NH3L2) assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. The Ammonia II assay is an enzymatic method, with glutamate dehydrogenase.

This document describes the Ammonia II assay for the quantitative determination of ammonia in human plasma. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative ("All data passed the predetermined acceptance criteria") rather than specific numerical thresholds presented in a consolidated table. However, the reported performance data for each test indicates the values achieved. Based on the provided text, a summary of performance can be extracted:

Ammonia II Assay Performance Summary

2. Sample sizes used for the test set and the data provenance

• Precision: Not explicitly stated as a "test set" in the context of diagnostic accuracy but involves replicate measurements of various controls and human plasma samples over 21 days.
• LoB, LoD, LoQ:
  • LoB: One analyte-free sample measured with three lots in 10-fold determination in 6 runs (60 measurements per lot).
  • LoD: Five samples with low-analyte concentration measured with three lots in two-fold determination in 6 runs (60 measurements per lot).
  • LoQ: A low-level sample set (7 human plasma samples) tested in 5 replicates per sample on 5 days.
• Linearity: Not explicitly stated, typically involves a range of spiked samples.
• Endogenous Interferences: Pooled human plasma samples spiked with varying levels of interferent (10 dilution steps per sample), tested in triplicate.
• Exogenous Interferences (Drugs): Two sample pools (low and high NH3L2), each divided into aliquots. Reference aliquot (not spiked) tested n=3. Spiked aliquots tested in triplicate.
• Matrix Comparison: 52-53 tubes of K2 EDTA plasma and 52-53 tubes of K3 EDTA plasma for each of 3 reagent lots (total of ~156-159 tubes per anticoagulant type).
• Method Comparison to Predicate: 112 human plasma samples.

Data Provenance: The document generally refers to "human plasma" samples, suggesting human subjects. The country of origin is not specified but given the submitter is Roche Diagnostics (with registration numbers for Mannheim, Germany, Penzberg, Germany, and the United States), the data could be from multiple regions. The studies are prospective performance evaluations of the device conducted according to CLSI guidelines.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" for the performance characteristics (precision, limits, linearity, interference) is established by analytical methods and reference materials, not by expert interpretation of images or clinical cases.

4. Adjudication method for the test set

Not applicable. This is an IVD assay, and the studies are analytical performance evaluations, not clinical studies involving expert adjudication of diagnostics results or images.

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 is an IVD assay for quantitative ammonia measurement, not an AI-powered diagnostic imaging device or a decision support system for human readers.

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

Yes, directly. The studies described (Precision, LoB/LoD/LoQ, Linearity, Interference, Matrix Comparison, Method Comparison) evaluate the analytical performance of the Ammonia II assay itself, without a human-in-the-loop component for result generation. The device (Ammonia II assay on Roche/Hitachi cobas c systems) performs the quantitative determination of ammonia.

7. The type of ground truth used

The ground truth used for these analytical studies is based on:

• Reference materials and spiked samples: For linearity, LoB/LoD/LoQ, and interference studies, known concentrations of analyte or interferents are used to challenge the assay.
• Statistical methods: For precision, calculations of SD and CV reflect the inherent variability.
• Comparative methods: For method comparison, the results are compared against a legally marketed predicate device (Beckman Coulter Ammonia assay) using statistical regression.
• Clinical Laboratory Standards Institute (CLSI) guidelines: These guidelines (EP05-A3, EP17-A2, EP06-A) provide standardized methodologies for establishing analytical performance, which inherently define how "ground truth" is approached for these types of assays.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a distinct "training set." The performance studies are analytical evaluations of a chemical assay.

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

Not applicable, as there is no "training set" in the context of this device.

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Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems.

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically.

Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent.

The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the "Tina-quant Transferrin ver.2 (urine application) assay." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive human studies often seen with novel medical devices. Therefore, the information regarding acceptance criteria and study design will be primarily focused on analytical performance validation rather than multi-reader multi-case clinical studies involving human interpretation of images, as this is a laboratory reagent.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely implicit in the fact that "All data passed the predetermined acceptance criteria" for each analytical study. The performance is reported as the results of these studies.

