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.

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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

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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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.

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):

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

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

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

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

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

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

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

Device: Access OV Monitor Immunoassay

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

• Not Applicable. See point 8.

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The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer.

The Access BR Monitor assay, Access BR Monitor Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay Amalyzer for the quantitative determination of CA 15-3 antigen levels in human serum and plasma (heparin) using the Dxl 9000 Access Immunoassay Analyzer.

Here's a breakdown of the acceptance criteria and study information for the Access BR Monitor device, based on the provided FDA document:

1. Table of Acceptance Criteria and Reported Device Performance

• Slope: 0.95 (95% CI: 0.94 - 0.96)
• Intercept: 0.70 (95% CI: 0.31 - 1.4)
• Correlation Coefficient (R): 1.00
  (Implied acceptance if comparable to predicate) |
  | Imprecision (Within-Laboratory) | - SD ≤ 1.5 U/mL at concentrations ≤ 15 U/mL
• CV ≤ 10.0% at concentrations ≥ 15 U/mL | Met acceptance criteria.
• Sample 1 (4.2 U/mL): SD 0.1, CV 3.4%
• Sample 2 (19 U/mL): CV 2.9%
• Sample 3 (34 U/mL): CV 3.2%
• Sample 4 (79 U/mL): CV 3.0%
• Sample 5 (105 U/mL): CV 3.0%
• Sample 6 (425 U/mL): CV 3.2%
• Sample 7 (825 U/mL): CV 4.0% |
  | Linearity | Not explicitly stated numerically, but stated as being linear throughout the analytical measuring interval. | Met acceptance criterion, indicating linearity throughout the analytical measuring interval (0.8 – 1,000 U/mL). |
  | Limit of Blank (LoB) | 0.4 U/mL | Met acceptance criterion. LoB estimate: 0.1 U/mL. |
  | Limit of Detection (LoD) | 0.5 U/mL | Met acceptance criterion. LoD estimate: 0.3 U/mL. |
  | Limit of Quantitation (LoQ) | Not explicitly stated numerically, but two different LoQ definitions are provided. | - 20% CV LoQ estimate: 0.3 U/mL
• LoQ at 20% within-laboratory imprecision estimate: 0.8 U/mL |

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

• Method Comparison: N = 163 samples.
  • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
• Imprecision:
  • Sample 1, 2: N = 126
  • Sample 3, 4, 5, 6, 7: N = 120
  • Data Provenance: Not specified.
• Linearity, LoB, LoD, LoQ: Sample sizes not explicitly stated for these specific studies, beyond the "N" for method comparison and imprecision.
  • Data Provenance: Not specified.

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

There is no mention of experts or ground truth establishment for the test set in the provided document. The studies described are analytical performance studies (method comparison, imprecision, linearity, limits) of an immunoassay device, which typically compare the device's measurements against a reference method or predetermined values, not against expert consensus on clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable, as the studies are analytical performance assessments of an immunoassay, not studies involving human interpretation or adjudication of clinical cases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is an immunoassay for measuring CA 15-3 antigen levels, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

Yes, the studies described (Method Comparison, Imprecision, Linearity, LoB, LoD, LoQ) are all examples of standalone performance evaluations of the immunoassay system. The device itself (Access BR Monitor on the Dxl 9000 Access Immunoassay Analyzer) operates as an "algorithm only" in the sense that it automates the measurement of the analyte; there is no human-in-the-loop for the measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" for these analytical studies is either:

• Reference method/Predicate device results: For the method comparison study, the Access 2 Immunoassay System served as the reference (predicate) for comparison.
• Known concentrations/values: For studies like Imprecision, Linearity, LoB, LoD, and LoQ, calibrated samples or controls with known or expected analyte concentrations are used as the reference against which the device's measurements are assessed. The document refers to "predetermined values" or "calculated estimates" based on established statistical methods (e.g., CLSI guidelines).

