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510(k) Data Aggregation
(83 days)
The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody II assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with the thyroglobulin protein. The TgAb in the sample binds to the thyroglobulin coated on the particles. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. The thyroglobulin-alkaline phosphatase conjugate is added and binds to the TgAb.
After second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a detailed breakdown of the acceptance criteria and study information for the Beckman Coulter Access Thyroglobulin Antibody II device, extracted from the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Modified Device - Dxl 9000 Access Immunoassay Analyzer) |
|---|---|---|
| Intended Use | Quantitative determination of thyroglobulin antibody levels in human serum and plasma to aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. | Same (No change in Intended Use) |
| Analyte Measured | Thyroglobulin Antibody | Same |
| Technology / Format / Method | Sandwich immunoassay / Chemiluminescent / Automated | Same |
| Sample Type | Human serum or plasma | Same |
| Sample Volume | 10 uL | Same |
| Measuring Range | 1.5 - 2,500 IU/mL | Same |
| Blocker Reagents | Biotin and alkaline phosphatase included in reagent pack as blockers | Same |
| Biotin Interference | No significant interference (± 10%) observed in samples containing up to 3,510 ng/mL of biotin. | Same (Explicitly stated in the comparison table) |
| Imprecision (Repeatability) | SD ≤ 1.5 for values < 15 IU/mL; CV ≤ 10.0% for values ≥ 15 IU/mL and < 1000 IU/mL; CV ≤ 15.0% for values ≥ 1000 IU/mL | Within-Laboratory Imprecision: - Sample 1 (2.4 IU/mL): 5.2% CV (meets ≤ 1.5 IU/mL SD, which is equivalent to 62.5% CV. The actual SD is 0.1, making the %CV 4.2% for repeatability) - Sample 2 (188 IU/mL): 4.1% CV (meets ≤ 10.0% CV) - Sample 3 (727 IU/mL): 4.2% CV (meets ≤ 10.0% CV) - (Partial data for Sample ~1000 IU/mL is cut off, but the predicate applies CV ≤ 15.0% for values ≥ 1000 IU/mL) |
| Reproducibility | Not explicitly stated as a separate acceptance criterion for the predicate, but implied by the imprecision criteria. | Reproducibility (Overall): - Sample 1 (2.6 IU/mL): 5.8% CV (within expected range for low concentration) - Sample 2 (184 IU/mL): 3.8% CV (well within 10.0% CV) - Sample 3 (744 IU/mL): 3.1% CV (well within 10.0% CV) - Sample 4 (1503 IU/mL): 3.6% CV (well within 15.0% CV) - Sample 5 (1966 IU/mL): 6.4% CV (well within 15.0% CV) |
| Linearity | The assay demonstrates linearity across the measuring interval. | Determined to demonstrate linearity across the measuring interval (no quantitative data given, but implied successful). |
| Limit of Blank (LoB) | Assumed to be ≤ 0.1 IU/mL (based on reported value) | 0.1 IU/mL |
| Limit of Detection (LoD) | Assumed to be ≤ 0.2 IU/mL (based on reported value) | 0.2 IU/mL |
| Limit of Quantitation (LoQ) | ≤ 1.5 IU/mL for ≤ 20% within-lab CV | 1.5 IU/mL (at ≤ 20% within-lab CV) |
| Method Comparison (Slope) | Assumed to be close to 1.0 (for substantial equivalence to predicate) | 0.97 (95% CI: 0.95 – 0.99) |
| Method Comparison (Intercept) | Assumed to be close to 0 (for substantial equivalence to predicate) | -0.37 (95% CI: -0.99 – 0.047) |
| Method Comparison (Correlation Coefficient) | Assumed to be close to 1.0 (for substantial equivalence to predicate) | 1.00 |
Note: The primary goal of this submission (K240996) is to demonstrate substantial equivalence of the same device on a new instrument platform (Dxl 9000 Access Immunoassay Analyzer) compared to its predicate on the Access 2 Immunoassay System. Therefore, the "acceptance criteria" are largely derived from the established performance of the predicate device.
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison Study (CLSI EP09c):
- Sample Size: N = 114
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, such studies typically use clinical samples that may be either retrospectively collected or prospectively collected for validation purposes.
- Imprecision Study (CLSI EP05-A3):
- Sample Size: 3 distinct "Samples" (concentrations) were tested. Each sample was tested 80 times (duplicate R.L per day for a minimum of 20 days).
- Data Provenance: Not explicitly stated. Assumed to be laboratory samples or controls prepared for method validation.
- Reproducibility Study (CLSI EP05-A3):
- Sample Size: 5 distinct "Samples" (concentrations) were tested. Each sample was tested 75 times (replicates of 5 per day for a minimum of 5 days on 3 instruments).
- Data Provenance: Not explicitly stated. Assumed to be laboratory samples or controls prepared for method validation.
- Detection Capability (LoB, LoD, LoQ) Study (CLSI EP17-A2):
- Sample Size: Not explicitly stated for each determination, but these studies typically involve multiple replicates of blank, low-level, and higher-level samples.
- Data Provenance: Not explicitly stated. Assumed to be laboratory samples or controls.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes a clinical laboratory device (an immunoassay), not an AI/imaging device requiring expert interpretation of results for ground truth. Therefore, the concepts of "experts to establish ground truth" (in the context of clinical interpretation or diagnosis from an image) and their "qualifications" are not applicable here.
For this type of device, ground truth is established through:
- Reference Methods / Predicate Devices: The Access 2 Immunoassay System (predicate) served as the comparator for the method comparison study to assess the "truth" of the Dxl 9000 system's measurements.
- Certified Reference Materials/Standards: Calibrators and controls with known analyte concentrations, often traceable to international standards, are used to establish accuracy and calibration.
