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VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack:

For in vitro diagnostic use only

For the quantitative measurement of total 25-OH vitamin D in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System.

The results of the VITROS 25-OH Vitamin D Total assay are used in the assessment of Vitamin D sufficiency. Assay results may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators:

For in vitro diagnostic use only.

For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH vitamin D in human serum.

The VITROS Immunodiagnostic Products Vitamin D test system comprises three main elements:

• 1. The VITROS Immunodiagnostic range of products. In this case the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators are required to perform a VITROS Vitamin D test.
• The VITROS Immunodiagnostic and Integrated Systems: Instrumentation, which 2. provides automated use of the immunoassay kits.

The VITROS ECi/ECiQ Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). This product was updated to the VITROS ECiQ Immunodiagnostic System by addition of a flat panel monitor with an accompanying articulating arm, cosmetic changes to the instrument cabinetry, and with FDA notification in January of 2004.

The VITROS 3600 Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K083173).

The VITROS 5600 Integrated System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Integrated System was cleared for market by a separate 510(k) pre-market notification (K081543).

• 3. Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
     The VITROS Immunodiagnostic and Integrated Systems and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided 510(k) summary describes the acceptance criteria and performance data for the VITROS® Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack and Calibrators.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a single, consolidated table with pass/fail remarks. Instead, it presents performance study results. The implied acceptance criteria are the demonstrated performance characteristics (e.g., precision, linearity, limit of detection, specificity, and method comparison results meeting statistical thresholds).

Table: Implied Acceptance Criteria and Reported Device Performance

• ECI/ECIQ System 1 Lot 1: 5.5-15.3%
• ECI/ECIQ System 2 Lot 2: 5.4-16.4%
• 3600 System 1 Lot 1: 6.0-16.5%
• 3600 System 1 Lot 3: 4.8-15.8%
• 5600 System 1 Lot 2: 5.6-12.8% |
  | Linearity/Measuring Range | Assay should be linear across the claimed measuring range. | Linear from 12.8 to 126 ng/mL (32.0 to 315 nmol/L). |
  | Limit of Detection (LoD) | LoD should be adequately low for clinical utility. | 8.64 ng/mL (21.6 nmol/L) (with 10% bias at indicated concentrations in 25-OH Vitamin D concentrations of 30-80 ng/mL, with the exception of Paricalcitol (Zemplar). |
  | Specificity (Cross-Reactivity) | Cross-reactivity should be characterized and acceptable. | 25-OH Vitamin D2: 104.9%
  25-OH Vitamin D3: 98.9%
  (Other listed substances showed lower or context-dependent cross-reactivity/bias) |
  | Method Comparison (Correlation with Predicate) | Strong correlation (high 'r' value) and acceptable slopes/intercepts compared to predicate device. | VITROS 5600 vs IDS-iSYS: r = 0.92, Slope CI (0.86-1.12), Intercept CI (-10.2 to -0.53)
  VITROS 3600 vs IDS-iSYS: r = 0.93, Slope CI (0.96-1.22), Intercept CI (-12.4 to -2.95)
  VITROS ECi/ECiQ vs IDS-iSYS: r = 0.94, Slope CI (0.86-1.09), Intercept CI (-14.2 to -4.69) |

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

• Precision: 3 patient samples and 1 commercial control sample per system/lot condition. Each sample tested as 2 replicates per day, on at least 20 different days (total 80 observations per sample per system/lot combination).
• Linearity: Two pools of patient samples (low and high) were used to create 7 intermediate pools.
• Limit of Detection: 1 blank and 6 low-level samples, with 700 determinations in total.
• Specificity (Interference/Cross-reactivity): Patient samples near 30 ng/mL and 80 ng/mL Vitamin D. The exact number of individual samples for interference testing is not specified, but the cross-reactivity table shows results for specific compounds.
• Method Comparison: A minimum of 117 human serum samples were used.
• Reference Range: 399 apparently healthy adults.
• Data Provenance:
  • For the reference range study, samples came from individuals in the North, South, and Central regions of the United States, collected in both summer and winter. This indicates prospective collection of samples specifically for this study.
  • For other studies (precision, linearity, method comparison), the document mentions "patient samples" and "human serum samples." The specific country of origin or whether these were purely retrospective or prospectively collected is not explicitly stated, but they are clearly human-derived samples.

