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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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The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitation of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation.

For In Vitro Diagnostic use.

Lp(a) Ultra assay is composed by 2 ready to use liquid reagents (Reagent 1and Reagent 2) that are supplied in the following configuration: Reagent 1 fill volume 18 mL in a 20 mL wedge and Reagent 2 fill volume 9 mL in a 20 mL wedge, 1 wedge of each/kit.

The kit contains one plastic (HDPE) vial of Reagent 1 and one plastic (HDPE) vial of Reagent 2, which allows the customer to perform 86 tests (on AU680 automatic analyzer).

The provided text describes the performance testing of the Lp(a) Ultra assay, an in vitro diagnostic device, and its acceptance criteria. This is a lab-based assay, not an AI/ML medical device, and therefore the concepts of human readers, AI assistance, ground truth experts, and training/test sets as understood in AI/ML are not directly applicable in the same way. However, I can extract and present the information in a table format that parallels the requested structure for acceptance criteria and performance against those criteria.

Key takeaway: This document describes a traditional in-vitro diagnostic device, not an AI/ML based device. Therefore, many of the requested fields (e.g., number of experts, adjudication methods, MRMC studies, AI assistance) are not relevant.

1. Table of Acceptance Criteria and Reported Device Performance

• Intralipid® Sterile Fat Emulsion: up to 1000 mg/dL
• Conjugated bilirubin: up to 60 mg/dL
• Unconjugated bilirubin: up to 60 mg/dL
• Rheumatoid Factor: up to 500 UI/mL
• Hemoglobin: up to 1000 mg/dL
• Ascorbic Acid: up to 180 mg/dL

• Triglycerides: Tested up to 1000 mg/dL; no significant interference from 461 to 715 mg/dL. |
  | Stability (On Board/Calibration) | Demonstrate stated on-board and calibration stability claims. | Calibration Stability: 15 days on AU 680 Analyzer.
  On-board stability: 30 days on AU680 analyzer.
  %bias for levels 1-5 within acceptable ranges (-4.8% to 5.1%). |
  | Prozone Effect | No high-dose hook effect (prozone) observed within the claimed measuring range. | No Prozone effect observed up to 500.0 mg/dL. No prozone effect claimed up to the upper limit of the measuring range. |
  | Method Comparison vs. Predicate Device | Demonstrate substantial equivalence in performance to the predicate device. | Correlation Coefficient (r): 0.995 (Passing & Bablok fit and Linear fit).
  Slope: 0.9850 (0.9706 - 1.0000) for Passing & Bablok; 0.9771 (0.9612-0.9929) for Linear fit. |
  | Matrix Comparison (Serum vs. Plasma) | Demonstrate correlation between serum and various plasma types (Lithium Heparin, Sodium Heparin, Di-Potassium EDTA, Tri-Potassium EDTA). | Lithium Heparin: r=0.997, Slope=0.99 (0.95-1.03).
  Sodium Heparin: r=0.999, Slope=0.99 (0.95-1.01).
  Di-Potassium EDTA: r=0.997, Slope=0.97 (0.95-1.01).
  Tri-Potassium EDTA: r=0.998, Slope=0.99 (0.95-1.03). |

