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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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Optilite® Freelite Mx Kappa Free Kit:
The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains in serum and urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

Optilite® Freelite Mx Lambda Free Kit:
The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains in serum and urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

The provided FDA 510(k) clearance letter and its associated 510(k) Summary pertains to the Optilite Freelite Mx Kappa Free Kit and Optilite Freelite Mx Lambda Free Kit. The submission sought to add a claim for the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) to the intended use statement (in serum).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria in terms of pre-defined numerical thresholds for sensitivity, specificity, or positive/negative rates that were required to be met for the MGUS claim. Instead, it describes clinical performance studies designed to demonstrate the utility of the device for MGUS evaluation. The conclusion states that "The studies generated successful results where all pre-defined acceptance criteria were met," implying these criteria were internal to the manufacturer's study design and not explicitly detailed in the public document as numerical targets.

However, we can infer the de facto "reported device performance" based on the results of Study 1 and Study 2.

Inferred Performance/Results:

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

• Study 1 (Evaluation of MGUS and disease controls at single time points):

  • MGUS Test Set: 229 samples from patients with clinically confirmed MGUS.
  • Disease Control Test Set (non-MGUS): 136 samples from patients with polyclonal hypergammaglobulinemia.
  • Provenance: Retrospective study. The country of origin is not explicitly stated, but the submitter (The Binding Site Ltd) is based in the United Kingdom.

• Study 2 (Evaluation of MGUS progression):

  • Total Patients: 49 MGUS patients.
    • Stable MGUS Cohort: 45 patients.
    • Progressive MGUS Cohort: 4 patients (who progressed from MGUS to MM).
  • Total Samples: 185 samples (up to 4 individual draws for stable, up to 6 for progressive).
  • Provenance: Retrospective study. Country of origin not explicitly stated.

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

• The document states that the clinical diagnostic criteria for MGUS and disease controls were "confirmed with each site" and "as practiced clinically."
• For the progressive MGUS study, changes were defined as clinical progression from MGUS to MM.
• No specific number of experts or their qualifications (e.g., "Radiologist with 10 years of experience") are mentioned in the provided text. The ground truth relies on "clinical diagnosis" or "clinical truth," which typically implies the consensus opinion of treating clinicians or established diagnostic criteria within the medical community (e.g., IMWG guidelines for MGUS/MM).

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the clinical ground truth. It relies on "clinical diagnosis" or "clinical truth" established by the sites providing the samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This device is an in vitro diagnostic (IVD) kit for quantitative measurement of biomarkers, not an image-based AI device that would typically involve human readers interpreting images. The closest analog would be a clinical utility study comparing outcomes with and without the FLC test, but that is beyond the scope of a 510(k) for an IVD kit unless explicitly requested for a novel claim.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This is a standalone study. The Optilite Freelite Mx Kappa and Lambda Free Kits are laboratory assays. The "performance data" presented (positive rates, negative rates, tracking of progression) are derived solely from the measurements made by the device (Optilite Analyser) on patient samples, compared against established clinical diagnoses (ground truth). There is no "human-in-the-loop" aspect to the device's direct measurement and result generation. The results are then interpreted by clinicians in conjunction with other findings, but the device's output itself is standalone.

7. Type of Ground Truth Used

• The ground truth used was clinical diagnosis/clinical truth.
  • For Study 1: "clinically confirmed MGUS" and "polyclonal hypergammaglobulinemia confirmed by study testing... with supporting clinical information." The diagnostic criteria for MGUS were stated to align with or be similar to those outlined by the International Myeloma Working Group (IMWG).
  • For Study 2: "clinically determined stable or progressive status" for MGUS patients, with progression defined as conversion from MGUS to Multiple Myeloma (MM) based on clinical diagnosis. FLC results criteria adapted from IMWG guidelines were used for evaluation of the device's performance, but the patient's status (stable/progressive) was the "clinical diagnosis."

8. Sample Size for the Training Set

• The document states, "The devices in this submission have not materially changed since originally cleared under K150658." This implies that the core analytical performance studies (e.g., analytical measuring range, precision, accuracy) were previously established and referenced from prior 510(k) submissions (K173732 and K150658).
• For the new MGUS claim, the performance data presented are for clinical validation on the test sets described in points 1 and 2.
• The document does not describe a distinct "training set" for the clinical claim of MGUS evaluation, nor is it typical for IVD kits to have a "training set" in the machine learning sense for their clinical claims. The performance studies demonstrate the device's ability to measure FLCs in patient populations relevant to MGUS, and these measures are compared against clinical ground truth. The assay itself (reagents, instrument) would have been "trained" (i.e., optimized and validated analytically) during its initial development and previous clearances.

