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The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The system is for in vitro diagnostic use only.

The chemistry module of the DxC 500i Clinical Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (OC) material and other accessories. The immunoassay module of the DxC 500i Clinical Analyzer is an in-vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

The Access Cortisol assay is a competitive binding immuno-enzymatic assay designed for use on Beckman Coulter's Access immunoassay analyzers in a clinical laboratory setting.

The DxC 500i Clinical Analyzer is an integrated chemistry-immunoassay work cell that combines Beckman Coulter's DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a single instrument presentation. The DxC 500i instrument has a single user interface and common point of entry for sample racks; the sample handling unit operates as a parallel processor and sample manager for both sides of the instrument. The DxC 500i operates in conjunction with the existing reagents, calibrators, controls, and system solutions for the AU and Access instrument families.

The provided text describes the Beckman Coulter Access Cortisol assay on the DxC 500i Clinical Analyzer and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

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The i-STAT hs-Tnl cartridge with the i-STAT 1 System is in the in vitro quantification of cardiac troponin I (cTnl) in whole blood or plasma samples in point of care or clinical laboratory settings.

The i-STAT hs-Tnl cartridge with the i-STAT 1 System is intended to be used as an aid in the diagnosis of myocardial infarction (MI).

The i-STAT hs-TnI cartridge is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma samples using the i-STAT 1 analyzer in point of care or clinical laboratory settings.

The i-STAT hs-TnI test uses an enzyme-linked immunosorbent assay (ELISA) method with electrochemical detection of the resulting enzyme signal. The test reports a quantitative measurement of the sample concentration of cTnI in units of ng/L in approximately 15 minutes.

The i-STAT hs-TnI immunoassay test method uses anti-cTnI antibodies for labeling and capture. The capture antibodies are coated on para-magnetic microparticles. Both label and capture antibodies are contained within the cartridge on a biosensor chip. The ELISA is initiated when the test cartridge is inserted into the analyzer. The sample is positioned over the biosensor chip to dissolve the reagents. This forms the ELISA sandwich (detection antibodylabel/antigen/capture antibody). The sample and excess antibody-conjugate are then washed off the sensors. An enzyme within the ELISA sandwich generates an electrochemically detectable product. The biosensor chip measures the enzyme product which is proportional to the concentration of cTnI within the sample.

The i-STAT hs-TnI cartridge is a single use test cartridge. The cartridge contains a biosensor chip and all reagents required to execute the test cycle. All fluid movements within the cartridge (test sample or reagent) are automatically controlled by the i-STAT 1 analyzer by electromechanical interaction with the cartridge. The analyzer executes the test cycle, acquires and processes the electrical sensor signals converting the signals into quantitative results. These functions are controlled by a microprocessor.

The i-STAT 1 System is comprised of the i-STAT 1 analyzer and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator, i-STAT Printer and i-STAT 1 9V NiMH Rechargeable Battery).

Assay quality control materials are also available for use with the i-STAT hs-TnI cartridge and include i-STAT hs-TnI Control Level 1. i-STAT hs-TnI Control Level 2. i-STAT hs-TnI Control Level 3, and the i-STAT hs-TnI Calibration Verification Levels 1-3.

Acceptance Criteria and Device Performance for i-STAT hs-TnI Cartridge with i-STAT 1 System

This response outlines the acceptance criteria and the study that demonstrates the i-STAT hs-TnI Cartridge with the i-STAT 1 System meets these criteria, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a single, consolidated table with pass/fail remarks. Instead, it presents performance characteristics and states whether the results "met the acceptance criteria" or "demonstrated acceptable performance." Based on this, the table below synthesizes the reported performance against inferred acceptance criteria.

Table: Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • 20-Day Precision: 240 replicates per level for 6 plasma samples (total 1440 tests across 3 cartridge lots, 20 days).
  • Whole Blood and Plasma Precision: Min. 24 replicates per level (6 levels) per site (3 sites) for whole blood and plasma specimens. Total number of replicates for whole blood was 576, and for plasma was 576.
  • Precision in Control Materials: 25 replicates per level (5 levels) for control materials.
  • Multi-site Multi-Day Precision: 90 replicates per level (6 plasma samples) (total 540 tests across 3 sites, 5 days, 2 operators).
  • Linearity: Not explicitly stated as a single number but implied by samples covering the reportable range.
  • Sample Type Comparison (WB vs. Plasma): Not explicitly stated, implied by samples covering the reportable range.
  • High Dose Hook Effect: Not explicitly stated.
  • LoB/LoD: Not explicitly stated, but involved 4 healthy donors for each sample type and multiple cartridge lots.
  • LoQ: Not explicitly stated, but involved a low-level cTnI whole blood and plasma samples and 4 cartridge lots.
  • Interference: Tested at two cTnI levels using various interfering substances.
  • Cross-reactivity: Tested at three cTnI concentrations for each cross-reactive substance.
  • Hematocrit Sensitivity: Whole blood samples at two cTnI levels and seven hematocrit levels.
  • Altitude: Not explicitly stated as a single number but involved whole blood and plasma samples at relevant cTnI levels.
  • Matrix Equivalence (Non-Anticoagulated WB vs. Li-Heparin WB): 88 paired specimens (including 8 contrived).
  • Matrix Equivalence (Li-Heparin Tube with Separator Gel vs. Li-Heparin Tube): 87 paired specimens (including 8 contrived).
  • Clinical Sensitivity and Specificity: 3585 subjects presenting to the Emergency Department.

