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The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.

The IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 High Sensitivity CRP assays are immunological test systems designed for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma. These devices are intended to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, associated diseases, and in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used with traditional clinical evaluations of acute coronary syndrome, may also serve as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

1. Table of Acceptance Criteria and Reported Device Performance:

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The IMMULITE® 2000 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE® 2500 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE 2000, IMMULITE 2500 Vancomycin assay is a solid phase competitive chemiluminescent enzyme immunoassay. The solid phase (bead) is coated with ligandlabeled vancomycin. The reagent contains alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine antivancomycin in the patient sample competes with the ligand-labeled solid phase for vancomycin binding sites on the monoclonal murine anti-vancomycin enzyme conjugate. The excess sample and reagent are removed by a centrifugal wash. Finally, chemiluminescent substrate is added to the bead and signal is generated in proportion to the bound enzyme. The assay includes an automatic on-board predilution of 1/20 prior to immunoreaction. Immunoreaction incubation time is 30 minutes. The sample volume required is 10 µL for the test and 250 uL dead volume. The sample types are serum and plasma (heparin or EDTA).

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_table": [
      {
        "Criterion": "Reportable Range",
        "Acceptance Criteria": "Not explicitly stated as a separate acceptance criterion, but the reported range is 3.0 µg/mL – 50 µg/mL.",
        "Reported Device Performance": "3.0 µg/mL – 50 µg/mL for both IMMULITE 2000 and IMMULITE 2500 Vancomycin assays."
      },
      {
        "Criterion": "Limit of Blank (LoB)",
        "Acceptance Criteria": "The highest value expected to be seen in a series of results for samples that contain no analyte, based on CLSI guideline EP17-A. Computed as mean CPS - 1.65 * total SDcps, then converted to vancomycin dose.",
        "Reported Device Performance": "0.4 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Limit of Detection (LoD)",
        "Acceptance Criteria": "The actual concentration at which an observed test result is likely to exceed the Limit of Blank (LoB) and may therefore be declared as detected, based on CLSI guideline EP17-A. Formula: LoD = LoB + 1.65 * SD.",
        "Reported Device Performance": "0.9 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Precision (IMMULITE 2000)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 47 µg/mL should not be greater than 10.2% and 6.8%, respectively.",
        "Reported Device Performance": "Max statistics across 3 lots show intra-assay CV% not greater than 10.2% and inter-assay CV% not greater than 6.8% over the range of approximately 5 to 47 µg/mL."
      },
      {
        "Criterion": "Precision (IMMULITE 2500)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 45 µg/mL should not be greater than 6.1% and 6.0%, respectively.",
        "Reported Device Performance": "Max statistics for one kit lot show intra-assay CV% not greater than 6.1% and inter-assay CV% not greater than 6.0% over the range of approximately 5 to 45 µg/mL."
      },
      {
        "Criterion": "Linearity (Average Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable for patient samples. The reported value is 96.0%.",
        "Reported Device Performance": "Average recovery for patient samples tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay was 96.0%."
      },
      {
        "Criterion": "Spiked Recovery (Average % Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable. The reported value is 101%.",
        "Reported Device Performance": "Average % recovery for spiked patient samples was 101%."
      },
      {
        "Criterion": "Interfering Substances (Bilirubin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Bilirubin up to 20 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Hemoglobin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Hemoglobin up to 600 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Triglycerides)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Triglycerides up to 3000 mg/dL."
      },
      {
        "Criterion": "Cross-Reactivity",
        "Acceptance Criteria": "No detectable cross-reactivity to various potential cross-reactants when vancomycin-spiked human serum sample is tested.",