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

• As a "training set" for the clinical claim is not explicitly mentioned or relevant for this type of IVD 510(k), this question is not directly applicable. For the device itself, analytical validation and calibration would have established its operational parameters, but this isn't "ground truth" in the diagnostic performance sense. The clinical ground truth for the test sets was derived from established clinical diagnoses and diagnostic criteria.

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The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA) that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma assays into a ratio of pTau 217 to β-Amyloid 1-42 concentrations using the LUMIPULSE G1200 System.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer's disease.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is indicated for adult patients, aged 50 years and older, presenting at a specialized care setting with signs and symptoms of cognitive decline.

A test result ≤ 0.00370 is a negative result which is consistent with patients who are unlikely to have amyloid pathology. These patients should be investigated for other causes of cognitive decline.

A test result ≥ 0.00738 is a positive result which is consistent with patients who are likely to have amyloid pathology. This result does not establish a diagnosis of Alzheimer's disease or other cognitive disorders.

A test result between 0.00371 and 0.00737 is an indeterminate result which is consistent with patients who are uncertain to have amyloid pathology. These patients should be considered for further testing.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio results must be interpreted in conjunction with other patient clinical information.

This test is not intended as a screening or stand-alone diagnostic test.

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is a test that combines the test results of the Lumipulse G pTau 217 Plasma assay and Lumipulse G β-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio from 0.00000 – 1.00000. The numerical ratio will be compared to the established cutoffs.

Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio = Lumipulse G pTau 217 Plasma (results in pg/mL) / Lumipulse G β-Amyloid 1-42-N Plasma (results in pg/mL) = a numerical value targeted up to 1.00000.

The Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma are assay systems including a set of immunoassay reagents for the quantitative measurement of pTau 217 and β-amyloid1-42, respectively, in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology. The LUMIPULSE G1200 is an instrument platform that can perform automated chemiluminescence immunoassays of specimens using LUMIPULSE G reagents. The LUMIPULSE G1200 reports the results of the two individual assays separately, and the ratio calculation must be done manually by the operator.

This document describes the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) Clearance Letter for the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test.

Acceptance Criteria and Device Performance Study for Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio

The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic test intended to aid healthcare providers in identifying patients with amyloid pathology associated with Alzheimer's disease. The FDA 510(k) clearance letter details various performance characteristics and clinical study results that demonstrate the device meets its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is primarily evaluated against its ability to classify patients into "Positive," "Indeterminate," and "Negative" categories based on their Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, correlated with amyloid pathology confirmed by PET imaging or CSF testing.

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The Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFine must be confirmed by a trained operator.

The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) test system is an indirect immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic antibodies (ANCA) of the IgG isotype in human serum by manual fluorescence microscopy or with dIFine. The presence of ANCA in conjunction with other clinical and laboratory findings can be used to aid in the diagnosis of ANCA associated vasculitis (AAV). All suggested results obtained with dIFine must be confirmed by a trained operator.

Not Found

The provided FDA 510(k) clearance letter for "Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)" and "Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)" from ZEUS Scientific does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria.

This document is primarily a clearance letter, confirming that the device is substantially equivalent to a predicate device and outlining regulatory guidelines and requirements. It mentions the "dIFine" system, which likely refers to an automated interpretation component, but it does not provide any specific performance data, study design, or methodology for demonstrating the device's accuracy or effectiveness.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 mentioned. The letter states that "All suggested results obtained with dIFine must be confirmed by a trained operator," implying a human-in-the-loop, but no study details are provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, although the statement about human confirmation suggests the primary use case is not standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain this information, you would typically need to refer to the 510(k) Summary or the full 510(k) submission document, which often includes a detailed description of the validation studies conducted. The clearance letter itself is a summary of the FDA's decision, not the full technical dossier.

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The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

The provided FDA 510(k) clearance letter and summary for the NOVEOS Specific IgE (sIgE) Assay outlines the device's performance, but it does NOT describe "acceptance criteria" in an explicit, quantifiable manner that is typically found in a clinical study report. Instead, the document presents study results and compares them to a predicate device (ImmunoCAP Specific IgE) to demonstrate substantial equivalence, and also to clinical diagnosis of allergic status. The closest approximations to acceptance criteria are implicit in the performance metrics presented (e.g., target ranges for sensitivity, specificity, agreement, precision, linearity).

This device is an in vitro diagnostic (IVD) assay, not an AI/ML-based diagnostic imaging or analysis system. Therefore, the concepts of "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "number of experts," "adjudication method," and "training set ground truth establishment" do not directly apply in the same way they would for AI-powered diagnostic imaging devices. The "ground truth" for this IVD device is established through reference methods (Skin Prick Test, Oral Food Challenge, ImmunoCAP predicate device) or established clinical diagnosis.

Here's a breakdown of the information that is provided and how it relates to the requested points, with interpretations where necessary for IVD context:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit acceptance criteria are not stated. However, the performance data presented effectively serves as the "reported device performance" that presumably met the FDA's requirements for substantial equivalence. I will present the key performance metrics from the document.

