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For in vitro diagnostic use only.

For the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin), using the VITROS 5600 Integrated System. The VITROS CA 19-9 test is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA 19-9 test can be used to monitor the disease status in patients with confirmed pancreatic cancer who show measurable CA 19-9 values over the course of their disease. Serial CA 19-9 test results should be used in conjunction with all other available clinical and laboratory data before a medical decision is determined.

The VITROS Immunodiagnostic Products CA 19-9 assay (test) is performed using the VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack and VITROS CA 19-9 Calibrators on the VITROS 5600 System.

An immunometric immunoassay technique is used, which involves the simultaneous reaction of 1116-NS-19-9 defined antigen present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-1116-NS-19-9 defined antigen) bound to Streptavidin. In a second incubation a Horseradish Peroxidase (HRP)- labelled antibody conjugate (Mouse monoclonal anti-1116-NS-19-9 defined antigen) binds to the immobilized 1116-NS-19-9 defined antigen. Unbound materials are removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of conjugate bound is directly proportional to the concentration of 1116-NS-19-9 defined antigen present in the sample.

VITROS Immunodiagnostic Products CA 19-9™ Reagent Pack contains:
1 reagent pack containing:

• 100 coated wells (antibody, mouse monoclonal anti-1116-NS-19-9 defined antigen, binds >49 U 1116-NS-19-9 defined antigen/well)
• 13.4 mL assay reagent (buffer containing bovine gamma globulin and antimicrobial agent)
• 20.0 mL conjugate reagent (HRP-mouse monoclonal anti-1116-NS-19-9 defined antigen, binds ≥326 U 1116-NS-19-9 defined antigen/mL) in buffer with bovine serum albumin, bovine gamma globulin and antimicrobial agent.

VITROS CA 19-9 Calibrator contains:

• 1, 2, and 3 (OC 1116-NS-19-9 defined antigen in buffer with bovine serum albumin and antimicrobial agent, 1.75 mL); nominal values 15; 60 and 700 U 1116-NS-19-9 defined antigen/mL
• 24 calibrator bar code labels (8 for each calibrator)

This document describes the non-clinical performance studies conducted for the VITROS CA 19-9 assay to demonstrate its safety and effectiveness. The information focuses on analytical performance characteristics rather than clinical diagnostic accuracy studies involving human experts for ground truth, which are typically found in studies for AI/ML-based medical devices or imaging diagnostics.

Since this device is an in-vitro diagnostic (IVD) assay for measuring a tumor-associated antigen (CA 19-9) in human serum and plasma, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily based on established analytical performance parameters, not on human-expert-validated diagnostic accuracy. Therefore, several points from your request (e.g., number of experts, adjudication methods, MRMC studies, human-in-the-loop performance) are not directly applicable or reported in this type of submission.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents validation studies against established guidelines (e.g., CLSI documents) and compares the modified device's performance to its predicate. The nature of these acceptance criteria is based on quantitative analytical performance characteristics.

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

The "test set" here refers to the samples used in the analytical validation studies. These are not human-interpreted images or clinical datasets in the AI/ML sense but rather biological samples.

• Stability Studies: Four runs on each of 3 lots at monthly intervals for long-term; 3 lots up to 12 weeks for on-board stability. Number of samples not explicitly stated but implies sufficient runs to validate stability claims.
• Precision: 6 precision fluids; 2 replicates, 2 runs/day for 20 days (total 80 data points per fluid).
• Detection Capability (LoB): 4 endogenous fluids with no CA19-9; 2 replicates, 2 runs/day for 5 test days (20 reps/fluid) x 4 fluids = 80 replicates x 3 lots = 240 total replicates.
• Detection Capability (LoD/LoQ): 5 samples; 6 replicates, 2 runs/day for 5 test days (60 reps/fluid) x 5 fluids = 300 replicates x 3 lots = 900 total replicates.
• Linearity: 16 levels in the test panel; 5 replicates of each level run on 3 reagent lots over 2 days.
• Matrix Comparison: 41 specimens for Li-Hep vs. Serum and 41 specimens for EDTA vs. Serum.
• Analytical Specificity (Interferences): Tested at CA 19-9 concentrations of ~5.0 U/mL and ~50.0 U/mL. Specific sample numbers for this testing are not given but are implied to be within CLSI guidelines.
• Expected Values (Reference Interval): 60 normal blood donors.
• Method Comparison: 118 patient serum samples.

Data Provenance: The document does not explicitly state the country of origin for the samples or if they were retrospectively or prospectively collected. The studies appear to be laboratory-based analytical validation studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable to this type of IVD analytical device validation. The "ground truth" for the performance of a CA 19-9 assay is established by the known concentration of the analyte in control samples, reference materials, or by comparison to a well-validated predicate method, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of IVD analytical device validation. Adjudication is typically used for reconciling disagreements among human experts in diagnostic imaging interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study is not applicable to this device. This type of study assesses how human readers' diagnostic accuracy changes with or without AI assistance, which is for AI/ML-based diagnostic devices (e.g., imaging AI). This device is a quantitative immunoassay.