        "Reported Device Performance": "No detectable cross-reactivity to a long list of substances (e.g., Acetaminophen, Amikacin, etc.) at high concentrations (typically 500 µg/mL), or Teicoplanin/CDP-1 at relevant concentrations."
      },
      {
        "Criterion": "Interference (HAMA/RF)",
        "Acceptance Criteria": "No detectable interference from HAMA or Rheumatoid Factor (RF) in tested samples.",
        "Reported Device Performance": "No detectable interference from HAMA (up to 1880 ng/mL) and RF (up to 2330 IU/mL)."
      },
      {
        "Criterion": "Sample Type Correlation (SST Serum vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For SST vs Serum: slope 1.00 (95% CI: 0.96 to 1.05), intercept -0.07 (95% CI: -1.43 to 1.28), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X - 0.07; slope = 1.00 (95% CI: 0.96 to 1.05); intercept = -0.07 (95% CI: -1.43 to 1.28); r = 0.99. Deming Regression: Y= 1.01 X - 0.28; slope = 1.01 (95% CI: 0.97 to 1.06); intercept = - 0.28 (95% CI: - 1.64 to 1.09)."
      },
      {
        "Criterion": "Sample Type Correlation (Lithium Heparin vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For Lithium Heparin vs Serum: slope 1.02 (95% CI: 0.97 to 1.06), intercept 0.03 (95% CI: -1.25 to 1.30), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y=1.02 X + 0.03; slope = 1.02 (95% CI: 0.97 to 1.06); intercept = 0.03 (95% CI: -1.25 to 1.30); r = 0.99. Deming Regression: Y= 1.02 X - 0.15; slope = 1.02 (95% CI: 0.98 to 1.06); intercept = - 0.15 (95% CI: -1.43 to 1.14)."
      },
      {
        "Criterion": "Sample Type Correlation (EDTA vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For EDTA vs Serum: slope 1.00 (95% CI: 0.96 to 1.04), intercept 0.001 (95% CI: -1.19 to 1.19), r= 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X + 0.001; slope = 1.00 (95% CI: 0.96 to 1.04); intercept = 0.001 (95% CI: -1.19 to 1.19); r= 0.99. Deming Regression: Y=1.01 X - 0.15; slope =1.01 (95% CI: 0.97 to 1.05); intercept = - 0.15 (95% CI: - 1.35 to 1.05)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2000 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.971. Slope = 1.022 (95% CI: 0.983 to 1.061), Intercept = 0.727 (95% CI: 0.060 to 1.394)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.966. Slope = 1.028 (95% CI: 0.985 to 1.071), Intercept = 0.495 (95% CI: -0.236 to 1.226)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs IMMULITE 2000)",
        "Acceptance Criteria": "High correlation (r=0.970) between methods, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.970. Slope = 0.981 (95% CI: 0.943 to 1.019), Intercept = 0.170 (95% CI: -0.526 to 0.866)."
      },
      {
        "Criterion": "Assay Kit Stability",
        "Acceptance Criteria": "Support a claim of 360 days shelf life when stored at 2-8°C, based on real-time and accelerated stress studies.",
        "Reported Device Performance": "Results of real-time and accelerated stress studies support the claim of 360 days shelf life for the assay kits when stored at 2-8°C."
      }
    ],
    "2_sample_size_and_data_provenance_test_set": {
      "Limit of Blank": {
        "Sample Size": "60 replicates of a zero analyte heparin plasma and serum sample, and the assay zero calibrator. Assayed across 3 IMMULITE 2000 kit lots (with 3 instruments per lot) and 1 IMMULITE 2500 kit lot (with 3 instruments per lot).",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Limit of Detection": {
        "Sample Size": "Five different samples with low concentrations of vancomycin (>0.4 ug/mL to 1.6 ug/mL). Assayed using 3 IMMULITE 2000 kit lots (2 instruments per lot) and 1 IMMULITE 2500 kit lot (2 instruments per lot). Eight runs of 2 replicates per sample over 8 separate days.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Precision": {
        "Sample Size": "Two aliquots of each test sample in two runs per day over 20 different days, for a total of 80 replicates per test sample per lot. Three different kit lots on IMMULITE 2000 platform and one lot on IMMULITE 2500, with two instruments used per lot. Precision pools targeted 5, 10, 20, 30, and 45 µg/mL.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Linearity": {
        "Sample Size": "10 patient samples (neat, 4 in 8, 2 in 8 and 1 in 8 dilutions) across the therapeutic range (9 to 46 ug/mL). Each assayed in triplicate.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Spiked Recovery": {
        "Sample Size": "6 patient sample pools spiked with various concentrations of 3 different spiking solutions.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Interfering Substances/Cross-Reactivity/HAMA/RF": {