- Clinical Diagnosis: For the "Indications for Use," the device aids in diagnosis, meaning its results are interpreted by clinicians in conjunction with other clinical information. The diagnostic accuracy studies (sensitivity, specificity) in relation to a "gold standard" clinical diagnosis are typically part of a larger clinical trial not detailed in this specific 510(k) summary for a platform change.
4. Adjudication Method for the Test Set
Not applicable. As this is an immunoassay device assessing quantitative levels of an antibody, there is no "adjudication method" in the sense of reconciling divergent expert interpretations of qualitative or semi-quantitative data. The "test set" results—the quantitative values—are compared statistically to the reference method (predicate device) and assessed against performance specifications (imprecision, linearity, detection limits).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where multiple human readers interpret complex cases (e.g., medical images) and AI assistance might improve their performance. This document is for a medical laboratory immunoassay for quantitative measurement of thyroglobulin antibody, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device operates "standalone" in the sense that the instrument performs the assay and generates a quantitative result without human intervention during the analytical process, this is not an "algorithm-only" study in the context of AI. The performance studies (imprecision, linearity, method comparison, detection capability) represent the standalone analytical performance of the instrument/reagent system. The "human-in-the-loop" would be the clinician interpreting the numerical result in the context of a patient's overall clinical picture, but the device itself functions automatically.
7. The Type of Ground Truth Used
- Quantitative Reference Values: For the performance studies, the ground truth is established through various means:
- Method Comparison: The results obtained from the predicate device (Access Thyroglobulin Antibody II on the Access 2 Immunoassay System) serve as the reference standard.
- Imprecision & Reproducibility: Derived from repeated measurements of samples (often control materials or pooled patient samples) to assess variability. The "true" value for these samples is either assigned by the manufacturer or determined through extensive testing.
- Linearity: Determined by creating serially diluted samples from a high-concentration sample, where the expected concentration of each dilution is the "ground truth."
- Detection Capability (LoB, LoD, LoQ): Established using blank samples and low-concentration spiked samples, with statistical methods determining the lowest detectable/quantifiable levels.
8. The Sample Size for the Training Set
This document does not describe a machine learning or AI algorithm development that would typically involve a "training set." The studies described are for analytical validation of an immunoassay on a new instrument platform, focusing on demonstrating equivalent performance to a predicate device. Therefore, a "training set" in the AI sense is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of AI or machine learning for this immunoassay device.
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(85 days)
Access Thyroglobulin assay is a paramagetic particle, chemiluminescent immunossay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
The Access Thyroglobulin assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Thyroglobulin Sample Diluent, substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
Lumi-Phos PRO substrate was used with this pack. The modification does not affect the indications of the device or alter the fundamental scientific technology of the device.
The provided text is a 510(k) summary for the Access Thyroglobulin assay, which is a diagnostic device and not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies, such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "sample size for the training set," are not applicable.
However, I can extract the relevant information regarding acceptance criteria and study results for this diagnostic device.
Acceptance Criteria and Reported Device Performance for Access Thyroglobulin Assay (K240927)
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from reported results and CLSI guidelines) | Reported Device Performance (Access Thyroglobulin on Dxl 9000) |
|---|---|---|
| Method Comparison | Slope of 1.00 (95% CI covering 1.00); Intercept of 0.00 (95% CI covering 0.00); High Correlation Coefficient (R close to 1.00) | Slope: 1.00 (0.99 - 1.00); Intercept: 0.0044 (-0.029 - 0.021); Correlation Coefficient R: 1.00 |
| Imprecision (Within-lab/Total) | CV ≤ 10.0% at concentrations > 1.0 ng/mL; SD ≤ 0.1 ng/mL at concentrations ≤ 1.0 ng/mL | Achieved across all tested concentrations (e.g., 8.4% at 0.30 ng/mL, 6.8% at 5.5 ng/mL, 6.3% at 22 ng/mL, 2.5% at 111 ng/mL, 3.6% at 376 ng/mL, 3.6% at 417 ng/mL) |
| Reproducibility | Not explicitly stated as a separate acceptance criterion, but results imply meeting acceptable reproducibility for clinical use. | Example: Within-run CV 5.9% (0.34 ng/mL), Reproducibility CV 7.4% (0.34 ng/mL); Within-run CV 2.5% (402 ng/mL), Reproducibility CV 5.9% (402 ng/mL) |
| Linearity | Assay demonstrates linearity across the measuring interval. | Demonstrated linearity across the measuring interval. |
| Limit of Blank (LoB) | Not explicitly stated as a numerical criterion, but a low value is expected for accurate detection. | 0.03 ng/mL |
| Limit of Detection (LoD) | Not explicitly stated as a numerical criterion, but a low value is expected for accurate detection. | 0.05 ng/mL |
| Limit of Quantitation (LoQ) ≤20% within-lab CV | ≤ 0.1 ng/mL at 20% within-lab CV (explicitly stated criteria) | 0.1 ng/mL |
2. Sample sizes used for the test set and the data provenance
- Method Comparison: N = 187 samples. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Imprecision: For each sample, N = 88 or 80. Data provenance is not specified.
- Reproducibility: For each sample, N = 75. Data provenance is not specified.
- Linearity, LoB, LoD, LoQ: Sample sizes for specific points within the linearity study or number of samples for LoB/LoD/LoQ determinations are not explicitly given, but the studies were conducted using "multiple samples," "multiple reagent lots," and "multiple days." Data provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a quantitative immunoassay for measuring thyroglobulin levels. The 'ground truth' for such a device is established by the analytical reference measurement procedures using a reference method or known concentrations, rather than expert consensus on diagnostic images or clinical assessments. Therefore, this question is not applicable in the context of this device.
4. Adjudication method for the test set
Not applicable for a quantitative immunoassay. The comparison is statistical analysis of measured values against a predicate device or expected values from reference materials.
