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The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.

The detection of TPOAb is an aid in the diagnosis of thyroid autoimmune disorders.

The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPO Ab) levels in human serum and plasma using the Access Immunoassay Systems.

The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of TPO Antibody levels in human serum and plasma using the Access Immunoassay Systems.

The Access TPO Antibody assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with thyroperoxidase protein. The serum or plasma TPO Ab binds to the thyroperoxidase. After 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.

The provided document, a 510(k) summary for the Beckman Coulter Access TPO Antibody assay, describes the analytical performance studies conducted to demonstrate substantial equivalence to a predicate device. This is a common regulatory pathway for in vitro diagnostic devices, focusing on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document presents acceptance criteria implicitly through the study designs and results, as it's a submission for an IVD kit rather than an AI/ML algorithm. The performance is assessed by comparing the new device (Access TPO Antibody Assay on Dxl 9000 Access Immunoassay System) to its predicate device (Access TPO Antibody Assay on Access 2 Immunoassay System).

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

This submission focuses on an In Vitro Diagnostic (IVD) assay (Access TPO Antibody), not an AI/ML algorithm. Therefore, many of the questions related to AI/ML development (training set, experts for ground truth, MRMC studies) are not directly applicable in the way they would be for an AI-based medical device. However, I will interpret them in the context of an IVD assay where possible, based on standard IVD validation practices.

1. Sample Size Used for the Test Set and Data Provenance:

   • Method Comparison: N = 219 patient samples.
   • Imprecision: N = 80 replicates (for each of 5 samples).
   • Linearity & Detection Capability: Sample sizes for these studies are not explicitly stated, but are governed by CLSI guidelines (EP06-Ed2 and EP17-A2 respectively), which typically involve analyzing serially diluted samples.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be analytical performance studies conducted on patient samples, but whether they were retrospective or prospective is not specified. Given the nature of an IVD, these are typically conducted prospectively in a lab setting using banked or newly collected samples.

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

   • Not Applicable in the traditional AI/ML sense. For an IVD assay, the "ground truth" for the test set is either:
     • Clinical Diagnosis: For the diagnostic claim ("aid in the diagnosis of thyroid autoimmune disorders"), the ground truth would be established by independent clinical diagnosis (e.g., by endocrinologists) typically using a variety of clinical data and other diagnostic tests. This information is usually part of clinical utility studies, which are not detailed in this analytical performance summary.
     • Reference Method/Predicate Product: For the analytical performance studies like Method Comparison, the "ground truth" or reference is the result obtained from the predicate device (Access TPO Antibody Assay on Access 2 Immunoassay System). The predicate device itself is validated against established (often clinical) criteria.
     • Known Concentrations/Materials: For linearity, imprecision, and detection capability studies, the "ground truth" is established by using characterized materials with known concentrations, or by measuring the variability around the mean of repeated measurements. This doesn't involve medical experts in the adjudication sense.

3. Adjudication Method for the Test Set:

   • Not Applicable. Adjudication is typically for subjective interpretations (like image reading). For an IVD, the results are quantitative measurements from an instrument. The "adjudication" is essentially the statistical analysis (e.g., Passing-Bablok regression, CV calculations) of these quantitative results against predefined criteria or a reference method.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is relevant for interpreting subjective data (like medical images) where human readers are involved. This document describes the analytical performance of an in vitro diagnostic assay that produces quantitative results, not an image interpretation or decision support AI.

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

   • Yes, in the context of an IVD. The entire analytical performance evaluation (Method Comparison, Imprecision, Linearity, Detection Capability) describes the standalone performance of the Access TPO Antibody assay on the Dxl 9000 system. It functions automatically based on its chemiluminescent immunoassay technology to produce a quantitative result. There is no "human-in-the-loop" aspect to the measurement itself, though human lab personnel operate the instrument and interpret the results.

