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510(k) Data Aggregation
(80 days)
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.
| Performance Metric | Implied Acceptance Criteria (Inferred from text) | Reported Device Performance (Access OV Monitor on Dxl 9000) |
|---|---|---|
| Method Comparison | ||
| R² (Concordance) | R² ≥ 0.90 | 1.00 |
| Slope | 1.00 ± 0.09 | 0.98 (95% CI: 0.97 - 0.99) |
| Intercept | (Not explicitly stated numeric criterion, evaluated with CI) | -0.14 (95% CI: -0.38 - 0.13) |
| Imprecision (Within-Laboratory/Total %CV) | (Performance depends on concentration level; generally, lower %CV desired) | Ranged from 2.6% to 6.1% for concentrations > 15 U/mL. SD of 0.2 for concentrations ≤ 15 U/mL. (See full table in source document) |
| Linearity | Device should be linear across its analytical measuring interval | Linear throughout the analytical measuring interval of approximately 2.0 - 5,000 U/mL |
| Limit of Blank (LoB) | (Specific value to be determined and met; typically lowest possible) | 0.5 U/mL |
| Limit of Detection (LoD) | (Specific value to be determined and met) | 0.7 U/mL |
| Limit of Quantitation (LoQ) | (Specific value to be determined and met) | 2.0 U/mL |
| Measuring Range | Consistent with predicate and intended use | 2.0 - 5,000 U/mL (Compared to predicate's 0.5 - 5000 U/mL) |
| Sample Volume | (Not an "acceptance criterion" but a characteristic change) | 30 uL (Predicate: 25 uL) |
| Substrate | (Not an "acceptance criterion" but a characteristic change) | Lumi-Phos PRO substrate (Predicate: Access Substrate) |
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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(8 days)
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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(44 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Specificity (Therapeutic Drugs) | No significant interference (<10% change) from specified therapeutic drugs. | Doxorubicin (100 µg/mL), Amthopterin (500 μg/mL), Carboplatin (1000 μg/mL), Cyclophosphamide (1000 μg/mL), 5-Fluorouracil (1000 µg/mL), Cisplatin (2000 µq/mL), Melphalan (100 µg/mL), Acetominopehn (200 µg/mL), Aspirin (500 µg/mL), Paclitaxel (10 ng/mL), Biotin (50 ng/mL), Vitamin D2 (1 U/mL) all showed no significant interference. |
| Specificity (Sample Contaminants) | No significant interference (<10% change) from specified sample contaminants. | Total protein (9%), Bilirubin (20 mg/dL), Hemoglobin (1000 mg/dL), and Triglycerides (1800 mg/dL) all showed no significant interference. |
| Analytical Sensitivity (Lowest Detectable Level) | Distinguishable from zero. | 0.2 U/mL (Calibrator S0). |
| Analytical Sensitivity (Claimed in Labeling) | 0.5 U/mL. | |
| Measurement Range | Accurate measurement between lower limit of detection and highest calibrator value. | Approximately 0.5 U/mL to 5,000 U/mL. |
| Recovery (Linearity Studies) | Average recovery within an acceptable range, with individual recoveries also acceptable. | Average recovery of 107%, with individual recoveries ranging from 100% to 118%. |
| Precision (Within-run Imprecision) | Coefficient of Variation (CV) within acceptable limits for various concentrations. | Ranged from 1.3% CV to 2.4% CV for concentrations from ~24 to 2962 U/mL. |
| Precision (Between-run Imprecision) | CV within acceptable limits. | Ranged from 3.3% CV to 6.0% CV. |
| Precision (Total Imprecision) | CV within acceptable limits. | Ranged from 3.9% CV to 6.0% CV. |
| Method Comparison | ||
| Correlation (vs. Predicate Device) | Acceptable correlation coefficient (r). | r = 0.9871 (compared to Abbott Axsym CA 125 assay). |
| Bias (vs. Predicate Device) | Acceptable bias (slope, intercept). | y = 1.197 + (-0.985) across the range of the Axsym assay (0 - 600 U/mL). |
| Clinical Performance | ||
| Clinical Sensitivity (vs. Predicate Device) | Comparable to predicate device. | 84.4% (95% CI = 71.2% - 92.3%) |
| Clinical Specificity (vs. Predicate Device) | Comparable to predicate device. | 82.5% (95% CI = 82.5% - 90.0%) |
| Monitoring Ovarian Cancer Patients | CA 125 concentrations obtained with the device should be comparable and parallel those of the FDA cleared predicate device. | Results from 20 female subjects with ovarian cancer (stages I to IV), monitored for 7-53 months, demonstrated comparable and paralleled CA 125 concentrations to the FDA cleared predicate device. |
2. Sample Size for Test Set and Data Provenance
- Specificity (Therapeutic Drugs & Sample Contaminants): The exact number of samples tested for each compound/contaminant is not specified, but the compounds themselves are listed. Each compound was tested at a specific concentration.