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 not an AI/ML device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an automated immunoassay system. The performance studies ("Method Comparison," "Imprecision," "Reproducibility," "Linearity," "Detection Capability") represent the standalone performance of the assay and instrument without human interpretation of raw signals influencing the final quantitative result.
7. The type of ground truth used
For this immunoassay device, the "ground truth" implicitly refers to:
- Reference measurements from the predicate device (Access 2 Immunoassay System): Used for the method comparison study.
- Known concentrations/reference materials: Used to assess imprecision, linearity, and detection capabilities (LoB, LoD, LoQ) against expected values.
8. The sample size for the training set
Not applicable. This is a traditional diagnostic device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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(18 days)
Access Thyroglobulin assay is a paramagetic particle, chemiluminescent immunossay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
The Access Thyroqlobulin assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Thyroglobulin Sample Diluent, substrate and wash buffer. The Access Tq assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The change does not impact or change the other components that are used with this reagent pack. The modification does not affect the indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidinand coupled to biotinylated mouse monoclonalantithyroglobulin antibodies, suspended in a TRIS buffer withprotein (bovine), < 0.1% sodium azide, and 0.1% ProClin**300. |
| R1b: | Mouse monoclonal anti-thyroglobulin-alkaline phosphatase(bovine) conjugate in a TRIS buffer with protein (bovine,murine), < 0.1% sodium azide, and 0.1% ProClin 300. |
| R1c: | HEPES buffer with protein (bovine and mouse), < 0.1% sodiumazide, and 0.5% ProClin 300. |
The provided document is a 510(k) Premarket Notification from the FDA for the Access Thyroglobulin assay. It does not describe an AI/ML-based medical device. Therefore, many of the requested criteria about AI/ML studies (such as MRMC studies, ground truth establishment for training sets, number of experts for test set ground truth, etc.) are not applicable to this submission.
The acceptance criteria and study proving the device meets them are related to the analytical performance of an immunoassay, not a software algorithm.
Here's a breakdown based on the provided text, addressing the applicable points and noting where information is not present or not relevant to AI/ML:
1. A table of acceptance criteria and the reported device performance
The document focuses on demonstrating substantial equivalence to a predicate device, primarily through a matrix comparison study for a new sample type (plasma in addition to serum). The "acceptance criteria" are implied by the statistical analyses and acceptable ranges for slope, intercept, and correlation coefficient in the matrix comparison, aiming for agreement between the new sample type and the established serum sample type.
Acceptance Criteria (Implied by Study Design for Matrix Comparison):
For the Matrix Comparison study, the implicit acceptance criteria are that the Passing-Bablok linear regression results (slope, intercept, and correlation coefficient) demonstrate substantial equivalence between the new sample types (Li-heparin plasma, Na-heparin plasma) and serum. While explicit numeric acceptance criteria are not stated, typically for such comparisons, a slope close to 1, an intercept close to 0, and a high correlation coefficient (e.g., >0.97) are expected within their confidence intervals.
Reported Device Performance (Matrix Comparison):
| Plasma/Serum | N | Range (ng/mL) | Slope (95% CI) | Intercept (95% CI) | Correlation Coefficient (r) |
|---|---|---|---|---|---|
| Li-heparin plasma vs Serum | 45 | 0.227 to 494.070 | 1.000 (0.983; 1.015) | 0.163 (-0.212; 0.712) | 0.999 |
| Na-heparin plasma vs Serum | 45 | 0.227 to 494.070 | 1.021 (1.010; 1.039) | 0.147 (-0.246; 0.952) | 0.999 |
Other Performance Claims Transferred from Predicate:
The document states that claims for "method comparison, imprecision, reproducibility, high-dose hook effect, linearity, dilution recovery, detection capability and analytical specificity are being transferred from file K220972." This implies these studies were performed and met acceptance criteria for the predicate device, and the current modification (addition of plasma sample type) does not invalidate them. Explicit tables for these are not in the provided text.
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: For the Matrix Comparison study, 45 matched sets of serum and plasma samples were used for each comparison (Li-heparin plasma vs Serum, and Na-heparin plasma vs Serum). The minimum specified was 40 matched sets.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given it's a clinical lab device, the samples would typically be from clinical settings.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is an immunoassay, not an AI/ML device relying on human interpretation of images or other complex data for ground truth. The "ground truth" here is the quantitative measurement of thyroglobulin by the predicate method (serum measurement) against which the new sample type (plasma measurement) is compared. The reference values are analytical measurements, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for an immunoassay analytical validation. The ground truth (serum concentration) is established by the assay itself, not by human adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and there are no "human readers" interpreting images assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "standalone" performance for this device refers to its analytical performance as a laboratory test. The Matrix Comparison study assesses the device's capability to accurately measure thyroglobulin in plasma samples compared to serum samples, without human interpretive input affecting the measurement itself. The results shown in point 1 demonstrate this "standalone" analytical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the matrix comparison study was the quantitative thyroglobulin concentration measured in human serum using the previously cleared Access Thyroglobulin assay. The new sample types (plasma) were compared to these established serum values.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The assay's parameters are determined through reagent development and analytical validation, not machine learning training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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(692 days)
The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goter, and Graves' disease.
The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody II assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The assay is run on Access 2 Immunoassay Analyzers.