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

Not applicable. For in vitro diagnostic (IVD) assays like this one, "ground truth" is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on images or interpretations. The product measures a specific analyte concentration.

4. Adjudication method for the test set

Not applicable. This is an IVD device for quantitative measurement of a biomarker, not a diagnostic imaging device requiring expert adjudication of interpretations.

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 in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

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

Yes, the device is a standalone in vitro diagnostic (IVD) system. Its performance (e.g., precision, linearity, limit of detection, and quantitative measurements in method comparison studies) represents the "algorithm only" performance, as it directly quantifies 25-OH Vitamin D in human serum samples on automated immunodiagnostic systems without human interpretation of results influencing the measurement itself.

7. The type of ground truth used

The "ground truth" for this quantitative assay is established by:

• Reference measurements/Predicate Device Comparison: The method comparison study uses a legally marketed predicate device, the IDS-iSYS® 25-Hydroxy Vitamin D Assay, as the reference for comparison, and demonstrates substantial equivalence.
• Internal analytical validation: Performance claims (precision, linearity, LoD/LoQ, specificity) are established through rigorous analytical testing against recognized CLSI guidelines, implying accepted analytical standards for correctness.

8. The sample size for the training set

The document does not explicitly mention "training set" or "validation set" in the context of an algorithm. For IVD devices, a "training set" in the machine learning sense is not typically used. Instead, the analytical performance (precision, linearity, etc.) is established using various samples, and calibration is performed using specific calibrators.

• The linearity study used two pools of patient samples.
• The precision study used patient samples and commercial controls.
• The specificity studies used patient samples.

These samples are used to characterize the device's performance, not to "train" an algorithm.

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

Not applicable, as a "training set" in the machine learning sense for an algorithm is not described. For the types of samples used in analytical studies:

• Patient samples: Their ground truth would be their actual 25-OH Vitamin D concentration, as measured by a highly accurate or reference method at the time of study or by the predicate device (as in the method comparison).
• Commercial control samples: These have assigned target values for specific analytes, often established through an internal reference method or inter-laboratory consensus.

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For quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin) to aid in the early detection of pregnancy.

For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (EDTA or heparin).

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of human chorionic gonadotropin (hCG) and its ß-subunit.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The assay is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Total B-hCG II Reagent Pack, the VITROS Immunodiagnostic Products Total B-hCG II Calibrators, and the VITROS Immunodiagnostic Products Total B-hCG II Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS Total B-hCG II assay).

2. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).

3. Common reagents - used by the VITROS Immunodiagnostic System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total β-hCG Calibrators 510(k) premarket notification (K970894).

The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the VITROS Immunodiagnostic Products Total β-hCG II assay.

Please note: This document is a 510(k) summary for an in-vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., sample size for test set/training set, number of experts for ground truth, adjudication method, MRMC study, human reader improvement) are not applicable or available in this type of submission. This summary focuses on demonstrating substantial equivalence to a predicate device, primarily through performance characteristics of the assay itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implicitly established by demonstrating substantial equivalence to the predicate device. This is primarily done by comparing performance characteristics such as analytical sensitivity, specificity, precision, and measuring range, and showing that the new device performs comparably or better.

Here's a table summarizing the reported device performance compared to the predicate, which serves as the de-facto acceptance criteria. The new device must meet or exceed the performance of the predicate to demonstrate substantial equivalence.

Note: The "Expected Values" table is also presented for comparison, but these are typically reference ranges derived from clinical populations rather than strict acceptance criteria for the device's technical performance.