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

This concept is not applicable in the context of an IVD assay. The "algorithm" is the biochemical reaction and the instrument's measurement system. The device's "standalone" performance is what these non-clinical analytical studies demonstrate. The results are quantitative measurements of the CA 19-9 antigen, not classifications or detections that would then be presented to a human for interpretation.

7. The Type of Ground Truth Used

• Analyte Concentration: For precision, detection capability, linearity, known interferences, and dilution, the "ground truth" is based on the known or reference concentrations of CA 19-9 in control materials, spiked samples, or reference standards.
• Comparative Method: For method comparison, the "ground truth" is established by the results from the legally marketed predicate device (VITROS CA 19-9 assay, K052889).
• Normal Population Reference: For expected values, the "truth" is established by determining the range of values observed in a healthy, "normal" population.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning. For an IVD assay, the development process involves reagent formulation, instrument calibration, and optimization using iterative testing and refinement, not a distinct "training set" of data in the AI/ML sense. The studies described are validation activities for the final device.

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

As there is no "training set" in the AI/ML sense for this IVD, this question is not applicable. The "ground truth" for developing and calibrating an IVD like this would be established through highly controlled laboratory preparations of samples with known concentrations of the target analyte, often traceable to international standards if available. Calibration itself establishes the relationship between the measured signal and the concentration of the analyte.

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Lumipulse® G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA 19-9 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.

The assay is to be used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA 19-9 at some point in their disease process. Serial testing for patient CA 19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.

The Lumipulse G CA19-9-N Immunoreaction Cartridges (cat. # 235126) consists of 3 x 14 tests. Each kit contains the following:

1. Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µq/mL anti-CA19-9 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 ℃ or lower. Preservative: sodium azide.
2. Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-CA19-9 monoclonal antibody (mouse), protein stabilizers (bovine, calf, and mouse) and chemical stabilizers in 0.05 M sodium chloride/Bis-Tris buffer. Preservative: sodium azide.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Context: This document describes a Special 510(k) submission for the Lumipulse G CA19-9-N device, specifically addressing a change in the tested concentration of the therapeutic interferent Tamoxifen. The device is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA 19-9, used as an aid in the management of patients with cancer of the exocrine pancreas.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated for the "Supplemental Therapeutic Interference Study." However, the tables comparing the cleared vs. modified device list "Samples (Mean Test Concentrations (U/mL) (n=3))" and "Samples (Mean Control Concentrations (U/mL) (n=3))" for three serum pools. This suggests that for each serum pool, there were likely 3 replicates tested (n=3).
   • Data Provenance: Not specified, but given it's an in vitro diagnostic measuring a biomarker, the samples would be human serum/plasma. The document does not mention country of origin or whether the data was retrospective or prospective, though interference studies are typically laboratory-based and prospective using spiked samples or naturally interfering samples.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. This study is an interference study for an in vitro diagnostic device measuring a quantitative biomarker (CA 19-9). Ground truth is established by the known concentration of the substance being measured (CA 19-9) and the known concentration of the interferent (Tamoxifen). Expert consensus or pathologist review is not relevant for this type of test.

3. Adjudication Method for the Test Set: Not applicable. This is an interference study for a quantitative assay, not a subjective diagnostic interpretation.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, an MRMC study was not done. This type of study is typically performed for image-based diagnostics where multiple readers interpret cases with and without AI assistance. This document pertains to an in vitro diagnostic assay.

5. If a Standalone Performance Study was done: Yes, a standalone performance study in the form of a "Supplemental Therapeutic Interference Study" was conducted. This study assessed the device's performance (specifically, its susceptibility to Tamoxifen interference) without human interpretation in the loop, by comparing results with and without the interferent to a control.

6. The Type of Ground Truth Used: The ground truth for this interference study is established by:

   • The known, pre-established concentrations of CA 19-9 in the serum pools used.
   • The known concentration of Tamoxifen added to the samples.
   • The "control" measurements (samples without Tamoxifen) serve as the reference for determining the "percent difference."

7. The Sample Size for the Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" for such an assay is its analytical development and optimization.

8. How the Ground Truth for the Training Set was Established: Not applicable, as there is no training set for this type of in vitro diagnostic device in the context of machine learning. The assay is built on established chemical and immunological principles, with performance characteristics determined through analytical validation studies (like interference studies).

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Lumipulse G CA19-9-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of CA19-9 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.

The assay is to be used as an aid in the management of patients diagnosed with cancer of the exocrine pancreas who have detectable levels of CA19-9 at some point in their disease process. Serial testing for patient CA19-9 assay values should be used in conjunction with other clinical methods used for monitoring cancer of the exocrine pancreas.