Key Performance Metrics (Implicit Acceptance Criteria)

• G010 (Johnson Grass): 72.9% (95% CI 62.7% to 81.2%)
• T007 (Oak): 71.7% (95% CI 58.4% to 82.0%)
• G002 (Bermuda Grass): 76.1% (95% CI 66.3% to 83.8%)
• W001 (Common Ragweed): 62.0% (95% CI 50.3% to 72.4%)
• E005 (Dog Dander): 71.9% (95% CI 54.6% to 84.4%)
• T003 (Common Silver Birch): 55.1% (95% CI 41.3% to 68.1%)
• F001 (Egg White): 52.8% (95% CI 37.0% to 68.0%)
• F002 (Cow's Milk): 50.0% (95% CI 34.1% to 65.9%)
  Literature citation provided for lower sensitivity values to support observed performance. |
  | Clinical Specificity | High, to minimize false positives | Varies by Allergen:
• G010 (Johnson Grass): 99.2% (95% CI 95.9% to 99.9%)
• T007 (Oak): 97.8% (95% CI 92.5% to 99.4%)
• G002 (Bermuda Grass): 97.1% (95% CI 92.9% to 98.9%)
• W001 (Common Ragweed): 93.6% (95% CI 86.8% to 97.0%)
• E005 (Dog Dander): 100.0% (95% CI 95.2% to 100.0%)
• T003 (Common Silver Birch): 100.0% (95% CI 93.2% to 100.0%)
• F001 (Egg White): 100.0% (95% CI 97.4% to 100.0%)
• F002 (Cow's Milk): 100.0% (95% CI 97.2% to 100.0%) |
  | Positive Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 84.7%
• T007 (Oak): 83.8%
• G002 (Bermuda Grass): 89.4%
• W001 (Common Ragweed): 72.8%
• E005 (Dog Dander): 91.7%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 89.6%
• F002 (Cow's Milk): 64.5% |
  | Negative Agreement (vs. ImmunoCAP) | High, demonstrating comparability to predicate device | Varies by Allergen:
• G010 (Johnson Grass): 99.3%
• T007 (Oak): 94.6%
• G002 (Bermuda Grass): 96.8%
• W001 (Common Ragweed): 95.0%
• E005 (Dog Dander): 96.7%
• T003 (Common Silver Birch): 96.1%
• F001 (Egg White): 96.2%
• F002 (Cow's Milk): 98.9% |
  | Total Agreement (vs. ImmunoCAP) | High, demonstrating overall comparability | Varies by Allergen:
• G010 (Johnson Grass): 92.5%
• T007 (Oak): 88.5%
• G002 (Bermuda Grass): 93.8%
• W001 (Common Ragweed): 82.2%
• E005 (Dog Dander): 94.1%
• T003 (Common Silver Birch): 96.0%
• F001 (Egg White): 94.3%
• F002 (Cow's Milk): 86.9% |
  | Precision (Total %CV) | Typically low %CV for quantitative assays (e.g.,

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K-ASSAY® CRP (Ver.2) is intended to be used for the quantitative determination of C-reactive protein (CRP) in human serum and plasma (potassium-EDTA or lithium-heparin) by immunoturbidimetric assay. Measurement of CRP aids in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. FOR IN VITRO DIAGNOSTIC USE.

The K-ASSAY® CRP (Ver.2) assay quantifies C-reactive protein based on immunoturbidimetric assay. The reagent uses latex combined with goat polyclonal antibody specific to human CRP. By adsorbing CRP in the sample to the surface of the latex particles and reacting it with the anti-CRP antibody, specific aggregation corresponding to the CRP concentration occurs. Since the absorbance of the reaction changes in proportion to the amount of aggregation, the concentration of CRP in the sample is determined based on the calibration curve prepared using a standard of known CRP concentrations. The K-ASSAY® CRP (Ver.2) assay can be run using a chemistry analyzer. 6 levels of calibrators from the K-ASSAY® CRP Calibrator (Ver.2) calibrators are used for quantifying the levels of CRP present in the patient's sample.

This document describes the FDA 510(k) clearance for the K-ASSAY CRP (Ver.2) IVD device. This device is an in-vitro diagnostic test system, which means it analyzes biological samples in a lab setting rather than directly interacting with a patient.

Therefore, the concepts of "human readers," "AI assistance," "effect size," "multi reader multi case (MRMC) comparative effectiveness study," and "standalone (i.e. algorithm only without human-in-the loop performance)" are not applicable in this context. These terms are typically used for medical imaging AI/ML devices where human interpretation is involved.

For this in-vitro diagnostic device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to its analytical performance characteristics when compared to a predicate device, and the reported device performance refers to the results of these analytical studies.