Study Details

Given this is a 510(k) for an in-vitro diagnostic assay (laboratory test), the study design differs significantly from that of an AI/ML device.

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

   • The document does not explicitly state a "test set" sample size in the context of a diagnostic test for comparing against ground truth. Instead, performance characteristics (precision, sensitivity, specificity, measuring range) are evaluated using various types of samples.
   • Specificity and Analytical Sensitivity: The document states 0.70 mIU/mL analytical sensitivity and ≤ 10% cross-reactivity for FSH, LH, and TSH without providing specific sample counts for these tests.
   • Precision: Precision studies involved measuring samples multiple times to calculate Coefficients of Variation (CV). The specific number of samples for these studies is not detailed in the summary, but typical studies involve multiple replicates over several days with different operators and instrument runs.
   • Expected Values: The table for "Expected Values" in Table 1 shows sample sizes (n) for different gestational age groups: 1-10 weeks (n=112 for new device, n=50 for predicate), 11-15 weeks (n=43 for new device, n=50 for predicate), 16-20 weeks (n=50 for new device, n=50 for predicate), and 23-40 weeks (n=45 for new device, n=50 for predicate). This data provenance is generally from clinical populations.
   • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for all performance data, though the manufacturer site is in the United Kingdom. The "Expected Values" imply clinical samples.

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

   • Not applicable / Not explicitly stated. For an immunoassay, the "ground truth" for analytical performance tests (sensitivity, specificity, precision) is established through reference methods, certified reference materials, and standardized laboratory practices, not typically by expert consensus of human readers. For clinical reference ranges ("Expected Values"), the ground truth is derived from the measured hGC levels in a healthy population or population with known pregnancy status, often confirmed by clinical means (e.g., last menstrual period, ultrasound), but not requiring human expert adjudication of visual data.

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

   • Not applicable. Adjudication methods like 2+1 are used for human interpretation of images or complex data where consensus is needed to establish ground truth. For an automated immunoassay, the result is quantitative or qualitative based on the assay's chemical reaction and signal detection.

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

   • Not applicable. An immunoassay is an automated diagnostic test; it does not involve human "readers" interpreting results in the way an AI medical device for image analysis would. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

   • Yes, in essence. Immunoassays are inherently "standalone" in that once the sample is loaded and the test is run, the instrument produces the result without further human interpretation beyond reporting the quantitative value. The performance metrics discussed (sensitivity, specificity, precision, measuring range) are all measures of the device's standalone analytical performance.

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

   • The "ground truth" for demonstrating the performance of this in-vitro diagnostic device would typically involve:
     • Reference standards/materials: For analytical sensitivity and linearity, using known concentrations of hCG.
     • Clinical samples: For establishing expected values and potentially for cross-reactivity studies, samples from healthy individuals or individuals with confirmed conditions (e.g., pregnant patients, patients with elevated FSH/LH/TSH) might be used.
     • Comparative methods: Often, performance is validated by comparing results to a gold standard or well-established reference method.
   • The document does not explicitly detail the exact nature of the "ground truth" for all studies, but it is inferable from the types of performance claims made.

7. The sample size for the training set:

   • Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a "training set" in the computational sense. The assay's chemistry and detection principles are pre-determined during development, not "trained" on data.

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

   • Not applicable. As there is no training set for an immunoassay, there is no ground truth established for it in this context.

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VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.

VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).

VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).

1. The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
2. The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
3. Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
   Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
   The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

This 510(k) summary describes the VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators, and Range Verifiers, designed for the quantitative measurement of cardiac Troponin I (cTnI). The submission aims to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implied by a comparison to a predicate device (BECKMAN Access® AccuTnI Troponin I assay) and various clinical and analytical standards. The document primarily focuses on establishing "substantial equivalence" rather than specific numerical acceptance criteria for each performance characteristic. However, the listed "Differences" section in Table 1 can be interpreted as the reported device performance compared to specific characteristics of the predicate.

