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The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

The Access CEA assay is a two-site immunoenzymatic "sandwich" assay using two mouse monoclonal anti-CEA antibodies (MAb) which react with different epitopes of CEA. The Access CEA reagent kit is in a liguid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.

The provided text describes the 510(k) submission for the Beckman Coulter Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer. This document focuses on demonstrating substantial equivalence to a predicate device (Access CEA on the Access Immunoassay Analyzer), primarily through analytical performance studies rather than clinical or AI-assisted diagnostic studies.

Therefore, many of the requested criteria related to AI performance, human reader studies, and expert ground truth are not applicable or cannot be extracted from this document. The information provided is characteristic of a submission for an in vitro diagnostic (IVD) device, which relies heavily on analytical performance characteristics.

Here's the breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria and performance for various analytical studies.

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

• Method Comparison: A total of 153 serum samples were evaluated.
• Imprecision: Multiple samples (7 distinct concentration levels) were tested with a minimum of three replicates in 2 runs per day for a minimum of 20 days. The "N" column in the table refers to the total number of measurements for each sample level (e.g., 126 for Sample 1, 120 for Sample 2, etc.).
• Data Provenance: The document does not specify the country of origin of the data or whether the samples were retrospective or prospective. This is typical for IVD analytical performance studies.

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

• This information is not applicable to this type of device and study. The ground truth for analytical performance studies like Method Comparison, Imprecision, Linearity, LoB, LoD, and LoQ is established by the reference measurement method (in this case, the predicate device for method comparison, or precise measurements by the instrument itself for other analytical characteristics) and laboratory standards, not by expert human interpretation like a radiologist reading an image.

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

• This is not applicable. Adjudication methods are used in studies involving human interpretation or challenging diagnoses, not for analytical performance of an IVD assay measuring a biomarker 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:

• This is not applicable. This is an in vitro diagnostic device (immunoassay for CEA), not an AI-powered image analysis or diagnostic assist device for human readers. No human interpretation or AI assistance study was performed or required for this type of submission.

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

• This is not applicable in the context of AI algorithms. The device itself (Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer) is a standalone automated analytical instrument. Its performance is evaluated as an "algorithm only" in the sense that it performs the measurement independently, but it's a chemical and optical measurement process, not an AI algorithm.

7. The type of ground truth used:

• For the Method Comparison study, the "ground truth" or reference method was the predicate device (Access CEA on the Access Immunoassay Analyzer).
• For other analytical studies (Imprecision, Linearity, LoB, LoD, LoQ), the ground truth is established through controlled spiking, dilutions, and repeated measurements according to established analytical validation guidelines (e.g., CLSI EP-05-A3 for imprecision). These are intrinsic analytical properties of the assay and instrument combination, verified against laboratory standards.

8. The sample size for the training set:

• This is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The development of an immunoassay involves optimizing reagents, antibodies, and instrument parameters, which is a different process from training a machine learning model.

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

• This is not applicable for the reasons stated in point 8.

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For In Vitro Diagnostic Use Only

For the quantitative measurement of carcinoembryonic antigen (CEA) concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System, to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.

The VITROS Immunodiagnostic Products CEA Reagent Pack (test) is performed using the VITROS CEA Reagent Pack and VITROS CEA Calibrators on the VITROS 5600 System.

An immunometric immunoassay technique is used, which involves the reaction of CEA present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-CEA) bound to Streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (Mouse monoclonal anti- CEA). Unbound (HRP)-labeled anti-CEA antibody 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 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 HRP conjugate bound is directly proportional to the concentration of CEA present in the sample.