        "Sample Size": "Varies by substance. Typically, neat normal human serum and human serum spiked with 25 ug/mL vancomycin, spiked with the potential interfering substance. Assayed in 2 replicates. For HAMA/RF, 6 normal human samples for HAMA, 5 RF-positive human samples and 1 normal for RF.",
        "Data Provenance": "Human serum samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Alternate Sample Types (Correlation Study)": {
        "Sample Size": "SST vs Serum: N=33. Lithium Heparin vs Serum: N=32. EDTA vs Serum: N=31. Matched sets of human serum, SST, lithium heparin and EDTA samples spiked with various concentrations of vancomycin. Each run in duplicate.",
        "Data Provenance": "Human samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Clinical Sample Population (Method Comparison)": {
        "Sample Size": "IMMULITE 2000 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs IMMULITE 2000: N=164 endogenous serum patient samples.",
        "Data Provenance": "Endogenous serum from patients being treated with vancomycin. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      }
    },
    "3_number_and_qualifications_of_experts_ground_truth": "N/A. This document describes the validation of an in vitro diagnostic assay (a laboratory test) for quantitative measurement of vancomycin. The 'ground truth' for this type of device is typically established through analytical methods and comparisons to a predicate device, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device (AxSYM® Vancomycin II) serves as the reference for method comparison.",
    "4_adjudication_method_test_set": "N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology diagnosis) to establish ground truth from multiple readers. This document describes analytical performance studies of a quantitative assay, where objective measurements are compared against reference methods or established analytical criteria. No human adjudication is mentioned or implied.",
    "5_mrmc_comparative_effectiveness_study": "No. This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers. The studies focus on the analytical performance of the device and its comparison to a predicate device, not on human-in-the-loop performance or the effect size of AI assistance for human readers.",
    "6_standalone_performance_study": "Yes. The entire document describes standalone performance studies of the IMMULITE 2000/2500 Vancomycin assays. The reported metrics (e.g., Limit of Blank, Limit of Detection, Precision, Linearity, Spiked Recovery, Interference, Cross-Reactivity, Sample Type Correlation, Method Comparison) represent the algorithm's (assay's) performance without human intervention in the measurement process, beyond initiating the automated assay and interpreting the quantitative result.",
    "7_type_of_ground_truth_used": "The ground truth for the analytical and method comparison studies relies on several approaches:\n\n*   **CLSI Guidelines:** For LoB and LoD, the 'ground truth' calculation methodology is defined by CLSI guidelines (EP17-A). Precision is guided by CLSI EP5-A2.\n*   **Analytical Standards/Spiking:** For linearity, spiked recovery, interfering substances, and cross-reactivity, ground truth is established by preparing samples with known, precise concentrations of vancomycin or potential interferents.\n*   **Predicate Device:** For method comparison and sample type correlation, the predicate device (Abbott AxSYM Vancomycin II) or the serum sample type (for correlation studies) serves as the reference or 'ground truth' method against which the new device's measurements are compared. This demonstrates substantial equivalence.",
    "8_sample_size_training_set": "N/A. For these in vitro diagnostic assays, the concept of a 'training set' in the machine learning sense is not directly applicable. The assay 'learns' and establishes its Master Curve at the site of manufacture using calibrators, which are not provided to customers. The document states that calibrators are used at the site of manufacture to establish the Master Curve. The specific sample size for this manufacturing calibration process is not provided in the document.",
    "9_how_ground_truth_for_training_set_was_established": "N/A. Similar to the training set concept, the 'ground truth' for the manufacturing calibration is established internally by DPC based on their proprietary calibration process using reference materials (Vancomycin adjustors and calibrators). The document states: \"In all IMMULITE platform instruments, calibrators are used at the site of manufacture to establish the Master Curve, which is encoded in the kit barcode label.\" The calibrators themselves are likely traceable to recognized reference standards for vancomycin concentration, establishing their 'ground truth'."
  }
}