8. The Sample Size for the Training Set

Not applicable. This device is an immunoassay, not a machine learning or AI model that requires a "training set." Its calibration is established through a stored calibration curve, as mentioned in the "Comparison of Technological Characteristics" table.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this immunoassay device. The "calibration curve" for the immunoassay is established using calibrators, which are materials with known concentrations of the analyte, manufactured and tested according to quality control standards.

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For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of CA15-3 antigen in human serum and plasma, as an aid in the detection of recurrence in previously treated stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

The IMMULITE® 2000 BR-MA assay was cleared under K013984. The components of the cleared assay were modified to reduce biotin interference. The modified IMMULITE® 2000 BR-MA Assay is comprised of the following components: BR-MA Bead Pack (L2BR12), BR-MA Reagent Wedge (L2BRA2) - Well 1, BR-MA Reagent Wedge (L2BRA2) - Well 2, and BR-MA Adjustors (LBRL, LBRH). The IMMULITE 2000 BR-MA is a solid-phase, two-step chemiluminescent immunometric assay. There are two incubation cycles of 30 minutes each. During the initial 30-minute cycle, the patient sample is incubated with biotinylated antibody coated bead (bead pack) and a buffer (reagent wedge well 1). The biotinylated antibody on the bead captures the antigen in the patient sample. On completion of the first 30-minute cycle, unbound sample/buffer are then removed via a centrifugal wash. During the second 30-minute cycle, alkaline phosphatase antibody conjugate in buffer (reagent wedge well 2) is added to complete the bead pair immunocomplex sandwich consisting of capture Ab-antigen-detection Ab. On completion of the second 30-minute cycle, unbound conjuqate is removed by centrifugal wash. The amount of alkaline phosphatase bound is directly proportional to the patient sample. Following the two 30-minute incubation periods. IMMULITE chemiluminescent substrate (L2SUBM) is added for a further 5-minute incubation period to generate the luminogenic reaction. The chemiluminescent substrate undergoes hydrolysis in the alkaline phosphatase to yield an unstable intermediate, which then emits photons. The sustained emissions are measured by the luminometer. The resulting relative light units are proportional to the concentration of CA15-3 in the sample, which is expressed as U/mL.

The retrieved document describes the acceptance criteria and performance of the IMMULITE 2000 BR-MA assay, which is a tumor-associated antigen immunological test system for CA15-3. The modifications to the device primarily focus on reducing biotin interference.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" against "reported device performance" in a single table. Instead, it presents performance characteristic studies that implicitly demonstrate the device meets certain standards. I've aggregated these into a table format below, using typical performance metrics for such devices. The "Acceptance Criteria" are implied by common laboratory standards (e.g., CLSI guidelines) and the successful outcome of the tests.

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

• Detection Limits (LoB, LoD, LoQ): The specific sample size for determining LoB, LoD, and LoQ is not explicitly stated as a number of individual patient samples, but the study was conducted "in accordance with CLSI EP17-A2," which provides methodologies for these determinations.
• Linearity/Measuring Interval: A high and low sample pool were used to prepare a panel of ten levels. The number of individual patient samples contributing to these pools is not specified.
• Method Comparison: 274 patient samples.
• Assay Precision: Five serum samples. Each tested in duplicate over 20 days, two runs per day (total 80 replicates per sample). Total N for data points is 400 (5 samples * 80 replicates).
• Assay Reproducibility: Five serum samples. Each tested over 5 days, with 5 replicates per sample (total 25 replicates per sample) across 3 reagent lots. Total N of data points is 375 (5 samples * 25 replicates * 3 reagent lots).
• Recovery: 5 neat samples spiked with 3 different concentrations of CA15-3 solution.
• Interference: Not specified as a number of patient samples, but various compounds were tested.
• Hook Effect: Not specified as a number of patient samples.
• Reference Range Verification: 69 apparently healthy female samples across 3 lots (total 207 results).
• Matrix Comparison: Not explicitly specified, but "comparable values to serum samples" were demonstrated across SST, Lithium Heparin, and EDTA tube types.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to human serum and plasma samples and "patient samples" and "apparently healthy female samples" without further geographical or temporal details.