WARNING: The concentration of CA19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA 19-9 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining serial levels of CA 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse & CA19-9-N should not be used for cancer screening or diagnosis.

WARNING: Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA19-9 antigen even in the presence of malignant tissue. Phenotyping for the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA19-9 based on gene dosage effect.

The Lumipulse G CA19-9-N Immunoreaction Cartridges (cat. # 235126) consists of 3 x 14 tests. Each kit contains the following:

1. Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-CA19-9 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: sodium azide.
2. Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.5 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-CA19-9 monoclonal antibody (mouse), protein stabilizers (bovine, calf, and mouse) and chemical stabilizers in 0.05 M sodium chloride/Bis-Tris buffer. Preservative: sodium azide.

The provided text describes the analytical and clinical performance of the Lumipulse G CA19-9-N device, a chemiluminescent enzyme immunoassay for the quantitative measurement of CA19-9 in human serum or plasma.

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

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a codified table for each test, but rather presents the study results and implicitly demonstrates that the device's performance metrics meet internal or regulatory thresholds for clearance. Based on the provided performance characteristics, the following can be inferred as acceptance criteria and the corresponding reported performance:

Study Details:

This document focuses on the analytical performance and clinical utility for an in vitro diagnostic (IVD) device, specifically an immunoassay for CA19-9. It does not describe a typical image-based AI/CADe/CADx study, therefore, many of the typical questions for such studies (e.g., number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context.

Here's a breakdown of the information available for this IVD device:

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

   • 20-Day Precision: 6 native human serum-based panels, tested in replicates of two separate times per day for 20 non-consecutive days (n=80 for each sample).
   • Site-to-Site Precision: 6 serum samples, assayed in triplicate per run with two runs per day across five non-consecutive days for a total of ten runs per site (n=30 replicates per site). Tested at an internal lab and two additional sites.
   • Lot-to-Lot Precision: 6 native serum samples, assayed in triplicate per run with 2 runs per day across 5 non-consecutive days for a total of 10 precision runs per lot (n=30 replicates per lot, 90 replicates per Panel across all three lots). Tested at the internal laboratory.
   • Linearity: High and low sample pools created using patient serum samples.
   • Spike Recovery: 3 normal human serum specimens.
   • Detection Limit: 2 blank and 7 low-level serum specimens, tested in replicates of ten over 3 days on 2 LUMIPULSE G1200 Systems with 2 runs per day and 2 Lumipulse G CA19-9-N lots tested (60 determinations for each specimen per lot).
   • Interfering Substances: Human serum specimen pools with three different CA 19-9 concentrations.
   • High Dose Hook Effect: Samples containing approximately 200,000 U/mL of CA 19-9.
   • Specimen Stability: Data derived from testing specimens under various storage conditions.
   • Matrix Comparison: Fifty (50) matched sets of serum (red top and serum separator tubes (SST)) and plasma (K2EDTA, sodium heparin and lithium heparin) samples.
   • Method Comparison: A total of 84 matched human serum samples. Later, 103 samples that required dilution were also included.
   • Clinical Supportive Data (Monitoring): 83 patients, 374 pairs of observations, with an average of 5.6 observations per patient.
   • Expected Values/Reference Range: 240 serum specimens from an "apparently healthy adult population" (22-93 years old).
   • Disease Prevalence Studies (Contextual Data): 75 serum samples from patients with benign pancreatic conditions and 120 from patients with malignant pancreatic disease. Also, samples from patients with other benign conditions and other malignant conditions (e.g., Biliary, Breast, CRC, Gallbladder, Liver, Lung, Ovarian, Stomach cancer).

   Data Provenance: Not explicitly stated regarding country of origin, but described as "native human serum-based panels," "patient serum samples," and "human serum specimens." The studies were performed at "internal laboratory," "external laboratory," and "two additional sites," suggesting clinical laboratory settings. The studies for 510(k) devices are typically retrospective, using banked clinical samples, though this is not explicitly stated as retrospective or prospective for all studies. The "Monitoring of Disease State" study with serial samples implies a prospective design in collecting follow-up data, but the collection itself might have been retrospective of existing patient records.

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

   • N/A. This is an IVD immunoassay, not an imaging device. Ground truth for most analytical performance studies is established by the known concentration of analytes in reference materials or by comparison to a legally marketed predicate device/method.
   • For the "Monitoring of Disease State" study, the "disease status" (progression/no progression) serves as the ground truth. This would typically be established by a clinician's assessment based on various clinical methods and follow-up, but the number and qualifications of such clinicians are not specified in this document.

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

   • N/A. Not relevant for an IVD immunoassay.

4. Medical Reader Multi-Case (MRMC) comparative effectiveness study:

   • N/A. This is not an AI/CADe/CADx device that assists human readers.