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

• Precision and Analytical Sensitivity (LoB, LoD, LoQ):
  • Precision (Repeatability and Intermediate Precision): 5 human urine sample pools and 2 control samples. Tested for 21 days, 1 run/day, with 2 aliquots per sample in singlicate per part. This setup generates a large number of individual measurements over time to assess variability.
  • LoB: One analyte-free sample, measured 10-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
  • LoD: Five human urine samples with low-analyte concentration, measured 2-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
  • LoQ: A low-level sample set prepared by diluting 5 human urine samples, tested in 5 replicates per sample on 4 days, 1 run per day.
• Linearity/Assay Reportable Range: Dilution series prepared using human urine sample pools (number of pools not specified, but likely at least one concentrated pool), with 13 concentrations measured on 3 lots in triplicate.
• Endogenous Interferences: Two human urine pools (at two transferrin concentrations) were used for each interferent. Each pool was divided into two aliquots (spiked with interferent vs. solvent control). A dilution series of 11 steps was prepared and 3 aliquots per level were tested.
• Exogenous Interferences – Drugs: Two human urine sample pools (spiked with approximately 0.433 and 2.48 mg/dL transferrin concentrations) were used for each drug. Each pool was divided into two aliquots (drug spiked vs. solvent control), measured in triplicate.
• Method Comparison to Predicate: One hundred and seven (107) routine fresh, never-frozen human urine samples. Two samples were excluded (pH >8, value outside measuring range), so 107 samples were truly used in the comparison.
• Data Provenance: The document explicitly states "human urine samples" or "human urine sample pools." For the method comparison, samples were "routine fresh, never-frozen human urine samples." There is no specific mention of the country of origin, but Roche Diagnostics Operations (RDO) is located in Indianapolis, Indiana, USA, and Roche Diagnostics GmbH, Mannheim, Germany is also mentioned as having the establishment registration. The studies are prospective analytical validation studies conducted with collected samples, not retrospective analysis of clinical patient data in the typical sense for imaging.

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

This type of in vitro diagnostic device (IVD) aims for quantitative measurement of a biomarker. Therefore, the "ground truth" is established through analytical reference methods, certified reference materials, or highly rigorous internal validation processes tied to metrological traceability, rather than human expert consensus on subjective findings (as would be the case for an imaging AI).

• The ground truth for the test set is established by the analytical measurement on the reference method (for method comparison study), and by the known concentrations/dilutions of samples prepared for analytical studies (e.g., linearity, sensitivity, interference).
• No "experts" in the sense of radiologists interpreting images were involved in establishing the ground truth for these analytical performance studies. The accuracy of measurements is verified against the reference standard or predetermined analytical values.

4. Adjudication Method for the Test Set

Not applicable for this type of analytical performance study. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where multiple human readers independently assess data (like images) and then a consensus or tie-breaking mechanism is needed to establish ground truth or assess agreement. For an IVD, the "truth" is typically defined by the analytical method itself or a reference method.

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 a quantitative laboratory assay (a reagent for measuring transferrin in urine), not an AI imaging algorithm that assists human readers. No MRMC study was performed as it is irrelevant to the device's function.

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

Yes, the analytical performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) represent the "standalone" performance of the assay itself (the reagent/instrument system) without human intervention in the result generation beyond operating the analyzer according to instructions. This is the primary form of performance evaluation for an IVD.

7. The Type of Ground Truth Used

• For Precision, Analytical Sensitivity, Linearity, and Interference studies: The ground truth is effectively derived from known concentrations in prepared samples (e.g., analyte-free samples, low-concentration samples, dilution series, spiked samples) or reference materials/controls with established values.
• For Method Comparison: The ground truth is the measurement obtained from the predicate device, the "N Antisera to Human Transferrin (Siemens) on the BN ProSpec analyzer." This establishes substantial equivalence to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires "training data" in the conventional sense. It's a chemical reagent for an established analytical method (immunoturbidimetry). The development process would have involved formulation and optimization, but not "training" on a data set in the way an AI model would be.

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

Not applicable, as there is no "training set" for this type of IVD, which relies on chemical and immunological principles rather than machine learning from data.

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cobas b 101 system: The cobas b 101 instrument is a multi-assay system designed to quantitatively analyze cobas reagent discs. The system is intended for professional, in vitro diagnostic use in a clinical laboratory setting or point-of-care (PoC) locations.

HbA1c test: The cobas HbA1c Test is an in vitro diagnostic test designed to quantitatively determine glycated hemoglobin (HbA1c) in human capillary and venous whole blood on the cobas b 101 instrument. The system is intended for professional use in a clinical laboratory setting or point-of-care (PoC) locations. Measurement of hemoglobin A1c is used to assess the level of control of a patient's diabetes and to monitor long term blood glucose control. Elevated levels of hemoglobin A1c indicate uncontrolled diabetes in a patient.

The cobas b 101 system is a bench top analyzer which measures HbA1c. The system is fully automated, self-contained and utilizes a single use reagent disc. The system has the ability to measure capillary or venous whole blood samples. Sample is applied directly from the fingerstick or via a pipette when testing venous whole blood. The operator simply applies sample to the disc and places the disc in the instrument. There are no pre-analytics needed as the disc is self-filling by capillary forces. There is no intervention by the operator during measurement. At completion of the test, the instrument displays a quantitative result. No calculations or interpretation are required by the operator.

Calibration of the instrument is completed as part of the manufacturing process. Calibration information is contained on each disc and is read when the disc is loaded on the instrument. No calibration intervention is required by the operator.

An optional barcode scanner can be provided to read barcode information for patient identification. The barcode scanner uses LED as the light source. Results can be printed out by using an optional external printer.

