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The Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin, sodium heparin or K2 EDTA) on the Atellica® CH Analyzer.

Measurements from Atellica® CH High Sensitivity C -Reactive Protein 2 (hCRP2) may be used as an aid in identification of individuals at risk for future cardiovascular disease. Measurement of hCRP2, when used in coniunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.

The Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay is used for the quantitative determination of C-Reactive protein in human serum and plasma using the Atellica CH analyzer. This device is two ready-to-use reagent packs consisting of 23.1mL Phosphate buffer, polidocanol (1.9g/L), and sodium azide (0.1%) in Pack 1 and 12.3mL Mouse anti-CRP monoclonal antibodies (13mg/L), polystyrene particles (1g/L), human albumin (0.05%) and sodium azide (

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

Device: Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Detection Capability:
  • LoB: 3 reagent lots, 6 blank samples, 5 replicates per sample = 90 determinations.
  • LoD: 495 determinations (270 blank, 225 low-level replicates) using 3 reagent lots.
  • LoQ: 5 native low analyte serum samples, 5 replicates each = 25 determinations.
• Precision (Repeatability/Within-Lab): 80 replicates per specimen (5 serum samples + 1 QC, total 6 specimens).
• Reproducibility (Multi-site/Multi-lot): 225 replicates per specimen (5 serum samples + 3 QCs, total 8 specimens).
• Assay Comparison (Method Comparison): 100 patient samples.
• Specimen Equivalency: 55 patient samples for each specimen type (Sodium Heparin, Potassium EDTA, Lithium Heparin).
• Interferences (HIL & Non-interfering Substances): Not explicitly stated, but typically involves a smaller number of samples spiked with interferents at multiple analyte concentrations.

Data Provenance: Not explicitly stated, but the sample types are human serum and plasma, diluted with Atellica CH diluent (saline) or enriched as needed. This usually implies a mix of commercially sourced and/or in-house collected human samples. There is no information regarding the country of origin or whether the studies were retrospective or prospective.

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

This device is an in vitro diagnostic test for C-Reactive Protein (CRP) concentration. The "ground truth" for a quantitative assay like this is typically established by:

• Reference methods/standards (e.g., ERM-DA474/IFCC for CRP, as mentioned).
• Comparative analysis against a legally marketed predicate device (BN ProSpec CardioPhase hsCRP).
• Standard preparation and gravimetric/volumetric assurance for spiked samples or known concentrations.

Therefore, "experts" in the sense of clinical reviewers or pathologists establishing a diagnostic ground truth is not applicable here. The accuracy of the measurements is compared against established analytical criteria and methodologies.

4. Adjudication Method for the Test Set:

Not applicable in the context of this type of IVD performance study, as there is no subjective interpretation requiring adjudication of results from different observers. The output is a quantitative value (mg/L).

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic tests where human interpretation plays a significant role and AI assistance might influence reader performance. For a quantitative in vitro diagnostic assay like high-sensitivity CRP, the measurement is automated and objective.

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

Yes, the studies described (Detection Capability, Precision, Reproducibility, Assay Comparison, Specimen Equivalency, Interferences, High-Dose Hook Effect) are all standalone performance evaluations of the Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) assay as an automated laboratory test on the Atellica CH Analyzer. The device is intended for in vitro diagnostic use, meaning it operates without direct human interpretive input beyond running the test and reading the numerical result.

7. The Type of Ground Truth Used:

The ground truth for this device is established through:

• Analytical Standards: The assay is traceable to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference material ERM-DA474/IFCC, which serves as a primary ground truth for CRP concentration.
• Predicate Device Comparison: The performance is compared against a legally marketed predicate device (BN ProSpec CardioPhase hsCRP assay), where the predicate's measurements serve as a comparative standard.
• Reference Intervals: Expected values for cardiovascular risk prediction are based on established clinical guidelines (Pearson TA et al., 2003).
• Spiked Samples: For interference studies, known concentrations of interfering substances are added to samples, and the known concentration of the analyte is the ground truth.

8. The Sample Size for the Training Set:

Not explicitly stated in the 510(k) summary. For a device like this, the "training set" would refer to the samples used during the development and optimization phase of the assay (e.g., reagent formulation, calibration curve development), rather than a machine learning training set. The approval document focuses on the validation or test sets.

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

Similar to point 7, the ground truth for potential "training" (development/optimization) would involve analytical standards (like ERM-DA474/IFCC), purified CRP, and well-characterized human serum/plasma samples, often with known CRP concentrations determined by reference methods or gravimetric/volumetric preparation. The goal would be to develop a robust assay that accurately measures CRP across its analytical range.

