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510(k) Data Aggregation
(267 days)
MSW
The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer.
Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
The Atellica IM Thyroglobulin (Tg) assay includes:
- Tg ReadyPack primary reagent pack:
- Lite Reagent: mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives (7.5 mL/reagent pack).
- Solid Phase: streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives (15.0 mL/reagent pack).
- Ancillary Well Reagent: BSA; bovine gamma globulin; buffer; preservatives (6.0 mL/reagent pack).
- Tg CAL: After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives (2.0 mL/vial).
The following devices are sold separately:
- Atellica IM Tg MCM:
- MCM 1: After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives (1.0 mL/vial).
- MCM 2–5: After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives (1.0 mL/vial).
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Atellica IM Thyroglobulin (Tg) assay:
Device: Atellica IM Thyroglobulin (Tg) Assay
Purpose: Quantitative measurement of thyroglobulin in human serum and plasma as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes various performance characteristics, which serve as acceptance criteria for the device. The reported performance is directly from the summary.
| Acceptance Criteria Category | Specific Acceptance Criteria (implicit from study design) | Reported Device Performance |
|---|---|---|
| Detection Capability | LoB, LoD, LoQ determined per CLSI EP17-A2 | LoB: 0.039 ng/mL (0.059 pmol/L) |
| LoD: 0.044 ng/mL (0.067 pmol/L) | ||
| LoQ: 0.050 ng/mL (0.076 pmol/L) | ||
| Precision | Precision determined per CLSI EP05-A3 (within-laboratory and repeatability) | Repeatability (CV%): 1.2% - 6.4% across various concentrations |
| Within-Laboratory Precision (CV%): 2.3% - 9.0% across various concentrations | ||
| Reproducibility | Reproducibility determined per CLSI EP05-A3 (across sites, runs, days) | Reproducibility (CV%): 1.9% - 5.8% across various concentrations |
| Linearity | Linearity determined per CLSI EP06-ed2 within stated assay range | Linear for 0.050–150 ng/mL (0.076–227 pmol/L) |
| Specimen Equivalence | Performance equivalence across serum, EDTA plasma, lithium heparin plasma | Performance confirmed equivalent across serum, EDTA plasma, lithium heparin plasma, and associated gel barrier tubes. |
| Interferences (HIL) | Bias 10% observed for tested HIL substances. | |
| Interferences (Other Substances) | Bias 10% observed for tested other substances. | |
| Cross-Reactivity | Cross-reactivity |
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(85 days)
MSW
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)
MSW
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 streptavidin |
| and coupled to biotinylated mouse monoclonal | |
| antithyroglobulin antibodies, suspended in a TRIS buffer with | |
| protein (bovine), |
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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(458 days)
MSW
Immunoassay for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used as an 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). The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
The Tg II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Tg-specific antibody and monoclonal Tg-specific antibodies labeled with a ruthenium complex. The Tg II immunoassay is intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma. Determination of Tg is used 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). It is intended for use on the cobas e immunoassay analyzers. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode or e-barcode.
The Elecsys Tg II device is an immunoassay intended for the in vitro quantitative determination of thyroglobulin in human serum and plasma, used as an 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.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for all performance measures in a comparative table against the reported performance. However, based on the studies conducted and their results, one can infer the implicit acceptance criteria by observing the measured performance and statements like "All deviations from linearity met the specification" or "Non-significant interferences were defined as %interferences within ± 10 %".
Below is a table summarizing the reported device performance, with inferred acceptance criteria where direct ones are not explicitly stated, but are implied by the reported "met specifications" or similar statements.