- Analytical Sensitivity: Not explicitly stated as a separate "test set" but likely derived from a series of dilutions or measurements around the lower limit.
- Recovery: 6 human serum samples.
- Precision: Not explicitly stated as a separate "test set" size, but concentrations from 24 to 2962 U/mL were tested, implying multiple measurements at these levels.
- Correlation: 290 samples.
- Clinical Data (Sensitivity & Specificity): The total number of subjects used to calculate clinical sensitivity and specificity is not explicitly stated, but it is derived from the comparison between the Access OV Monitor and the Abbott Axsym CA 125 assays.
- Clinical Data (Monitoring): 20 female subjects diagnosed with ovarian cancer (stages I to IV).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, although the monitoring study for clinical data implies a prospective approach over an extended period (7 to 53 months).
3. Number of Experts for Ground Truth and Qualifications
This information is not provided in the given text. For an immunoassay, the "ground truth" is typically established by the reference measurement method itself or by clinical diagnosis, rather than by human expert interpretation of an image or a complex medical case.
4. Adjudication Method
This information is not applicable as the studies described pertain to an in vitro diagnostic immunoassay, not a device requiring interpretation or adjudication by human experts in the context of a "test set" like in radiological imaging. The "truth" for this type of device is based on analytical measurements and correlation with an existing, cleared device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted, and therefore, the effect size of human readers improving with AI assistance is not applicable. This type of study design is typically used for imaging diagnostics where human interpretation is a critical component, not for quantitative immunoassays.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. All the analytical performance studies (Specificity, Analytical Sensitivity, Recovery, Precision) and the correlation study against the Abbott Axsym CA 125 assay represent the standalone performance of the Access® OV Monitor assay. The clinical sensitivity and specificity calculations also reflect the standalone performance of the device in comparison to a predicate.
7. Type of Ground Truth Used
- Analytical Performance (Specificity, Analytical Sensitivity, Recovery, Precision): The ground truth was established through reference analytical methods and standards (e.g., spectrophotometry for total protein, known concentrations of therapeutic drugs, calibrated reference materials).
- Correlation: The ground truth was based on the quantitative results obtained from the Abbott Axsym CA 125 assay, which served as the predicate device.
- Clinical Data (Sensitivity & Specificity): The ground truth for disease status (ovarian cancer) would have been established by clinical diagnosis, possibly confirmed by pathology or other definitive medical diagnoses. The specific method for determining "true positive" and "true negative" cases is not detailed but would align with clinical standards.
- Clinical Data (Monitoring): The ground truth for monitoring effectiveness was implicitly established by comparing the CA 125 concentration trends to clinical outcomes and the trends observed with the FDA-cleared predicate device against the known disease progression of the 20 ovarian cancer patients.
8. Sample Size for Training Set
This information is not provided in the document. For an in vitro diagnostic assay like this, "training set" typically refers to studies performed during the development and optimization phase, rather than a distinct, formally reported dataset as seen in machine learning applications.
9. How the Ground Truth for the Training Set Was Established
As the concept of a formal "training set" for this type of immunoassay is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. However, during the development of such an assay, internal studies would use well-characterized samples (e.g., spiked samples, clinical samples with known CA 125 levels from reference methods, samples from patients with confirmed clinical status) to optimize reagents, calibrate signals, and establish initial operating parameters.
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