• Data Provenance:

  • Analytical Performance Studies (Precision, Linearity, Hook Effect, LoB/LoD/LoQ, Interference, Cross-reactivity, Hematocrit, Altitude): These studies used a combination of frozen plasma samples, native venous whole blood and plasma specimens (prospectively collected), whole blood/plasma samples altered via spiking, control materials, and healthy donor samples. The studies were conducted at various clinical sites and internally at Abbott Point of Care.
  • Reference Interval Study: United States (US) based general population, prospectively collected venous whole blood specimens from 895 apparently healthy subjects at 8 clinical sites.
  • Matrix Equivalence Studies: Prospectively collected venous whole blood and plasma specimens from patients in point of care settings at two (2) clinical sites.
  • Clinical Sensitivity and Specificity (Pivotal Study): Prospectively collected venous whole blood and plasma specimens at 28 clinical sites in the United States. These sites were geographically diverse EDs associated with acute care hospitals, medical centers, tertiary care facilities, and primary care clinics.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Sensitivity and Specificity Study (Pivotal Study):

  • Number of Experts: Not explicitly stated as a specific number, but referred to as "board-certified cardiologists and/or emergency medicine physicians."
  • Qualifications: Board-certified cardiologists and/or emergency medicine physicians. No specific years of experience are detailed.
  • Role: Adjudicated subjects based on the fourth universal definition of MI.

• Other Studies: The document does not indicate the involvement of external experts for establishing ground truth for other analytical performance or matrix equivalence studies. Ground truth for these was established through standard laboratory methods, spiked samples, and reference materials.

4. Adjudication Method for the Test Set

• Clinical Sensitivity and Specificity Study: The adjudication method for the clinical study involved "adjudication by board-certified cardiologists and/or emergency medicine physicians based on the fourth universal definition of MI." The adjudicators were blinded to the i-STAT hs-TnI test results, indicating an independent review process. The specific number of adjudicators per case (e.g., 2+1, 3+1) is not provided, but the mention of plural "physicians" suggests at least two.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance. The device is an in vitro diagnostic test (IVD) for quantitative measurement of cTnI, not an imaging device or AI-powered diagnostic aide for human interpretation.

6. Standalone (Algorithm Only) Performance Study

• The performance studies described are inherently standalone for the device itself. The i-STAT hs-TnI cartridge with the i-STAT 1 System is a diagnostic test that provides a quantitative result. The clinical sensitivity and specificity are reported for the device's output (cTnI levels) as an aid in MI diagnosis, without human-in-the-loop interpretation of raw data from the device beyond reading the final numerical result.

7. Type of Ground Truth Used

• Clinical Sensitivity and Specificity Study: The ground truth for the diagnosis of MI was established by expert consensus (board-certified cardiologists and/or emergency medicine physicians) based on the fourth universal definition of MI. This is a clinical outcome/diagnostic ground truth.
• Analytical Studies:
  • Precision, Linearity, Hook Effect, LoB/LoD/LoQ, Interference, Cross-reactivity, Hematocrit, Altitude, Matrix Equivalence: Ground truth was established using a combination of:
    • Known concentrations in spiked samples.
    • Reference methods/materials (e.g., NIST SRM2921 for traceability).
    • Standard laboratory measurements and pre-defined expected values for linearity and comparison studies.
    • Clinical classification based on robust biomarker criteria (for the reference interval study of healthy subjects).

8. Sample Size for the Training Set

• The document describes performance evaluation studies and does not explicitly differentiate a "training set" for an AI/machine learning model. The i-STAT hs-TnI test is an immunoassay (ELISA method with electrochemical detection), not a device based on AI/ML. Therefore, the concept of a "training set" for an algorithm is not directly applicable in the context of this device description. The studies described are for analytical and clinical validation of the assay.

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

• As stated in point 8, the device is an immunoassay, not an AI/ML system, so there isn't a "training set" in that conventional sense. The "ground truth" for the various analytical and clinical studies (which could be considered analogous to data used for establishing performance) was established as described in point 7.

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The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.

The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.

MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer:

The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations.

MAGLUMI 25-OH Vitamin D assay:

MAGLUMI 25-OH Vitamin D kit consists of the following reagents:

Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, NaN3 (

The provided text describes the performance characteristics of the MAGLUMI 25-OH Vitamin D assay and MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer as part of a 510(k) summary for FDA clearance. The information focuses on analytical performance rather than clinical validation with human-in-the-loop studies.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of predefined acceptance criteria. Instead, it reports the analytical performance of the device, which implicitly demonstrates that the device meets some internal or expected performance metrics for an in vitro diagnostic device. The performance data is presented in the "11. Performance Characteristics" section.