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VITROS Anti-HAV IgM Reagent Pack: For the in vitro qualitative determination of IgM antibody to hepatitis A virus (anti-HAV IgM) in human adult and pediatric serum or plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results in conjunction with other clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A.

VITROS Anti-HAV IgM Calibrator: For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative determination of IgM antibody to hepatitis A viral antigen (HAV) in human serum and plasma (EDTA, heparin or citrate.

VITROS Anti-HAV IgM Controls: For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of anti-HAV IgM.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products range of immunoassay products (in this case the VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack and the VITROS Immunodiagnostic Products Anti-HAV IgM Calibrators) and VITROS Immunodiagnostic Products High Sample Diluent B which are combined by the VITROS Immunodiagnostics System to perform the VITROS Anti-HAV IgM assay. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent.

The VITROS Anti-HAV IgM assay utilizes an antibody class capture assay design, for the measurement of IgM antibodies to hepatitis A antigen, in human serum or plasma. The assay involves dilution of the sample and the simultaneous reaction of IgM in the diluted sample with biotinylated mouse monoclonal anti-human IgM antibody. The immune complex is captured by streptavidin on the wells, unbound materials are removed by washing. Horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HAV antibody that has been complexed with inactivated HAV antigen (conjugate) is then captured by anti-HAV specific IgM bound to the wells. Unbound material is removed by washing. Enzyme substrate is then added and bound HRP conjugate is measured by a luminescent reaction. He binding of HRP conjugate is indicative of the presence of anti-HAV IgM.

Here's a summary of the acceptance criteria and study details for the VITROS Immunodiagnostic Products Anti-HAV IgM assay, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity/specificity thresholds. Instead, it presents the "Summary of Performance" as the demonstration that the device is "safe and effective for the stated intended uses and is substantially equivalent to the cleared predicate devices."

The performance data presented serve as the evidence that the device meets an implied standard of effectiveness in line with its predicate.

Study Details

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

   • Prospectively Collected Samples (High-Risk/Symptomatic):
     • Positive: 32 samples
     • Negative: 1159 samples
     • Total: 1191 samples
     • Provenance: Samples obtained in the U.S. and India. The study was multi-center.
   • Known Anti-HAV IgM Reactive Samples: 77 samples. (Provenance not explicitly stated, but likely from clinical settings.)
   • Low-Risk Pediatric Subjects: 110 samples. (Provenance not explicitly stated, but implies healthy pediatric population.)

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not explicitly stated in the provided document. The ground truth for hepatitis A IgM status would typically be established through a combination of clinical diagnosis, other reference laboratory tests (e.g., PCR, serology), and patient history. The document refers to "samples from subjects known to be anti-HAV IgM reactive," implying an established ground truth.

3. Adjudication Method for the Test Set: Not explicitly stated. Given that it's an in vitro diagnostic assay, adjudication typically refers to the process of resolving discrepancies between the new device's results and the established ground truth. This is generally handled by the study design and statistical analysis method rather than a reader adjudication process.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this type of study was not conducted. MRMC studies are typically for imaging or interpretive devices where human readers evaluate cases. This document describes an in vitro diagnostic assay, which does not involve human readers interpreting results in the same way. The comparative effectiveness assessment is against a predicate device and established ground truth.

5. Standalone Performance: Yes, the described study assesses the standalone performance of the VITROS Anti-HAV IgM assay. The performance metrics (positive percent agreement, negative percent agreement) are purely based on the algorithm's output compared to the ground truth, without human intervention in the result determination process.

6. Type of Ground Truth Used: The ground truth appears to be based on:

   • Clinical Diagnosis/Known Status: For the prospectively collected samples, they were from "individuals at high risk for hepatitis and/or with signs or symptoms of hepatitis." For validation, "samples from subjects known to be anti-HAV IgM reactive" and "pediatric subjects at low risk for hepatitis" were used. This implies reliance on established clinical diagnoses, reference laboratory tests, and patient histories to classify samples as positive or negative for anti-HAV IgM.