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

   • Yes, in essence. Diagnostic assays like this device operate standalone to produce a quantitative result. The device's performance is measured and reported directly (e.g., U/mL for CA19-9). The "human-in-the-loop" aspect is the clinician interpreting the result in conjunction with other clinical methods.

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

   • Analytical Performance: Ground truth is based on known concentrations for linearity, detection limits, spike recovery, and established reference methods (e.g., ARCHITECT CA 19-9XR as predicate) for method comparison.
   • Clinical Supportive Data (Monitoring): The ground truth for correlating CA19-9 changes was "changes in disease status," defined as "disease progression" or "no progression." This "disease status" is typically determined by physician's assessment based on imaging, biopsies, clinical symptoms, and other diagnostic tests (i.e., outcomes data/clinical assessment), not pathology in itself for every observation.

7. The sample size for the training set:

   • N/A. This is a traditional immunoassay, not a machine learning/AI device requiring a separate "training set" in the computational sense. The "training" of such a device primarily involves the development and optimization of the reagent formulation and assay parameters based on extensive R&D data, which is distinct from a machine learning training set.

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

   • N/A. As above, not a typical AI/ML training set.

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The LOCI CA19-9 method is an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 19-9 are indicated for the serial measurement of CA19-9 to aid in managing patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.

The LOCI 7 CAL is an in vitro diagnostic product for the calibration of the Cancer Antigen 19-9 (CA19-9) method on the Dimension Vista® System.

The CA19-9 method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCl® reagents include two synthetic bead reagents and a biotinylated anti-CA 19-9 monoclonal 1116-NS-19-9 anibody fragment. The first bead reacent (Chemibeads) is coated with an anti-CA 19-9 monoclonal antibody (1116-NS-19-9) and contains a chemilyminescent dye. The second bead reagent (Sensibeads) is coated with and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 19-9-biotinylated antibody sandwiches. Sensibeads are added and bind to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the CA 19-9 concentration in the sample when measured against a calibration curve.

The LOCI 7 calibrator is a liquid, frozen bovine serum albumin, based product containing CA 19-9 from human cell culture. The kit consists of ten vials, two vials per level (A-E), 2.0 mL per vial.

This document is a 510(k) summary for a diagnostic test, not a study reporting on the device's performance against specific acceptance criteria. A 510(k) is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, it does not typically include detailed acceptance criteria tables or specific studies proving the device meets those criteria in the way a clinical trial or performance evaluation report would.

However, based on the provided text, I can extract information related to the device's reported specifications and the general nature of the evidence presented for substantial equivalence.

Here's an analysis of the provided text in relation to your request, highlighting what is not available in this specific document:

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

This document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical study. Instead, it offers a "Comparison of Similarities and Differences" table between the new device (LOCI CA 19-9 Flex® Reagent Cartridge and LOCI 7 Calibrator) and its predicate devices. This comparison focuses on features such as intended use, sample type, measuring range, sample size, measurement principle, matrix, preparation, number of calibrator levels, target concentrations, and storage.

The document states: "Comparative testing described in the submission substa[ntiates substantial equivalence]" but does not provide the details of this testing or specific performance metrics with acceptance criteria.

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

This information is not available in the provided 510(k) summary. The summary refers to "comparative testing" but does not detail the sample size (number of patients or samples) or data provenance.

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 available in the provided 510(k) summary. Given that this is an in vitro diagnostic test for biomarker measurement, the ground truth would likely refer to the true concentration of CA 19-9, often established by reference methods or gravimetric preparation for calibrators/controls, rather than expert interpretation of images or clinical outcomes.

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

This information is not available in the provided 510(k) summary. Adjudication methods are typically relevant in studies involving human interpretation or subjective assessments, which is not the primary focus of validating an in vitro diagnostic assay like this.

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 information is not applicable/available. The device is an in vitro diagnostic reagent and calibrator for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this device.

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

This information is not applicable/available. The device is a laboratory assay, not an algorithm. Its performance is inherent to the chemical and physical processes of the assay itself when run on the specified instrument.

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

For a quantitative in vitro diagnostic test, the "ground truth" for the test set (clinical samples) would typically be the true concentration of the analyte (CA 19-9) as determined by a highly accurate reference method, or for manufactured calibrators, it would be the gravimetrically prepared target concentration. Specific details are not provided in this summary, but the context implies it relates to accurate measurement of CA 19-9 levels.

For the calibrator (Dimension Vista® LOCI 7 Calibrator), the ground truth for its concentrations are "Target Concentrations: Level 1 (CAL A): 0 U/mL, Level 2 (CAL B): 30 U/mL, Level 3 (CAL C): 131 U/mL, Level 4 (CAL D): 525 U/mL, Level 5 (CAL E): 1050 U/mL". This acts as the "ground truth" for calibration.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. For in vitro diagnostic devices, the concept of "training set" is generally not applied in the same way as for AI models. Assay development involves optimization and validation using various samples, but these are typically not categorized as a distinct "training set" in the context of a 510(k) summary.