VITROS CEA Reagent Pack contains:
1 reagent pack containing:

• 100 coated wells (antibody, mouse monoclonal anti-CEA, binds ≥8ng CEA/well); ●
• 9.7 mL assay reagent (buffer containing bovine serum albumin, bovine gamma globulin and . antimicrobial agent).
• 9.7 mL conjugate reagent (HRP-mouse monoclonal anti-CEA, binds ≥123ng CEA/mL). ●

VITROS CEA Calibrator contains:

• 1 set of VITROS CEA Calibrators 1 and 2 (human CEA in bovine serum with ● antimicrobial agent, 2 mL); nominal values 3 and 250 ng/mL (us/L)
• 16 calibrator bar code labels (8 for each calibrator) ●

The provided document describes the safety and effectiveness information for the VITROS Immunodiagnostic Products CEA Reagent Pack (K231517), which is intended for the quantitative measurement of carcinoembryonic antigen (CEA) in human serum and plasma to aid in the prognosis and management of cancer patients. The document primarily focuses on nonclinical performance studies to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a singular table alongside performance for all aspects. However, it implicitly defines acceptance by stating that certain studies were performed "consistent with CLSI document" guidelines and that "all results were acceptable" or "met the acceptance criteria." For linearity, it specifies "Allowable nonlinearity." For matrix comparison, it states "The results met the acceptance criteria."

Here's an attempt to synthesize the acceptance criteria and performance from the text for key analytical characteristics:

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

• Precision:
  • 5600 System (Table 1): 4 precision fluids. 2 replicates per fluid, 2 occasions per day, for 20 days. Total 80 data points per fluid.
  • Additional Precision Analysis (Table 2): 4 precision fluids (PP1-PP4). 240 observations per sample (likely 2 replicates per run, multiple runs, over multiple days/lots as per CLSI guideline EP05-A3).
• Detection Capability (LoB): 4 endogenous fluids. 2 replicates per run, 2 runs per day, over 5 test days. Total 20 replicates per test fluid x 4 fluids = 80 replicates total for LoB. Tested on 3 lots, so 240 total replicates.
• Detection Capability (LoD & LoQ): 5 samples. 6 replicates per run, 2 runs per day, over 5 test days. Total 60 replicates per fluid x 5 fluids = 300 replicates total for LoD/LoQ. Tested on 3 lots, so 900 total replicates.
• Linearity: 13 levels, five replicates for each level.
• Matrix Comparison: Not specified precisely, but samples were "spanning the expected measuring interval."
• Analytical Specificity (Interferents): Not specified (e.g., number of replicates or distinct samples).
• High Dose Hook: Panel of ten fluids. Tested in singleton.
• Method Comparison (Accuracy): 110 human serum samples. Tested in singleton.

Data Provenance:
The document consistently refers to "human serum" or "patient samples." For the method comparison, it states "Human serum samples were obtained from certified vendors." For detection capability, it mentions "endogenous fluids" and "admixtures of serum samples containing endogenous CEA combined with CEA affinity stripped serum." For expected values, it refers to "healthy non-smokers (n=68)" and "healthy smokers (n=72)."
The country of origin is not specified but the submitter is Ortho-Clinical Diagnostics Inc. from the UK. The studies are nonclinical performance studies, often conducted in-house or by contract research organizations. These studies are prospective in nature, as they are designed experiments to evaluate specific performance characteristics.

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

Ground truth for these studies is analytically derived, not expert consensus interpretation. For in vitro diagnostic devices like the CEA assay, the "ground truth" for test sets in nonclinical studies typically refers to:

• Reference values assigned by highly accurate reference methods or known concentrations of analytes (e.g., spiked samples) for linearity, detection, and accuracy studies.
• The known physiological state of samples (e.g., healthy non-smokers, healthy smokers) for reference intervals.
• The known presence/absence and concentration of interferents for specificity studies.

Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation (like radiologists for imaging) is not applicable here. The ground truth is established by the design of the analytical experiment and the reference materials/methods used.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of data (e.g., images) forms the ground truth, and discrepancies need to be resolved. This is not relevant for the analytical performance studies of a laboratory immunoassay described in this document.

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

No. An MRMC study is relevant for devices involving human interpretation (e.g., medical imaging) to assess how the device impacts human reader performance. This document describes the analytical performance of an in vitro diagnostic immunoassay.