The device modifications described in this submission impact the Access Thyroqlobulin Antibody II reagent pack only; they do not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidin andcoupled to biotinylated human thyroglobulin, suspended in a TRISbuffer with protein (bovine), < 0.1% sodium azide, and 0.1%ProClin** 300. |
| R1b: | Human thyroglobulin-alkaline phosphatase (bovine) conjugate in aTRIS buffer with protein (bovine), < 0.1% sodium azide, and 0.1%ProClin 300. |
| R1c: | TRIS buffer with protein (bovine), < 0.1% sodium azide and 0.1%ProClin 300. |
| R1d: | TRIS buffer with blocking polymer, < 0.1% sodium azide and 0.1%ProClin 300. |
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the "Access Thyroglobulin Antibody II" device:
Device: Access Thyroglobulin Antibody II
The study in the document focuses on the modified Access Thyroglobulin Antibody II assay and compares it to the previously cleared predicate device (Access Thyroglobulin Antibody II Assay, FDA 510(k) Number K112933). The goal is to demonstrate substantial equivalence of the modified device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a dedicated table format. Instead, it describes performance characteristics and the results obtained. I've reconstructed a table based on the implicit criteria derived from the reported performance, especially where a target value or range is given (e.g., for imprecision, biases, or correlation).
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance (Modified Device) |
|---|---|---|
| Measuring Range | (Compared to predicate's 0.9-2,500 IU/mL) | 1.5-2,500 IU/mL |
| Imprecision | Predicate: SD < 1.5 for values < 15 IU/mL; CV < 10% for values ≥ 15 IU/mL | Within Laboratory (Total): - SD ≤ 1.5 at concentrations < 15 IU/mL - CV ≤ 10.0 % at concentrations ≥ 15 IU/mL and < 1000 IU/mL - CV ≤ 15.0% for concentrations ≥ 1000 IU/mL |
| Reproducibility | (Not explicitly defined for predicate, but performance is reported) | Reproducibility: - SD ≤ 2.3 at concentrations < 15 IU/mL - CV ≤ 15.0 % at concentrations ≥ 15 IU/mL and < 1000 IU/mL - CV ≤ 20.0% for concentrations ≥ 1000 IU/mL |
| High-dose Hook Effect | No significant hook effect expected. | No high-dose hook effect at concentrations up to at least 50,000 IU/mL. |
| Linearity | (Expected to be linear across the measuring range) | Demonstrated to be linear across the range of the assay (1.5 to 2,500 IU/mL) in both serum and plasma samples. |
| Limit of Blank (LoB) | (Lower than LoD/LoQ) | 0.0 IU/mL |
| Limit of Detection (LoD) | (Lower than LoQ) | 0.4 IU/mL |
| Limit of Quantitation (LoQ) | ≤ 20% within-lab CV at LoQ. | 1.5 IU/mL (with ≤ 20% within-lab CV) |
| Analytical Specificity | 100% agreement with predicate for cross-reactive disease states; No significant interference (≤ ±1.5 IU/mL for <15 IU/mL, ≤ ±10% for ≥15 IU/mL) | - Cross-reactive disease states: 100% total agreement with the predicate assay. - Potential interferents (including 3510 ng/mL biotin): No significant interference (defined as change in concentration within ± 1.5 IU/mL for samples < 15 IU/mL and within ± 10% for samples ≥ 15 IU/mL) observed at clinically relevant concentrations (approx. 4 IU/mL and 100 IU/mL). |
| Matrix Comparison | Slope of 1.00 ± 0.12 and R² ≥ 0.92 for correlation between serum, lithium heparin, and EDTA plasma samples. | Results met the acceptance criteria of slope of 1.00 ± 0.12 and R² ≥ 0.92. |
| Method Comparison | (Comparison to a commercially available immunoassay, showing good correlation and agreement, implicitly) Reported statistics: Slope 1.03 (1.00-1.06), Y-Intercept -0.13 (-0.68-0.30), R 0.99 (Passing-Bablok) | Slope: 1.03 (95% CI: 1.00-1.06) Y-Intercept: -0.13 (95% CI: -0.68-0.30) Correlation Coefficient R: 0.99 (Passing-Bablok regression) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison:
n = 123samples. Data provenance not specified (country of origin, retrospective/prospective). - Imprecision: Not specified, but involved reagent lots and instrument details suggest laboratory testing.
- Reproducibility: Not specified, but involved reagent lots and instrument details suggest laboratory testing.
- High-dose Hook Effect: Not specified how many samples were tested, but concentrations up to 50,000 IU/mL were used.
- Linearity: Not specified how many samples were tested, but both serum and plasma samples were used.
- Sensitivity (LoB, LoD, LoQ): Not specified how many samples were used, but involved 2 reagent lots and 2 instruments over a minimum of 3 days (LoB) or 5 days (LoD, LoQ).
- Analytical Specificity:
- Cross-reactive disease states: "Samples with potential cross-reactive disease states were tested." Number of samples not specified.
- Potential interferents: "Patient serum samples containing two levels of thyroglobulin antibody at clinically relevant concentrations of approximately 4 IU/mL and 100 IU/mL." Number of samples not specified, but specific interferents (like biotin at 3510 ng/mL) were tested.
- Matrix Comparison: Fifty (50) matched sets of serum, lithium heparin plasma, and EDTA plasma samples.
Data Provenance: The document does not specify the country of origin for any of the samples used in these studies, nor does it explicitly state if the studies were retrospective or prospective, though "patient samples" implies retrospective collection or prospective enrollment for the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This device is an in vitro diagnostic (IVD) immunoassay, not an imaging device typically requiring expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in the traditional sense of clinical diagnosis (e.g., radiologists, pathologists) does not directly apply here.
For IVDs, "ground truth" is typically established by:
- Reference methods/devices.
- Certified reference materials.
- Pathology or histopathology (for certain tests).
- Clinical outcomes/diagnosis (for certain tests).
- Known concentrations in spiked samples or characterized panels.
In this document:
- The "Method Comparison" used a "commercially available immunoassay" as a comparator, which serves as a de facto reference for comparison.
- Analytical specificity testing used "potential cross-reactive disease states" and "potential interferents" for which the expected results (presence/absence of Thyroglobulin Antibody, or known interference levels) would be pre-established or determined by a reference method.
- Sensitivity studies (LoB, LoD, LoQ) involve statistical calculations based on repeated measurements of samples with very low or zero analyte concentrations, not expert consensus.