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The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

IMMULITE 2500 Vitamin B12 is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 Folic Acid is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

The provided text is a 510(k) summary for the IMMULITE 2500 Vitamin B12 and IMMULITE 2500 Folic Acid assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with specific acceptance criteria and detailed performance statistics as might be found in a PMA submission or a full clinical study report.

Therefore, the document does not contain the detailed information required to fill out all sections of your request. Specifically, it lacks:

• Explicit acceptance criteria: While the claim of "substantial equivalence" implies that performance is comparable to the predicate, specific quantitative acceptance criteria for each analytical performance parameter are not listed.
• Detailed study results (test set sample size, provenance, ground truth establishment, expert details, adjudication methods, MRMC studies, standalone performance): The summary states the conclusion of substantial equivalence based on information presented in the Special 510(k), but it doesn't provide the raw data, study design, or methodology for how that equivalence was demonstrated in terms of clinical performance or specific analytical studies for new aspects of the device. Special 510(k)s often refer to changes that do not affect the intended use or fundamental scientific technology, relying on previous data and analytical verification.
• Training set details: Information on a separate training set is not present as this is typically required for AI/ML device submissions, which this is not.

Based on the information available:

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

This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (IMMULITE 2000 Vitamin B12 and IMMULITE 2000 Folic Acid), implying that its performance is critically comparable to that predicate. Specific numerical acceptance criteria and detailed performance results of verification and validation studies are not included in this summary document. Performance data would typically be found in the manufacturer's internal validation reports, which are not publicly available in this summary.

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

This information is not provided in the given 510(k) summary.

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):

This information is not applicable as this device is an in-vitro diagnostic test for quantitative measurement of biomarkers, not an imaging device requiring expert interpretation for ground truth establishment.

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

This information is not applicable as this device is an in-vitro diagnostic test.

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

This information is not applicable. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable in the context of an "algorithm only" performance for an IVD test in the same way it would be for an AI/ML device. The device's performance is intrinsically standalone as it quantitatively measures a biomarker. The summary implies the device's analytical performance (accuracy, precision, linearity, etc.) was assessed, but details are not provided here.

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

For an in-vitro diagnostic device like IMMULITE 2500 Vitamin B12, the "ground truth" would typically refer to the true concentration of Vitamin B12 in a sample. This "ground truth" is usually established through:

• Reference Methods: Comparison against established, highly accurate reference methods, often involving mass spectrometry or validated laboratory methods.
• Certified Reference Materials: Using materials with known, accurately assigned concentrations of the analyte.
• Spiked Samples: Samples artificially augmented with known amounts of the analyte.

The specific methods used to establish this "ground truth" for the performance studies are not detailed in this 510(k) summary.

8. The sample size for the training set:

This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.

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

This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.

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For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively.

IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.

Here's an analysis of the IMMULITE®/IMMULITE® 1000 Turbo Intact PTH device's acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

IMMULITE 2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

Please note that the provided text describes an in vitro diagnostic (IVD) device, which measures biomarkers in patient samples. Such devices are evaluated based on analytical performance criteria (e.g., accuracy, precision, linearity, limits of detection) rather than clinical performance criteria like those for AI/ML-driven diagnostic aids. Therefore, many of the requested fields (multi-reader multi-case studies, expert adjudication, ground truth definition for training sets, effect size of human readers improving with AI) are not applicable to this type of device and will be marked as "N/A".

Here's an analysis of the provided text based on your request:

Device Name: IMMULITE® 2500 CK-MB, IMMULITE® 2500 Myoglobin, IMMULITE® 2500 STAT Troponin I

Device Type: In vitro diagnostic (IVD) chemiluminescent enzyme immunoassays for the quantitative measurement of cardiac biomarkers.

Intended Use:

• IMMULITE 2500 CK-MB: Quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
• IMMULITE 2500 Myoglobin: Quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
• IMMULITE 2500 STAT Troponin I: Quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

1. Table of Acceptance Criteria and the Reported Device Performance

The provided 510(k) summary documents typically focus on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and often summarize the analytical performance data without listing specific pre-defined acceptance criteria values alongside achieved performance. The document states that "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence." This implies that the presented data met the FDA's requirements for substantial equivalence, which would include acceptable analytical performance.

However, specific quantitative acceptance criteria (e.g., "bias must be less than X%", "CV must be less than Y%") are not explicitly stated in this summary document. The document refers to the data being sufficient for FDA clearance rather than providing a detailed breakdown of acceptance criteria and performance against those criteria.