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

• Precision (Repeatability/Reproducibility):
  • Inter-Assay: 5 samples at different concentrations. 2 replicates per sample, 2 runs per day, for 28 testing days. (Total of 280 measurements per sample level over the entire study for 5 levels? The specific number of measurements is implied but not explicitly stated as 'n=X' for the total dataset.)
  • Intra-Assay: 5 samples at different concentrations. 20 replicates per sample, run on 3 different runs. (Total of 300 measurements over the entire study: 5 samples x 20 replicates x 3 runs).
• Linearity: 2 different reagent lots. No specific sample count is given, but "dilution series" are implied.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: 4 saline samples (zero-analyte) for two reagent lots, tested in 5 replicates in 3 different runs. (Total of 60 measurements per lot).
  • LoD & LoQ: The guidelined CLSI EP17-A2 was followed, but specific sample counts were not explicitly stated for these sections beyond the general method.
• Interference: "Low: ~30 mg/dL" and "High: ~50 mg/dL" Lp(a) concentrations. Two aliquots of serum pool per concentration. Tested in different replicates for paired difference and then diluted. Specific numbers of individual patient samples tested for interference effects for each substance are not provided.
• Stability (On Board Calibration): 5 samples at different concentrations (20 mg/dL to 100 mg/dL).
• Prozone Study: Last calibrator level used to reach a high concentration (approx. 500.0 mg/dL). Sample diluted in saline.
• Method Comparison vs. Predicate Device: Not explicitly stated but usually involves a significant number of patient samples covering the assay range to demonstrate correlation. The CLSI document EP09c 3rd Edition was followed.
• Matrix Comparison:
  • Lithium Heparin: 57 serum and Lithium Heparin plasma samples "derived from the same patients", tested in duplicate.
  • Sodium Heparin: 58 serum and Sodium Heparin plasma samples "derived from the same patients", tested in duplicate.
  • Di-Potassium EDTA: 57 serum and Di-Potassium EDTA plasma samples "derived from the same patients", tested in duplicate.
  • Tri-Potassium EDTA: 56 serum and Tri-Potassium EDTA plasma samples "derived from the same patients", tested in duplicate.

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that they used "human serum and plasma" samples. Given it's a 510(k) submission from an Italian company for an in vitro diagnostic device, the samples are typically human biological samples obtained under ethical guidelines, often from healthy volunteers or patient populations relevant to the assay's indication.

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):

Not applicable for this type of IVD device. The "ground truth" for quantitative assays is established by reference methods, traceable calibrators, and robust analytical procedures, not through expert consensus like in image interpretation. The performance is assessed by direct measurement and comparison to established analytical performance metrics and standard reference materials.

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

Not applicable. Adjudication methods are typically used in clinical trials involving human interpretation of medical images or symptoms where there might be inter-reader variability. For an IVD assay, performance is determined by instrumental measurements and statistical analysis against predefined acceptance criteria.

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 in vitro diagnostic device, not an AI/ML-driven analysis tool for human readers. No human interpretation or AI assistance is involved in its direct operation or intended use.

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

Not applicable in the context of an AI algorithm. The device, Lp(a) Ultra, is a standalone reagent (assay) used on an automated analyzer (Beckman Coulter AU680). Its performance is inherently "standalone" in that it measures analyte concentration without human interpretation of raw signals; humans perform the testing and interpret the numerical results from the analyzer.

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

The "ground truth" for this in vitro diagnostic assay is established through:

• Reference standards and calibrators: Used to define known concentrations of Lp(a).
• Defined analytical methods: Following recognized guidelines (e.g., CLSI EP05-A3, EP15-A3, EP06, EP17-A2, EP07, EP25-A, EP09c) for precision, linearity, sensitivity, interference, etc.
• Comparison to a legally marketed predicate device: "Ground truth" for demonstrating substantial equivalence is the performance of the predicate device (Diazyme Lipoprotein (a) Assay).
• Known concentrations in spiked samples or characterized biological samples: Used for studies like linearity and interference.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set" in that sense. The device is a chemical reagent kit with defined analytical characteristics.

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

Not applicable. See point 8.

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The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.

Not Found

The provided text is a 510(k) clearance letter for a medical device, the Diazyme PLAC® Test for Lp-PLA2 Activity. It largely focuses on regulatory aspects and the indication for use, not detailed study data or acceptance criteria. Therefore, I cannot extract the information required to populate all sections of your request from the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance information.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

The only relevant information I can derive is the device name and its intended use:

Device Name: Diazyme PLAC® Test for Lp-PLA2 Activity

Indication for Use: "The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events."

To fulfill your request for detailed acceptance criteria and study information, you would need access to the full 510(k) summary or the premarket submission itself, as this letter is merely the FDA's clearance notification.

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The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.

Not Found

This document is a 510(k) premarket notification acceptance letter from the FDA for a device called "Diazyme Lipoprotein (a) Assay." It is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment, which are typical for AI/ML device submissions, is not present in this document.

The document focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory classifications and general controls (e.g., annual registration, GMP, labeling).
• Indications for Use for the Diazyme Lipoprotein (a) Assay, which is for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum.

To answer your questions, I would need a different type of document, such as a clinical study report or a detailed premarket submission summary (e.g., from the FDA's 510(k) database if it provided more detail than this letter).