A connection to a Data Management System is possible either via a USB interface to a local PC or via an Ethernet converted to a Laboratory Information Management System (LIMS). The communication protocol is defined according to the CLSI approved POCT1-A2 standard.

HbA1c (glycated hemoglobin) can be determined by using samples from capillary blood directly from the fingertip or from venous whole blood with heparin or EDTA (K2 or K3) anticoagulant. The blood sample is diluted and mixed with TRIS buffer to release hemoglobin from the erythrocytes. A fraction of the sample is conveyed into a reaction chamber where it is mixed with sodium lauryl sulfate (SLS). SLS is used to form the SLS-hemoglobin complex. The concentration of total hemoglobin is calculated by measuring SLS-hemoglobin complex with a wavelength of 525 nm. Hemoglobin A1c (HbA1c) in another fraction of the sample is first denaturated by potassium ferricyanide and sucrose laurate. The denatured HbA1c bonds with HbA1c antibody on the latex particle. Latex agglutination inhibition reaction then occurs by reacting the agglutinator that has synthetic antigen which can bond with HbA1c antibody. The concentration of HbA1c is calculated by measuring the latex agglutination inhibition reaction with a wavelength of 625 nm. The % hemoglobin A1c value is measured using a ratio of concentrations of HbA1c to total hemoglobin.

The provided document describes the cobas b 101 system and cobas HbA1c Test, an in vitro diagnostic device for quantitative determination of glycated hemoglobin (HbA1c).

Here's an analysis of the acceptance criteria and the studies performed to meet them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state a single table of "acceptance criteria" against which all performance metrics are measured. Instead, it discusses various performance evaluations with implicit acceptance criteria (e.g., "no significant interference," "within acceptance criteria," "met the predefined acceptance criteria," "non-significant interference was defined as ≤ 10% difference").

Based on the provided information, I can construct a summary table and highlight what can be inferred as acceptance criteria for those tests:

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

• Precision (Internal): 8 K2EDTA or K3EDTA venous whole blood samples and 2 control samples. Each sample measured 84 times (duplicate in 2 runs per day for 21 days).
• Precision (External): 4 human sample pools and 3 lots of controls. Each assessed 168 times (duplicate 2x/day for 21 days per site), for a total of 504 measurements per sample/control pool combined across 3 sites.
• Linearity/Assay Reportable Range: 11 dilutions of a low (3.6% HbA1c) and high (12.9% HbA1c) K2EDTA whole blood sample. (Number of replicates per dilution not specified but implied to be sufficient for CLSI EP06-A).
• Hemoglobin Linearity: 4 K2EDTA and Li-Heparin venous whole blood samples. For each, a 10-level dilution series (using NaCl as diluent) was prepared and tested in triplicate.
• Endogenous Interferences: Two HbA1c levels (normal and pathological range) for each interferent. Sample pools were K2EDTA venous whole blood. Varying dilutions mixed to create dilution series. (Number of replicates per dilution not specified but implied to be sufficient for CLSI EP07-A2).
• Exogenous Interferences (Drugs): K2EDTA venous whole blood pools. Each sample tested in 5 replicates.
• Cross-Reactivity (Carbamylated Hb, Acetylated Hb, Labile HbA1c): K2EDTA venous whole blood samples at normal and pathological HbA1c levels. Each dilution level tested in singlicate on 3 instruments.
• Cross-Reactivity (HbA0): Approximately 60 K2EDTA whole blood samples.
• Cross-Reactivity (HbA1a, HbA1b): 11 K2EDTA samples of varying HbA1a+b concentrations. Each measured in triplicate on the cobas b 101 instrument.
• Hemoglobin Variants: 130 samples total, covering HbAS (20), HbAC (20), HbAD (20), HbAE (20), Elevated F (20), Elevated A2 (10). Each sample tested once.
• Method Comparison: Capillary whole blood (N=125, 133, 121 per site), EDTA (K2) whole blood (N=125, 133, 121 per site), Lithium Heparin whole blood (N=125, 130, 117 per site). All from prospective blood sampling. Tested in singlicate.
• Matrix Comparison: 91 samples of EDTA (K2) and EDTA (K3) whole blood. Tested in singlicate.

Data Provenance: Most studies use human blood samples, either K2EDTA/K3EDTA venous whole blood or capillary whole blood. The External Precision and Method Comparison studies were conducted at "3 Point-of-Care sites," implying real-world or near-real-world clinical settings, likely within the country where the studies were conducted (not specified, but often the manufacturer's location or major market). The data appears to be prospective for the clinical performance (Method Comparison) as it mentions "prospective blood sampling" and "No contrived samples were tested." For other non-clinical performance studies (e.g., interferences, linearity), samples were prepared according to CLSI guidelines, which may involve spiking or diluting samples to achieve specific concentrations.