Note: For IVD devices, acceptance criteria typically include parameters like:

• Precision/Reproducibility: Within-run, between-run, total precision (e.g., %CV at various concentrations).
• Accuracy/Method Comparison: Correlation and agreement with a reference method or predicate device (e.g., Deming regression analysis, absolute bias).
• Linearity/Analytical Measurement Range: The range over which results are proportional to the analyte concentration.
• Limit of Detection (LoD) / Limit of Quantitation (LoQ): The lowest concentration that can be reliably detected/quantified.
• Interferences: Effects of common interfering substances (hemolysis, lipemia, icterus, etc.).
• Specificity: Cross-reactivity with structurally similar compounds.
• Stability: Reagent and calibration stability.

Since these specific quantitative criteria and results are not detailed in the provided text, a comprehensive table cannot be generated. The document only confirms that "The data presented [...] is the data that the Food and Drug Administration used in granting DPC substantial equivalence."

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

The document does not explicitly state the sample sizes used for the analytical performance studies (test sets) or the provenance (country of origin, retrospective/prospective nature) of the samples. For IVD devices, samples are typically patient samples (serum, plasma) collected under defined protocols to assess analytical performance.

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

N/A. For IVD assays measuring biomarkers, "ground truth" is typically established by reference methods, comparison to predicate devices, or clinical diagnosis. The analytical performance studies do not involve experts establishing a "ground truth" in the way a radiological image interpretation study would.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1 or 3+1) are common in image interpretation studies or clinical trials where expert consensus is needed to define a ground truth from subjective assessments. This is not applicable to quantitative biomarker measurements in IVD devices.

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

N/A. This is an IVD device measuring biomarkers, not an AI-driven image analysis tool or decision support system that would involve human "readers" or AI assistance.

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

Yes, in a sense, the device operates in a standalone manner as an automated immunoassay system. The analytical performance studies evaluate the device's ability to accurately and precisely measure the target biomarkers in biological samples without direct human-in-the-loop interpretational performance being part of the primary evaluation. The "performance" here refers to the analytical performance of the assay itself.

7. The type of ground truth used

For these IVD products, the "ground truth" for evaluating analytical performance is typically:

• Reference methods: Highly accurate and precise laboratory methods.
• Predicate device comparison: Measurement of the same samples on a legally marketed, substantially equivalent predicate device.
• Assigned values: For quality control materials or calibrators, values might be assigned through rigorous consensus or characterization methods.
• Clinical diagnosis: While not directly establishing "ground truth" for the biomarker level itself, samples may be derived from patients with confirmed clinical diagnoses (e.g., AMI positive, non-AMI negative) to assess clinical performance characteristics (e.g., diagnostic sensitivity and specificity), though this specific detail is not provided in the summary.

The document implicitly suggests that the ground truth was established through comparison with the predicate devices (IMMULITE/IMMULITE 1000 Turbo CK-MB, IMMULITE/IMMULITE 1000 Turbo Myoglobin, IMMULITE/IMMULITE 1000 Turbo Troponin I), common practice for demonstrating substantial equivalence.

8. The sample size for the training set

N/A. This is an immunoassay kit, not an AI/ML device that requires a training set in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and assay protocols.

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

N/A. As above, the concept of a "training set" and establishing ground truth for it is not applicable to a traditional immunoassay. Assay development involves optimizing reagents and parameters to achieve desired analytical performance characteristics.

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The DPC IMMULITE 2500 analyzer is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE 2000. The intent of the system is to impart the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE 2000. Examples of the array of assays to be used with the DPC IMMULITE 2500 are two for which data in support of a claim of substantial equivalence have been submitted to FDA: hCG (product code: DHA) and TSH (JLW). The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the predicate system, IMMULITE 2000.

The IMMULITE® 2500 is an Automated Immunoassay Analyzer. It is a discrete photometric chemistry analyzer for clinical use intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The IMMULITE 2500 uses ¼ inch polystyrene antibody coated beads and assay specific antibody or antigen labeled with alkaline phosphatase. The chemiluminescent detection system is a phosphate ester stabilized dioxetane. Cleavage of the phosphate ester by alkaline phosphatase results in the decomposition of the dioxetane and the emission of photons, which are quantified by a luminometer and are proportional to the quantity of analyte present.