Here's an approximation of an acceptance criteria table based on the reported performance, assuming the reported values are the achieved performance that meets internal criteria for release:

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

• Precision Study:

  • Sample Size: 240 measurements per material (two controls, two calibrators, one spiked patient serum pool, three native patient sample pools) across three instruments. Each measurement was taken in duplicate, with 2 runs per day over 20 days.
  • Data Provenance: Not explicitly stated, but common practice for IVD analytical studies focuses on sample types and analytical conditions, not patient demographics or geo-location beyond what's relevant to endogenous interferents. The samples include "patient serum pool" and "native serum pool," implying human biological samples.

• Linearity Study:

  • Sample Size: Eleven linearity samples, each measured in quadruplicate on 3 lots of reagent.
  • Data Provenance: Samples prepared by blending "a low serum sample pool and a high serum sample pool," implying human serum. No country of origin specified.

• Detection Limit Study:

  • LOB: 60 measurements of 25-OH Vitamin D depleted serum samples using 3 different lots of reagents over 3 days.
  • LOD: Four levels of low samples, each measured in 60 replicates over 3 days per sample using 3 lots of reagents.
  • LOQ: Six low serum samples, in five replicates per run, one run per day, over 3 days, using 3 lots of reagents.
  • Data Provenance: "Serum samples," "low serum samples," implying human serum. No country of origin specified.

• Interference Study:

  • Sample Size: Three base serum samples (10, 50, 100 ng/mL 25-OH VD) for endogenous substances and common drugs; human serum samples for HAMA, RF, total protein.
  • Data Provenance: "Human serum pools" and "human serum samples." No country of origin specified.

• Method Comparison Study:

  • Sample Size: 329 native, single donor patient serum samples (121 male, 208 female, age 7 to 98 years).
  • Data Provenance: "Human serum samples." No country of origin specified explicitly, but this is typically retrospective collection of de-identified clinical samples.

• Reference Range Study:

  • Sample Size: 312 serum samples from normal, apparently healthy adult (21 years and older) individuals (181 males, 131 females).
  • Data Provenance: Samples collected from three regions (Central, Southeast and Northeast) in the US. This specifies the country of origin (USA) and regional distribution. This would be considered retrospective.

• Matrix Comparison Study:

  • Sample Size: 78 serum/plasma pairs from the same donor.
  • Data Provenance: "Samples drawn into serum and plasma collection tubes," "from the same donor." No country of origin specified.

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 document describes an In Vitro Diagnostic (IVD) device, specifically a quantitative immunoassay. For such devices, "ground truth" is typically established by:

• Reference methods (e.g., LC-MS/MS for Vitamin D, which is considered a gold standard).
• Master Lot/Calibrator values.
• Comparison to a legally marketed predicate device (as done in the "Comparison Studies" section).

There is no mention of human experts (like radiologists) establishing ground truth for individual samples in this context. The "ground truth" in this analytical study is the quantitative concentration of 25-OH Vitamin D as determined by reference materials, calibrators, or the established predicate method.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving qualitative or semi-quantitative assessments (e.g., image-based diagnosis) where multiple human readers interpret data, and discrepancies need to be resolved. This document pertains to the analytical performance of a quantitative immunoassay analyzer, where the output is a numerical concentration.

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

Not applicable. This device is an automated immunoassay analyzer for a quantitative biomarker (25-OH Vitamin D). It is not an AI-assisted diagnostic tool that aids human readers in interpreting complex data like medical images. Therefore, an MRMC study or AI assistance is not relevant to its stated purpose or performance evaluation.

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

The device is inherently a "standalone" system in an analytical sense. The MAGLUMI X3 analyzer and the MAGLUMI 25-OH Vitamin D assay perform the quantitative determination automatically. The performance characteristics (precision, linearity, detection limit, interference, method comparison) are all tests of the algorithm's performance (i.e., the instrument and reagent system) without human interpretation affecting the result generation process itself. Clinical interpretation of the numerical results (e.g., patient has vitamin D deficiency based on the number) happens downstream by a clinician, but the device performance itself is standalone.

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

For the analytical performance:

• Precision, Linearity, Detection Limit, Interference: Ground truth is established by the known concentrations of controls, calibrators, spiked samples, and highly characterized depleted/low concentration samples. The "truth" is the intended/expected concentration as determined by a highly accurate measurement or formulation.
• Method Comparison: The predicate device, MAGLUMI 2000 25-OH Vitamin D assay manufactured by SNIBE, served as the comparative "truth" or reference. The study measures agreement between the new device and the predicate. It states "Comparison of the MAGLUMI 25-OH Vitamin D assay (y) with the predicate device, MAGLUMI 2000 25-OH Vitamin D assay (x)."
• Reference Range: Established from empirically tested healthy individuals.