Therefore, I cannot populate the table or answer the specific questions about the study design, ground truth, and expert involvement based on the provided text.

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The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.

The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.

The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity.

The PLAC® Test for Lp-PLA2 Activity consists of the reagents, Lp-PLA2 Activity Test Calibrators and Lp-PLA2 Activity Test Controls for the measurement of Lp-PLA2 activity in EDTA-plasma or serum on automated clinical laboratory analyzers.

Lp-PLA2, in plasma or serum, hydrolyzes the sn-2 position of the substrate, 1myristoyl-2-(4-nitrophenylsuccinyl) phosphatidylcholine, producing a colored reaction product, 4-nitrophenol. The rate of formation of 4-nitrophenol is measured spectrophotometrically for 8.5 minutes and the Lp-PLA2 activity is calculated from the rate of change in absorbance. A set of five Lp-PLA2 calibrators is used to generate a standard curve fit of change in absorbance versus Lp-PLA2 activity level in nmol/min/mL from which the sample Lp-PLA2 activity is derived.

The PLAC® Test for Lp-PLA2 Activity also includes controls. Controls should be included in each run or in accordance with the user's laboratory's quality control policies.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLAC® Test for Lp-PLA2 Activity:

The document primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device. There is limited information on clinical acceptance criteria against specific clinical endpoints derived from a prospective study. The "acceptance criteria" presented are primarily for analytical performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides analytical performance criteria rather than clinical effectiveness criteria. The "Acceptance Criteria" column below is extracted directly from the precision tables or implied by the statements for other analytical metrics.

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For in vitro diagnostic use in the quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests.

The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry Lipoprotein(a) (LPA) assay.

The Lipoprotein(a) reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Lipoprotein(a) calibrator is a single analyte, human serum based product containing human lipoprotein (a). The kit consists of 1 vial each of 5 calibrator levels which are lyophilized. The target concentrations of these calibrators are 7.5, 15, 30, 65, and 95 mg/dL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.

Here's a breakdown of the acceptance criteria and study details for the ADVIA® Chemistry Lipoprotein(a) Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a definitive, quantified table for all performance characteristics. Instead, it describes studies that "gave acceptable results when compared to the predicate device" and lists the numerical outcomes of these studies. Therefore, this table is constructed by inferring the implied acceptance from the reported "acceptable results" and direct comparisons to the predicate device where available.

• Unconjugated bilirubin: 0-60 mg/dL
• Conjugated bilirubin: 0-60 mg/dL
• Intralipid: 0-1000 mg/dL
• Hemoglobin: 0-1000 mg/dL |

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

• Precision: Not explicitly stated as a separate "test set" for precision, but studies used:
  • Serum sample pools and serum-based controls.
  • Each sample assayed 2 replicates per run, 2 runs per day, for at least 20 days.
• Linearity/Assay Reportable Range:
  • Sample Size: Nine diluted samples (prepared from high and low serum pools).
• Limit of Blank, Limit of Detection, Limit of Quantitation:
  • Sample Size: 160 replicates of "zero" serum pool and several serum pools (number not specified) with Lp(a) concentrations up to 4x LoD level.
• Method Comparison (Serum):
  • Sample Size: 68 serum samples.
• Matrix Comparison (Plasma):
  • Sample Size: 44 plasma samples.
• Analytical Specificity:
  • Specific concentrations of interferents (unconjugated bilirubin 0-60 mg/dL, conjugated bilirubin 0-60 mg/dL, Intralipid 0-1000 mg/dL, hemoglobin 0-1000 mg/dL) were tested with samples at 3 specific Lp(a) levels (e.g., 14, 28, 47 mg/dL for bilirubin). The exact number of individual samples/replicates isn't specified beyond "in 14, 28, and 47 mg/dL lipoprotein (a) samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The samples are referred to as "human serum" or "human plasma."

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

This type of blood assay does not typically use human experts to establish "ground truth" in the same way an imaging device or AI algorithm would. Instead, the ground truth for an in vitro diagnostic assay is established through:

• Reference Methods: Comparison against an established, legally marketed (predicate) device.
• Known Concentrations: Use of accurately prepared and characterized calibrators and controls with known concentrations of the analyte.
• Spiking Experiments: Addition of known amounts of interferents or analyte to assess impact.