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

This information is not available in the provided 510(k) summary for the above reasons.

Summary Table of Device Specifications (from the "Similarities and Differences" comparison, not "Acceptance Criteria" actively met by a study):

Study Details Mentioned (Limited):

• Type of Study: The document refers to "Comparative testing" to demonstrate substantial equivalence to the predicate device (ADVIA Centaur CA 19-9 assay, K031393). This implies analytical performance studies (e.g., precision, accuracy, linearity, interference) were performed to show that the new device performs similarly to the predicate. However, specific results or detailed methodologies are not included in this summary.
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.
• Conclusion: The LOCI CA 19-9 method and LOCI 7 calibrator are considered substantially equivalent to their respective predicate devices based on the comparative testing described in the full submission.

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For the in vitro quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma (EDTA or heparin). The VITROS CA19-9 assay is to be used to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The VITROS CA19-9 assay can be used to monitor the disease status in patients with confirmed pancreatic cancer who show measurable CA19-9 values over the course of their disease. Serial CA 19-9 test results should be used in conjunction with all other available clinical and laboratory data before a medical decision is determined.

The VITROS CA 19-9 assay is performed using the VITROS CA 19-9 Reagent Kit and the VITROS Immunodiagnostic System. An immunometric assay is performed. CA 19-9 antigen present in the sample reacts with a biotinylated antibody (mouse monoclonal anti-1116-NS-19-9 defined antigen). The antigen-biotinylated antibody complex binds to the wells, unbound materials are removed by washing. In a second incubation a horseradish peroxidase (HRP)-labeled antibody Conjugate (mouse monoclonal anti-1116-NS-19-9 defined antigen) binds to the immobilized complex. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic Substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP Conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs the emission. The light signals are read by the system. The light produced is directly proportional to the concentration of 1116-NS-19-9 defined antigen present.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 19-9 Reagent Pack, VITROS Immunodiagnostic Products CA 19-9 Calibrator Kit, and the VITROS Immunodiagnostic Products CA 19-9 Range Verifier Kit, which are used by the VITROS Immunodiagnostic System to perform the VITROS CA 19-9 assay).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919).
3. Common Reagent Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent, which were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the device's performance in clinical application (e.g., specific sensitivity/specificity targets). Instead, it focuses on demonstrating substantial equivalence to a predicate device and showing an association between changes in marker value and changes in disease state.

The "reported device performance" section focuses on the concordance between changes in the VITROS CA 19-9 assay and changes in the disease state for pancreatic cancer patients.

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

• Comparison Study (vs. Predicate):
  • Sample Size: 176 specimens.
  • Data Provenance: Not explicitly stated, but given the context of a 510(k) summary for a US submission, it is likely to be a combination of retrospective samples or samples collected specifically for this validation. The document does not specify country of origin.
• Pancreatic Cancer Serial Specimens Study:
  • Sample Size: 74 patients, yielding 261 evaluable observations (average 3.5 observations per patient) and 187 observation pairs for the change analysis.
  • Data Provenance: Not explicitly stated, but inferred to be clinical data. The document does not specify country of origin or if it's retrospective/prospective. It mentions "staging was available from the chart," suggesting retrospective chart review.

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

The document does not mention the use of experts to establish the ground truth for the test set in either the comparison study or the pancreatic cancer serial specimens study.

• In the comparison study, the ground truth is implicitly the result from the predicate device (Fujirebio Diagnostics, Inc. CA 19-9 RIA).
• In the pancreatic cancer serial specimens study, the "Change in Disease State (Progression / No Progression)" is the ground truth. The method for determining this change is not detailed but would typically come from clinical assessments (e.g., imaging, clinical symptoms, physician's diagnosis), not expert consensus based on re-reading.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either study to establish ground truth or assess discrepancies.

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

No MRMC comparative effectiveness study was done. The device is an in vitro diagnostic assay, not an imaging device typically evaluated with MRMC studies or human reader performance. The "effectiveness" is shown through clinical correlation and substantial equivalence to a predicate, not through human reader improvement.

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

Yes, the studies presented are standalone performance evaluations of the assay itself. The device is a laboratory assay (VITROS CA 19-9), and its performance is measured directly, without human interpretation or adjustment influencing the assay's output. The output (CA 19-9 value) is then interpreted by clinicians in conjunction with other data.

7. The Type of Ground Truth Used

• Comparison Study: The "ground truth" was the results obtained from the predicate device (Fujirebio Diagnostics, Inc. CA 19-9 RIA).
• Pancreatic Cancer Serial Specimens Study: The "ground truth" was the clinical determination of disease state change (Progression vs. No Progression). This likely came from a composite of clinical factors, imaging, and physician assessment, rather than a single direct measure like pathology at every time point for all patients.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an IVD assay like this, development typically involves method development and verification using various samples, but a formally defined "training set" in the machine learning sense is not applicable. The studies described are performance validation studies.