Here's the breakdown of the information provided within the scope of this IVD device:

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD device like the K-ASSAY® CRP (Ver.2), the acceptance criteria are generally established by demonstrating equivalent or superior analytical performance compared to a legally marketed predicate device, and meeting established CLSI guidelines for accuracy, precision, linearity, and interference. The "reported device performance" refers to the actual study results for these characteristics.

• Within-Run CV: 0.8% to 2.2%
• Between-Run CV: 0.0% to 0.6%
• Within-Lot CV: 0.9% to 1.9%
• Between-Lot CV: 0.0% to 1.2%
• Total CV: 0.9% to 2.3%
  Multisite Precision (Combined Data From 3 Analyzers):
• Repeatability CV: 0.5% to 1.5%
• Between-Run CV: 0.0% to 1.1%
• Between-Day CV: 0.6% to 1.8%
• Between-Site CV: 0.9% to 1.8%
• Reproducibility CV: 1.1% to 2.5% |
  | Interference: No significant interference from common endogenous and exogenous substances (recovery within 10% of initial value). | Endogenous Substances (up to listed concentrations, no significant interference): Bilirubin C (40 mg/dL), Bilirubin F (40 mg/dL), Cholesterol (300 mg/dL), Hemoglobin (1,000 mg/dL), Intralipid (500 mg/dL), Rheumatoid Factor (1,000 IU/mL), Triglycerides (1,000 mg/dL).
  Exogenous Substances (up to listed concentrations, no significant interference): Acetaminophen (1.5 mM), Amoxicillin (400 µmol/L), Aspirin (3.6 mM), Cephalexin (360 µmol/L), Fluconazole (480 µmol/L), Ibuprofen (2.5 mg/dL), Methotrexate (1,400 µmol/L), Prednisolone (2 µmol/L), Vitamin C (500 mg/L). |
  | Method Comparison: Strong correlation and minimal bias against the predicate device. | Regression Equation: y = 1.005x - 0.002, r = 0.999 (n = 175 clinical native serum samples), where y = K-ASSAY® CRP (Ver.2), x = predicate device. |
  | Linearity: Demonstrates linearity across the claimed assay range. | Regression Equation: y = 0.9709x - 1.095, r = 0.999 (tested range: 4.6 - 441.2 mg/L). |
  | Limit of Quantitation (LoQ): Clinically acceptable LoQ (within-laboratory precision ≤ 20% CV). | Reported LoQ: 1.0 mg/L (highest observed across 3 reagent lots). Claimed LoQ: 5.0 mg/L. |
  | Matrix Comparison: No significant difference in results across different sample matrices (serum vs. plasma). | K2-EDTA Plasma vs Serum: y = 1.007x - 0.141, r = 0.999
  Li-Heparin Plasma vs Serum: y = 0.972x + 0.074, r = 0.999 |
  | Expected Values (Verification): Distribution in normal population consistent with clinical literature. | 168 normal U.S. serum samples tested; 4 out of 168 samples (>5.0 mg/L, 2.4%) consistent with literature (≤ 5 mg/L indicates apparently healthy). |

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

• Method Comparison: n = 175 clinical native serum samples.
• Linearity: The number of samples/dilutions used is not explicitly stated, but the tested range was 4.6 - 441.2 mg/L.
• Limit of Quantitation (LoQ): Not specified in terms of sample size for the LoQ determination itself (typically involves low-concentration samples measured multiple times).
• Matrix Comparison: 42 donor samples (each collected into 3 different tubes: serum, K2-EDTA plasma, Li-Heparin plasma).
• Precision (Single-site): For each of the 7 samples/controls, N=240 individual measurements (2 runs/day x 2 replicates/run x 20 days x 3 lots).
• Precision (Multisite): For each of the 7 samples/controls, N=75 individual measurements (1 run/day x 5 replicates/run x 5 days x 3 analyzers).
• Interference: The number of unique samples tested for interference is not explicitly stated. Typically, a few samples (e.g., low, medium, high concentration) are spiked with interferents and compared to unspiked controls.
• Expected Values: 168 normal serum samples.
• Data Provenance: The document states for "Expected Values" that 168 normal serum samples were "taken from healthy individuals in the U.S." This indicates a U.S. origin for at least this specific study. For other studies (Method Comparison, Precision, Linearity, Interference, Matrix Comparison), the specific country of origin is not mentioned. All studies are retrospectively analyzed in the sense that they were completed performance validation studies submitted to FDA.

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

For an in-vitro diagnostic device like this CRP assay, the "ground truth" is established through highly accurate and precise reference methods or established predicate devices, adhering to rigorous analytical chemistry best practices and guidelines (e.g., CLSI standards). There isn't a panel of human "experts" like radiologists interpreting images. The "ground truth" is quantitative and objective, derived from reference measurements.