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CardioPhase® hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

The CardioPhase hsCRP assay is an in vitro diagnostic reagent for the quantitative determination C-reactive protein, in human serum, and heparinized and EDTA plasma by means of particle-enhanced immunoassay determination. Polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

This document describes the CardioPhase® hsCRP device, a C-reactive protein immunological test system, and a Special 510(k) submission for a change in its reference standard material from ERM-DA470 to ERM-DA474/IFCC.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria for all performance characteristics, but rather describes the studies performed and their satisfactory outcomes which imply meeting internal acceptance limits. For instance, for linearity, the stated ranges confirm the measuring range, implying that the observed linearity falls within acceptable deviations. For matrix comparison, high correlation coefficients and slopes close to 1 with intercepts close to 0 indicate acceptable equivalence.

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The CRP Vario assay is intended for the quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma. Cardiac CRP High Sensitive (cCRP) may be used for aid in identification of individuals at risk for cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the cCRP may be useful as an independent marker of prognosis for recurrents, in patients with stable coronary disease or acute coronary syndrome.

Not Found

The provided text is a 510(k) Premarket Notification clearance letter for a device called "CRP Vario." This document primarily
confirms the FDA's determination of substantial equivalence for a medical device to
a legally marketed predicate device.

Crucially, this document focuses on regulatory clearance and does NOT contain the detailed study information required to answer the
questions about acceptance criteria and device performance.

Specifically, the document states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
• The "Indications for Use" section describes what the device is intended for (quantitative immunoturbidimetric determination of C-reactive protein in human serum or plasma, and its use as an aid in identification of individuals at risk for cardiovascular disease).

To answer your questions about the acceptance criteria and the study that proves the device meets them, one would typically
need access to the underlying 510(k) submission document itself or efficacy study reports, which are not part of this
publicly available clearance letter.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets, data provenance, training set size, or how ground truth was established.
3. Details about expert involvement (number, qualifications, adjudication methods).
4. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
5. The type of ground truth used.

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The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin or potassium EDTA) on the ADVIA Chemistry systems. In acute phase response, increased levels of a number of plasma proteins, including CRP, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurement of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.

The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase High Sensitivity C-Reactive Protein method.

The ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma on the ADVIA Chemistry systems. The CardioPhaseTM hsCRP latex reagent is a suspension of uniform polystyrene latex particles coated with anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.

The ADVIA® Chemistry CardioPhase™ High Sensitivity C-Reactive Protein Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted values (lot specific) of 0, 0.53, 1.05, 1.58, 5.25, and 10.50 mg/L.

The calibrators (1 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.

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

Important Note: The provided document is a 510(k) summary for an in vitro diagnostic (IVD) device, specifically a C-Reactive Protein (CRP) assay. For IVDs, the "device performance" and "acceptance criteria" are typically related to analytical performance (e.g., precision, accuracy, linearity, interference) rather than diagnostic accuracy (e.g., sensitivity, specificity, AUC) in the way a medical imaging AI would be evaluated. The "ground truth" and "experts" mentioned in your request are more relevant to AI/imaging diagnostics. Therefore, I will adapt the answers to fit the context of this IVD device.

Acceptance Criteria and Device Performance for ADVIA® Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Assay (K081294)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an IVD device, acceptance criteria are generally established against pre-defined analytical performance targets or by demonstrating substantial equivalence to a predicate device. The document explicitly states that "All of the evaluation studies gave acceptable results compared to the predicate device." While specific numerical acceptance limits aren't always explicitly listed in the summary, the reported performance metrics are presented in comparison to the predicate or against generally accepted analytical standards for such assays.

• 0.21: 3.2%
• 1.04: 1.1%
• 3.12: 0.8%
• 10.27: 1.4% |
  | Imprecision (Total CV%) | Comparable to predicate device; generally low CV% for IVD assays. | Levels (mg/L):
• 0.21: 4.2%
• 1.04: 1.2%
• 3.12: 1.3%
• 10.27: 1.6% |
  | Method Comparison (Correlation with Predicate) | Strong linear correlation (e.g., slope near 1, intercept near 0, high r value) with predicate. | Regression Equation (Passing Bablok): Y = 1.00x + 0.01
  Regression Equation (Least Squares): Y = 1.01x - 0.01
  Correlation Coefficient (r): 0.998 |
  | Interfering Substances (Effect % Change) | Minimal interference (e.g., within +/- 10% or pre-defined clinical significance). | Effect (Max % Change from listed substances):
• Hemoglobin: -9%
• Lipids: -7%
• Bilirubin, free: 4%
• Bilirubin, conjugated: 0%
• Rheumatoid Factor: 8% |
  | Analytical Range | Appropriately wide and clinically relevant range. | 0.16 to 10 mg/L |

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

• Sample Size for Method Comparison (Test Set): 167 (for serum samples comparing the new device to the predicate).
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of laboratory method comparison studies, these are typically prospective evaluations using clinical samples collected for testing.