| Performance Characteristic | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Performance | ||
| Sensitivity | High sensitivity required for monitoring recurrent/metastatic disease (e.g., >90%). | 98.91% (91/92) with 95% CI: (94.10%; 99.81%) |
| Specificity | Acceptable specificity for the intended use (the exact value is not explicitly stated as an initial acceptance criterion, but the reported value is presented as performance). | 53.42% (234/438) with 95% CI: (48.74%; 58.05%) |
| Negative Predictive Value (NPV) | High NPV desired for ruling out disease (-ve result, truly -ve). | 99.89% with 95% CI: (99.42%; 99.98%) (calculated at 4.99% prevalence) |
| Positive Predictive Value (PPV) | Acceptable PPV for the intended use. | 10.03% with 95% CI: (9.16%; 11.03%) (calculated at 4.99% prevalence) |
| Analytical Performance | ||
| Limit of Blank (LoB) | Must be very low (e.g., in the picogram/mL range) to detect low levels of Tg. No explicit criterion given, but the reported value is the outcome of the study designed to determine it. | 0.02 ng/mL (Determined according to CLSI EP17-A2) |
| Limit of Detection (LoD) | Must be very low, enabling early detection of disease recurrence. No explicit criterion given, but the reported value is the outcome of the study designed to determine it. | 0.04 ng/mL (Determined according to CLSI EP17-A2) |
| Limit of Quantitation (LoQ) | %CV of within-laboratory precision ≤ 20% and %bias within ±15%. | 0.1 ng/mL (%CV for samples around this level ranged from 7.56% to 4.00% for repeatability, and within-laboratory CVs were 9.34%, 8.75%, 5.67% for HS1, HS2, HS3 respectively, all below 20%. Bias not explicitly shown in summary table but met criteria.) |
| Linearity | Deviations from linearity ≤ ±10% for values ≥0.3 ng/mL and within ±0.03 ng/mL for values |
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(529 days)
MSW
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 streptavidin |
| and coupled to biotinylated mouse monoclonal | |
| antithyroglobulin antibodies, suspended in a TRIS buffer with | |
| protein (bovine), |
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 |
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(11 days)
MSW
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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(169 days)
MSW
DYNOtest Tg-pluS is a immunoradiometric assay (IRMA) for the quantitative determination of thyroglobulin in human serum. It is intended to aid in the monitoring for the presence of local or metastatic thyroid tissue in patients who have had thyroid gland ablation (by surgery with or without radioiodine therapy). DYNOtest Tg-pluS is also indicated for detecting the presence of thyroid tissue in patients with differentiated thyroid cancer when used with radioiodine whole body scans after recombinant thyrotropin (TSH) stimulation or thyroid hormone withdrawal. DYNOtest Tg-pluS includes a recovery test to aid in the detection of interfering anti-thyroglobulin antibodies or other substances.
DYNOtest Tg-pluS is a two-step immunoradiometric assay for the quantitative determination of thyroglobulin in human serum using a coated tube technique. Two antigen specific antibodies that recognize different binding sites on the antigen (thyroglobulin) are used in excess. In the first step, thyroglobulin in the sample, standard or control binds to rabbit anti-human Tg polyclonal antibodies attached to the solid phase. Following incubation, unbound thyroglobulin and serum components are washed from the tube. In the second step, the radioactive tracer (mouse antihuman thyroglobulin monoclonal antibody) reacts with the bound antigen forming a sandwich complex fixed to the side of the tube. Following a second incubation, unreacted tracer is washed from the tube and remaining radioactivity in the tubes is measured. The measured radioactivity is directly proportional to the quantity of thyroglobulin in the sample, standard or control. The standard curve is used to derive the thyroglobulin concentration in the patients samples.
Recovery Test: Because non-specific interferents and anti-thyroglobulin antibodies can result in falsely low thyroglobulin values, DYNOtest Tg-pluS includes a recovery test, the purpose of which is to aid in the detection of such interferences. In the recovery test, recovery buffer containing a known quantity of thyroglobulin, is added to the patient sample. In parallel, the recovery buffer is added to a recovery reference sample (thyroglobulin free serum). The patient sample, recovery sample and recovery reference sample are all run using DYNOtest Tg-pluS. The percentage recovery is determined by subtracting the patient Tg value from the patient recovery sample and dividing this result by the recovery reference Tg value:
Recovery Tg - Patient Tg x 100 = % Recovery Recovery reference Tg
Recovery values between 70% and 130% are considered valid. Values 130% are due to interferences; these patient results should be considered invalid.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to evaluate the DYNOtest Tg-pluS device:
Acceptance Criteria and Device Performance for DYNOtest Tg-pluS
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific threshold values for the clinical study. Instead, it presents the results of a clinical performance study and a comparison to a predicate device. The effective acceptance criteria can be inferred from the reported performance characteristics.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Comparison to Predicate Device | ||
| Concordance (Overall Agreement) | High agreement with predicate device (Nichols Institute Diagnostics Chemiluminescent Thyroglobulin assay) | 96.9% (129/133) for results using 1.0 ng/mL (DYNOtest Tg-pluS) vs. 2.0 ng/mL (predicate) as cutoffs. |
| Clinical Performance (Cut-off > 1.0 ng/mL) | ||
| Overall Clinical Sensitivity | Reasonably high sensitivity for diagnostic aid | 78.1% (64/82) |
| Overall Clinical Specificity | Reasonably high specificity for diagnostic aid | 90.2% (46/51) |
| Positive Predictive Value (PPV) | Reasonably high PPV for diagnostic aid | 92.8% (64/69) |
| Negative Predictive Value (NPV) | Reasonably high NPV for diagnostic aid | 71.9% (46/64) |
| Sensitivity (Active Metastatic Disease) | Very high sensitivity expected for detecting active disease | 100% (35/35) |
| Sensitivity (Residual Thyroid/Thyroglossal Duct Remnants) | Moderate sensitivity | 61.7% (29/47) |
| Specificity (Free of Normal/Malignant Tissue) | High specificity expected for healthy individuals | 90.2% (46/51) |
| Analytical Performance | ||
| Analytical Sensitivity | 130%). Most disturbed samples had Tg 800 kilounits/L. (This is a specific acceptance criterion mentioned in the text for the recovery test). |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set:
- Clinical Performance Study: 133 patients diagnosed with thyroid cancer.