8. The sample size for the training set

This document describes the validation of an immunoassay kit and analyzer, not a machine learning or AI model that requires a "training set" in the computational sense. The "training" for such a system refers to the development and optimization of the chemical reagents, assay protocol, and instrument calibration algorithms by the manufacturer during product development, prior to the validation studies described here. The document does not provide details on the sample sizes or data used during this internal "training" or development phase.

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

As noted above, "training set" is not applicable in the context of a traditional immunoassay system validation as described here. The "ground truth" for the development and optimization of the assay would typically involve:

• Certified Reference Materials (CRMs): Substances with accurately known concentrations of the analyte, often traceable to international standards.
• Internal Reference Materials: Carefully prepared and validated in-house samples.
• Established Reference Methods: Highly accurate and precise methods (e.g., LC-MS/MS) used to characterize samples during development.
• Cross-validation with existing, well-characterized methods/platforms.

These elements guide the chemical formulation, antibody selection, and instrument parameter setting during the development phase.

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iFlash-HCG is a paramagnetic particle chemiluminescent immunoassay (CLIA) for quantitative detection of the intact human chorionic gonadotropin (hCG) molecule and the hCG ß-subunit (ß-hCG) in human serum and plasma using the automated Chemiluminescence Immunoassay Analyzer (Model: iFlash-HCG assay is to be used by laboratory professionals as an aid in early detection of pregnancy together with other clinical methods.

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative or qualitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

iFlash-HCG that includes testing reagents and three levels of calibrators is based on chemiluminescence immunoassay. HCG and hCG ß-subunit (ß-hCG) in the sample reacts with anti-HCG antibody coated paramagnetic microparticles and acridinium-labeled anti-HCG antibody conjugate to form a sandwich complex, after chemiluminescent reaction, HCG amount in the sample is derived from RLUs (relative light units) using a calibration curve. iFlash-HCG is intended to be used on Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C).

Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a fully-automated, chemiluminescence immunoassay analyzer intended for quantitative determination of analytes in human body fluids taken from clinical settings. It is used together with its supporting chemiluminescence immunoassay reagents. The Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is intended for use in clinical laboratories.

The provided text describes the performance of the iFlash-HCG and Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) for the quantitative detection of human chorionic gonadotropin (hCG). However, it does not detail acceptance criteria in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in terms of clinical performance against defined benchmarks with human experts, as would be typical for an AI/ML-based diagnostic device where acceptance criteria often relate to sensitivity, specificity, and agreement with ground truth.

Instead, the document focuses on detailed non-clinical performance studies demonstrating the analytical characteristics and substantial equivalence to a predicate device. Many of the listed studies (e.g., precision, detection capability, linearity, interference, analytical specificity, method comparison, stability, trueness, sample dilution, reference interval, carryover) are standard for in vitro diagnostic (IVD) devices.

Given the input, I will interpret "acceptance criteria" as the performance specifications demonstrated by the non-clinical studies and "study that proves the device meets the acceptance criteria" as the results of these non-clinical studies. I will also clarify that this is not an AI/ML device per se, so the typical AI/ML study components (experts for ground truth, MRMC, standalone algorithm performance) are not applicable in their traditional sense.

Here's the information extracted and structured based on your request, with caveats where the information is not present or not applicable to an IVD device of this type:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not provide a pre-defined table of "acceptance criteria" in the sense of pass/fail thresholds for clinical performance but rather lists the results of various analytical performance studies, I will present the key performance parameters and their achieved values. The "acceptance criteria" here are implicitly met if the reported performance is deemed suitable for the intended use and demonstrates substantial equivalence to predicate devices.

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

• Test Set (for performance studies):

  • Precision: 9 levels of female serum samples and 2 levels of controls (total samples tested over 20 days: 9 samples * 2 runs * 2 replicates * 20 days * 3 lots * 3 analyzers = substantial, specific number of unique patients/samples not given).
  • Detection Limit (LoB): 5 analyte-free samples * 4 times/day * 3 days * 3 reagent lots (60 results per reagent lot).
  • Detection Limit (LoD): 5 low-concentration samples * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
  • Detection Limit (LoQ): 5 samples near LoD * 4 times/day * 3 days * 3 reagent lots (60 test results per reagent lot).
  • Linearity: 11 different concentration levels of samples for each of 3 linearity intervals tested on 3 reagent lots.
  • Hook Effect: 3 high concentration samples and their serial dilutions.
  • Interference Study: Not specified, but likely involved multiple samples spiked with interferents.
  • Analytical Specificity: Not specified, but likely involved multiple samples spiked with cross-reactants.
  • Specimen Types Study: 97 female serum samples compared with plasma samples.
  • Method Comparison: 110 serum samples.
  • Trueness Study: Samples formulated from WHO International Standard (3 concentration levels).
  • Sample Dilution Fold Study: Samples prepared with HCG positive material (3 theoretical concentrations).
  • Reference Interval Study: Non-pregnant premenopausal women (N=130), Postmenopausal women (N=125).
  • Carryover Study: Test samples with high HCG in triplicate followed by low HCG in triplicate, for five runs.