7. Sample Size for the Training Set: Not explicitly stated. The document focuses on the performance study (test set). For in vitro diagnostic devices, the "training set" might refer to samples used during the assay development and optimization phases, which are rarely detailed in 510(k) summaries unless they contribute directly to a specific algorithm's performance claim within the submission.

8. How the Ground Truth for the Training Set Was Established: Not explicitly stated. As with point 7, details about development/training phases are not typically provided in this level of summary for IVD assays. It's presumed that standard methods for establishing HAV IgM status (e.g., reference assays, clinical correlation) would have been used during development.

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VITROS Anti-HAV Total Reagent Pack: For the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis A virus (anti-HAV) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) using the VITROS ECi/ECiQ Immunodiagnostic System. The assay is indicated, in conjunction with other serological and clinical information, as an aid in the clinical laboratory diagnosis of individuals with acute or past hepatitis A virus infection, or as an aid in the identification of HAV-susceptible individuals prior to HAV vaccination. The detection of HAV-specific antibodies in human serum or plasma is laboratory evidence of acute or recent HAV infection.

VITROS Anti-HAV Total Calibrator: For in vitro use in the calibration of the VITROS Immunodiagnostic System for the qualitative detection of antibodies to hepatitis A virus (anti-HAV) in human serum and plasma (EDTA, heparin or citrate).

VITROS Anti-HAV Total Controls: For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the detection of antibodies to Hepatitis A virus (anti-HAV).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products range of immunoassay products (in this case the VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and the VITROS Immunodiagnostic Products Anti-HAV Total Calibrators) and VITROS Immunodiagnostic Products High Sample Diluent B which are combined by the VITROS Immunodiagnostics System to perform the VITROS Anti-HAV Total assay. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent. The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Anti-HAV Total assay utilizes a competitive assay design for the measurement of antibody to HAV Total (IgG and IgM). The competitive assay technique is used which involves pre-incubation of anti-HAV in the sample with HAV antigen in the Assay Reagent followed by incubation with a Conjugate Reagent that contains biotinylated mouse monoclonal anti-HAV antibody and horseradish peroxidase (HRP)-labeled mouse monoclonal anti-HAV antibody. The immune complex is captured by streptavidin on the wells, unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS System. The binding of HRP is indicative of the absence anti-HAV antibody. The VITROS Immunodiagnostic Products Anti-HAV Total Controls is comprised of two levels of human plasma that have been targeted to produce negative or positive results when used with the VITROS Immunodiagnostic Products Anti-HAV Total assay.

Here's a breakdown of the acceptance criteria and study information for the VITROS Immunodiagnostic Products Anti-HAV Total assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for positive percent agreement (PPA) and negative percent agreement (NPA). However, it reports performance metrics from a multi-center study. The implication is that these reported numbers met the internal standards for substantial equivalence.

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

• Overall Multi-center Study: The specific total sample size for this study is not explicitly stated, but it involved "samples obtained in the U.S. and India from individuals at high risk for hepatitis and/or with signs or symptoms of hepatitis."
• Anti-HAV IgM Reactive Samples: 77 samples were tested against a reference assay.
• Pediatric Samples: The sample size for the pediatric study is not explicitly stated beyond the percentages reported.
• Provenance: Data was collected from the U.S. and India. The section states the study was "multi-center" and involved "combined prospective samples," indicating a prospective data collection. Additionally, plasma from healthy individuals from "US population residing in areas of high (Western, US) and low (Eastern US) HAV disease prevalence" was used to determine expected results.

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

The 510(k) summary does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. It mentions comparison to a "reference anti-HAV assay" and "subjects known to be anti-HAV IgM reactive" for some parts of the study, implying established diagnostic methods and clinical status were used as ground truth.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe an adjudication method (like 2+1 or 3+1 consensus) for the test set. Ground truth appears to be based on "reference anti-HAV assay" results or known clinical status ("subjects known to be anti-HAV IgM reactive").