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

Yes, this entire submission describes the standalone performance of the VITROS Immunodiagnostic Products CEA Reagent Pack and the VITROS 5600 Integrated System. The data presented are purely analytical measurements performed by the device, without human interpretive input or assistance being part of its core function.

7. The Type of Ground Truth Used

• Stability: Time points with known age of reagents/calibrators/samples.
• Precision: Control materials or patient samples where inherent variability is being measured. No "ground truth" in the sense of an absolute true value is typically assigned for precision, but rather the repeatability and reproducibility of the measurements around a mean.
• Detection Capability: Samples confirmed to contain no measurable CEA (for LoB) or samples with targeted, known low concentrations of CEA (for LoD and LoQ), often prepared by spiking.
• Linearity: Samples covering a wide range of concentrations, often prepared by dilution of a high-concentration sample with known low-concentration diluent, such that the "expected value" is calculable.
• Matrix Comparison: Patient samples (serum vs. various plasma types) where a comparison between matrices is the objective, not an absolute ground truth value.
• Analytical Specificity: Samples spiked with known concentrations of potential interfering substances, with the expectation that the CEA measurement should not be significantly biased.
• High Dose Hook: Samples with extremely high, known CEA concentrations to ensure the device correctly reports high values and doesn't "hook" and report falsely low.
• Method Comparison (Accuracy): Patient samples compared against a legally marketed predicate device (VITROS CEA assay K041322) on the same system. The predicate device's results serve as the comparative measure, assumed to be accurate for the purpose of demonstrating equivalence.
• Expected Values: Clinically healthy subjects (non-smokers and smokers) categorized by their CEA levels.

In summary, the ground truth is primarily based on analytical reference materials, known spiked concentrations, and comparative measurements against a predicate device, all within the domain of quantitative laboratory measurements.

8. The Sample Size for the Training Set

This document describes nonclinical performance testing for an in vitro diagnostic device, not a machine learning or AI algorithm in the typical sense that would involve a "training set." The device is a chemical reagent pack used on an automated immunoassay system. While there were certainly development and validation phases during the device's creation (which might involve analogous processes to "training"), the document provided does not detail a "training set" in the context of an AI/ML algorithm. The studies described are validation studies of the finalized product.

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

As noted in point 8, the concept of a "training set" with established ground truth as typically understood for AI/ML is not applicable to this kind of device and its regulatory submission. The document focuses on demonstrating the analytical performance of a developed immunoassay kit.

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For in vitro diagnostic use in the quantitative measurement of carcinoembryonic antigen (CEA) in serum and plasma (EDTA and lithium heparin) to aid in the management of cancer patients in whom changing concentrations of CEA are observed using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems.

The assay reagents come in the following configurations:
5 ReadyPack primary reagent packs containing ADVIA Centaur CEA Lite Reagent and Solid Phase ADVIA Centaur CEA Master Curve card (500 Tests)
1 ReadyPack primary reagent pack containing ADVIA Centaur CEA Lite Reagent and Solid Phase ADVIA Centaur CEA Master Curve card (100 Tests)
The ReadyPack consists of the following:
ADVIA Centaur® CEA ReadyPack® primary reagent pack; Lite Reagent: 5.0 mL/reagent pack polyclonal rabbit anti-CEA antibody (~400 ng/mL) labeled with acridinium ester in phosphate buffered saline with protein stabilizers, sodium azide (0.12%), and preservatives
ADVIA Centaur® CEA ReadyPack® primary reagent pack; Solid Phase Reagent: 25.0 mL/reagent pack monoclonal mouse anti-CEA antibody (~120 µg/mL) covalently coupled to paramagnetic particles in phosphate buffered saline with protein stabilizers, sodium azide (0.11%), and preservatives
ADVIA Centaur® CEA ReadyPack® ancillary reagent pack; CEA Diluent: 5.0 mL/reagent pack bicine buffer, gelatin, and BSA with preservatives and sodium azide (0.1%)
ADVIA Centaur® CEA Diluent: 10.0 mL/reagent vial bicine buffer, gelatin, and BSA with preservatives and sodium azide (0.1%)

This document describes the acceptance criteria and the study proving that the ADVIA Centaur® CEA assay meets these criteria, specifically for the addition of plasma (EDTA and lithium heparin) sample claims.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported performance characteristics, especially for specimen equivalence and interference, as the submission focuses on demonstrating equivalence to a previously cleared device.