• Data Provenance: The document does not explicitly state the country of origin for the clinical samples used in these studies. It does indicate that the submitter is based in Shenzhen, Guangdong, China. The studies are described as non-clinical performance studies, often implying controlled laboratory conditions rather than broad population-based data collection. All studies appear to be prospective as they are specifically conducted to evaluate device performance.

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

This is an IVD device for quantitative measurement of hCG, not an AI/ML medical image analysis or similar diagnostic device that typically relies on human expert interpretation for "ground truth." The ground truth for this device's performance is established by reference methods, certified reference materials (like WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364), and comparison with legally marketed predicate devices. Therefore, the concept of "experts" establishing conventional ground truth as applied to AI/ML clinical studies is not applicable here.

4. Adjudication Method for the Test Set

As there are no human experts classifying or interpreting data for "ground truth" in the AI/ML sense, there is no adjudication method described or applicable. The determination of results is based on the chemical reaction and optical detection by the automated analyzer, with analytical results compared to established reference values or predicate device results.

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

An MRMC study is relevant for diagnostic devices (often imaging-based or AI-assisted) where human reader performance is a key outcome. This document describes an automated IVD assay, not an imaging device or an AI assistance tool for human readers. Therefore, no MRMC comparative effectiveness study was done, and the concept of human readers improving with AI assistance is not applicable.

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

This device is a standalone automated analyzer ("algorithm only" in the sense of the instrument performing the test independently). The entire suite of non-clinical performance studies (precision, detection limits, linearity, interference, method comparison, etc.) constitutes the demonstration of its standalone analytical performance. It does not require human-in-the-loop for its operation or result generation in the same way an AI diagnostic algorithm might.

7. The Type of Ground Truth Used

The "ground truth" for the analytical validation of this IVD device is primarily based on:

• Reference materials/standards: Notably, the WHO International Standard 5th WHO IS Chorionic Gonadotrophin 07/364 is used for trueness studies.
• Spiked samples: Known concentrations of analytes or interferents are added to samples to confirm recovery and specificity.
• Comparison to predicate devices: The results from the iFlash-HCG are compared against those from the cleared predicate devices (Elecsys HCG+β reagent and Cobas e 801 analyzer) to demonstrate substantial equivalence.
• Consensus methods/protocols: CLSI guidelines (EP05-A3, EP17-A2, EP06 2nd Edition, EP07-A3, EP37 1st Edition, EP09c 3rd Edition, EP25-A, EP34 1st Edition, EP28-A3c, H26-A2) provide the "ground truth" for how studies should be designed and how performance metrics should be calculated and interpreted.

8. The Sample Size for the Training Set

This document describes a conventional IVD assay and analyzer, not an AI/ML system that undergoes a distinct "training" phase with a large dataset. Therefore, the concept of a "training set" for an AI/ML algorithm is not applicable in this context. The methodology relies on established chemical and physical principles, not machine learning from data.

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is inherently determined by its design specifications, reagents, and analytical principles, validated through the non-clinical studies.

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The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.

The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:

The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For in vitro diagnostic use only.

The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilised antibodies specific to different Drugs of Abuse (DOA) compound classes, A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.

The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.

Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.

The Evidence MultiSTAT System uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT Analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.

The provided text describes a 510(k) premarket notification for the Randox Laboratories Limited, Evidence MultiSTAT DOA Urine Multiplex, and Evidence MultiSTAT device. This device is an in-vitro diagnostic (IVD) for the qualitative determination of drugs of abuse in human urine.

Crucially, the document does NOT describe the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.

The document details the device's intended use, methodology (competitive immunoassay), analytes tested, and cut-off values. It mentions that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices" but does not provide any specific data, acceptance criteria values, or details of these studies.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML context, because the provided text is for an IVD immunoassay device, not an AI/ML-powered medical device.

To answer your request based on the provided text, I can only state what is missing from the document related to AI/ML acceptance criteria and studies:

• No AI/ML Component: The device described is an immunoassay system (Evidence MultiSTAT DOA Urine Multiplex and Evidence MultiSTAT analyzer), which works based on chemical reactions and light detection, not artificial intelligence or machine learning.
• No Acceptance Criteria or Performance Data Provided: The document states that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices," but it does not provide any of the acceptance criteria themselves, nor the results of these studies. Therefore, no table of acceptance criteria vs. reported performance can be generated from this text.
• No Test Set Details: Since no performance study details are given, there is no information on:
  • Sample size for the test set.
  • Data provenance (country, retrospective/prospective).
  • Number or qualifications of experts.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone (algorithm-only) performance.
  • Type of ground truth used.
• No Training Set Details: As this is not an AI/ML device, there is no mention of a training set or how ground truth for a training set would be established.

In summary, the provided FDA 510(k) clearance letter and summary pertain to a traditional in-vitro diagnostic immunoassay system and do not contain any information relevant to the acceptance criteria or performance studies of an AI/ML-powered medical device.

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The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:

The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.

The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.

The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.

The TC cassette is for the quantitative determination of total cholesterol in whole blood.

· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

· Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®.