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

The document does not mention the use of "experts" to establish ground truth in the traditional sense of consensus reading for image-based diagnostics. For HbA1c measurements, the ground truth is established by reference methods or predicate devices, which are themselves highly standardized and validated laboratory instruments.

• For Method Comparison vs. Reference, the reference method used was the Tosoh G8 HPLC Analyzer. This is a well-established and validated laboratory instrument for HbA1c measurement.
• For Hemoglobin Variants, reference methods were "selected based on no interference for a particular variant." The specific reference methods for each variant are not listed, but they are implied to be established, accurate methods.
• For Cross-Reactivity (HbA0), the reference system was the cobas c 501.

Therefore, the "ground truth" is analytical, derived from established laboratory methods, not expert consensus on qualitative interpretation.

4. Adjudication Method (for the test set)

Not applicable. This device provides quantitative measurements of HbA1c. "Adjudication method" typically refers to how disagreements among multiple human readers are resolved in qualitative or semi-quantitative assessments (e.g., radiology reads). Here, the comparison is against an objective reference measurement.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging or similar scenarios where human readers interpret cases, and the AI's impact on reader performance (e.g., accuracy, efficiency) is evaluated. The cobas b 101 system and cobas HbA1c Test is an in vitro diagnostic device for quantitative chemical analysis, not a device interpreted by human readers in the same manner.

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

Yes, the entire document describes the standalone performance of the cobas b 101 system and cobas HbA1c Test. All the precision, linearity, interference, cross-reactivity, and method comparison studies were performed on the device itself comparing its quantitative output to established reference methods or accepted criteria. There is no human-in-the-loop component in the direct measurement and reporting of HbA1c values by the device. The "user" interaction involves sample application, but the analytical process is fully automated within the instrument.

7. The Type of Ground Truth Used

The ground truth used is primarily analytical measurements from established reference methods.

• Tosoh G8 HPLC Analyzer: Used as the reference method for the main method comparison studies for capillary, EDTA (K2), and Lithium Heparin whole blood.
• cobas c 501: Used as a reference system for HbA0 cross-reactivity.
• Selected reference methods: Used for hemoglobin variant testing.
• Calculated values: For linearity studies and some cross-reactivity studies, target concentrations were prepared by dilution from known high/low samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the cobas b 101 system or the cobas HbA1c Test. This is typical for an IVD device like this, which likely uses a rule-based algorithm and/or pre-calibrated sensor systems rather than a machine learning model that requires a distinct training phase. The "calibration information is contained on each disc and is read when the disc is loaded on the instrument," suggesting an internal calibration process defined by the manufacturer rather than a data-driven training set used by the end-user.

If there were any internal development or calibration data used by the manufacturer during the design of the reagent or instrument, it is not disclosed as a "training set" in this 510(k) summary.

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

As no specific "training set" is identified for a machine learning model, this question is not directly applicable. For the development and calibration of the device (if that's considered analogous to "training"), the ground truth would have been established through a rigorous process of using known standards, calibrators, and reference materials, similar to how the "ground truth" for the test set was established (i.e., against established analytical reference methods and validated materials). The document states the "Calibration of the instrument is completed as part of the manufacturing process," implying this process.

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ALP IFCC Gen.2 is an in vitro test intended for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma on COBAS INTEGRA systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The Roche ALP IFCC Gen.2 assay provides quantitative measurement of the catalytic activity of alkaline phosphatase in human serum and plasma in accordance with a standardized method.. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (position B) and SR (position C).

In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitrophenol. The p-nitrophenol released is directly proportional to the catalytic ALP activity. It is determined by measuring the increase in absorbance.

Here's an analysis of the provided text regarding the acceptance criteria and study information:

This document is a 510(k) summary for a diagnostic assay, not an AI/ML device. Therefore, many of the typical questions for AI/ML studies (like MRMC studies, reader performance, training set details, etc.) are not applicable here. The acceptance criteria and performance are for an in vitro diagnostic (IVD) reagent and its analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes modifications to an existing device (ALP IFCC Gen.2). The acceptance criteria are implicit in the "Pass/Fail criteria" for the verification and validation tests performed. The "reported device performance" refers to the characteristics of the modified device and the confirmation that it met these criteria.

Summary of the Study:

The document describes a Special 510(k) Premarket Notification for modifications to an existing in vitro diagnostic device, ALP IFCC Gen.2. The core purpose was to change the traceability standard of the assay and add specific interference claims. The "study" refers to the verification, validation, and testing activities conducted to confirm that these modifications did not adversely affect the device's performance and that the new claims were supported.

