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The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The Access OV Monitor assay is a sandwich immunoenzymatic assay. The Access OV Monitor assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access OV Monitor assay reagent pack, Access OV Monitor assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The document provided is an FDA 510(k) clearance letter and a 510(k) summary for the Beckman Coulter Access OV Monitor assay. This device is an in vitro diagnostic (IVD) immunoassay for measuring CA 125 antigen levels to aid in the management of ovarian cancer patients.

The information requested pertains to the performance study design for AI/ML-based diagnostic devices, which is typically quite different from the validation of an immunoassay. Specifically, sections like "Number of experts used to establish ground truth", "Adjudication method", "Multi-Reader Multi-Case (MRMC) comparative effectiveness study", and "Effect size of how much human readers improve with AI vs without AI assistance" are relevant to AI/ML device validation studies, not typically to immunoassay validation.

An immunoassay like the Access OV Monitor is validated by demonstrating its analytical performance characteristics (e.g., precision, linearity, limits of detection) and method comparison against a predicate device, rather than by human reader studies or expert consensus on images.

Therefore, many of the requested fields are not applicable to this type of device and the information provided in the document. However, I will do my best to extract the relevant information where it exists and explicitly state when a requested criteria is not applicable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Access OV Monitor assay:

Device: Access OV Monitor Immunoassay

The study primarily focuses on demonstrating the substantial equivalence of the new Access OV Monitor assay run on the Dxl 9000 Access Immunoassay Analyzer to its predicate device (Access OV Monitor assay on the Access Immunoassay System, K023597). This is achieved by comparing their analytical performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a tabulated format for each performance metric, but rather lists the study results and implies they met predefined criteria (e.g., "met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.09"). The "acceptance criteria" column below is inferred from these statements and typical IVD validation expectations.

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

• Method Comparison Study: 152 samples.
• Imprecision Study: 120 replicates per sample level (e.g., Sample 1, Sample 2, etc, see N column in table). "Multiple samples" tested in triplicate in 2 runs per day for a minimum of 20 days.
• Data Provenance: The document does not specify the country of origin of the data or whether samples were retrospective or prospective. It is typical for immunoassay validation studies to use a mix of clinical samples (retrospective) and spiked samples.

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

• Not Applicable. This is an immunoassay, not an AI/ML diagnostic imaging device. The "ground truth" for the performance characteristics of an immunoassay is its analytical measurements, often compared against a reference method or validated predicate, not expert consensus on images.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• Not Applicable. This is an immunoassay, not an AI/ML diagnostic imaging device intended to assist human readers.

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

• Not Applicable. This is an immunoassay, the "performance" is the analytical output of the instrument-reagent system itself, which is inherently "standalone" in generating the quantitative result. There's no separate "algorithm" performance in the sense of an AI model.

7. The Type of Ground Truth Used

For an immunoassay, "ground truth" refers to the true concentration of the analyte, which is established through:

• Reference Methods: Highly accurate and precise methods not explicitly detailed but implied by standard validation practices.
• Comparative Measurements against a Predicate Device: The current study uses the predicate device (Access OV Monitor on the Access Immunoassay System) as its primary comparator to establish substantial equivalence.
• Known Concentrations: For linearity and limits studies, samples are often prepared at known concentrations (e.g., by diluting a high-concentration sample).

8. The Sample Size for the Training Set

• Not Applicable. This is an immunoassay, not an AI/ML device that requires a "training set" in the machine learning sense. The assay is "trained" or developed through biological and chemical methods, and its performance is characterized through analytical validation.

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

• Not Applicable. See point 8.

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The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The Access® OV Monitor reagents, calibrators and the Access Immunoassay Systems family comprise the Access Immunoassay System for the quantitative determination of CA 125 antigen in human serum and plasma.

The provided text describes the 510(k) submission for a modification to the Access OV Monitor Assay. The modification is to add a new instrument platform, the Beckman Coulter UniCel™ DxI 800 Access® Immunoassay System. The study conducted aimed to demonstrate that the Access OV Monitor assay on the DxI system is substantially equivalent to the Access OV Monitor assay on the Access 2 system.

Here's an analysis of the acceptance criteria and the study based on the provided information:

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

The document states: "The Access OV Monitor assay met the established acceptance criteria for method comparison, precision and analytical sensitivity." However, the specific quantitative acceptance criteria and the detailed reported performance values are not provided in this summary.

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

• Sample Size: The document does not explicitly state the sample size used for the test set in the method comparison, precision, or analytical sensitivity studies.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 as the device is an in-vitro diagnostic (IVD) immunoassay, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The ground truth would typically be established through analytical methods and reference materials.

4. Adjudication method for the test set:

This information is not applicable for an IVD immunoassay. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by experts, which is not the case here.

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

This information is not applicable as the device is an IVD immunoassay and does not involve human readers interpreting images with or without AI assistance. The study focuses on the analytical performance of the immunoassay on a new instrument.

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

The study conducted was a standalone performance evaluation of the Access OV Monitor assay on the DxI system, demonstrating its analytical performance without human intervention in the assay's execution, beyond standard lab procedures. The device itself (the immunoassay system) operates without human-in-the-loop performance for result generation.

7. The type of ground truth used:

For method comparison, precision, and analytical sensitivity studies of an immunoassay, the "ground truth" is typically established by:

• Reference Standards/Materials: For analytical sensitivity, known concentrations of the analyte (CA 125 antigen) would be used.
• Predicate Device/Method: For method comparison, results from the legally marketed predicate device (Access OV Monitor Assay on the Access 2 system) would serve as the comparative ground truth.
• Certified Reference Materials: For accuracy or calibration, materials with assigned values are used.

The document does not explicitly state the exact type of ground truth but implies comparison to the predicate device and established analytical methods.

8. The sample size for the training set:

This information is not applicable. The device is an immunoassay system, not an AI/machine learning model that requires a training set in the conventional sense. The "training" of the device involves its design, calibration, and validation as an analytical system.

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

This information is not applicable for the reasons stated above.

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The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The Access® OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma, using the Access® Immunoassay Systems.

Acceptance Criteria and Device Performance for Access® OV Monitor ELISA

This document outlines the acceptance criteria and the performance of the Access® OV Monitor assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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