- Concentration ranges for linearity were established using characterized samples.
Therefore, no information on human experts establishing ground truth is provided, as it's not relevant for this type of device validation.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret medical images or complex data, and their interpretations need to be reconciled to establish a ground truth.
Since this is an in vitro diagnostic device measuring an analyte concentration, and the gold standard for comparison typically involves laboratory methods or reference materials, an adjudication method for a test set is not applicable or described in this document. The "ground truth" for the various performance characteristics is established by analytical methods and comparisons to reference standards or predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for medical imaging devices where the performance of human readers, with and without AI assistance, is evaluated using a set of cases. This document describes an in vitro diagnostic device, an immunoassay, which does not involve human interpretation of images or complex data in a way that MRMC studies would be applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are all standalone performance evaluations of the Access Thyroglobulin Antibody II assay. This means the studies assess the device's ability to measure thyroglobulin antibody levels independent of human intervention in the interpretation of the result in the context of the device's analytical performance. The Access Immunoassay Systems are automated, and the assay's performance metrics (imprecision, linearity, sensitivity, specificity, etc.) are solely based on the analytical capabilities of the device itself.
7. The Type of Ground Truth Used
The type of "ground truth" used varies depending on the specific study:
- Method Comparison: A "commercially available immunoassay" served as the comparative standard. The results from this predicate/reference immunoassay formed the basis for comparing the new device's measurements.
- Imprecision & Reproducibility: Ground truth is implicit in the known characteristics of the control materials or spiked samples used, and the statistical variability observed from repeated measurements defines the performance.
- High-dose Hook Effect & Linearity: Ground truth is established by using samples with known or precisely characterized concentrations, often prepared by dilution or spiking.
- Sensitivity (LoB, LoD, LoQ): Statistical models are used based on repeated measurements of blank samples and samples with very low (but known) analyte concentrations.
- Analytical Specificity:
- Cross-reactive disease states: Likely involved samples from patients with these conditions, where the presence/absence of TgAb would have been characterized by a reference method or clinical diagnosis. The "ground truth" then is the expected TgAb status based on the sample's origin.
- Potential interferents: Involved adding known concentrations of interfering substances to samples with known TgAb concentrations. The "ground truth" is the expected TgAb concentration without interference.
- Matrix Comparison: Used matched samples from different matrices (serum, plasma), where the inherent TgAb concentration within a given patient sample is the ground truth against which each matrix measurement is compared.
In summary, the ground truth for this IVD device is primarily established through comparisons to established reference methods/predicate devices, known concentrations in characterized samples (spiked or diluted), and statistical analysis of performance with control materials.
8. The Sample Size for the Training Set
The document describes studies for validation of a modified device, demonstrating substantial equivalence to a predicate. It does not mention a "training set" in the context of developing an algorithm or AI model. This is an immunoassay, not a machine learning model that typically requires a large training dataset. The studies focus on analytical performance rather than diagnostic accuracy determined by a machine learning pipeline.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no mention of a "training set" or "ground truth" established for training in this document, as the device is an immunoassay not based on a trainable algorithm.
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(529 days)
Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thyroglobulin antibodies.
Access Thyroqlobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum using the Access Immunoassay Systems. This device is intended to aid in monitoring for the presence of persistent or recurrent /metastatic disease in patients who have differentiated thyroid cancer (DTC) and have had thyroid surgery (with or without ablative therapy), and who lack serum thvroglobulin antibodies.
The Access Tg assay consists of the reagent pack and calibrators. Other items needed to run the assay include the Access Tg sample diluent substrate and wash buffer. The Access Tg assay along with the Access wash buffer and substrate are designed for use with the Access Immunoassay Systems in a clinical laboratory setting.
The device modification described in this submission impacts the Access Thyroqlobulin reagent pack only; the change does not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device.
A description of the reagent pack is provided below.
| Well | Ingredients |
|---|---|
| R1a: | Dynabeads* paramagnetic particles coated with streptavidinand coupled to biotinylated mouse monoclonalantithyroglobulin antibodies, suspended in a TRIS buffer withprotein (bovine), < 0.1% sodium azide, and 0.1% ProClin**300. |
| R1b: | Mouse monoclonal anti-thyroglobulin-alkaline phosphatase(bovine) conjugate in a TRIS buffer with protein (bovine,murine), < 0.1% sodium azide, and 0.1% ProClin 300. |
| R1c: | HEPES buffer with protein (bovine and mouse), < 0.1% sodiumazide, and 0.5% ProClin 300. |
The provided text describes the Beckman Coulter Access Thyroglobulin assay, a chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum. This device is intended to aid in monitoring for persistent or recurrent/metastatic differentiated thyroid cancer (DTC) in patients who have undergone thyroid surgery and lack serum thyroglobulin antibodies.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance for all aspects. Instead, acceptance criteria are generally mentioned within the description of each study. Below is a compilation of the criteria and reported performance for key studies.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | R ≥ 0.90 and slope 1.00 ± 0.09 | Met (R and slope not explicitly provided but stated as met) |
| High-dose Hook Effect | No high-dose hook effect | No high-dose hook effect at concentrations up to at least 40,000 ng/mL |
| Reference Range | Linear across the range of the assay | Linear across the range of the assay (0.1 to approximately 500 ng/mL) |
| Limit of Blank (LoB) | ≤ 0.03 ng/mL | 0.02 ng/mL |
| Limit of Detection (LoD) | ≤ 0.05 ng/mL | 0.05 ng/mL |
| Limit of Quantitation (LoQ) | ≤ 0.1 ng/mL | 0.05 ng/mL |
| Analytical Specificity (Cross-reactivity) | Change in concentration between diluent control and test samples within ± 10% | No significant cross-reactivity for T3, T4, TBG, TSH |
| Analytical Specificity (Interference) | Change in concentration between diluent control and test samples within <± 10% | No significant interference observed, including with biotin at 3510 ng/mL |
Note: For Imprecision and Reproducibility, specific acceptance criteria (e.g., maximum allowable %CV) are not explicitly stated. The tables provide the observed performance metrics (SD, %CV) and imply that these are acceptable.