The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.

The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.

The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.

The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.

A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.

The provided text is a 510(k) summary for the Cholestech LDX™ System and primarily discusses device modifications and comparison to a predicate device. It certifies that verification studies were performed as required by risk analysis and all acceptance criteria were met. However, it does not provide the specific details of the acceptance criteria or the reported device performance for these studies. It also does not contain information about the sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for test and training sets.

Therefore, based solely on the provided text, I cannot fulfill most of the requested information regarding the study that proves the device meets the acceptance criteria. The document states that such studies were done and met acceptance criteria, but omits the specifics.

Here's what can be inferred or stated from the provided text, and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Text: The document explicitly states, "Verification studies were performed as required by risk analysis and all acceptance criteria were met." However, it does not list the specific acceptance criteria (e.g., specific accuracy thresholds, precision ranges, etc.) or the detailed reported device performance (e.g., actual measured accuracy, precision values, etc.) from these studies. The modification pertains to updating the performance claim related to conjugated and unconjugated Bilirubin interference. While it mentions that less than 10% interference was seen at specified levels for various substances, this is a general statement from the predicate device's limitations, not a specific acceptance criterion for the current modification or the exact performance data achieved.

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

Information Not Available in the Text: The document states that "verification studies" were performed, but it does not specify the sample size (e.g., number of patients, number of samples) used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective nature of the data collection).

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

Information Not Available in the Text: The document details changes to an in vitro diagnostic (IVD) device for measuring cholesterol, triglycerides, and glucose. For IVD devices, ground truth is typically established by reference laboratory methods, not by human experts interpreting images or clinical cases. Therefore, the concept of "experts" as in radiologists or pathologists establishing ground truth is not applicable here. Even if it were (e.g., for method comparison studies requiring expert clinical correlation), the document does not mention any role for experts in establishing ground truth.

4. Adjudication Method for the Test Set

Information Not Available in the Text: Since the ground truth for an IVD device is generally established using reference methods (as opposed to human interpretation needing adjudication), an adjudication method as typically used in AI studies of imaging (e.g., 2+1, 3+1) is not applicable or described in this document.

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

Information Not Applicable/Available in the Text: This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this type of device and are not mentioned in the documentation.

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

Information Not Applicable/Available in the Text: The Cholestech LDX™ System is a chemical analyzer, not an AI algorithm. Its performance is inherent to the device's enzymatic and solid-phase technology. The concept of "standalone algorithm performance" without human-in-the-loop is not directly applicable in the same way it would be for a software-as-a-medical-device (SaMD) that processes and interprets data for human review. The document describes the device's direct measurement capabilities.

7. The Type of Ground Truth Used

Inferred from Text: For an in vitro diagnostic device measuring analytes (cholesterol, HDL, triglycerides, glucose), the ground truth is typically established by reference laboratory methods (e.g., highly accurate and precise methods run on core laboratory instruments). While the document does not explicitly state "reference laboratory comparison" for ground truth, the context of an IVD device submission, especially one measuring these specific analytes, strongly implies this method.

8. The Sample Size for the Training Set

Information Not Applicable/Available in the Text: This is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's operation is based on established enzymatic and chemical reactions, not on data-driven learning. Therefore, there is no "training set" in the context of AI/ML.

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

Information Not Applicable/Available in the Text: As noted above, there is no "training set" for this type of IVD device in the context of AI/ML. The device's calibration and performance are based on chemical principles and validation studies, not on learning from a training dataset.

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The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.

System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU/DxC AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes. Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.

The sodium test system is intended for the quantitative measurement of sodium in serum, plasma, and urine.

Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated photometric clinical analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Electrolyte measurement is performed using a single cell lon Selective Electrode (ISE) which is also common among the other members of the AU family.

The ISE module for Na+, K+, and Cl- employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.

In this Beckman Coulter procedure, glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6phosphate dehydrogenase (G6P-DH) specifically oxidizes G-6-P to 6phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH). The change in absorbance at 340/660 nm is proportional to the amount of glucose present in the sample.

The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. In this procedure, the measurement of the rate of decrease in light intensity transmitted through particles suspended in solution is the result of complexes formed during the immunological reaction between the CRP of the patient serum and rabbit anti-CRPantibodies coated on latex particles. Two measuring range settings are available: Normal application (CRP Concentrations ranging between 5.0-480 mg/L) and Highly Sensitive (Cardiac) Application- (CRP concentrations ranging between 0.2-80mg/L).

This document describes the acceptance criteria and supporting study for the Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer and its associated reagents (Glucose, CRP Latex, ISE Reagents for Sodium, Potassium, and Chloride).

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated across several metrics. The table below summarizes the acceptance criteria (often implied by the "Pass" result and the specific targets within the CLSI guidelines references) and the reported performance for key tests:

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The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassum EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use.

The Atellica CI Analyzer with Atellica® Rack Handler supports both clinical chemistry (CH) and Immunoassay (IM) features and contains all the necessary hardware, electronics, and software to automatically process samples and generate results, including sample and reagent dispensing, mixing, and incubating.