Breakdown of Information Request:

1. Table of acceptance criteria and reported device performance: See table above.

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

   • Sample Size: Not explicitly stated. The document mentions "verification, validation and testing activities" including "recovery in controls, linearity, method comparison, within run precision and interference characteristics." For these types of analytical studies, samples typically include:
     • Controls: Multiple replicates, often 2-3 levels, run over several days/runs for precision and recovery.
     • Linearity samples: A series of diluted or spiked samples across the measuring range.
     • Method Comparison samples: A set of patient samples (often 40-100+) covering the assay range, compared against a reference method or the predicate device.
     • Interference samples: Patient samples or spiked samples tested with various concentrations of interferents (hemoglobin, bilirubin, lipids).
   • Data Provenance: Not explicitly stated, but standard practice for Roche Diagnostics (a global company with manufacturing in Germany and operations in the US) would be internal lab testing, likely at their R&D facilities in Germany or the US. It would be prospective testing of the modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This question is not applicable in the context of an IVD reagent analytical performance study. "Ground truth" for an IVD assay's performance would be established by:
     • Highly accurate reference measurement procedures (e.g., the IFCC (2011) reference method cited for traceability).
     • Certified reference materials.
     • Comparison against a legally marketed predicate device or a clinical laboratory's established, validated method.
   • No "experts" in the sense of clinical reviewers are typically used to establish ground truth for analytical performance, but rather highly skilled laboratory scientists and metrologists ensure the accuracy of the reference methods and measurements.

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

   • This question is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving human interpretation (e.g., image reading), where disagreements among reviewers need resolution. This document describes analytical performance testing of a reagent where results are quantitative and objective.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. An MRMC study assesses the performance of human readers, often with and without AI assistance, on a set of cases. This document is about the analytical performance of an in vitro diagnostic reagent, not an AI/ML device or human reader performance.

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

   • This is not applicable. The device is an in vitro diagnostic reagent executed on an automated instrument (COBAS INTEGRA systems). Its performance is inherently "standalone" in functionality (it performs the assay automatically), but it's not an algorithm in the AI/ML sense that would have an "algorithm only" performance study. Its performance is the instrument's performance running the reagent.

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

   • For this type of analytical IVD study, the "ground truth" for method comparison and traceability would be:
     • Reference Measurement Procedures: Specifically, the modified IFCC (2011) reference method for ALP activity.
     • Certified Reference Materials/Calibrators: These provide established, highly accurate values.
     • Comparison to Predicate Device: The performance of the modified device was compared to the legally marketed predicate, which itself would have been validated against established clinical laboratory methods or reference methods.

8. The sample size for the training set:

   • This is not applicable. This is an IVD reagent, not an AI/ML algorithm that requires a "training set." The reagent's formulation and associated analytical procedures are developed through biochemical and analytical chemistry principles, not machine learning training.

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

   • This is not applicable for the same reason as point 8.

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The cobas c 513 clinical chemistry analyzer is a fully automated, standalone clinical chemistry analyzer intended for the in-vitro quantitative determination of analytes in body fluids.

The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the Roche/Hitachi cobas c 513 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The cobas c 513 clinical chemistry analyzer is a fully automated, software controlled analyzer system for in vitro quantitative determination of analytes in human body fluids. The cobas c 513 analyzer system includes a control unit and an analyzer with a closed tube sampling functionality.

The cobas c 513 control unit includes a computer (PC) located in the sampler unit, a touchscreen monitor, soft-keyboard, a mouse (optional use), and a printer. The control unit is used to perform tasks on the analyzer and the PC runs the software that controls the analyzer.

The software manages all instrument functions, all system functions, and all information related to orders and results. The software offers a graphical user interface (GUI) to control all functions by the operator. The control unit contains System Control software including interfaces to a Medical Device Data System (cobas Link) and to the customer Laboratory Information System (LIS).

The analyzer is composed of the sampler unit and the analytical unit. The sampler unit is composed of the rack loading/unloading areas, a barcode reader, a rack rotor, a STAT port, and conveyor lines. It is used to load and unload racks, power on the system, access the PC, and manage the conveyance of samples to the analytical unit.

The analytical unit is comprised of the reagent area, the sample area, and the reaction disk. Samples are conveyed to the analytical unit from the sample unit for photometric analysis before being returned to the sample unit.

Anticoagulated whole blood is hemolyzed either manually or automatically prior to determination of HbAlc by a turbidimetric inhibition immunoassay. Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbAlc from the HbAlc/Hb ratio according to a user selected protocol, either IFCC or NGSP protocols.

The assay offers separate applications that are specific to the sample types whole blood and hemolysate. The Whole Blood Application differs from the Hemolysate Application in the hemolyzing step. For the Whole Blood Application, whole blood samples are placed on the analyzer. Hemolysis occurs onboard the analyzer. For the Hemolysate Application, hemolyzed samples are placed on the analyzer. Hemolysis occurs manually before placing the samples onboard the analyzer. The two applications yield the same results.