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

• Accuracy/Method Comparison: 201 samples (range of 2.00 to 78.93 ng/mL).
• Specimen Equivalence:
  • Dipotassium EDTA plasma vs. Serum: 64 samples (range of 2.08-97.10 ng/mL).
  • Lithium Heparin plasma vs. Serum: 46 samples (range of 2.11-97.10 ng/mL).
• Interferences: Analyte concentrations were tested at 5-6 ng/mL and 55-61 ng/mL for each interferent (Dipotassium EDTA and Heparin). The exact number of samples per concentration is not specified, but it implies a controlled experimental setup.

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. However, given the context of a 510(k) submission for a diagnostic device, the data would typically be derived from controlled, prospective studies conducted in a clinical or laboratory setting.

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

This information is not applicable. The device measures a quantitative analyte (CEA) in blood samples. The "ground truth" for the test set is established by the reference method (ACS:180 CEA assay for accuracy/method comparison, or the serum sample itself for specimen equivalence) and the intrinsic concentration of the analyte, rather than expert consensus on interpretive tasks.

4. Adjudication Method (for the test set)

Not applicable, as the "ground truth" is based on quantitative measurements by a reference method or direct comparison, not subjective interpretation requiring adjudication.

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

No MRMC study was done. This type of study is typical for imaging or interpretive AI devices comparing human performance with and without AI assistance. The ADVIA Centaur® CEA assay is an in vitro diagnostic device for quantitative chemical measurement, not an AI-powered interpretive tool.

6. Standalone Performance

Yes, a standalone performance study was done. The document reports the detection capability (LoB, LoD, LoQ), method comparison, specimen equivalence, and interference studies of the ADVIA Centaur® CEA assay as a standalone device. These studies evaluate the assay's characteristics directly without a human-in-the-loop component for interpretation.

7. Type of Ground Truth Used

• Accuracy/Method Comparison: The ground truth was established by comparison to a legally marketed predicate device, the ACS:180 CEA assay. This essentially uses the measurements from an established, accepted method as the reference.
• Specimen Equivalence: The ground truth was the CEA concentration measured in serum samples, against which plasma samples (EDTA and lithium heparin) were compared.
• Detection Capability and Interferences: The ground truth for these studies would be based on known concentrations of CEA and interferents in control samples, which are objectively measurable.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" for the assay itself. For in vitro diagnostic devices like this, the development process involves extensive calibration, reagent optimization, and verification using various samples, but these are generally considered part of development and verification, not a distinct "training set" in the machine learning sense. The clinical studies described (method comparison, specimen equivalence) serve as external validation of the device's performance.

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

Not applicable, as there is no explicitly defined "training set" in the context of machine learning for this in vitro diagnostic assay. The device's performance is driven by the biochemical interactions of the reagents, not by a learned model from a training set. The calibration and standardization of the assay are traceable to an internal standard manufactured using highly purified material, as stated in the "Standardization" section of Table 1.

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The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.

The Olympus CEA Calibrator is for calibrating the quantitative Olympus CEA assay on the Olympus AU3000i Immunoassay System.

The Olympus CEA Control is used for quality control of the Olympus CEA assay on the Olympus AU3000i Immunoassay System.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is primarily an FDA 510(k) clearance letter and an "Indications for Use" statement for the Olympus Carcinoembryonic antigen (CEA) Test System. It confirms the device's substantial equivalence to a predicate device and outlines its intended use but does not delve into the specifics of performance studies or acceptance criteria.

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VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.

The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).

After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.

A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.

During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

The provided document describes the VIDAS® CEA (S) Assay, a medical device for measuring Carcinoembryonic antigen (CEA) in human serum, and compares its performance to a predicate device, the TOSOH ST AIA-PACK CEA. This is an In Vitro Diagnostic (IVD) device, not an AI or imaging device, so many of the requested fields (like number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set information) are not applicable or typically reported for this type of device.