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

Since no explicit training set is mentioned in the context of machine learning, this question is not directly applicable. For the development and verification of the assay itself, the ground truth would have been established through well-characterized reference materials, known concentrations, and comparisons to established methods during the research and development phases.

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The ARCHITECT CA 19-9xR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9xR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

Patients known to be genotypically negative for the Lewis blood group antigen will be unable to produce the CA 19-9 antigen even in the presence of malignant tissue. Phenotyping for the presence of the Lewis antigen may be insufficient to detect true Lewis antigen negative individuals. Even patients who are genotypically positive for the Lewis antigen may produce varying levels of CA 19-9 based on gene dosage effect.

The ARCHITECT CA 19-9xR assay is a two-step immunoassay for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

In the first step, sample and 1116-NS-19-9 coated paramagnetic microparticles are combined. 1116-NS-19-9 reactive determinants present in the sample bind to the 1116-NS-19-9 coated microparticles. After washing, 1116-NS-19-9 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of 1116-NS-19-9 reactive determinants in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT® CA 19-9™xR Assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma. It is intended to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and summarizing performance characteristics rather than explicit 'acceptance criteria' in the format of a clinical trial endpoint table. However, based on the reproducibility and comparison studies, we can infer performance targets and the achieved results.

• Per-Patient Analysis: Total Concordance (C) = 68.92% (95% CI: 57.10% - 79.17%), Positive Concordance (C+) = 68.18% (95% CI: 45.13% - 86.14%), Negative Concordance (C-) = 69.23% (95% CI: 54.90% - 81.28%) (based on 74 patients). |

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

• Reproducibility: Not explicitly stated as a test set size, but samples were tested consisting of two panels of standards, one panel of serum with added determinants, and controls. Each sample was tested two separate times per day for 20 nonconsecutive days, using two lots of reagents, in replicates.
• Comparison Study: 259 serum specimens. Data provenance is not specified, but typically for clinical studies supporting US regulatory submissions, samples would be sourced from a diverse US population or explicitly identified as international if applicable. The document does not state whether it was retrospective or prospective.
• Reference Ranges (Apparently Healthy Population): 360 serum specimens from apparently healthy individuals. Data provenance not specified.
• Patient Groups (Disease Distribution): 978 individual serum samples from various non-malignant and malignant disease groups. Data provenance not specified.
• Pancreatic Cancer Serial Specimens (Concordance Study): 74 patients, yielding 261 evaluable observations (average 3.5 observations per patient) for the observation-pair analysis, and 74 for the per-patient analysis. Data provenance not specified. The average age was 61.8 years (range 17-85 years), 55% were men, 45% women. Staging was available for 70 of the 74 patients.

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

The document describes an in vitro diagnostic (IVD) assay measuring a tumor marker, CA 19-9. The "ground truth" for such assays typically refers to the confirmed clinical diagnosis of pancreatic cancer and the progression/regression of the disease.

• The document does not explicitly state the number or qualifications of experts used to establish the clinical ground truth (e.g., pancreatic cancer diagnosis, disease progression/no progression) for the patient samples used in the reference ranges, patient group distribution, or concordance studies.
• However, for the "Association between Change in Marker Value and Change in Disease State" study, the ground truth for "Change in Disease State (W)" (Progression vs. No Progression) was established. This likely involved clinical assessment by medical professionals (e.g., oncologists, radiologists) based on various clinical methods like imaging, biopsy, and other clinical observations. The document itself is a 510(k) summary, which often omits granular details about clinical expert involvement if not directly related to the device's technical performance.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for establishing the "Change in Disease State (W)" in the concordance study. Clinical diagnoses and disease state changes are typically determined by treating clinicians based on standard clinical practice, which may inherently involve a form of consensus or judgment, but a specific, formalized adjudication process involving multiple independent reviewers is not mentioned.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay that provides a quantitative measurement of a biomarker. MRMC studies are typically performed for imaging devices or algorithms where human readers interpret images or data, and the AI's impact on their performance is being evaluated. This document focuses on the analytical and clinical performance of the assay itself.

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

• Yes, this entire submission effectively describes a standalone performance evaluation of the ARCHITECT CA 19-9xR assay. As an IVD test, it generates results independently. The "performance" described (reproducibility, correlation, reference ranges, association with disease state) is the performance of the assay system itself, not in conjunction with human interpretation of its results in a structured reader study. Its intended use is "as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods," implying its results are interpreted by clinicians.