This document, a 510(k) premarket notification, describes the performance evaluation of the cobas c 513 Analyzer and cobas c 513 Tina-quant HbA1cDx Gen.3 Assay. It does not describe an AI/ML powered device, but rather an in-vitro diagnostic system for measuring Hemoglobin A1c. Therefore, many of the typical acceptance criteria and study designs relevant to AI/ML based devices (e.g., expert consensus, MRMC studies, training set details) are not applicable or detailed in the same way.

However, I can extract and present the information as per your request based on the provided document, interpreting "acceptance criteria" as the performance criteria the device was tested against and "study" as the non-clinical performance evaluation conducted.

Device Name: cobas c 513 Tina-quant HbA1cDx Gen.3 Assay

Device Type: In-vitro diagnostic reagent system for quantitative determination of HbA1c.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an in-vitro diagnostic (IVD) device, the "acceptance criteria" are not explicitly listed in a single table with pass/fail remarks as might be seen for an AI/ML algorithm. Instead, the document details various performance studies (e.g., precision, linearity, method comparison, interference) and their results, implicitly demonstrating that the device meets an acceptable level of performance for its intended use based on standard IVD guidelines.

The table below summarizes the key performance metrics and their reported values. The "Acceptance Criteria" column reflects typical expected performance ranges or goals for such IVDs based on general industry standards and the context provided by the results themselves. The document states "All acceptance criteria for method comparison were met" and "All acceptance criteria for drug interferences were met," indicating that internal predefined criteria were satisfied.

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

• Limit of Blank (LoB): One analyte-free sample measured 10-fold with three lots, over six runs distributed over >3 days on one c 513 analyzer. Total 60 measurements per lot.
• Limit of Detection (LoD): Five samples with low-analyte concentration measured 2-fold with three lots, over six runs distributed over >3 days on one c 513 analyzer. Total 60 measurements per lot.
• Precision: Eight samples (two controls, seven human samples with varying HbA1c concentrations) measured in two aliquots per sample, once each in two runs per day for 21 days, on three cobas c 513 analyzers using 3 reagent lots per system.
• Method Comparison: 155 samples (Hemolysate) and 154 samples (Whole Blood) from the secondary NGSP reference laboratory. Samples were tested over a 3-day period with one lot of reagent on one cobas c 513 analyzer.
• Linearity: Two separate dilution series consisting of at least 11 levels, using human hemolysate sample pools. Samples measured in triplicate.
• Matrix Comparison: At least 40 samples of each sample type (anticoagulant and fill volume) and at least 40 half-filled tubes of each sample type. Overall sample count not explicitly summed but implies a substantial number.
• Endogenous Interference: 12 spiked samples (2 HbA1c levels x 6 interferents). Each treated pool (spiked and control) had a dilution series of at least 10 levels. Dilution series tested 10-fold.
• Drug Interferences: Native patient samples at 2 different HbA1c levels (approx. 6% and 8% HbA1c) were spiked with 16 common drugs at two defined concentrations. Samples measured in 10-fold.
• Cross-reactivity: Multiple experiments for each cross-reactant (HbA0, HbA1a+b, Acetylated Hb, Carbamylated Hb, Glycated Albumin, Labile HbA1c). Each involved a series of dilutions or concentration variations, with 10 replicates per sample.
• Hemoglobin Variants: 20 samples each for HbS, HbC, HbE, HbD, Elevated F. 13 samples for HbA2. Each tested once in at least one run.

Data Provenance: The document does not explicitly state the country of origin for the human samples used in these studies. The studies were non-clinical performance evaluations (laboratory-based testing). The samples for method comparison were obtained from a secondary NGSP (National Glycohemoglobin Standardization Program) reference laboratory. This implies a standardized and presumably well-characterized dataset. The studies are prospective in the sense that they are designed performance evaluations conducted specifically for device submission, rather than analysis of existing stored data.

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

This document describes a laboratory diagnostic device, not an AI/ML algorithm that interprets medical images or other complex data requiring human expert consensus for ground truth.

• Ground truth for HbA1c values: For the method comparison study, the ground truth was established by a secondary NGSP reference laboratory using a Tosoh HPLC system. This is a recognized and standardized reference method for measuring HbA1c. The document mentions "Traceability: This method has been standardized against the approved IFCC reference method for the measurement of HbA1c in human blood and can be transferred to results traceable to DCCT/NGSP by calculation." This indicates that the ground truth is established via an internationally recognized and highly accurate analytical method, rather than through expert human assessment.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in the context of an AI/ML diagnostic for image interpretation is not directly applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth for this IVD device is established through a laboratory reference method (Tosoh HPLC system) traceable to international standards (IFCC, NGSP), not through human expert assessment needing adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the performance of an in-vitro diagnostic instrument and assay, not an AI/ML application intended to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study and the concept of "how much human readers improve with AI vs. without AI assistance" are not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, in essence. The performance studies detailed in this document (precision, method comparison, linearity, interference, etc.) directly evaluate the cobas c 513 Tina-quant HbA1cDx Gen.3 Assay and cobas c 513 Analyzer as a standalone system for quantitative determination of HbA1c in patient samples. The results are generated entirely by the instrument and reagents, independent of human interpretive input beyond standard laboratory procedures for operating the device and reporting results. There is no "human-in-the-loop" interpretive component that would require a separate "standalone" versus "human-in-the-loop" performance evaluation as might be seen for an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the HbA1c values, particularly in the method comparison study, was established using a Tosoh HPLC system operated by a secondary NGSP (National Glycohemoglobin Standardization Program) reference laboratory. This method is traceable to the approved IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) reference method and linked to DCCT/NGSP standards. This represents a highly standardized and analytically robust reference method/pathology/analytical outcome data rather than expert consensus on subjective findings.