6. The Type of Ground Truth Used:

   • Known concentrations, reference method results (predicate device), and statistical averages.
     • For Method Comparison, the "ground truth" for comparison is the result obtained from the predicate Access 2 Immunoassay System.
     • For Imprecision, the "ground truth" is the mean concentration of the samples derived from repeated measurements, and the variability around that mean.
     • For Linearity, the ground truth is derived from known dilutions of a high-concentration material.
     • For Detection Capability (LoB, LoD, LoQ), the ground truth involves the statistical analysis of measurements of blank samples and low-concentration samples.

7. The Sample Size for the Training Set:

   • Not Applicable. This is an IVD assay relying on chemical and immunological reactions, not a machine learning algorithm that requires a "training set" in the AI/ML sense. The device's parameters are determined during its design and optimization phases by Beckman Coulter, based on established immunoassay principles.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. As above, there is no "training set" for this type of device in the AI/ML context. The assay's performance characteristics (e.g., reactivity, linearity, precision) are inherent to its reagent formulation and instrument design, which are optimized by the manufacturer using internal R&D processes guided by scientific principles and regulatory standards.

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The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.

The detection of TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders.

The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of thyroperoxydase antibody (TPO) levels in human serum and plasma.

Here's a breakdown of the acceptance criteria and the study details for the provided device, based on the input text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Imprecision: Not explicitly stated as a single "test set" sample size but tested across concentrations from approximately 0.6 to 809 IU/mL. Data provenance not specified.
   • Dilution Recovery (Linearity): "Multiple dilutions of serum samples were analyzed." Specific sample size not given. Data provenance not specified.
   • Methods Comparison: 119 values. Data provenance not specified.
   • Analytical Specificity: Not specified. Data provenance not specified.
   • Stability: Specific sample sizes not given for stability testing. Data provenance not specified.
   • Expected Values:
     • Healthy male population <30 years: Sample size not explicitly stated for the primary reference range establishment, but criteria outlined by NACB were followed. Data provenance: United States.
     • Normal population (18-80 years): 679 normal samples collected, with 492 samples ultimately tested after screening. Data provenance: United States.
   • Clinical Sensitivity:
     • Hashimoto's Thyroiditis: 54 patients. Data provenance not specified.
     • Graves' Disease: 40 patients. Data provenance not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an immunoassay designed to quantitatively measure a biomarker. "Ground truth" is based on the chemical measurement itself and comparison to established reference methods or clinical diagnosis. Clinical diagnoses (Hashimoto's Thyroiditis, Graves' Disease) forming the basis for clinical sensitivity would have been made by medical professionals, but the number and qualifications are not detailed here.

3. Adjudication method for the test set: Not applicable for a quantitative immunoassay. Test results are numerical outputs directly from the device.

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: Not applicable. This device is an automated immunoassay, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, all analytical and clinical performance studies described are for the device (Access TPO Antibody assay on Access Immunoassay Systems) operating in a standalone, automated fashion without human intervention in the result determination process itself. Human involvement is in sample collection, running the assay, and interpreting the results in a clinical context.

6. The type of ground truth used:

   • Analytical Studies: Ground truth is based on established laboratory methodologies and expected performance characteristics for assays (e.g., linearity, precision, recovery, non-interference). For method comparison, the "ground truth" is the result from the predicate or commercially available immunoassay system.
   • Clinical Studies:
     • Expected Values: Clinical criteria for healthy individuals, including TSH levels and absence of thyroid/autoimmune disease, defined the "normal" ground truth. For the <30 age group, NACB criteria were used.
     • Clinical Sensitivity: Clinical diagnosis of Hashimoto's Thyroiditis and Graves' Disease by medical professionals served as the ground truth.

7. The sample size for the training set: Not applicable in the context of machine learning or AI. This is a traditional immunoassay, not an algorithm that has a "training set" in that sense. The assay is developed and validated, but it doesn't "learn" from a training set in the way an AI model does.

8. 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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