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

1. Table of Acceptance Criteria and Reported Device Performance

For IVD devices like the VIDAS® CEA (S) Assay, acceptance criteria are typically demonstrated through analytical and clinical performance studies that show equivalence to a legally marketed predicate device. The document uses the TOSOH ST AIA-PACK CEA as its predicate. The key performance metrics are analytical precision (intra-assay and inter-run) and method comparison (correlation with the predicate device).

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The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Dimension Vista® CEA Flex® reagent cartridge: The CEA method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CEA monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-CEA monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CEA-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Ulumination 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 CEA concentration in the sample.

Dimension Vista® LOCI 5 Calibrator: LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® CEA Flex® reagent cartridge and Dimension Vista® LOCI 5 Calibrator, based on the provided text:

Acceptance Criteria and Device Performance

The study demonstrates substantial equivalence to the predicate device, Beckman Access® CEA Reagents on the Access® Immunoassay System. The acceptance criteria are implicitly defined by showing comparable performance characteristics, particularly in method comparison (correlation) and precision.

• Within Run: 3.01 – 3.97 %CV
• Total: 3.80 - 4.51 %CV | Repeatability: 1.3 - 2.9 %CV
  Within-Lab: 2.1 - 3.6 %CV |
  | Measuring Range | 0.1 - 1000.0 ng/mL | 0.2 - 1000.0 ng/mL |

Study Details

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

   • Method Comparison:
     • 141 values for correlation study, range 0.8 - 974 ng/mL [µg/L].
     • 46 values for correlation study, range 0.8 - 17.1 ng/mL [ug/L].
   • Precision:
     • Multiple test materials (Liquichek™ Immunoassay Plus Control Levels 1 & 2, Serum pools 1-5, Plasma pool) were analyzed. Specific sample numbers for each material are not explicitly stated, but the testing involved "two separate runs, with two test samples, for each test material, were analyzed for 20 days."
   • Data Provenance: Not explicitly stated, but clinical laboratory studies are typically prospective. No country of origin is specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative measurement, and "ground truth" is established by the reference method (predicate device) and analytical precision. No human expert interpretation of results is part of this type of study for device performance.

3. Adjudication method for the test set: Not applicable. This is an analytical performance study, not a study involving human interpretation or adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone analytical performance study of the Dimension Vista® CEA Flex® reagent cartridge on the Dimension Vista® System. The performance metrics (correlation, precision) are for the assay system itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for method comparison was established by the predicate device (Beckman Access® CEA Reagents on the Access® Immunoassay System). For precision, standard reference materials and pooled samples were used as typical in analytical chemistry.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses a "training set" in the conventional sense. The device is a chemical reagent and instrument system.

8. How the ground truth for the training set was established: Not applicable. (See #7).

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VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA assay. 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) pre-market notification (K962919). Common reagents used by the VITROS System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than novel performance metrics against acceptance criteria in a clinical study.

Therefore, many of the requested categories for a typical medical device performance study, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable in the context of this 510(k) submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the traditional sense, as it aims to show substantial equivalence. Instead, the performance is demonstrated by comparing the characteristics of the new formulation device to the predicate device. The conclusion of the study is that the performance is "substantially equivalent."

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

The document states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range."

• Sample Size: Not specified. The number of "human samples" used is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not Applicable: This is an IVD device measuring an analyte concentration. Ground truth would typically be established by reference methods or clinical outcomes, not expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

• Not Applicable: Not relevant for an IVD assay measuring analyte concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

• Not Applicable: This is an IVD assay, not an imaging or diagnostic device requiring human reader interpretation in the context of MRMC studies.

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

• Done (implicitly): The device (VITROS CEA assay) is the standalone "algorithm" or system that quantitatively measures CEA. Its performance is compared to the predicate device. The performance data presented (e.g., precision, accuracy, linearity—though not detailed in this summary) are inherently "standalone" in the context of an IVD.