2. Sample size used for the test set and the data provenance
- Method Comparison: 102 serum samples.
- Imprecision: Not explicitly stated as a general sample count; involved multiple samples (6 different samples with varying concentrations) run in duplicate over 20 days.
- Reproducibility:
- Study 1: 2 samples run in 3 replicates.
- Study 2: 3 samples run in 5 replicates.
- High-dose Hook Effect: Not specified how many samples or what types were used, but concentrations up to 40,000 ng/mL were tested.
- Linearity: Serum samples were used across the assay range.
- Dilution Recovery: Serum samples were used across and above the assay range.
- Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): Not explicitly stated how many individual samples were used for these studies, but they were determined based on specific testing procedures.
- Analytical Specificity (Cross-reactivity): Serum patient samples at two thyroglobulin concentrations (approx. 20 ng/mL and 100 ng/mL) were used. The number of unique patient samples is not specified.
- Analytical Specificity (Interference): Patient serum samples containing two levels of Thyroglobulin (approx. 25.0 ng/mL and 100.0 ng/mL) were used. The number of unique patient samples is not specified.
Data Provenance: The document does not specify the country of origin for the data or whether the samples were collected retrospectively or prospectively. It consistently refers to the use of "human serum" or "patient serum samples."
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 (an in-vitro diagnostic immunoassay). The ground truth for such assays is established by the intrinsic biochemical properties and analytical performance of the assay itself (e.g., accuracy against reference methods, precision, detection limits using reference standards or well-characterized samples), rather than expert interpretation of images or clinical cases.
4. Adjudication method for the test set
This information is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology for AI-assisted diagnosis), where there might be disagreement among experts. For an immunoassay, the results are quantifiable and objective measurements, not subject to subjective adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable to this device. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human readers are interpreting cases. The Access Thyroglobulin assay is an automated laboratory test that directly measures a biomarker, without a "human reader" component in the interpretation of the primary data within the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Access Thyroglobulin assay is a standalone device in the sense that it performs the measurement algorithmically via its chemiluminescent immunoassay system without direct human interpretation of the raw signal output. The "algorithm only" performance is what these analytical studies (imprecision, linearity, LoD, etc.) demonstrate. Human involvement is in sample preparation, loading, and interpretation of the final quantitative result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on analytical performance characteristics established through:
- Reference methods or predicate device comparison (for method comparison study).
- Use of well-characterized samples or reference materials (e.g., for LoB, LoD, LoQ, linearity).
- Known concentrations of potential cross-reactants and interferents (for analytical specificity studies).
- Statistical analysis of repeated measurements (for imprecision and reproducibility).
8. The sample size for the training set
This document describes the performance studies for a modificated device that is compared to a previously cleared predicate and is not a new AI/machine learning device that typically involves a distinct "training set." The studies mentioned are validation studies, not training. Therefore, a specific "training set sample size" is not applicable in the context of this submission. The development and optimization of the immunoassay reagents and protocols would have occurred during the assay's development, but this document focuses on its validation.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an AI/machine learning model for this immunoassay submission, the question of how its ground truth was established is not applicable. The "ground truth" for the performance studies described in this document is derived from established analytical methods, reference materials, and the comparative performance against the predicate device.
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(85 days)
The Access Thyroglobulin Antibody II assay is a paramagnetic chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody II reagents, Thyroglobulin Antibody II calibrators, and the Access Immunoassay analyzers comprise the Access lmmunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II for use on the Access Immunoassay Systems, as extracted from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Summary of Studies" section, which describes the performance characteristics that were measured and deemed acceptable for demonstrating substantial equivalence. Exact numerical acceptance thresholds for each test (e.g., "imprecision must be less than X%") are not explicitly stated as distinct criteria, but the reported performance values are presented as evidence of meeting acceptable levels.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device | New = m(predicate)1.0 ± 0.12, R² ≥ 0.92 (for 397 samples, range <0.9 to 2500 IU/mL) |
| Imprecision | Low imprecision across various concentrations | Within-run: 3.6 to 5.7 %CVBetween-run: 0.0 to 5.2 %CVTotal: 4.8 to 7.7 %CV (at 26.9 to 1889.6 IU/mL).Overall: < 10% CV for ≥ 15 IU/mL; < 1.5 IU/mL SD for < 15 IU/mL. |
| High-dose Hook Effect | No hook effect at high concentrations | No hook to 50,000 IU/mL |
| Linearity | Linear across the assay's measuring range | Linear across the range of the assay (0.0 to 2500 IU/mL) |
| Limit of Blank (LoB) | Lowest measurement with no analyte | 0.9 IU/mL (n=221) |
| Limit of Detection (LoD) | Lowest detectable concentration (95% probability) | 0.9 IU/mL |
| Analytical Specificity | No significant interference; 100% agreement for autoimmune samples | No significant interference from total protein, bilirubin, hemoglobin, or triglycerides. 100% total agreement with autoimmune disease state samples. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 397 samples were used for the method comparison study. The LoB study used 221 samples. The number of samples for other studies (imprecision, linearity, analytical specificity) is not explicitly stated, although "samples with autoimmune disease state" were "tested" for analytical specificity.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a prospective study, as it involves running samples on both the new device and the predicate device for comparison and performance characterization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic (IVD) immunoassay that measures an analyte (thyroglobulin antibody) directly. Therefore, there is no "ground truth" established by human experts in the way that would apply to image-based diagnostic AI. The "ground truth" for method comparison and performance comes inherently from the measurements of the predicate device and established analytical methods.