The IMMULITE® 2500 Automated Immunoassay Analyzer is an automated immunoassay system that intends to assay the same broad range of analytes in patient samples as the IMMULITE 2000. The device is intended to provide the same automation to the same array of immunoassays in the same hospital and commercial laboratory settings as the IMMULITE 2000.

The 510(k) summary only mentions two analytes for which data was submitted to FDA in support of a claim of substantial equivalence: hCG (human chorionic gonadotropin) and TSH (thyroid-stimulating hormone). However, it does not explicitly state the acceptance criteria for these tests nor does it provide a table of performance data. The FDA's substantial equivalence determination letter refers to "indications for use stated in the enclosure" but this enclosure is not provided in the document.

Therefore, specific acceptance criteria and detailed device performance data are not available in the provided text.

Based on the limited information available:

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

This information is not provided in the text. The document refers to "data in support of a claim of substantial equivalence have been submitted to FDA" for hCG and TSH, but the acceptance criteria and the actual performance data (e.g., sensitivity, specificity, accuracy, precision) are not detailed within the provided summary or the FDA letter.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as this is an in-vitro diagnostic device measuring analytes, not relying on expert interpretation of images or clinical findings for ground truth in the typical sense. The ground truth for analytical performance would typically be established by reference methods or gravimetric methods for controls and calibrators, and clinical outcome for patient samples. However, no details on how "ground truth" was established for the comparison studies are provided.

4. Adjudication method for the test set:

Not applicable for an in-vitro diagnostic device like this, which assesses analytical performance rather than diagnostic interpretation requiring 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 an automated immunoassay analyzer, not a device requiring human readers or AI assistance in interpretation. The comparison is between the performance of the IMMULITE 2500 and its predicate device, IMMULITE 2000, in terms of analytical output.

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

Yes, the IMMULITE 2500 is an automated immunoassay system, implying standalone performance. The intent is "to impart the same automation to the same array of immunoassays" as its predicate, the IMMULITE 2000, with "safe and effective performance when used by medical laboratory personnel." This indicates a standalone performance study against the predicate device.

7. The type of ground truth used:

While not explicitly stated, for an immunoassay analyzer, the "ground truth" for demonstrating substantial equivalence would typically involve:

• Reference methods: Comparing results from the IMMULITE 2500 to established, validated reference methods for measuring hCG and TSH.
• Comparison to predicate device: Direct comparison of results from patient samples and control materials analyzed on the IMMULITE 2500 against those analyzed on the IMMULITE 2000 (the predicate device). This would involve assessing correlation, bias, and agreement.
• Known concentrations: Using control materials with known concentrations of analytes to verify accuracy and precision.

8. The sample size for the training set:

Not applicable. This device is an immunoassay analyzer and does not utilize a "training set" in the context of machine learning. Its performance is based on its established biochemical and detection technology.

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 IMMULITE/IMMULITE 1000 Total Testosterone is for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

The IMMULITE 2000 Total Testosterone is for in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

IMMULITE/IMMULITE 1000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE and IMMULITE 1000 Analyzers.

IMMULITE 2000 Total Testosterone is a solid-phase, two-site competitive chemiluminescent immunoassay for use with the IMMULITE 2000 Analyzer.

The provided text describes diagnostic devices for measuring testosterone, but it does not contain information about acceptance criteria or specific studies demonstrating how the device meets such criteria.

The document is a 510(k) summary for the IMMULITE®/IMMULITE® 1000 Total Testosterone and IMMULITE® 2000 Total Testosterone devices, aiming to demonstrate substantial equivalence to previously cleared predicate devices. While it describes the technology (solid-phase, competitive chemiluminescent immunoassay) and intended use, it does not include performance data, clinical study results, or specific acceptance criteria for precision, accuracy, sensitivity, or other performance characteristics that would typically be part of a study proving a device meets acceptance criteria.

The "Conclusion" section explicitly states: "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE/IMMULITE 1000 Total Testosterone and IMMULITE 2000 Total Testosterone." This implies that the full data set, which would include performance studies and their results against acceptance criteria, was submitted to the FDA separately and is not part of this public 510(k) Summary.