7. The Type of Ground Truth Used

• The summary indicates that "equivalent performance was demonstrated... testing human samples near the low end of the assay range." For an IVD, the "ground truth" would typically be established through:
  • Reference methods: Comparing results to a recognized gold standard method for CEA measurement.
  • Clinical correlation: Showing that the measured CEA levels correlate with clinical status or outcomes as expected, similar to the predicate device.
  • Known concentrations: Using samples with accurately known CEA concentrations (e.g., controls, spiked samples).

The summary does not explicitly detail the type of ground truth, but implies comparison against the predicate device's established performance, and potentially reference methods for accuracy.

8. The Sample Size for the Training Set

• Not Applicable: This is a traditional immunoassay, not a machine learning or AI-based device requiring a separate "training set" in the computational sense. The "training" of the device is through its manufacturing and calibration processes.

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

• Not Applicable: See point 8.

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The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate and wash buffer.

The provided text describes a 510(k) premarket notification for a modification to the Access® CEA Reagents on the Access® Immunoassay Systems. The modification involves adding a new instrument platform, the Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System, to the existing family of Access Immunoassay Systems.

The study aimed to demonstrate that the Access CEA assay on the Dxl system is substantially equivalent to the Access CEA assay on the Access 2 system.

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 states that the Access CEA assay met established acceptance criteria for "method comparison, precision and analytical sensitivity." However, the specific numerical acceptance criteria for these parameters (e.g., specific ranges for agreement, coefficients of variation, or limits of detection) are not detailed in the provided summary. Similarly, the reported performance values from the studies (e.g., actual method comparison results, precision data, or analytical sensitivity figures) are not provided. The text only offers a general statement of compliance.

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

The document does not specify the sample sizes used for the method comparison, precision, or analytical sensitivity studies. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This device is an immunoassay for quantitative determination of Carcinoembryonic Antigen (CEA) levels, which relies on a chemical reaction to produce a numerical result. Therefore, there is no ground truth established by human experts in the same way it would be for an imaging device requiring expert interpretation. The "ground truth" for evaluating this device would be established by reference methods or established analytical standards. The document does not provide details on how this was established for the comparison.

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

Since this is an immunoassay seeking substantial equivalence to a predicate device, the "adjudication method" in the context of human expert review is not applicable. The evaluation relies on quantitative analytical comparisons, not human interpretation consensus.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for medical imaging or diagnostic interpretation tasks where human readers are involved. This device is an automated immunoassay system, and its evaluation focuses on analytical performance metrics rather than human reader improvement.

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

Yes, the studies described (method comparison, precision, and analytical sensitivity) inherently represent standalone performance of the algorithm/device. The device itself performs the quantitative determination of CEA levels. Human involvement would be in operating the instrument and interpreting the numerical output, but the performance being evaluated is that of the automated system. The document states that the new system (Dxl) uses the same reagents and calibrators as the predicate (Access 2), implying that the algorithm/assay itself is unchanged, and the evaluation is on the new instrument platform's ability to produce equivalent results.

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

The "ground truth" for these types of studies would typically be established by:

• Predicate device results: For method comparison, the results from the legally marketed Access® CEA Reagents on the Access® Immunoassay Analyzer (K981985, K991707) would serve as the comparator or "reference."
• Reference materials/standards: For precision and analytical sensitivity, the device would be tested against known concentrations of CEA or characterized control materials.

The document does not explicitly state the type of ground truth used beyond indicating that method comparison was against the predicate device.

8. The sample size for the training set

The document does not mention a training set. This is because the device is an immunoassay kit/system, not an artificial intelligence or machine learning algorithm that requires a distinct training phase. The "training" of such a system would involve its initial development and validation by the manufacturer, but not in the context of a dataset used to optimize an AI model.

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

As there is no "training set" in the context of an AI/ML algorithm for this immunoassay device, this question is not applicable.

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ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.