In this case:

• Method Comparison: The predicate device (K-ASSAY® CRP (3), K023828) serves as the comparator for method comparison, which represents the established "ground truth" for clinical samples.
• Linearity, LoQ, Precision, Interference, Matrix Comparison: The "ground truth" for these analytical performance studies is established by rigorous laboratory protocols, highly calibrated equipment, reference materials, and adherence to CLSI guidelines. The performance is assessed against predefined statistical criteria rather than expert consensus on individual cases.
• Expected Values: The ground truth comes from established clinical literature and verified normal ranges based on studies of healthy populations.

4. Adjudication Method for the Test Set

Not applicable for an IVD device. Adjudication methods (e.g., 2+1, 3+1) are used in studies where subjective human interpretation (e.g., image reading) requires consensus building for ground truth establishment. For quantitative IVD assays, the results are numerical and objectively measured; therefore, there's no need for adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. As explained above, this is an in-vitro diagnostic device, not an imaging AI/ML device involving human readers.

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

Yes, in essence, all the analytical performance studies (Method Comparison, Linearity, LoQ, Precision, Interference, Matrix Comparison) are "standalone" in nature for an IVD. The device's performance is evaluated based solely on its ability to accurately and precisely measure CRP concentrations in samples, without any human interpretation of the measurement itself or the involvement of an "algorithm" in the AI/ML sense. The device directly processes the sample and outputs a quantitative result.

7. The Type of Ground Truth Used

The ground truth for this IVD device's performance studies is primarily based on:

• Reference Method/Predicate Device Comparison: For the method comparison study, the predicate device serves as the reference against which the new device's measurements are compared.
• Reference Materials and Calibrators: For linearity, LoQ, and precision studies, the ground truth for concentration values is established using certified reference materials and meticulously prepared calibrators with known concentrations.
• Spiked Samples: For interference studies, known amounts of interfering substances are added to samples, and the true CRP concentration (before interference) serves as the baseline ground truth.
• Clinical Literature/Established Norms: For "Expected Values," the ground truth is derived from widely accepted clinical ranges and population studies cited in the literature.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for a traditional IVD device, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its chemical and physical principles (latex-enhanced immunoturbidimetric assay) and validated through the analytical studies detailed.

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

Not applicable, as there is no "training set" for this type of IVD device.

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The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from salva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).

The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person's overall risk of developing celiac disease. This report is most relevant for people of European descent.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "GlutenID Celiac Genetic Health Risk Test" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The letter is a formal notification of clearance, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as:

• The trade name and regulation details.
• General controls provisions and additional controls for Class II/III devices.
• Applicable regulations like Quality System (QS), Medical Device Reporting (MDR), and Unique Device Identification (UDI).
• Contact information for the FDA.
• The Indications for Use statement.

The document does NOT include information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, their provenance, or whether they were retrospective/prospective.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was performed or its effect size.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

This kind of detailed study information is typically found in the 510(k) submission itself, often in a more extensive "Summary of Safety and Effectiveness" or a dedicated study report, which is not part of this specific FDA clearance letter.

Therefore, I cannot fulfill your request based solely on the provided text.

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The Aptiva APS IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (all2GPI) IgG autoantibodies in human serum as an aid in the diagnosis of primary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.

The Aptiva APS IgG Reagent is intended for use with the Aptiva System.

The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.

The Aptiva APS IgM Reagent is intended for use with the Aptiva System.

The Aptiva APS IgG and Aptiva APS IgM reagent utilize particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (anti-cardiolipin [aCL] and anti-B2-Glycoprotein I [aB2GPI]) in the Aptiva APS IgG and Aptiva APS IgM reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG or human IgM capture antibody (IgG or IgM Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube.

The Aptiva instrument is a fully automated, random-access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface.

The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using a buffer located within the cartridge.

The Aptiva System dilutes the sample 1:8, then combines an aliquot of diluted sample, and reagent into a cuyette. The mixture is incubated at 37°C. After a wash cvcle, conjugated antihuman IgG or IdM antibodies are added to the particles and this mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle, and the particles are re-suspended in system fluid.

Multiple images are generated by the system to identify and count the two (2) unique analyte particles, as well as determine the amount of coniugate on each particle. Coated with goat anti-human lgG or IdM antibodies, is present as a control to flaq low concentrations of IgG or IgM in the sample as an assay verification step. The median fluorescent intensity (MFI) for each analyte is proportional to the concentration of conjugate bound to human IgG or IgM, which is proportional to the concentration of IgG or IgM antibodies bound to the corresponding particle population. The system uses the MFI from at least 50 particles of each population. The identity of the particles is determined by the unique signature of the particles.