- Predicate Device Comparison: 133 samples from patients diagnosed with thyroid cancer (likely the same cohort as the clinical performance study).
- Interference from Tg auto-antibodies: 77 sera.
- Data Provenance: The clinical performance study was prospective in the sense that the device was evaluated on a specific set of categorized patients. The location of the test set is specified as occurring "at a single site," but the country of origin is not explicitly stated. Given the manufacturer is German (BRAHMS AG) and the distributor is US-based (BRAHMS Diagnostica LLC), it's possible the clinical site was in the US or Germany.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (like 2+1 or 3+1). The "ground truth" (reference methodology) was established based on a combination of existing diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of the in-vitro diagnostic (IVD) device itself, not on how human readers' performance might change with or without AI assistance. The device is an assay, not an AI imaging interpretation tool.
6. Standalone Performance Study
Yes, the studies reported are for the standalone performance of the DYNOtest Tg-pluS device. The clinical performance section, including sensitivity, specificity, PPV, and NPV, directly evaluates the algorithm/assay without human-in-the-loop performance modifications.
7. Type of Ground Truth Used
The ground truth for the clinical performance study was established using a combination of existing clinical diagnostic results and reference methods:
- "Tg results from a reference method (immunochemiluminescent method)"
- "results from radioiodine whole body scans following TSH stimulation by administration of recombinant TSH or withdrawal of thyroid hormone therapy."
- Patients were categorized into three groups: (1) free of thyroid tissue, (2) active metastatic disease, and (3) residual thyroid/thyroglossal duct remnants.
For the auto-antibody interference study, the ground truth was based on samples that "tested positive for Tg auto antibodies using a radioimmunometric assay (DYNOtest anti-TGn)."
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of in-vitro diagnostic assay (IRMA) typically relies on extensive analytical validation and calibration to established standards (like CRM 457, in this case) rather than a "training set" in the machine learning sense. The "standards" and "controls" mentioned in the device description are used for calibration and quality control, not for training a predictive algorithm in the same way an AI model would be trained.
9. How Ground Truth for the Training Set Was Established
Since a distinct "training set" in the context of machine learning is not mentioned or applicable to this type of assay, the concept of establishing ground truth for it is also not applicable here. The assay is calibrated against a standard (CRM 457), which serves as a known reference for target values.
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The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectorny (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after either rhTSH administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies.
The Chemiluminescence Thyroglobulin kit has sufficient reagents for 100 tests. The throglobulin assay is a chemiluminescence sandwich immunoassay assay utilizing a biotinylated goat antiassay 1s a cheinnummicscented sunding monoclonal antibody labeled with acriding for detection. thyrogloutin for captare and a modio monomal and seprosilicate glass tube followed by the A U.200-IIL Serum Sample 1s added to a 12×10 uline and 0.050 mL of acridinium labeled antithyroglobulin reagents. Samples are also run at a 1/10 dilution (hook detection tube) to check for t thyroglountif teagents. Butiples are also in the assay. An avidin-coated bead is then added to the polentially mixture. The assay incubates at room temperature for 16-24 hours on top of a horizontal rotator set & 180 ± 10 rpm. Thyroglobulin in the serum sample binds to the biotinylated antibody and acridinium labeled antibody to form a sandwich-complex. Because of the high affinity between biotin and avidin, the captured sandwich complex binds to the avidin-coated bead. Free oetween brom and avidin, the capitaled antibody are separated from the complex bound to the bead by aspiration of the reaction mixture and subsequent washing. The tubes containing the washed beads are placed into a luminometer, which automatically injects Trigger 1 and 2, initiating the chemiluminescence reaction. The light is quantified by the luminometer and minating the onomianinessonts (RLU). The amount of acridinium labeled antibody bound is directly proportional to the concention of thyroglobulin in the sample. A log-log standard curve uncectly proportional to the concentration of the ordinate versus the respective concentration of each IS gelleration of proting the mount NFO shecissa. The concentration of thyroglobulin is determined directly from the standard curve.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core of the acceptance criteria seems to be framed around demonstrating substantial equivalence to a predicate device and showing clinical utility for its intended use. While explicit numerical acceptance criteria for sensitivity, specificity, etc., weren't
fully specified as pre-defined targets in the document, the clinical study's results (especially in Table 3) serve as the evidence for meeting acceptable performance for market clearance.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied / Contextual) | Reported Device Performance (Nichols Tg ICMA) |
|---|---|---|
| Method Comparison (Against Predicate) | ||
| Agreement ( |
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