8. The Sample Size for the Training Set

This document does not describe the development of an AI/ML algorithm that would have separate "training" and "test" sets in the conventional sense. This is an IVD device where performance characteristics are assessed on "test sets" (i.e., various sample groups used in the performance studies) to demonstrate its analytical capability. Therefore, the concept of a "training set" is not applicable here.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.

Here's a breakdown of the acceptance criteria and study details for the HDL-Cholesterol Gen.4 device, extracted from the provided document:

Device: HDL-Cholesterol Gen.4
Type: In vitro diagnostic test for the quantitative determination of HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

Acceptance Criteria and Reported Device Performance

• PreciControl ClinChem Multi 1 (Mean 28.0 mg/dL): SD 0.20 mg/dL, CV 0.7%
• PreciControl ClinChem Multi 2 (Mean 68.1 mg/dL): SD 0.44 mg/dL, CV 0.6%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.17 mg/dL, CV 1.8%
• Human Serum 2 (Mean 40.5 mg/dL): SD 0.26 mg/dL, CV 0.7%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.32 mg/dL, CV 0.5%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.51 mg/dL, CV 0.6%
• Human Serum 5 (Mean 141 mg/dL): SD 0.83 mg/dL, CV 0.6%
  Intermediate Precision:
• PreciControl ClinChem Multi 1 (Mean 28.4 mg/dL): SD 0.30 mg/dL, CV 1.1%
• PreciControl ClinChem Multi 2 (Mean 66.4 mg/dL): SD 0.9 mg/dL, CV 1.4%
• Human Serum 1 (Mean 9.48 mg/dL): SD 0.20 mg/dL, CV 2.2%
• Human Serum 2 (Mean 40.7 mg/dL): SD 0.33 mg/dL, CV 0.8%
• Human Serum 3 (Mean 59.4 mg/dL): SD 0.40 mg/dL, CV 0.7%
• Human Serum 4 (Mean 79.4 mg/dL): SD 0.65 mg/dL, CV 0.8%
• Human Serum 5 (Mean 141 mg/dL): SD 1.07 mg/dL, CV 0.8% |
  | Analytical Sensitivity (LoB, LoD, LoQ) | LoB, LoD, and LoQ should be below the claimed measuring range. | LoB Observed: 0.00 mg/dL (Claim: 3.09 mg/dL)
  LoD Observed: 0.50 mg/dL (Claim: 3.09 mg/dL)
  LoQ Observed: 2.89 mg/dL (Claim: 3.09 mg/dL) |
  | Linearity/Assay Reportable Range | Measurements should be linear across the claimed measuring range (3.09 to 150 mg/dL), with good correlation and low deviation. | Serum: Slope 1.020, Intercept -0.399, Correlation Coefficient (r2) 0.9992, Repeatability 1.5%
  Plasma: Slope 1.022, Intercept -0.173, Correlation Coefficient (r2) 0.9929, Repeatability 0.8%
  Claimed Measuring Range: 3.09 to 150 mg/dL (for both serum and plasma).
  Nonlinearity did not deviate by more than 10%. |
  | Endogenous Interferences | No significant interference (bias >10%) from common interferents like hemolysis, lipemia, icterus, and triglycerides at specified levels. | Hemolysis: No Interference up to 1200 H index
  Lipemia: No Interference up to 2000 L index
  Unconjugated Bilirubin: No Interference up to 60 I index
  Conjugated Bilirubin: No Interference up to 60 I index
  Triglycerides: No Interference up to 1200 mg/dL |
  | Exogenous Interferences (Drugs) | No significant interference from a panel of common drugs at specified concentrations. | Results provided in Table 7 (specific details of "no interference" for each drug are implied by listing them in a "Test Concentrations Results" table within the interference section, assuming they met the 10% bias criterion for non-interference). |
  | Method Comparison to Predicate | Strong correlation with a legally marketed predicate device, with acceptable bias at medical decision points. | Regression Analysis (HDL-Cholesterol Gen.4 vs. Predicate): y = 0.956x - 0.949, r = 0.995
  Bias at medical decision points:
  -6.7 % at 40.2 mg/dL
  -6.0 % at 59.9 mg/dL |
  | Matrix Comparison | Acceptable correlation between serum and various plasma anticoagulant types. | Serum vs. Serum Gel Separation: y = 0.99x - 0.33, r = 0.999
  Serum vs. Li-heparin: y = 0.99x - 0.32, r = 1.000
  Serum vs. K2-EDTA: y = 0.98x - 0.70, r = 0.999
  Serum vs. K3-EDTA: y = 0.95x - 0.08, r = 0.999 |