Each analyte in the Aptiva APS IgG Reagent and the Aptiva APS IgM Reagent is assigned a predefined lot specific master curve. The analyte specific master curve is stored on the reagent cartridge RFID label. Based on results obtained by running calibrators (supplied separately), the system creates individual working curves. Working curves are used by the software to calculate Fluorescent Light Units (FLU) for each analyte from the MFI values obtained for each sample.

Aptiva APS IgG and Aptiva APS IgM Calibrators and Aptiva APS IgG and Aptiva APS IgM Controls are sold separately.

The provided text describes the analytical and clinical performance characteristics of the Aptiva APS IgG and Aptiva APS IgM Reagents, which are immunoassays for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgG/IgM autoantibodies. This information is presented in the context of a 510(k) premarket notification for FDA clearance.

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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as a separate, quantified set of thresholds for each performance metric. Instead, it presents the results of various analytical and clinical studies, implying that these results met the internal criteria for substantial equivalence to predicate devices and overall performance claims for an in vitro diagnostic (IVD) device.

However, we can infer performance targets based on the presented data and the overall context of an FDA submission for an IVD. The primary performance metrics presented are related to precision, detection limits, linearity, interference, and clinical sensitivity/specificity.

Inferred Acceptance Criteria and Reported Device Performance (Summary)

• aCL IgG: 5.6% - 9.5% (generally decreasing with higher FLU)
• aβ2GPI IgG: 6.9% - 11.7% (generally decreasing with higher FLU)
• aCL IgM: 4.3% - 9.7% (generally decreasing with higher FLU)
• aβ2GPI IgM: 5.5% - 10.2% (generally decreasing with higher FLU)

Between-Site Reproducibility CV% (3 sites):

• aCL IgG: 5.2% - 9.3%
• aβ2GPI IgG: 6.4% - 10.0%
• aCL IgM: 5.4% - 10.0%
• aβ2GPI IgM: 5.9% - 10.5%

Between-Lot Reproducibility CV% (3 lots):

• aCL IgG: 6.6% - 13.3%
• aβ2GPI IgG: 8.5% - 12.1%
• aCL IgM: 6.1% - 11.4%
• aβ2GPI IgM: 6.0% - 10.5% |
  | Limit of Blank (LoB) | Very low, close to zero, ensuring no signal from blank samples. | aCL IgG: 0.00 FLU
  aβ2GPI IgG: 0.02 FLU
  aCL IgM: 0.01 FLU
  aβ2GPI IgM: 0.03 FLU |
  | Limit of Detection (LoD)| Low, indicating ability to detect small amounts of analyte. | aCL IgG: 0.07 FLU
  aβ2GPI IgG: 0.09 FLU
  aCL IgM: 0.04 FLU
  aβ2GPI IgM: 0.06 FLU |
  | Limit of Quantitation (LoQ)| Low, defining the lowest concentration that can be reliably quantified. | aCL IgG: 0.29 FLU
  aβ2GPI IgG: 0.21 FLU
  aCL IgM: 0.06 FLU (set to 0.10 FLU for AMR lower limit)
  aβ2GPI IgM: 0.09 FLU (set to 0.10 FLU for AMR lower limit) |
  | Analytical Measuring Range (AMR)| Wide enough to cover relevant clinical concentrations, with demonstrated linearity. | aCL IgG: 0.29 - 328.94 FLU
  aβ2GPI IgG: 0.21 - 256.70 FLU
  aCL IgM: 0.10 – 114.68 FLU
  aβ2GPI IgM: 0.10 – 95.86 FLU

Linearity demonstrated across these ranges with R2 values mostly ≥ 0.98. |
| High Concentration Hook Effect| No hook effect within or above the AMR. | Confirmed no hook effect up to theoretically calculated values: aCL IgG: 2645.36 FLU, aβ2GPI IgG: 1790.48 FLU, aCL IgM: 167.25 FLU, aβ2GPI IgM: 126.13 FLU. |
| Interference | No significant interference from common endogenous or exogenous substances at specified concentrations. | No interference detected for aCL IgG, aβ2GPI IgG, aCL IgM, and aβ2GPI IgM with tested interferents (bilirubin, hemoglobin, triglycerides, cholesterol, RF IgM, human IgG, ibuprofen, warfarin, prednisone, acetaminophen, aspirin, hydroxychloroquine, omeprazole, simvastatin, heparin) at their respective tested concentrations. Percent recoveries or FLU differences were within acceptable ranges (generally close to 100% recovery for spiked samples, or low FLU difference for negative samples). |
| Sample Stability | Samples should be stable for specific storage conditions and freeze/thaw cycles. | Samples stable up to 48 hours at room temperature, up to 14 days at 2-8°C, and for up to 5 freeze/thaw cycles. |
| Reagent Stability | Reagent shelf-life and in-use stability should be established. | Shelf-life: 9 months for Aptiva APS IgG Reagent, 7 months for Aptiva APS IgM Reagent (based on accelerated stability, verified by ongoing real-time studies).
In-use (onboard) stability: 28 days for both, with 14-day recalibration. |
| Clinical Sensitivity & Specificity| High sensitivity to detect disease (APS) and high specificity to correctly identify non-disease states (controls/non-APS). | Aptiva APS IgG:

• aCL IgG: Sensitivity 54.1% (95% CI: 45.3–62.7%), Specificity 99.5% (95% CI: 98.2–99.9%)
• aβ2GPI IgG: Sensitivity 53.3% (95% CI: 44.5-61.9%), Specificity 99.0% (95% CI: 97.5-99.6%)

Aptiva APS IgM:

• aCL IgM: Sensitivity 27.5% (95% CI: 22.7–32.9%), Specificity 97.5% (95% CI: 95.4–98.6%)
• aβ2GPI IgM: Sensitivity 24.7% (95% CI: 20.1–30.0%), Specificity 98.5% (95% CI: 96.8–99.3%) |
  | Predicate Method Comparison (Percent Agreement)| High agreement with legally marketed predicate devices. | Aptiva APS IgG (aCL IgG) vs. QUANTA Flash aCL IgG: PPA: 81.6%, NPA: 95.7%, TPA: 93.1% (N=202)
  Aptiva APS IgG (aβ2GPI IgG) vs. QUANTA Lite Beta 2GP1 IgG ELISA: PPA: 88.0%, NPA: 89.7%, TPA: 88.9% (N=108)
  Aptiva APS IgM (aCL IgM) vs. QUANTA Flash aCL IgM: PPA: 87.0%, NPA: 90.2%, TPA: 89.8% (N=422)
  Aptiva APS IgM (aβ2GPI IgM) vs. QUANTA Flash β2GPI IgM: PPA: 88.9%, NPA: 84.3%, TPA: 84.8% (N=244) |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Performance Test Set Sample Sizes:

  • Aptiva APS IgG (aCL IgG & aβ2GPI IgG): N=526 (122 APS combined, 404 controls/non-APS)
  • Aptiva APS IgM (aCL IgM & aβ2GPI IgM): N=689 (291 APS combined, 398 controls/non-APS)
  • Normal Population for Expected Values: N=200 apparently healthy blood donors.

• Method Comparison Test Set Sample Sizes:

  • Aptiva APS IgG (aCL IgG vs. QUANTA Flash aCL IgG): N=202
  • Aptiva APS IgG (aβ2GPI IgG vs. QUANTA Lite Beta 2GP1 IgG ELISA): N=108
  • Aptiva APS IgM (aCL IgM vs. QUANTA Flash aCL IgM): N=422
  • Aptiva APS IgM (aβ2GPI IgM vs. QUANTA Flash β2GPI IgM): N=244

• Analytical Performance Test Set Sample Sizes:

  • Precision: 7 samples for IgG, 7 samples for IgM (80 replicates each for within-lab; 75 replicates each for between-site/lot reproducibility from multiple sites/lots).
  • LoB/LoD/LoQ: Blanks (LoB: 4 samples, 60 data points/lot); Low-level samples (LoD/LoQ: 4 samples, 120 data points/assay/lot).
  • Interference: 6 human specimens (negative, cutoff, positive) for each analyte, spiked with various interferents and tested in 5 replicates.
  • Sample Stability: 5 serum samples (IgG), 5 serum samples (IgM) tested in duplicates over time/cycles.
  • In-use Stability: 11 samples (IgG), 7 samples (IgM) tested periodically.

• Data Provenance: The document states that a "cohort of characterized samples, none of which were used for establishing the reference range, was used to validate the clinical performance." It does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. However, for a 510(k) submission, clinical validation studies typically involve retrospective or prospectively collected clinical samples, but the exact nature (e.g., specific clinical sites, patient populations beyond disease groups) and geographic origin are not detailed here. The studies were likely conducted within a controlled laboratory setting by the manufacturer (Inova Diagnostics, Inc. in San Diego, CA) or its affiliates, using sourced human serum samples.

3. 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)

The establishment of "ground truth" for IVD devices like these typically relies on well-characterized clinical samples and established diagnostic criteria for the disease (Antiphospholipid Syndrome - APS).

• The document states that the clinical performance validation was performed using "a cohort of characterized samples." The characterization of these samples (i.e., whether they definitively represent APS or control) would serve as the ground truth.
• However, the document does not specify the number of experts or their qualifications (e.g., rheumatologists, clinical immunologists/pathologists) who established the diagnostic status (ground truth) of the clinical samples (APS vs. control) used in the clinical sensitivity and specificity studies. It is implied that these were "characterized samples," meaning their disease status was determined by established clinical and laboratory criteria, likely involving clinical consensus or previous diagnoses.
• For cut-off establishment, the reference population included "apparently healthy subjects," and the "internal APS samples (data not provided)" and "distribution of result values of healthy controls" were used. This suggests clinical characterization of these samples.