The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CEA present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AJA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CEA concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

The provided text is a 510(k) summary for the ST AIA-PACK CEA device. This type of document focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance details) is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

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

• Sample size for test set: Not mentioned.
• Data provenance: Not mentioned. The document states "performance characteristics of both assays are equivalent," implying that the original predicate device's performance data is being referenced, but no new test set data is provided for the modified device.

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

Not applicable. The document does not describe a new study with a test set requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable. No new test set data is described.

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 in-vitro diagnostic immunoassay for quantitative measurement of CEA, not an AI-assisted diagnostic imaging or interpretation device that would involve 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 immunoassay itself. The document explicitly states: "The performance characteristics of both assays are equivalent." This implies that the standalone performance of the modified device is considered equivalent to the previously cleared predicate device (Tosoh AIA-PACK CEA, P910053). Specific new standalone performance data for the modified device is not provided in this summary.

7. The type of ground truth used

The concept of "ground truth" as typically used in AI/diagnostic imaging studies (e.g., pathology, outcomes data) is not directly applicable here. For an immunoassay, the "ground truth" would be the true concentration of CEA in a sample, established through highly accurate reference methods or certified reference materials during the development and validation of the original predicate device. The current document asserts equivalence in performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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This in vitro immunoassay is intended to quantitatively measure CEA in human serum using ADVIA IMS CEA Assay on a Bayer ADVIA® IMS™. Carcinoembryonic Antigen (CEA) is a protein polysaccharide normally present at very low concentrations in the blood of healthy adults. Colorectal cancer and a variety of neonlantic and other disease processes cause significant elevation of CEA, thus issued as a tumor marker. CEA assay is designed to aid in the management and prognosis of cancer patients in whom changing concentrations of CEA are observed.

The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to qualitatively measure carcinoembryonic antigen (CEA) in human serum. CEA test results are to be used as an aid in the management of cancer patients by monitoring CEA concentrations. CEA testing is not recommended as a screening procedure to detect cancer in the general population.

Not Found

Here's an analysis of the acceptance criteria and study details based on the provided text, formatted to address your specific points:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the performance of the predicate device (Immuno 1) which the ADVIA IMS CEA Assay aims to be substantially equivalent to. The provided table directly compares the performance of the ADVIA IMS to the Immuno 1 for imprecision and minimum detectable concentration. For other metrics like correlation and interference, specific thresholds are not explicitly stated, but the reported values demonstrate acceptable performance relative to the predicate device and expected analytical specifications for such assays, leading to the conclusion of substantial equivalence.

Study Details

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

   • Sample Size: 89 serum specimens were used for the correlation study.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document indicates "human serum" samples were used.

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

   • This is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The "ground truth" for such assays is established through comparison to a well-characterized reference method or predicate device. Human experts are generally not involved in establishing the ground truth for an IVD's quantitative measurements in the same way they would be for image interpretation.

3. Adjudication method for the test set:

   • Not applicable. As this is a quantitative measurement compared to a predicate device, adjudication by multiple human readers is not relevant.

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

   • Not applicable. This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic tool for image interpretation or similar applications where MRMC studies are typically conducted.

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

   • Yes, the performance data presented (imprecision, correlation, interference, analytical range, minimum detectable concentration) represent the standalone performance of the ADVIA IMS CEA Assay device itself. It's a fully automated analytical system once the sample is loaded.

6. The type of ground truth used:

   • Predicate Device Comparison: The primary "ground truth" or reference for establishing the performance of the ADVIA IMS CEA Assay was the Immuno 1 CEA Assay. The study demonstrates correlation and comparative performance against this legally marketed predicate device.

7. The sample size for the training set:

   • Not specified. For an in vitro diagnostic assay, there isn't typically a "training set" in the machine learning sense. Assay development involves optimizing reagents, protocols, and instrument parameters, but not usually in a data-driven training paradigm like AI. The reported data pertains to the validation of the final developed assay.

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

   • Not applicable, as there isn't a "training set" in the context of an IVD assay's analytical performance validation. The performance characteristics are inherent to the assay's chemical and instrumental design.

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