Study Details

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

   • Precision (Repeatability & Intermediate Precision): 5 human serum pools and 2 control samples were used. Tested for 21 days with 4 replicates/day. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting (likely in the US or Germany, given Roche's locations). The nature of the study (analyzing human serum pools and controls) suggests prospective data collection for evaluating device performance.
   • Analytical Sensitivity (LoB, LoD, LoQ):
     • LoB: One analyte-free sample. Measured 10-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoD: Five samples with low-analyte concentration. Measured two-fold in 6 runs over 3 days, per reagent lot (total 60 measurements per lot).
     • LoQ: A low-level sample set prepared by diluting 5 human serum samples. Tested in 5 replicates per sample on 5 days.
   • Linearity/Assay Reportable Range: Dilution series prepared using 1 serum pool and 1 plasma pool. The dilution series contained 11 concentrations for serum and 15 concentrations for plasma.
   • Endogenous Interferences: Two human serum pools spiked with HDL-Cholesterol and interfering substances.
   • Exogenous Interferences (Drugs): Two human serum sample pools.
   • Method Comparison to Predicate: 111 routine laboratory serum samples. Additionally, 4 samples spiked with high human serum HDL-Cholesterol and 1 sample diluted with 0.9% NaCl. Data provenance is not explicitly stated as country of origin, but implied to be from a laboratory setting. The use of "routine laboratory serum samples" suggests retrospective collection, though the spiking and dilution aspects are prospective for the study design.
   • Matrix Comparison: 38 paired samples (serum and plasma) from single donors.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For this type of in vitro diagnostic device (quantitative measurement of a biomarker), "ground truth" is typically established by reference methods or validated comparative methods, not by human expert consensus or clinical adjudication as would be seen in imaging diagnostics.
   • The predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) serves as a comparative "ground truth" for the method comparison study. The precision, sensitivity, linearity, and interference studies establish the intrinsic performance properties of the device against predefined analytical standards (e.g., CLSI guidelines).
   • Therefore, the concept of "experts" as in "a radiologist with 10 years of experience" is not directly applicable here. The experts involved would be laboratory scientists, biochemists, and statisticians who designed and executed the studies according to CLSI guidelines and interpreted the analytical data.

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

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where subjective interpretation is involved.
   • For this in vitro diagnostic device, measurements are quantitative, and "adjudication" is done through statistical analysis and adherence to predefined acceptance criteria based on established analytical guidelines (e.g., CLSI EP5-A3 for precision, CLSI EP17-A2 for detection limits, CLSI EP6-A for linearity). There is no "human adjudication" process for individual results as there would be for image interpretation.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, and AI might assist or replace them. The HDL-Cholesterol Gen.4 is an in vitro diagnostic device that quantifies a substance in a laboratory sample; it does not involve human "readers" interpreting results in a subjective or visual manner that AI would enhance.

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

   • Yes, the performance evaluation reports are inherently demonstrating the "standalone" performance of the analytical algorithm/reagent system. The studies evaluate the device's ability to accurately and precisely measure HDL-cholesterol concentrations in samples, independent of further human interpretation beyond routine laboratory operation and quality control. The reported results (e.g., mean, SD, CV, regression equations) directly reflect the algorithm's performance.

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

   • Analytical Ground Truth: For the precision, sensitivity, linearity, and interference studies, the "ground truth" is based on the known concentrations of analytes in prepared samples (e.g., spiked samples, diluted samples, control materials) or the absence of analytes (blank samples), and performance is evaluated against established analytical standards and acceptable deviations.
   • Comparative Ground Truth: For the method comparison study, the predicate device (Ultra N-geneous HDL Cholesterol Reagent, K021316) served as the comparative "ground truth" or reference method for evaluating substantial equivalence. This is a common approach for 510(k) clearances.
   • No pathology or outcomes data was used for establishing the ground truth for device performance in this submission, as it's an analytical performance study for an IVD.

7. The sample size for the training set:

   • This document describes the pre-market notification (510(k)) studies for device validation, not the development or training of an AI algorithm. Therefore, there is no "training set" for an AI mentioned or implied in this submission. The device is a chemical reagent system, not an AI/ML independent medical device.

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

   • As noted above, no "training set" for an AI algorithm is described in this submission. The ground truth for the analytical studies described (e.g., precision, linearity) is based on the preparation of samples with known concentrations or comparative analysis against a validated predicate device, as per standard laboratory practice and CLSI guidelines.

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