The document implicitly relies on the predicate device (Randox Lipoprotein (a) assay on the Hitachi 717) as a "ground truth" reference for method and matrix comparison studies.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to clinical samples or control materials analyzed by the device, and their values are compared against a predicate device or expected values, not adjudicated by experts in a qualitative sense.

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 in vitro diagnostic assay for quantitative measurement of a biomarker, not an imaging device or an AI application that assists human readers.

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

Yes, this entire submission describes the standalone performance of the ADVIA Chemistry Lipoprotein(a) assay. The device measures Lp(a) concentration directly on the ADVIA Chemistry systems without human interpretation or intervention in the measurement process itself, other than preparing samples and operating the instrument.

7. The Type of Ground Truth Used

The ground truth used for performance validation is primarily:

• Predicate Device Measurements: For method and matrix comparisons, the results from the legally marketed Randox Lipoprotein(a) assay on the Hitachi 717 are considered the comparative "ground truth" for demonstrating substantial equivalence.
• Known Concentrations/Prepared Samples: For linearity, LoB/LoD/LoQ determinations, and analytical specificity, samples with known concentrations (e.g., "zero" serum pool, serum pools with Lipoprotein (a) concentration up to 4 x LOD level, diluted samples with expected values, samples with spiked interferents) serve as the ground truth.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This device is a classical in vitro diagnostic immunoassay, not an AI algorithm that requires training data. The development and calibration of such assays involve extensive R&D, but the data used in those phases are not typically referred to as a "training set" in this manner.

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

Not applicable, as there is no "training set" in the AI/machine learning sense for this device. The development of the assay's reagents and methodologies would have involved established chemical and immunological principles, and calibration of the assay (using the ADVIA Chemistry Lipoprotein(a) calibrator) uses products with assigned Lp(a) concentrations.

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

The Preciset Lp(a) calibrator set is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

The PreciControl Lp(a) Gen.2 control set is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

The TQ Lp(a) Gen.2 test principle is a particle-enhanced immunoturbidimetric assay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically. The Preciset Lp(a) Gen.2 calibrator set consists of five lyophilized calibrators based on a stabilized and lyophilized pool of human plasma. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. The PreciControl Lp(a) Gen.2 control set contains two lyophilized controls based on a human plasma matrix.

Here's a summary of the acceptance criteria and study information for the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device and reports performance characteristics rather than explicit acceptance criteria. However, we can infer some criteria from the comparative data and the general performance evaluation.

Study Proving Acceptance Criteria:

The document describes the submission as a 510(k) premarket notification, indicating a substantial equivalence study. The study's purpose is to demonstrate that the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System (candidate device) is as safe and effective as a legally marketed predicate device. This is primarily achieved through direct comparison of features and performance characteristics, as summarized in the tables provided in the document. The document lists "Evaluations summary" in Section 9, indicating that performance characteristics were evaluated.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., precision, interference studies, linearity, method comparison). It mentions evaluating "several performance characteristics."

• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It is implied to be laboratory-generated data for performance evaluations.

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

This type of information is generally not applicable to the evaluation of an in vitro diagnostic (IVD) device like the cobas c Tina-quant Lipoprotein (a) Gen.2 Test System. The "ground truth" for these tests is established by reference methods or accepted analytical principles, not by expert consensus in the same way it would be for, for example, image interpretation. The device measures a specific analyte concentration.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Analytical performance is typically evaluated against defined statistical metrics and analytical specifications, not through expert adjudication of results.

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 in vitro diagnostic device for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

This is an IVD assay, so its performance is inherently "standalone" in terms of measurement. The "algorithm" here refers to the immunoassay chemistry and detection system. Its performance is evaluated independently of human interpretation of raw signals, although human operators perform the testing and interpret the final quantitative results.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device would be established by:

• Reference materials/calibrators: The Preciset Lp(a) Gen.2 calibrator set is mentioned as being based on a "stabilized and lyophilized pool of human plasma," with concentrations adjusted for optimal calibration. This implies traceability to a higher-order reference method or material for determining Lp(a) concentrations.
• Method comparison against predicate device: The substantial equivalence comparison implies that the predicate device serves as a benchmark for acceptable performance.
• Physiological samples with known characteristics: For interference studies, samples spiked with known interferents would be used.