4. Adjudication Method for the Test Set
Not applicable, as the device is an immunoassay and does not involve human interpretation or adjudication for its raw output. The "comparison" is between the new device's quantitative output and the predicate device's quantitative output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. This device is an automated immunoassay system, not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device (immunoassay system), as it functions as an automated system producing quantitative results. There is no "human-in-the-loop" component for the actual measurement process.
7. The Type of Ground Truth Used
The "ground truth" used for comparison, particularly in the method comparison study, is the quantitative measurement provided by the predicate device (Access Thyroglobulin Antibody II, K062516). For other performance metrics (imprecision, linearity, LoB, LoD), the "ground truth" is derived from established analytical methods and reference materials (e.g., NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93 for standardization).
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such devices typically involves calibration using specific calibrators as described ("Utilizes a stored calibration curve").
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described above, there isn't a "training set" in the AI/ML context. The calibration of the immunoassay system uses specific calibrators, and its standardization is based on NIBSC Anti-Thyroglobulin Serum, Human First International Reference Preparation, WHO Coded 65/93.
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(38 days)
The Access Thyroglobulin Antibody II (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thryoglobulin Antibody II reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel DxI 800) comprise the Access Immunoassay Systems for the determination of thyroglobulin antibody (TgAb) levels in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access Thyroglobulin Antibody II Assay, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Imprecision | |
| Within-run CV | 4.0% CV to 5.8% CV |
| Between-run CV | 2.7% CV to 5.1% CV |
| Total Imprecision | 4.8% CV to 7.0% CV |
| Low Dose Imprecision (SD) | 0.3 to 0.8 SD |
| Dilution Recovery (Linearity) | Mean % recovery ranged from 118% to 127% |
| Analytical Sensitivity (Lowest detectable level distinguishable from zero with 95% confidence) | 0.9 IU/mL |
| Methods Comparison | |
| Positive % Agreement with predicate device | 95% |
| Negative % Agreement with predicate device | 99.6% |
| Overall Percent Agreement with predicate device | 99% |
| Analytical Specificity (No significant interference from potential sample contaminants) | No significant interference from bilirubin, hemoglobin, human serum albumin, triglycerides, and autoantibodies. |
| Expected Values (95% non-parametric upper reference limit in normal population) | Below 4 IU/mL (137 screened samples) and 96% of 519 normal samples below 4 IU/mL |
Study Details:
-
Sample size used for the test set and the data provenance:
- Methods Comparison: 832 values were used for comparison. The document does not explicitly state the country of origin, but given the applicant is in the US and the clinical studies for expected values were in the US, it is highly likely this data is from the United States. The study appears to be retrospective as it compares the new device with a "commercially available enzyme immunoassay kit" which implies existing samples.
- Imprecision, Dilution Recovery, Analytical Sensitivity, Analytical Specificity: Sample sizes are not explicitly given for each of these analytical studies, but details like "multiple dilutions," "20 replicates of the zero calibrator," and "sera samples obtained in the United States" are mentioned. For Expected Values, 137 screened samples and an additional 519 normal samples were collected in the United States. These appear to be prospective collections based on specific screening criteria.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an immunoassay for quantitative determination of antibody levels. The "ground truth" for the analytical studies (imprecision, linearity, sensitivity, specificity) is based on the inherent properties of the assay and reference materials, not expert interpretation.
- For the Methods Comparison, the "ground truth" was established by a "commercially available enzyme immunoassay kit." This implicitly means the established performance of that predicate device determined the reference. No human experts are mentioned for establishing ground truth in this context.
- For Expected Values, the "ground truth" for "normal" was defined by specific clinical criteria (serum TSH levels, no personal/family history of thyroid disease, absence of non-thyroid autoimmune disease). This relies on clinical diagnosis and laboratory results rather than expert consensus on individual cases for the test set.
-
Adjudication method for the test set:
- Not applicable as this is an immunoassay device, and the "ground truth" in the analytical studies is based on established laboratory methods, reference ranges, or a comparator device's results, not on expert adjudication of individual case results.
-
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 (IVD) immunoassay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (imprecision, dilution recovery, analytical sensitivity, analytical specificity, methods comparison) reflect the standalone performance of the Access Thyroglobulin Antibody II Assay as an automated immunoassay system. There is no human-in-the-loop component described for its primary function of quantitative determination.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical studies:
- Imprecision, Dilution Recovery, Analytical Sensitivity, Analytical Specificity: Ground truth is based on the intrinsic properties of the assay system, known standards, and controlled experimental conditions typical for IVD assay validation.
- Methods Comparison: Ground truth was established by the results from a commercially available enzyme immunoassay kit (the predicate device).
- For clinical studies (Expected Values): Ground truth for "normal" was established by clinical criteria (TSH levels, medical history) rather than a single type of definitive outcome or pathology for each individual.
- For analytical studies:
-
The sample size for the training set:
- The document describes the validation of the device, not the development of an algorithm that requires a "training set." This is an immunoassay, not a machine learning model. Therefore, the concept of a training set in the AI/ML sense is not applicable. The studies described are for validation of the assay's performance.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this immunoassay.
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(11 days)
The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma, using the Access Immunoassay Systems. This device is intended to aid in the monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
The Access® Thyroglobulin reagents consist of reagent packs, calibrators, substrate and wash buffer.
The provided text describes a 510(k) summary for the Access® Thyroglobulin Reagents on the Access® Immunoassay Systems. The submission is for a modification to add a new instrument platform (Beckman Coulter UniCel™ DxI 800 Access® Immunoassay System) to the existing system. The core of the study is to demonstrate substantial equivalence between the new instrument platform and the previously cleared Access 2 system.