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

This information is not applicable to this type of device. The IMMULITE 2000 BR-MA is an in vitro diagnostic assay that quantitatively measures CA15-3 antigen. Its performance characteristics are established through analytical studies (e.g., precision, linearity, interference) and comparisons to a predicate device or established laboratory methods, rather than through expert interpretation of outputs to establish a "ground truth" (as might be seen in imaging AI, for example). The ground truth for this device is the actual concentration of the analyte, verified through reference methods or spiked samples with known concentrations.

4. Adjudication Method for the Test Set

Not applicable. As described above, this device's performance is not evaluated through expert adjudication of results but rather by comparing its quantitative measurements to known values or to a predicate device, and assessing its analytical characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation system requiring human "readers." The "human reader" concept is not relevant here.

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

The device is an automated in vitro diagnostic assay. Its primary function is to perform quantitative measurements of CA15-3. The performance studies described (detection limits, linearity, precision, etc.) are all standalone performance evaluations of the assay itself, without a "human-in-the-loop" component in the sense of interpreting an output that then needs human review for diagnosis. The device provides a quantitative result (U/mL), which is then used by a clinician in conjunction with other clinical methods. So, yes, the performance data presented are for the standalone analytical performance of the device.

7. The Type of Ground Truth Used

The ground truth used in the performance studies includes:

• Known concentrations: For linearity, recovery, interference, and hook effect studies, samples are often prepared with known concentrations of the analyte or interferents.
• Reference methods/Predicate device: For method comparison, results from the candidate device are compared against results from the legally marketed predicate device.
• Statistical methods: Established CLSI (Clinical and Laboratory Standards Institute) guidelines provide the statistical framework and generally accepted methodologies for determining metrics like LoB, LoD, LoQ, precision, and linearity.
• Clinically defined healthy populations: For reference range verification, samples from "apparently healthy female samples" are used.

8. The Sample Size for the Training Set

The document describes performance studies for a modified in vitro diagnostic assay. These studies are typically for verification and validation, not for "training" an algorithm in the sense of machine learning. There is no mention of a "training set" in the context of algorithm development or machine learning. The studies primarily evaluate the analytical performance of the modified assay components.

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

As there is no mention of a "training set" for an algorithm, this question is not applicable. The device's mechanism is based on immunometric assay principles using chemical reactions, not on training data for a machine learning model.

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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.

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

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

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

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

Here's the breakdown based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

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

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B·R·A·H·M·S™ CgA II KRYPTOR™ is an automated immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE™) technology for quantitative determination of Chromogranin A concentration in human serum.

B·R·A·H·M·S™ CgA II KRYPTOR™ is to be used in conjunction with other clinical methods as an aid in monitoring of disease progression during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors (GEP-NETs, grade 1 and grade 2).

The B-R-A-H-M-S CgA II KRYPTOR assay is based on the formation of a complex comprised of a Chromogranin A (CgA) analyte "sandwiched" between two monoclonal mouse anti-CgA antibodies. One of the antibodies (537/H2) is directed at the epitope AA124–144 and labelled with DiSMP cryptate, the other antibody (541/E2) binds to AA280-301 and is labelled with Alexa Fluor®647.

The measurement principle is based on a non-radiative energy transfer from a donor (cryptate) to an acceptor (Alexa Fluor™647) when they are part of an immunocomplex (TRACE technology (Time-Resolved Amplified Cryptate Emission)).

The fluorescent signal is proportional to the concentration of the analyte to be measured.