The Atellica IM TSH3-UL assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection

The Atellica CH Albumin BCP (AlbP) assay is an adaptation of the bromocresol purple dy-e binding method reported by Carter and Louderback et al. In the Atellica CH AlbP assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The document provided is a 510(k) summary for in vitro diagnostic devices (IVDs), specifically the Atellica® CI Analyzer and its associated assays for Thyroid Stimulating Hormone (TSH3-UL) and Albumin (AlbP). IVDs, by their nature, measure specific analytes in biological samples and are evaluated against performance criteria such as precision, accuracy, linearity, and interference, rather than diagnostic accuracy metrics like sensitivity and specificity that would typically apply to AI/ML software. Therefore, many of the requested elements pertaining to AI/ML acceptance criteria and human-in-the-loop studies are not applicable to this type of device.

Here's a breakdown of the relevant information provided:

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

The document describes the performance characteristics for the Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay and the Atellica CH Albumin BCP (AlbP) assay. These are performance criteria, which serve as the acceptance criteria for the device's analytical performance.

Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) Assay:

Atellica CH Albumin BCP (AlbP) Assay:

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

• TSH3-UL Assay:
  • Precision: 80 samples for each type (Serum A-F, EDTA Plasma A-C, Heparin Plasma A-C, Control 1-3).
  • Assay Comparison (Serum): 112 samples.
  • Interferences (Specific substances): Not explicitly stated how many samples per substance, but concentrations tested at two analyte levels.
  • Specimen Equivalency: 64 samples for Plasma (Lithium heparin) and 64 for Plasma (EDTA).
  • Onboard Dilution Recovery: 3 samples (Serum and Plasma) tested at two dilution levels.
  • Linearity: Not explicitly stated, but "at least 14 levels created by mixing high and low serum samples" with N=5 replicates per level.
• AlbP Assay:
  • LoD: 486 determinations (270 blank, 216 low level replicates).
  • LoQ: n=5 replicates using 3 reagent lots over 5 days.
  • Precision: N ≥ 80 for each sample (Serum 1-3, Serum QC 1).
  • Reproducibility: 225 samples for each serum level (assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots).
  • Assay Comparison (Serum): 106 samples.
  • Specimen Equivalency: 76 samples for Plasma (Lithium heparin) and 55 for Plasma (Potassium EDTA).
  • HIL: Not explicitly stated how many samples per interferent, but concentrations tested at two analyte levels.
  • Non-Interfering Substances: Not explicitly stated how many samples per substance, but tested at two analyte concentrations.
  • Linearity: "at least nine levels created by mixing the high and low pools of serum" with N=5 replicates per level.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device intended for broad use, it's highly likely the studies were prospective analytical validation studies conducted under controlled laboratory conditions, typically in multiple sites to ensure robustness.

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 information is not applicable to this type of device. The "ground truth" for clinical laboratory assays like TSH and Albumin comes from established analytical methods, reference materials, and accepted scientific principles of chemistry and immunology. It's about measuring the concentration of an analyte, not interpreting an image or diagnosing a condition based on expert consensus. The "experts" involved would be clinical chemists, laboratory scientists, and engineers responsible for assay development and validation, following established guidelines like those from CLSI (Clinical and Laboratory Standards Institute).

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

This is not applicable for this type of device. Adjudication methods are used in studies involving subjective interpretations (e.g., image reading) where multiple readers provide opinions that need to be reconciled to establish ground truth. For quantitative chemical assays, the "truth" is determined by reference methods and the intrinsic properties of the analyte, not by human consensus or adjudication.

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

This is not applicable. An MRMC study is designed for evaluating the impact of a system on human readers' diagnostic performance, typically in the context of imaging. This document describes an automated in vitro diagnostic analyzer and its assays, which do not involve human "readers" in the sense of interpreting outputs like medical images.

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

The performance characteristics presented (precision, linearity, assay comparison, interference, etc.) represent the standalone performance of the device and its assays. The Atellica® CI Analyzer and its assays are automated systems designed to perform measurements without human interpretative input beyond setting up the instrument and following standard laboratory procedures for running samples and quality control.

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

The ground truth for these quantitative assays is established through:

• Reference Methods / Comparability: The performance is evaluated by comparing the new device's results to a legally marketed predicate device (Siemens Trinidad systems) which serve as the reference. This establishes the equivalence of the new device to already accepted technology.
• Traceability to International Standards: For TSH3-UL, traceability is to the World Health Organization (WHO) 3rd International Standard for human TSH (IRP 81/565). For AlbP, traceability is to ERM-DA470k Reference Material. These international standards or reference materials provide the "true" or accepted values against which the device's measurements are calibrated and verified.
• Analytical Procedures: The "ground truth" for characteristics like limit of detection, precision, and linearity are determined by rigorous statistical methods and established protocols (e.g., CLSI guidelines EP05-A3, EP07-ed3, EP09c-ed3, EP17-A2, EP06-ED2) during analytical validation.