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

This is not applicable in the typical sense for this IVD assay. For an IVD, the "ground truth" for method comparison is essentially the result obtained from the established, legally marketed predicate device. The analytical validity is determined by how closely the new device's results correlate with the predicate, rather than by expert interpretation of individual cases.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication process involving human experts interpreting results to establish a ground truth for a quantitative immunoassay like this. The comparison is purely numerical between two analytical instruments/methods.

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. MRMC studies are relevant for medical imaging diagnostics where human readers (e.g., radiologists) interpret images, and AI might assist in that interpretation. This document describes an automated laboratory assay for measuring a biomarker (CRP), not an imaging AI.

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

Yes, in the context of an IVD, the performance outlined is the "standalone" performance of the assay system itself. The reported imprecision, method correlation, and interference studies describe how the ADVIA Chemistry CardioPhase hsCRP assay performs autonomously on the ADVIA 1650 system. The human involvement is in operating the instrument and interpreting the quantitative results, not in a diagnostic interpretation loop that the device enhances or replaces.

7. The Type of Ground Truth Used

For the analytical performance studies:

• Method Comparison: The "ground truth" was established by the results from the predicate device (Siemens Healthcare CardioPhase™ High Sensitivity CRP on the BNII Systems). The objective was to show that the new device's measurements align with those of an already accepted method.
• Imprecision, Interfering Substances, Analytical Range: These studies used known concentrations of analytes (e.g., controls, spiked samples) as their internal reference ("ground truth") to measure the device's consistency, susceptibility to interference, and operational range.

8. The Sample Size for the Training Set

Not applicable in the context of this traditional IVD assay. "Training set" refers to data used to train machine learning algorithms. This device is a biochemical assay, not an AI/ML product, and therefore does not have a "training set" in that sense. Its development involved chemical and engineering optimization, and its performance is demonstrated through analytical studies.

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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High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry.

Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).

High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. The IMMAGE® 800 Immunochemistry Systems CCRP reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity. The rate of aggregate formation is directly proportional to the concentration of CRP in the sample.

CAL 5 Plus (Calibrator 5 Plus) is a frozen liquid serum matrix intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).

Here's a breakdown of the acceptance criteria and study information for the Immage® 800 Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for method comparison, linearity, or imprecision (e.g., "slope must be between X and Y"). However, it presents the results of these studies, and the FDA's decision to grant substantial equivalence implies that these results met their internal criteria for acceptance.

For the purpose of this analysis, I will infer the implicit acceptance criteria from the context of standard analytical performance requirements for diagnostic devices and the successful outcome of the 510(k) submission.

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High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with SYNCHRON LX® PRO System, UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma bv rate turbidimetry.

Clinical Significance:
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.

High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry. SYNCHRON® System(s) CRPH reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity.

Here's an analysis of the provided text regarding the SYNCHRON® Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent, addressing your specific questions:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence to previously cleared devices through performance data rather than defining explicit acceptance criteria in the typical sense of a target performance metric (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by the demonstration that the new device performs comparably to the predicate device and meets established analytical performance standards (linearity, imprecision).

The study that "proves the device meets the acceptance criteria" is the Summary of Performance Data presented in section 8.0.

1. Table of Acceptance Criteria and the Reported Device Performance

0.2 to 10 mg/L range:
Slope: 1.030
Intercept: -0.008
Correlation Coefficient (r): 0.9910 |
| Imprecision | Low variability (e.g., %CV within acceptable clinical laboratory limits) | Within-Run Imprecision (N=80 for each level):

• Level 1 (Mean 0.063 mg/dL): S.D. 0.0019 mg/dL, %C.V. 3.1
• Level 2 (Mean 1.368 mg/dL): S.D. 0.0222 mg/dL, %C.V. 1.6
• Level 3 (Mean 5.639 mg/dL): S.D. 0.0907 mg/dL, %C.V. 1.6

Total Imprecision (N=80 for each level):

• Level 1 (Mean 0.063 mg/dL): S.D. 0.0033 mg/dL, %C.V. 5.3
• Level 2 (Mean 1.368 mg/dL): S.D. 0.0381 mg/dL, %C.V. 2.8
• Level 3 (Mean 5.639 mg/dL): S.D. 0.1823 mg/dL, %C.V. 3.2 |
  | Linearity | Not explicitly detailed in the provided summary, but mentioned as performed | |
  | Stability | Not explicitly detailed in the provided summary, but mentioned as performed | |