Here's an analysis of the acceptance criteria and study as requested:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Device Performance Report |
|---|---|
| Method Comparison | The Access Thyroglobulin assay met the established acceptance criteria for method comparison when tested on the DxI system compared to the Access 2 system. |
| Precision | The Access Thyroglobulin assay met the established acceptance criteria for precision when tested on the DxI system. |
| Analytical Sensitivity | The Access Thyroglobulin assay met the established acceptance criteria for analytical sensitivity when tested on the DxI system. |
Note: The specific numerical values or ranges for "established acceptance criteria" are not provided in the summary. The document only states that the criteria were met.
2. Sample size used for the test set and the data provenance
The document states that "method comparison, precision and analytical sensitivity studies were conducted." However, it does not provide any details on the sample sizes used for these studies or the data provenance (e.g., country of origin, retrospective/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 to this type of device and study. The device is an immunoassay for quantitative determination of a biomarker, not an imaging or diagnostic device requiring expert interpretation for ground truth. The ground truth for such assays would typically be defined by reference methods or established laboratory standards.
4. Adjudication method for the test set
This information is not applicable as the study design does not involve human readers or interpretations that would require adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a laboratory immunoassay device, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Supporting Data" section indicates that "method comparison, precision and analytical sensitivity studies were conducted" for the Access Thyroglobulin assay on the DxI system to demonstrate substantial equivalence to the Access 2 system. This refers to the analytical performance of the instrument and reagents as a standalone system.
7. The type of ground truth used
The document does not explicitly state the "type of ground truth" in terms of clinical outcomes or pathology. For an immunoassay seeking substantial equivalence for a new instrument platform, the "ground truth" or reference for comparison would typically be the performance of the legally marketed predicate device (Access® Thyroglobulin Reagents on the Access® Immunoassay Systems on the Access 2 system). The studies would aim to show that the new platform produces equivalent analytical results (method comparison, precision, analytical sensitivity) to the predicate.
8. The sample size for the training set
This information is not applicable. The device is an immunoassay system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a system involves calibration using specific calibrator materials mentioned in the device description.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8. The "ground truth" for calibration would be established by the manufacturer based on certified reference materials or established laboratory standards for the calibrators.
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(53 days)
The Access® Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access® Thyroglobulin Antibody assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Analytical Specificity | No significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides). Only one discrepancy found between interpretations positive and negative when compared to the predicate device for autoimmune disease samples. |
| Analytical Sensitivity | Lowest detectable level: 1.5 IU/mL (at 95% confidence). An analytical sensitivity of 2.2 IU/mL will be used in labeling. |
| Dilution Recovery | Overall mean recovery: 95%. Individual mean sample recoveries: 90% to 100%. |
| Precision | Within-run imprecision: 3.99 to 5.04 % CV Between-run imprecision: 1.95 to 4.66 % CV Total imprecision: 4.47 to 6.74 % CV (at levels between 34.1 and 1,693 IU/ml) |
| Hook Effect | No hook effect demonstrated up to 350,000 IU/ml. |
| Relative Sensitivity vs. Predicate | 79.0% |
| Relative Specificity vs. Predicate | 87.6% |
| Method Comparison (Correlation with Predicate) | Correlation coefficient (r) = 0.816 Slope (y) = 0.957 Intercept = -5.886 |
| Reagent Stability | 56 days after opening. |
| Calibration Curve Stability | 56 days. |
Study Information
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Relative Sensitivity and Specificity: 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals).
- Method Comparison: 276 samples (values ranging from approximately <2.2 to 284 IU/ml).
- Analytical Specificity: Number of samples not specified, but involved samples from persons with autoimmune disease.
- Dilution Recovery: "Various dilutions of serum samples and serum sample pools" - specific number not provided.
- Data Provenance: Not explicitly stated, but assumed to be retrospective as patients with diagnosed conditions (Graves' disease, Hashimoto's disease, and normals) were used. No mention of geographical origin.
- Test Set Sample Size:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The study compares the device to a predicate device (Kronus Thyroglobulin Antibody RIA Kit) and categorizes samples based on existing diagnoses (Graves' disease, Hashimoto's disease, normals). The "ground truth" seems to be based on the established clinical diagnoses of the patients and the results of the predicate device, rather than a new adjudication by experts for this study.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not mentioned. The study relies on comparing results to a predicate device and established clinical diagnoses.
-
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, this is an in-vitro diagnostic (IVD) assay looking at the quantitative determination of a biomarker. MRMC studies are not applicable as there are no "human readers" interpreting images or clinical data in the context of AI assistance. The device is for laboratory use for biomarker measurement.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (analytical specificity, sensitivity, precision, etc.) and the comparison to the predicate device are standalone evaluations of the Access® Thyroglobulin Antibody assay. The assay is an automated chemiluminescent immunoassay, meaning its performance is evaluated as an algorithm/system without direct human-in-the-loop interpretation during the assay's operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Relative Sensitivity and Specificity, the ground truth for sample classification appears to be based on pre-existing clinical diagnoses (Graves' disease, Hashimoto's disease, and normal status). The comparison itself is against a predicate device's results.
- For Method Comparison, the "ground truth" is effectively the results obtained from the predicate device (Kronus Thyroglobulin Antibody immunoradiometric assay), against which the new device's measurements are correlated.
- For other analytical performance studies (sensitivity, precision, etc.), the "ground truth" refers to established analytical standards and measurements.
-
The sample size for the training set:
- Not specified. The document describes performance studies (similar to validation/test sets) but does not detail a separate "training set" or how it was used in the development of the assay. For an immunoassay, the "training" aspect often refers to assay development and optimization, rather than machine learning algorithm training with a distinct dataset.
-
How the ground truth for the training set was established:
- Not specified, as a distinct training set in the AI/ML sense is not described. For an IVD, the ground truth during development would typically be established through rigorous analytical methods using reference materials, spiked samples, and comparison to established methods or clinical samples with known characteristics.
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(31 days)
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