8. The sample size for the training set:

This information is not applicable in the context of an IVD where "training set" implies machine learning or AI model development. For an IVD, there is a development and validation process. The number of samples for analytical validation studies (which is what is presented) is given under point 2.

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

As this is not an AI/ML device, the concept of a "training set" for an algorithm and its associated ground truth establishment methods (e.g., expert annotations) are not applicable. The "ground truth" or reference for the development and validation of these IVD assays is based on established laboratory practices, chemical principles, certified reference materials, and comparison to predicate devices, as described in point 7.

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GLP systems Track:

The GLP systems Track is a modular laboratory automation system designed to automate pre-analytical and post-analytical processing, including sample handling, in order to automate sample processing in clinical laboratories. The system consolidates multiple analytical instruments into a unified workflow.

Alinity i Total β-hCG Reagent Kit:

The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (ß-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

Alinity i system:

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antibodies, and analytes in samples.

Alinity ci-series:

The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Almity c processing modules, or a combination of up to four of Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, climical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antibodies, and analytes in samples.

The GLP systems Track is a modular laboratory automation system (LAS) used to perform multiple pre-analytical and post-analytical steps to automate sample preparation and distribution processes in clinical laboratories. These processes include bar code identification of samples, centrifugation, aliquoting of samples, decapping of samples, transport of samples between processes (modules), delivery of samples to 1 or more Abbott and Third Party commercially available laboratory analyzer(s), capping of samples, and storage of samples. Due to the modular nature of the LAS, customers may select modules and configurations to fit their laboratory needs.

The provided text describes the 510(k) premarket notification for the GLP systems Track and the Alinity i Total β-hCG Reagent Kit. The focus of the acceptance criteria and study detailed in the document is on the GLP systems Track laboratory automation system, and its ability to maintain the performance of connected analyzers, specifically exemplified with the Alinity i Total β-hCG assay. The document does not provide specific acceptance criteria or performance data for the Alinity i Total β-hCG Reagent Kit as a standalone diagnostic assay; instead, it focuses on the GLP systems Track's compatibility and non-inferiority when integrated with such assays.

Here's a breakdown of the information based on your request:

Acceptance Criteria and Reported Device Performance

The document describes a method comparison study to demonstrate that the GLP systems Track does not negatively impact the performance of connected assays. The acceptance criteria are implicitly defined by the results of this method comparison.

Table of Acceptance Criteria and Reported Device Performance (Implicit for the GLP systems Track):

* **Slope:** 0.99
* **Correlation Coefficient:** 1.00                                                                                                                                                                       |

| Ensure acceptable performance for a representative immunoassay. | Demonstrated with the Alinity i Total β-hCG assay. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated as a number of samples. The range of mIU/mL for the tested samples is given as 4.78 to 14,965.80 mIU/mL, indicating a broad range of concentrations were tested.
   • Data Provenance: The study was described as "Nonclinical testing was performed on-site at Abbott." This indicates an internal, prospective study. Country of origin is implicitly the US, where Abbott Laboratories is located.

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

   • Not applicable. This was a method comparison study for a laboratory automation system, not a diagnostic study requiring human expert interpretation of results to establish ground truth. The "ground truth" was established by comparing direct loading (comparator method) to processing via the GLP systems Track (investigational method) using established laboratory procedures.

3. Adjudication Method for the Test Set:

   • Not applicable. As this was a method comparison of automated systems, there was no human adjudication process involved. The comparison was based on quantitative measurements.

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

   • No. An MRMC study is typically for image-based diagnostic aids where human readers interpret cases. This study focused on the performance of a laboratory automation system.

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

   • Yes, in essence. The study assessed the performance of the GLP systems Track (an automated system) without human intervention in the analytical process, demonstrating its ability to deliver results comparable to direct sample loading. The Alinity i Total β-hCG assay itself is a standalone quantitative assay.

6. The Type of Ground Truth Used:

   • Reference Method Comparison/Comparator Method. The "ground truth" was established by testing specimens on the Alinity i Total β-hCG assay when front-loaded (the comparator method/reference) and comparing those results to specimens loaded using the GLP systems Track (investigational method). This essentially assumes that the front-loaded method provides the accurate measurement.

7. The Sample Size for the Training Set:

   • Not applicable. The GLP systems Track is a mechanical/software automation system designed for sample processing, not an algorithm that undergoes "training" with data in the typical machine learning sense to learn patterns or make predictions. Its "training" would be through engineering design, development, and testing processes. The document does not mention any machine learning or AI components that would require a training set.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. (See point 7).

In summary, the provided document focuses on demonstrating the substantial equivalence of the GLP systems Track to its predicate and its ability to integrate with and maintain the performance of an existing cleared assay (Alinity i Total β-hCG) through a nonclinical method comparison study.

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The Alinity ci-series is intended for in vitro diagnostic use only.

The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.

The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.

The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.

The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.

The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.

The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."

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

The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.

• Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
• Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.

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

Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.

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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.

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

This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.

7. The type of ground truth used

The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.

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 model for this device.

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