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

The concept of "adjudication method" (like 2+1 or 3+1) is typically relevant for interpretative tasks, such as reading medical images, where multiple human readers interpret the same data and their interpretations need to be reconciled to establish a ground truth.

For these types of IVD assays, ground truth for clinical performance is established based on the clinical diagnosis of the patient from whom the sample was collected. This diagnosis is usually a culmination of clinical findings, established criteria (e.g., the revised Sapporo criteria for APS), and other laboratory tests, rather than an "adjudication" of multiple independent interpretations of the test results themselves.

Therefore, the document does not mention any adjudication method in the context of establishing ground truth for the test samples, as it's not applicable in the same way it would be for an AI-medical imaging device. The "ground truth" for the samples (APS vs. non-APS) is assumed to be pre-established clinical diagnosis.

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 MRMC study was conducted or is applicable here.

This device is an in vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or diagnostic aid that assists human readers (e.g., radiologists interpreting images). The device directly measures biomarker levels in a sample, and its output is a quantitative value (FLU) which then determines a semi-quantitative result (Positive/Negative/Indeterminate based on cut-offs). Human "readers" (laboratory personnel) operate the instrument and interpret the final quantitative results based on predefined cut-offs, but they are not subjectively interpreting complex data that AI would assist with, in the sense of an MRMC study.

Therefore, an MRMC comparative effectiveness study, and an effect size related to human reader improvement with AI assistance, are not relevant for this type of device and are not mentioned in the document.

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

This is a "standalone" device in terms of its core functionality, but the term "algorithm only" or "human-in-the-loop" isn't directly analogous.

• The Aptiva System is a fully automated, random-access analyzer (page 6). This means the instrument itself, with its integrated software and optical module, processes the samples, runs the reagents, and reports results independently after the sample is loaded and the assay initiated.
• The "performance" described here (sensitivity, specificity, precision, linearity, etc.) is the device's performance (including its internal algorithms and mechanics) in generating quantitative results. There isn't a separate "algorithm only" performance that needs to be differentiated from a "human-in-the-loop" performance, because the device is the automated system determining the FLU values. The human interaction is primarily in sample loading, reagent handling, and result review/reporting, not in interpreting raw data that the device itself would also interpret in an unassisted mode.

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

The ground truth for the clinical performance studies (sensitivity and specificity) was established based on "characterized samples" representing patients with Antiphospholipid Syndrome (APS) and various control groups (patients with other autoimmune/infectious diseases, apparently healthy subjects).

While the document doesn't explicitly state "expert consensus," it's highly implied that the "characterization" of these samples as APS or control would be based on:

• Clinical findings: Presenting symptoms, medical history.
• Other laboratory findings: Beyond the novel antibodies, other relevant diagnostic tests.
• Established diagnostic criteria: For APS, this would typically be the revised Sapporo classification criteria, which combine clinical and laboratory criteria.

So, it's a combination of established clinical diagnoses and potentially other laboratory data, which implicitly would involve the consensus or findings of medical experts involved in patient diagnosis. It is not based on pathology (e.g., tissue biopsy) or outcomes data (e.g., long-term disease progression as the sole ground truth).

8. The sample size for the training set

The document describes the submission of a "new device" and its performance characteristics. It does not explicitly mention or quantify a "training set" in the context of machine learning.

For IVD devices, a "training set" isn't a standard concept unless the device incorporates adaptive algorithms or AI that learns from data. In this case, the device is an immunoassay with predefined master curves and calibrated reagents. The master curves are generated "at Inova for each reagent lot, where in-house Master Curve Standards with assigned FLU values are run multiple times." These "in-house Master Curve Standards" could be considered analogous to a "training" or calibration process, but it's not a dataset for training a generalized AI model but rather for calibrating each reagent lot of a classical assay.

The sample sizes provided in the document are for:

• Analytical performance (precision, LoB/LoD/LoQ, linearity, interference, stability).
• Clinical validation (sensitivity/specificity studies).
• Method comparison studies.
• Reference range establishment.

None of these are explicitly labeled as a "training set."

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

As there is no explicitly defined "training set" for a machine learning model, the concept of establishing ground truth for such a set is not applicable here.

However, if we consider the "Master Curve Standards" as analogous to calibration/training data for the assay, their "ground truth" (assigned FLU values) would be established through a rigorous internal process by the manufacturer (Inova Diagnostics) based on:

• Carefully prepared and characterized aliquots (standards) with known or assigned concentrations of the target antibodies.
• Repeat measurements and statistical analysis for consistent and accurate assignment of FLU values.
• This is a standard practice for calibrating quantitative IVD assays, ensuring the device outputs accurate and traceable results.

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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:

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