Therefore, I cannot provide the requested information from the provided text.

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The IMMULITE® 2000 Allergen-Specific IgE assay is intended for in-vitro use with the IMMULITE® 2000 Automated Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 Allergen-Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay for use with the IMMULITE® 2000 Automated Analyzer.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® 2000 Allergen-Specific IgE device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: 7,520 serum samples were used for the method comparison study.
   • Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided in the text. The "ground truth" for the method comparison appears to be the results obtained from the predicate device (AlaSTAT Microplate Allergen-Specific IgE), rather than expert consensus on individual samples.

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

   • Adjudication methods involving multiple human readers are not applicable/not described for this type of in-vitro diagnostic method comparison study. The comparison is between the new device and a predicate 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:

   • No MRMC study was done. This device is an in-vitro diagnostic assay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

   • Yes, the performance data presented is for the standalone device (IMMULITE® 2000 Allergen-Specific IgE assay on the IMMULITE® 2000 Automated Analyzer). The method comparison is between this standalone device and another in-vitro diagnostic device (AlaSTAT Microplate Allergen-Specific IgE), both operating without direct human-in-the-loop interpretation of individual results in the same way an AI for imaging might.

6. The type of ground truth used:

   • The "ground truth" for the performance equivalence study was the results obtained from the predicate device, the AlaSTAT Microplate Allergen-Specific IgE assay. This is a common approach for demonstrating substantial equivalence for IVD devices.

7. The sample size for the training set:

   • The text does not mention a separate "training set" for the IMMULITE® 2000 Allergen-Specific IgE device. As an immunoassay, it is not "trained" in the machine learning sense. The performance data presented (calibration, linearity, precision, specificity, interference) are analytical performance characteristics, and the method comparison serves to demonstrate equivalence to a predicate.

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

   • Not applicable, as there is no training set in the machine learning sense for this immunoassay.

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IMMULITE/IMMULITE 1000 Calcitonin: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
IMMULITE 2000 Calcitonin: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin are solid-phase, chemiluminescent enzyme immunoassays for use with their respective IMMULITE/IMMULITE 1000 and IMMULITE 2000 Automated Analyzers.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE®/IMMULITE® 1000 Calcitonin and IMMULITE® 2000 Calcitonin devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "substantial equivalence" is implicitly defined by the demonstration of comparable performance to the predicate device, Nichols Advantage™ Calcitonin. The key performance metrics presented are related to inter-assay agreement as measured by linear regression and correlation.

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

• IMMULITE/IMMULITE 1000 Calcitonin:
  • Sample Size: 53 patient samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.
• IMMULITE 2000 Calcitonin:
  • Sample Size: 67 patient samples
  • Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "patient samples," implying human origin. It does not specify if the data was retrospective or prospective.

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

Not applicable. This study is a method comparison study between a new device and a predicate device (Nichols Advantage™ Calcitonin), not a study relying on expert-established ground truth for diagnostic classifications. The "ground truth" for each sample is the calcitonin concentration as measured by the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is a method comparison study and not a study involving human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic assay, comparing its quantitative results against a legally marketed predicate device. It does not involve human readers interpreting cases or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this is essentially a standalone performance study. The IMMULITE/IMMULITE 1000 Calcitonin and IMMULITE 2000 Calcitonin assays are in vitro diagnostic devices that directly measure a biomarker concentration. Their performance is evaluated based on the quantitative output of the automated analyzer, without human interpretation in the loop impacting the measurement itself. The comparison is directly between the new assay's output and the predicate assay's output.

7. The Type of Ground Truth Used

The "ground truth" for the comparison is the quantitative calcitonin measurement obtained from the predicate device, the Nichols Advantage™ Calcitonin assay. This is a form of comparative ground truth against an established and legally marketed assay.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" in the context of developing the IMMULITE Calcitonin assays. For in vitro diagnostic devices like these, method comparison studies are typically performed after the assay's development and optimization, so there isn't a "training set" in the machine learning sense. The samples used are for direct comparison/validation.

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

Not applicable, as there is no explicitly mentioned "training set" in the context of this submission. The assays are developed based on chemical and immunological principles, and their performance is then validated against established methods.

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The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.