7. The Type of Ground Truth Used:

• For the technical performance (reproducibility, comparison): The ground truth is the true concentration of CA 19-9 reactive determinants or reference method values.
• For the clinical performance (reference ranges, patient groups, concordance study): The ground truth for disease classifications and changes in disease state would be clinical diagnosis and disease progression/regression determined by treating physicians based on a combination of clinical methods (e.g., pathology reports, imaging studies, clinical assessment, treatment response, outcomes data). The document refers to "Change in Disease State (W)," which is derived from these clinical assessments.

8. The Sample Size for the Training Set:

• This submission describes a mature IVD product (ARCHITECT CA 19-9xR Assay) that is compared to an existing predicate device (Fujirebio Diagnostics, Inc. CA 19-9 RIA). IVD assays, especially for biomarkers, are typically developed using rigorous analytical validation rather than machine learning "training sets" in the conventional sense.
• Therefore, the concept of a "training set" as understood in AI/ML contexts does not directly apply to this type of device and study. The assay itself is a chemical measurement system, not a learning algorithm that requires a separate training phase. The studies described are for validation and performance assessment.

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

• As explained in point 8, there isn't a "training set" in the AI/ML sense for this device. The ground truth for developing and optimizing such an assay would involve extensive analytical validation against reference materials, known concentrations, and clinical samples with well-characterized disease states. This process is part of product development and analytical verification, not typically described as establishing ground truth for a "training set" in a 510(k) summary.

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The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 19-9 antigen to aid in the management of pancreatic cancer patients. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer whose serum CA 19-9 antigen levels exceed 10 U/mL, the cut-off value for individuals who are Lewis blood group antigen negative. Serial testing for patient CA 19-9 antigen concentrations should be used in conjunction with other clinical methods used for monitoring pancreatic cancer.

The Access GI Monitor reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of CA 19-9 antigen in human serum and plasma.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Imprecision: Not explicitly stated, but concentrations ranged from approximately 17 to 1665 U/mL. The study involved running samples to establish within-run, within-laboratory, and total imprecision.
• Dilution Recovery (Linearity): 6 human samples were diluted.
• Methods Comparison: 405 samples were used, ranging from 0.0 to 236.0 U/mL.
• Sample Type Comparison: 80 matched serum and lithium heparin plasma samples, ranging from 0.0 to 1650.9 U/mL.
• Clinical Studies (Reference Limit): The "apparently healthy subject population" was used to establish the 95th percentile (35 U/mL CA 19-9) as the upper reference limit. The size of this population is not specified.
• Clinical Studies (Pancreatic Cancer Monitoring): Patients diagnosed with pancreatic cancer were monitored. The number of patients is not specified.
• Clinical Studies (Sensitivity/Specificity): "Pancreatic cancer monitoring subjects" were used. The number of subjects is not specified.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for any of the studies. However, the mention of "human Dildion Nooorory (evels" (likely meant to be "human dilution recovery levels") and "human serum and plasma" samples suggests human biological samples were used.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the performance evaluations (imprecision, linearity, specificity, methods comparison, sample type comparison, stability) rely on laboratory measurements and comparisons to a predicate device. The clinical studies compare the device's performance to the predicate device's performance in terms of monitoring patient status and determining relative sensitivity and specificity.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as the studies are primarily analytical performance assessments and comparisons to a predicate device, rather than studies requiring expert consensus on outputs.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an imaging or diagnostic device that involves human readers interpreting results.

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

Yes, the studies described are all "standalone" in the sense that they evaluate the performance of the immunoassay system (reagents, calibrators, and analyzer) itself, without direct human interpretation of the assay results as part of the performance metrics. The results (CA 19-9 levels) are quantitative measurements produced by the automated system.

7. The Type of Ground Truth Used

• Analytical Studies:
  • Imprecision, Analytical Sensitivity, Dilution Recovery, Stability, Analytical Specificity: The "ground truth" for these studies is inherent in the design of the experiments, where known concentrations of analytes, controlled dilutions, or specific interfering substances are used to assess the device's ability to accurately and reproducibly measure CA 19-9.
  • Methods Comparison: The "ground truth" is the established predicate device (Fujirebio Diagnostics CA 19-9 RIA assay). The new device's measurements are compared to those of the predicate.
  • Sample Type Comparison: The "ground truth" is the agreement between a person's serum and plasma samples when measured by the same device.
• Clinical Studies:
  • Reference Limit: The "ground truth" is derived from the distribution of CA 19-9 levels in purportedly "healthy" individuals which establishes a statistical reference.
  • Pancreatic Cancer Monitoring: The "ground truth" for assessing monitoring effectiveness appears to be the observed clinical course of pancreatic cancer patients and how the device's CA 19-9 measurements "paralleled results obtained with the predicate device."
  • Sensitivity/Specificity: The "ground truth" is derived from diagnosed pancreatic cancer patients and the reference ranges (URL) for both the new device and the predicate device, implying comparison to a clinical diagnosis (presumed true positive/negative status) as well as the predicate device's established performance.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay, the development of which typically involves extensive R&D and optimization (which could be considered analogous to training) but is not usually described with a distinct "training set" in the same way as AI/ML algorithms. The analytical and clinical studies described are for the performance evaluation of the finalized device.