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

• Sample Size (Method Comparison):
  • 269 samples for the 0.2 to 80 mg/L range comparison.
  • 149 samples for the 0.2 to 10 mg/L range comparison.
• Sample Size (Imprecision): 80 replicates for each of the 3 levels tested (total 240 measurements for within-run, and 240 for total imprecision).
• Data Provenance: Not explicitly stated in the provided document (e.g., country of origin, retrospective or prospective). This information is typically found in the full study report, not necessarily in a 510(k) summary. Given the context of clinical laboratory testing, it's highly likely to be a prospective collection of human serum or plasma samples.

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

• Not Applicable. For an in vitro diagnostic (IVD) device like a C-Reactive Protein reagent, the "ground truth" is established by the results of a predicate quantitative assay, not by expert interpretation of images or patient data. The predicate method (Dade Behring CardioPhase hsCRP) serves as the reference standard whose results are compared to the new device.

4. Adjudication method for the test set

• Not Applicable. As this is a quantitative chemical assay, there is no "adjudication" in the sense of reconciling differing expert opinions. The comparison is directly between the numerical results of two laboratory methods.

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 IVD reagent (a laboratory test kit) for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation device that involves human readers.

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

• Yes, but framed differently. The "standalone performance" is essentially what's demonstrated in the Method Comparison and Imprecision studies. The SYNCHRON® Systems High Sensitivity Cardiac CRPH Reagent, in conjunction with the specified SYNCHRON LX 20 PRO System, UniCel® DxC 600/800 System(s), and SYNCHRON® Systems CAL 5 Plus, provides a quantitative result directly. There is no human intervention in the interpretation of the result to arrive at the CRP concentration, other than the standard laboratory procedures for running the test.

7. The type of ground truth used

• The ground truth for the method comparison study was the results obtained from the predicate device, Dade Behring CardioPhase hsCRP.
• For the imprecision study, the "ground truth" is the true concentration within the assayed samples, which the device aims to measure consistently. The reported mean values serve as the estimate of this truth for assessing variability.

8. The sample size for the training set

• Not explicitly stated/Not applicable in the AI sense. For an IVD reagent, there isn't a "training set" in the context of machine learning or AI algorithms. The "training" for such reagents involves optimizing the chemical formulation and assay parameters based on extensive laboratory testing and validation during development. The provided document shows the performance verification data.

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

• Not applicable in the AI sense. As there's no "training set" for an AI algorithm, there's no ground truth established in that manner. The development and optimization of the reagent formulation and assay procedure would have involved internal validation against known standards and reference materials, but these are part of the reagent's analytical design, rather than a "training set" for an algorithm.

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The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 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 noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,

The provided text is a 510(k) summary for the IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information needed to fill out all requested sections about acceptance criteria, device performance, ground truth establishment, or sample sizes for testing and training.

Therefore, I can only provide limited information based on the text provided.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of precision, accuracy, or correlation coefficients, nor does it present detailed study results proving the device meets particular thresholds. It asserts substantial equivalence to a predicate device, which inherently means its performance should align with the predicate's established performance for the intended uses. Without specific study data from the document, I cannot create a table of acceptance criteria and reported device performance.

Study Information Based on Provided Text:

Here's what can be inferred or explicitly stated from the given text:

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

   • Acceptance Criteria: Not explicitly stated in the provided document. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds presented in the summary.
   • Reported Device Performance: Not detailed in the provided document. The document describes the device and its intended use but does not present the results of performance studies (e.g., accuracy, precision, linearity).

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

   • Sample Size for Test Set: Not specified in the provided document.
   • Data Provenance: Not specified in the provided document.

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):

   • Number of Experts: Not applicable or specified. This device is an in vitro diagnostic (IVD) immunoassay. The "ground truth" for such devices typically refers to a reference method or validated standard, not expert consensus as in imaging studies.
   • Qualifications of Experts: Not applicable or specified.

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

   • Adjudication Method: Not applicable or specified. This is relevant for studies involving human interpretation (e.g., radiology), not typically for automated immunoassay performance evaluation.

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:

   • MRMC Comparative Effectiveness Study: Not applicable. This device is an automated immunoassay for quantitative measurement of C-reactive protein, not an AI-assisted diagnostic tool for human interpretation.

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

   • Standalone Performance: The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is an automated, standalone diagnostic test. Its performance is evaluated intrinsically through analytical studies (e.g., precision, accuracy, linearity) against reference methods, rather than in conjunction with human-in-the-loop scenarios. The summary does not provide details of these studies or their results.