The DPC IMMULITE 1000 product is essentially an upgrade of the current IMMULITE system. All of the current functionality will be retained; however, the system will be enhanced with regard to the user interface, casework, and system footprint. The operating system will be changed to a Windows 2000 environment. In addition, the system will be remodeled to give the IMMULITE a more "modern" look and feel to be part of the "IMMULITE Family". Finally, the total system footprint will be decreased by such mechanisms as integrating the PC into the architecture of the system and provide a defined area for storing bulk materials (i.e., waste, water, and, probe wash).

The provided text is a 510(k) summary for the IMMULITE® 1000 Automated Immunoassay Analyzer, which is essentially an upgrade of an existing system (IMMULITE). The document states that the modifications do not change the indications for use or the intended use, and the device is intended to assay the same broad range of analytes in patient samples as the predicate IMMULITE.

However, the 510(k) summary does not contain the detailed information required to answer many of the questions asked. This type of regulatory submission often focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive de novo study details with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies.

Here's an analysis based on the provided text, highlighting what's available and what's missing:

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

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, precision, limits of detection for various analytes) or report detailed device performance results against these criteria. It focuses on the equivalence to the predicate device.

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

The document does not specify the sample size used for any test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

This information is not provided. Since this is an automated immunoassay analyzer, the "ground truth" would typically come from reference methods or established clinical diagnostics, not from expert consensus interpreting images or other qualitative data.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in imaging studies where multiple readers interpret cases. For an immunoassay analyzer measuring analytes, performance is usually assessed quantitatively against reference standards.

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

An MRMC comparative effectiveness study is not mentioned. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret data. The IMMULITE 1000 is an automated immunoassay analyzer, not a diagnostic imaging AI system that "assists" human readers.

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

The IMMULITE 1000 is inherently a "standalone" automated system in the sense that it performs the immunoassay measurements without continuous human intervention during the assay process. The results are generated by the instrument. However, the document does not detail specific "standalone performance studies" in a structured way that would be typical for a novel AI algorithm's standalone evaluation. Instead, it implies that the performance is demonstrated to be equivalent to the predicate IMMULITE system.

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

The ground truth for an immunoassay analyzer would typically be established by:

• Reference Methods: Using established, highly accurate laboratory methods for analyte measurement.
• Certified Reference Materials/Standards: Calibrating and verifying performance against materials with known analyte concentrations.
• Comparison to Predicate Device: Given that this is a 510(k) for an upgrade, the primary "ground truth" implicitly relies on the proven performance of the predicate IMMULITE system for the broad range of analytes. The document states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer," implying that the data primarily demonstrated equivalence.

8. The sample size for the training set

This information is not provided. Immunoassay analyzers are not "trained" in the same way machine learning models are. Their "training" or calibration involves using specific calibrators and controls to establish a standard curve or reference points for measurement, which is a different concept than a "training set" for AI.

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

As mentioned above, the concept of a "training set" and its "ground truth" in the context of machine learning, is not directly applicable to this device in the way implied by the question. The "ground truth" for the calibration and verification of an immunoassay system would be established using certified calibrators and controls with known values, or by comparison to established reference methods and the predicate device. The document does not elaborate on these details.

Summary of what the document does communicate:

• Acceptance Criteria (Implied): The primary acceptance criterion for this 510(k) appears to be substantial equivalence to the predicate IMMULITE system. The device needs to produce "safe and effective performance" for the "same broad range of analytes in patient samples" as the IMMULITE.
• Study Proving Acceptance Criteria: The document states that "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for the IMMULITE 1000 Analyzer." This implies that studies were conducted to demonstrate that the IMMULITE 1000 performs comparably to the original IMMULITE system across its intended applications. These studies would typically involve method comparison, precision, linearity, and interference studies, but the specific results and methodologies are not detailed in this public 510(k) summary.
• Changes to the Device: The modifications are primarily focused on the user interface, casework, system footprint, and operating system (Windows 2000 environment), not fundamental changes to the underlying immunoassay technology (14-inch polystyrene antibody coated beads, alkaline phosphatase labeled antibody/antigen, chemiluminescent detection). This reinforces the focus on demonstrating equivalence rather than proving novel performance.

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