8. The Sample Size for the Training Set

No information is provided about a "training set" in the context of machine learning. For an IVD assay, method development involves extensive experimentation for optimization of reagents, reaction conditions, and calibration models. However, these are not typically referred to as "training sets" in the AI sense.

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

Not applicable for a chemical immunoassay, as there is no machine learning "training set" in the conventional sense. The "ground truth" for assay development and validation is established through analytical chemistry principles, use of reference materials, and comparison to established methods.

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The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma or serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis.

The PLAC® Test Reagent Kit consists of separately packaged reagents, calibrators and controls for the measurement of Lp-PLA2 in serum or plasma on automated clinical chemistry analyzers.

PLAC® Test Reagent Kit

• R1 Buffer solution with protein stabilizers
• R2 Suspension of polymeric microparticles coated with mouse monoclonal antibodies specific to Lp-PLA2 (2C10 and 4B4).

The PLAC® Test Reagent Kit is based on turbidimetric immunoassay technology utilizing two Lp-PLA3-specific monoclonal antibodies (2C10 and 4B4) coated to polymeric microparticles. A set of Lp-PLA2 calibrators is used to plot a standard curve of absorbance (y-axis) versus Lp-PLA2 concentration in ng/mL (x-axis) from which the Lp-PLA2 concentration in the test sample can be determined. The concentration of Lp-PLA, in each sample and control is then interpolated from the standard curve using a spline curve fit with appropriate calibration curve fitting software. The kit expiration date and storage conditions are indicated on the package.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the PLAC® Test Reagent Kit.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Methods Comparison Data

Imprecision Testing (Acceptance criteria are implied by the reported low %CVs, indicating good precision. Specific numerical acceptance criteria for %CV are not explicitly stated but are generally understood to be low for assays.)

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

• Sample Size for Test Set:
  • Methods Comparison: n = 742 (number of samples used for the comparison between the predicate and modified device).
  • Imprecision Testing: n = 40 for intra-assay and inter-assay, leading to a total of n = 80 for total assay %CV (per sample/control type).
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, though method comparison and imprecision studies are typically prospective tests performed during device development and validation.

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

This device is an in vitro diagnostic reagent kit for measuring a biomarker. The "ground truth" for such devices is typically established by reference methods or clinical outcomes. Experts are not usually involved in establishing ground truth in the same way as they would be for image-based diagnostics.

In this case, the predicate device (PLAC® Test ELISA Kit) serves as the reference method for the methods comparison study, effectively establishing the "ground truth" against which the new device's measurements are compared.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods are typically used in studies where human interpretation of data (e.g., medical images) is being assessed, often to resolve discrepancies between multiple readers. Here, the comparison is quantitative between two analytical methods.

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 relevant for evaluating the impact of AI on human reader performance, usually in diagnostic imaging. The PLAC® Test Reagent Kit is an automated quantitative immunoassay, not an AI-powered diagnostic imaging tool that assists human readers.

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

Yes, the performance data presented (Methods Comparison and Imprecision Testing) represents the standalone performance of the PLAC® Test Reagent Kit as an automated turbidimetric immunoassay. This is an "algorithm only" in the sense that the device itself performs the quantitative measurement without direct human-in-the-loop interpretative steps during the assay run.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the legally marketed predicate device, the PLAC® Test ELISA Kit. For the imprecision studies, the ground truth is the inherent concentration of the analyte in the tested samples/controls.

8. The Sample Size for the Training Set

The document does not specify a separate training set. For in vitro diagnostic assays, particularly those based on established immunoassay principles, a dedicated "training set" in the machine learning sense is not typically used. The development and optimization of the assay (e.g., antibody selection, reagent formulation, calibration curve fitting algorithm) would precede the validation studies, but these development activities don't usually involve a distinct "training set" with established ground truth in the same way an AI algorithm does.

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

As no explicit training set is mentioned for an AI/algorithm-based device, this question is not directly applicable. The "training" or optimization of such an assay involves laboratory development and analytical characterization, with the "ground truth" reflecting accurate and precise measurements of Lp-PLA2 concentration, often established using highly characterized reference materials or established laboratory methods during the assay development phase. The information provided focuses on the validation against a predicate device and within-device performance.