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

   • Type of Ground Truth: For an immunoassay, the "ground truth" for performance studies would typically be established using a reference method, a comparative method deemed accurate, or certified reference materials/calibrators with known concentrations of C-reactive protein. The specific method used is not detailed in this summary.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable or specified. This device is a traditional immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its reagents and calibration curves are developed and optimized through laboratory procedures, not by training on a dataset.

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

   • Ground Truth for Training Set: Not applicable. As explained above, this is not an AI/ML device that uses a training set with established ground truth labels in the typical sense. Reagent and assay development involves standard chemical and biological validation processes.

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The Stratus® CS Acute Care™ CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.

In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

The Stratus® CS Acute Care™ CardioPhase® hsCRP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology.

The provided text describes a 510(k) summary for the "Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak". This document focuses on demonstrating substantial equivalence to a predicate device for an in vitro diagnostic reagent and is not an AI/ML device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth for training set) are not applicable or not detailed in the context of an IVD reagent submission for an expanded indication of use (Point of Care settings). The study described is a comparison of performance between laboratory and non-laboratory personnel to support the expanded use.

Here's the information that can be extracted from the provided text, adapted to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Precision and accuracy data generated by 'non-laboratory' personnel is comparable to precision and accuracy data generated by 'laboratory' personnel." This implies the acceptance criteria was likely "comparability" of performance.

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

• Sample Size: Not explicitly stated for specific test sets but referred to as "Method comparison and precision analyses."
• Data Provenance: The study was conducted at "three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within one external evaluation site)." This suggests prospective data collection at these clinical sites. The country of origin is not specified, but the manufacturer is Dade Behring Inc. in Newark, DE (USA).

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

This is not applicable to a submission for an in vitro diagnostic reagent where performance is assessed through analytical studies (precision, accuracy, method comparison) rather than expert interpretation of images or other subjective data. The "ground truth" would be the established reference method or comparative device's results.

4. Adjudication Method

Not applicable for an in vitro diagnostic reagent performance study. Results are quantitative measurements compared against a reference.

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

This is not an AI/ML device, so an MRMC study is not applicable. The study involved different operators (laboratory vs. non-laboratory personnel) to assess performance in different settings.

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

This is an in vitro diagnostic reagent, not an algorithm. The device itself (reagent and instrument) is a standalone measurement system. The study compares its performance when operated by different types of users (laboratory vs. point-of-care personnel).

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation would be the results obtained by the predicate device (Dade Behring Stratus® CS CardioPhase® hsCRP TestPak, K060369) or a reference method, as the study is a method comparison and precision analysis.

8. The Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic reagent for which performance is analytically validated, not an AI/ML model that requires training data.

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

Not applicable, as it is not an AI/ML device requiring a training set.

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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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Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge: The CardioPhase® hsCRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry on the Dimension Vista™ System. High sensitivity CRP measurements may be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the high sensitivity C-reactive protein (hsCRP) method on the Dimension Vista™ System.

Dimension Vista™ high sensitivity CRP Control L and Dimension Vista™ high sensitivity CRP Control H: hsCRP Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista™ System.

Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge: Dimension Vista - Ourdror naoo nal antibodies specific to human CRP are Polystylene particles couled with samples containing CRP. These aggregates scater a beam aggregated when mixed with our prob seintersity of the scattered light is proportional to of light passed through the sample. The sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is a liquid human serum based product containing C-reactive protein (CRP).

Dimension Vista™ high sensitivity CRP Control L and H: Dimension Vista – Migh ochoand H are liquid human serum based products containing C-reactive protein.

The provided text describes the 510(k) summary for the Dimension Vista™ CardioPhase® hsCRP Flex® reagent cartridge, Dimension Vista™ Protein 2 Calibrator, and Dimension Vista™ high sensitivity CRP Control L and H. It details the device, its intended use, and claims substantial equivalence to previously marketed devices. However, the document does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested.

The "Device Performance Characteristics" section {2} mentions a "Method Comparison Study" that compared the new assay to a predicate device. It states, "The Dimension Vista™ CardioPhase® hsCRP assay was compared to the Dade Behring CardioPhase® hsCRP assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 0.169 to 8.922 mg/L. Regression analyses of these results yielded the following equations:" However, the actual regression equations, specific performance metrics (like accuracy, sensitivity, specificity, precision), and acceptance criteria for these metrics are missing from the provided text.

Therefore, I cannot provide the requested table or detailed information about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given document.

The document mainly focuses on the regulatory submission, product description, and intended use, rather than a detailed scientific study report with acceptance criteria and performance data.

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