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

As explained above, there isn't a "training set" in the common AI/ML sense presented in this document. The development and optimization of the immunoassay would have involved chemical and biological principles to ensure accurate binding, detection, and quantification of the CA 19-9 antigen. The ground truth for such development would involve precise measurements of known antigen concentrations, characterized antibodies, and optimized reaction conditions.

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The ADVIA Centaur® CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur System. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined. This assay is not intended for use on any other system.

The ADVIA Centaur CA 19-9 assay is a fully automated, two-step sandwich immunoassay using direct, chemiluminescent technology. The method utilizes a single monoclonal antibody (Mab), 116-NS-19-9, for both the Solid Phase and the Lite Reagent. The Mab is both covalently coupled to paramagnetic particles in the Solid Phase as well as labeled with acridinium ester in the Lite Reagent.

The sample and Solid Phase are first incubated at 37℃ for 7.5 minutes. This step is followed by a wash step to remove excess unbound antigen. The Lite Reagent is then reacted with the Solid Phase that is bound to CA 19-9 antigen for an additional 20-minute incubation. This two-step protocol eliminates any high-dose hook effect in this assay.

Here's a breakdown of the acceptance criteria and study information for the Bayer HealthCare Diagnostics Division ADVIA Centaur® CA 19-9 Assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantified format that one would typically find for a diagnostic test. Instead, it compares the performance characteristics of the new device (ADVIA Centaur CA 19-9 Immunoassay) to those of the predicate device (Fujirebio Diagnostics CA 19-9 RIA). The implication is that the new device's performance should be comparable or superior to the predicate for features where direct comparison is feasible. For clinical concordance, the new device's performance is presented on its own.

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

• Clinical Concordance Test Set: 131 clinical samples (patients with pancreatic cancer, monitored serially for changes in disease status).
• Method Comparison Test Set: 360 samples in the assay range of 1.2 - 700 Units/mL.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission, it's highly likely that these were prospective or a mix of prospective and retrospectively collected clinical samples, but this is not definitively stated.

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

The document states that the clinical concordance studies compare "changes in CA 19-9 value relative to disease progression." However, it does not provide details on:

• The number of experts.
• Their qualifications.
• The specific method used to establish the "Change in Disease State" (i.e., "Progression" or "No Progression"). This clinical status would serve as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used to establish the ground truth ("Change in Disease State") for the clinical concordance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or interpretation tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here. The study focuses on the performance of the assay itself and its correlation with clinical status and a predicate device.

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

• Yes, a standalone study was done. This entire submission describes the standalone performance of the ADVIA Centaur CA 19-9 Assay, an automated in vitro diagnostic device, without human intervention in the result generation process once the sample is loaded. The "clinical concordance" section assesses the direct relationship between the assay's output and clinical disease progression.

7. The Type of Ground Truth Used

• Clinical Outcomes/Disease State: For the clinical concordance study, the ground truth was "Change in Disease State" (Progression or No Progression), which is derived from a patient's overall clinical presentation and likely involves various clinical and diagnostic assessments over time. The document does not specify the exact methods or criteria used to define "Progression" or "No Progression."
• Predicate Device Measurements: For the method comparison study, the ground truth for measuring CA 19-9 values was essentially the measurement obtained from the Fujirebio Diagnostics CA 19-9 RIA predicate device.

8. The Sample Size for the Training Set

The document does not specify a separate training set size for the development of the ADVIA Centaur CA 19-9 Assay. This is common for traditional immunoassays, where the "training" involves optimizing reagents, chemistry, and instrument parameters rather than iterative machine learning on a distinct dataset. Clinical and analytical performance studies are typically conducted on independent samples after the assay development is complete.

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

As there's no explicitly defined "training set" in the context of machine learning, the question of its ground truth establishment is not applicable in the same way. The development of an immunoassay involves extensive biochemical research, optimization of antibody performance, fluorogenic labels, reaction kinetics, and calibration curves using known standards, rather than establishing a ground truth for a dataset to "train" an algorithm.

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AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.

AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for the AIA-PACK™ CA 19-9 device. The document is an FDA 510(k) clearance letter confirming substantial equivalence to a predicate device, and it does not include the detailed study information you are requesting.

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ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.

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This is a medical device approval letter. It does not provide the information needed to answer the request. The letter confirms the FDA's decision that the "ST AIA-PACK TM CA 19-9" device is substantially equivalent to legally marketed predicate devices. It discusses regulatory information and marketing authorization but does not contain details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a performance study.

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