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The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.

Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry.

Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.

The Diazyme Lipoprotein (a) Assay is based on a latex enhanced immunoturbidimetric assay. Lp(a) in the sample binds to specific anti-Lp(a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lp(a) in the sample.

Here's a breakdown of the acceptance criteria and the study details for the Diazyme Lp(a) Assay, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the Diazyme Lp(a) Assay by comparing its performance to a predicate device (Denka Lp(a) Assay) and reporting specific performance characteristics such as precision and accuracy. The "acceptance criteria" are implied by the performance of the legally marketed predicate device and the new device demonstrating "good agreement" and "substantially similar" results.

Note: The acceptance criteria are based on demonstrating "substantial equivalence" to the predicate device. This implies that the new device's performance should be comparable and within acceptable analytical limits, which are not explicitly defined as numerical thresholds beyond the reported performance metrics. The statement "good agreement with legally marketed assay" and "no significant deviation" act as the overarching acceptance criteria for accuracy.

Study Details

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

   • Test Set Sample Size:
     • Accuracy (Correlation studies): 76 serum samples.
     • Precision: Three levels of serum specimens. While not explicitly stating the number of unique patient samples, the study design involved testing these three levels with 2 runs per day, with duplicates, over 20 working days.
     • Interference: Human serum samples were used, but the exact number is not specified.
   • Data Provenance: Not explicitly stated, but the samples are "human serum" and "human plasma." There is no mention of country of origin or whether the data was retrospective or prospective.

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

   • This device is an in vitro diagnostic assay that quantifies a biomarker (Lp(a)). The "ground truth" for such assays is typically established by comparative methods, such as a legally marketed predicate device or a reference method. It does not involve human expert interpretation of images or clinical findings in the same way as, for example, a radiology AI device. Therefore, no information on human experts establishing ground truth for the test set or their qualifications is provided or relevant in this context.

3. Adjudication method for the test set:

   • Not applicable. As explained above, this is a quantitative diagnostic assay where the "ground truth" is typically the result from a reference method or predicate device, not subject to human expert adjudication. The comparison method is direct measurement against the predicate device.

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

   • Not applicable. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study and AI-assisted performance improvement are not relevant.

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

   • Yes, this is primarily a standalone device performance study. The Diazyme Lp(a) Assay is an automated quantitative assay. The reported performance metrics (precision, accuracy, interference) are for the device itself operating without human interpretation of its primary output beyond standard laboratory procedures for running an assay. The comparison against the predicate device reflects the standalone performance.

6. The type of ground truth used:

   • The "ground truth" for the accuracy study was established by comparison with an existing commercial Lp(a) assay method (the predicate device, Denka Lp(a) Assay, K013359). This is a common method for establishing accuracy and substantial equivalence for in vitro diagnostic devices.

7. The sample size for the training set:

   • No information about a "training set" is provided. This is typical for in vitro diagnostic assays based on chemical/immunological reactions, as they are not machine-learning algorithms that require a training phase with labeled data in the same way an AI device does. The device's performance characteristics are determined through analytical validation studies (precision, accuracy, interference, linearity, etc.).

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

   • Not applicable, as no training set for an AI/machine learning algorithm is mentioned or relevant for this type of in vitro diagnostic device.

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MPO Flex® reagent cartridge: The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.

MPO Calibrator: The MPO Calibrator is an in vitro diagnostic product intended to be used to calibrate the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

MPO Control: The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module.

The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for MPO, and conjugate reagent (13-galactosidase labeled monoclonal antibodies specific for MPO). A particle/MPO/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound fl-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-D-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of MPO present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm.

The provided text describes the Siemens Healthcare Diagnostics Dimension MPO Flex® reagent cartridge and its associated calibrator and control. The information focuses on demonstrating substantial equivalence to a predicate device, the PrognostiX CardioMPO™ Enzyme Immunoassay. The study does not involve an AI device, therefore, some of the requested information such as MRMC study, and number of experts to establish ground truth is not applicable.

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

1. Table of Acceptance Criteria (from predicate device) and Reported Device Performance:

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