With this principle B-R-A-H-M-S CgA II KRYPTOR is a homogenous one-step immunoassay for the quantification of CgA II in human serum. The linear direct measuring range of the assay is from 20-3,000 ng/mL, going up to 1,000,000 ng/mL with automated dilution. Results can be retrieved after a 29 min incubation time.

Here's an analysis of the acceptance criteria and study findings for the B.R.A.H.M.S CgA II KRYPTOR device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The provided document primarily describes analytical performance criteria and clinical performance measures (sensitivity, specificity) rather than explicit "acceptance criteria" in a pass/fail format for clinical decision-making. However, the sensitivity and specificity values obtained from the clinical study serve as the reported device performance against which implicit clinical acceptance would be judged. The analytical performance metrics are generally presented as numerical results meeting industry standards (CLSI guidelines).

Study Details:

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

   • Clinical Study (for Sensitivity and Specificity): 153 adult GEP-NET patients (grade 1 and 2), with 459 total observations (likely reflecting multiple monitoring visits per patient). The study was described as a prospective study.
   • Clinical Cut-off Derivation: 102 patients with diagnosed well-differentiated G1 and G2 GEP-NETs. This was a retrospective, bicentric observational pilot study.
   • Reference Range Determination: 206 samples from self-declared healthy individuals. Data provenance is USA.
   • Analytical studies: Various sample sizes were used, often involving replicates of pooled or individual human serum samples. For example, LoQ used 420 total replicates from 7 different pools of human serum samples.
   • Provenance for analytical samples: Not explicitly stated but generally implied to be from human subjects, for instance, "human serum samples".

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

   • For the clinical study, tumor progression was classified by RECIST 1.1 criteria. This implies that experts (typically radiologists or oncologists) were involved in interpreting imaging (CT/MRI) according to these established criteria to determine the ground truth for tumor progression.
   • The document does not specify the direct number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, RECIST 1.1 is an internationally recognized standard for evaluating cancer treatment response based on imaging, implying adjudication by qualified personnel.

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

   • The ground truth for tumor progression in the clinical studies was established using RECIST 1.1 criteria based on standard imaging (CT/MRI).
   • The document does not explicitly state an adjudication method like "2+1" or "3+1" for discordant interpretations if multiple readers were involved in RECIST assessment. However, RECIST guidelines themselves are designed to standardize interpretation, and clinical trials often employ independent central review or consensus panels for definitive RECIST ratings, though this specific detail is not provided here.

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

   • No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) for quantitative determination of Chromogranin A concentration in human serum, intended to be used in conjunction with other clinical methods as an aid in monitoring. It is not an AI-assisted imaging device or a device that directly aids human readers in interpreting images.

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

   • This is an IVD assay, which functions as a "standalone" measurement of a biomarker in serum. The results are generated by the automated instrument (B.R.A.H.M.S KRYPTOR compact PLUS analyzer) without direct human interpretation of the measurement itself. However, the device's output (CgA concentration) is explicitly stated to not be used for standalone diagnosis or monitoring but "in conjunction with other clinical methods." So while the analytical measurement is standalone, the clinical interpretation for decision-making is not.

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

   • For the clinical performance evaluation (sensitivity and specificity for tumor progression), the ground truth was imaging-based tumor assessment using RECIST 1.1 criteria. This is a form of expert assessment based on a standardized methodology, often relying on radiologists and oncologists to interpret imaging studies.

7. The sample size for the training set:

   • This document describes an IVD device submission, not a machine learning/AI device. Therefore, the concept of a "training set" for an algorithm in the typical AI sense does not directly apply. The development and validation of the assay itself would have involved numerous samples for optimization and establishment of analytical performance characteristics, but these are not referred to as a "training set" here.

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

   • As addressed above, the concept of a "training set" in the context of machine learning/AI is largely inapplicable here. The development of the assay's analytical characteristics (e.g., linearity, precision, detection limits) would be established through standard laboratory practices and reference materials, for which "ground truth" is defined by known concentrations or established analytical methods.

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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.

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.

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