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 as this device is an in vitro diagnostic (IVD) assay designed to detect antibodies, not an imaging or AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effect size for human reader improvement with AI are not relevant to this submission.

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

Yes, this was a standalone performance study of the VITROS Immunodiagnostic Products Anti-HAV Total assay. The device itself is an automated system for detecting antibodies, and its performance reported is its output, not an output requiring human interpretation of assisted results. The results (positive/negative) are directly generated by the device.

7. The Type of Ground Truth Used

The ground truth used in the studies appears to be a combination of:

• Reference Anti-HAV Assay: Explicitly mentioned for comparison where "the percent agreement was 96.1% (74/77) as three subjects were negative for HAV in the reference assay."
• Known Clinical Status: "samples from subjects known to be anti-HAV IgM reactive" and "pediatric subjects at low risk for hepatitis."
• Serological/Clinical Information: The intended use statement also refers to the assay as an "aid in the clinical laboratory diagnosis of individuals with acute or past hepatitis A virus infection," implying the results would be interpreted in conjunction with other patient data.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set for this device. This is typical for an IVD assay where the "training" (development and optimization) would occur during the assay's design and formulation, rather than through a machine learning training set as seen with AI/ML devices. The studies described are performance validation studies.

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

Since no training set is mentioned in the context of machine learning, there is no information provided on how ground truth for a training set was established.

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The measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The provided text describes a 510(k) premarket notification for a medical device, the VITROS Immunodiagnostic Products Cortisol Assay. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the following information cannot be fully extracted or is not explicitly stated in the document:

• A table of acceptance criteria and the reported device performance: The document only provides a comparison of device characteristics between the new and predicate devices (Table 1) and a general statement of "equivalent performance." It does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance data against those criteria.
• Sample sized used for the test set and the data provenance: The document states that "testing human samples throughout the assay range" was done, but does not provide specific sample sizes for test sets, data provenance (e.g., country of origin), or whether the study was retrospective or prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• Adjudication method for the test set: Not provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an in vitro diagnostic device, not an image-based AI system that would involve human readers. Therefore, an MRMC study is not applicable or mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an immunoassay system, not an algorithm in the context of AI. Its performance is inherent in its design and operation.
• The type of ground truth used: The document mentions "manufactured reagents, positive and negative controls and testing human samples." For an immunoassay, the 'ground truth' would typically be established by reference methods or validated clinical diagnoses/outcomes, but this is not explicitly detailed.
• The sample size for the training set: Not applicable in the context of an immunoassay for which no separate "training set" is described for an algorithm.
• How the ground truth for the training set was established: Not applicable.

Here's what can be extracted based on the provided text, focusing on the comparison to the predicate device and the general statement of performance:

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, bias thresholds). Instead, "equivalent performance" to the predicate device is the overarching acceptance criterion for the 510(k) submission.

Study Proving Acceptance Criteria:

The study described is a comparison study demonstrating substantial equivalence of the modified VITROS Immunodiagnostic Products Cortisol Assay to the previously cleared predicate device (K983990). The conclusion states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range."

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

• Sample Size: Not explicitly stated. The document only mentions "testing human samples throughout the assay range."
• Data Provenance: Not specified (e.g., country of origin not mentioned).
• Retrospective or Prospective: Not specified.

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)

• Not applicable as this is not an image-based diagnostic or expert interpretation study. The 'ground truth' for an immunoassay's performance would typically refer to the true concentration of cortisol in samples, usually determined by reference methods or clinical gold standards. The document does not detail how this ground truth was established for the "human samples."

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

• Not applicable for this type of immunoassay study.

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

• No. This is an in vitro diagnostic device, not an AI system.

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

• The device itself is a standalone immunoassay system. The performance evaluated is the direct output of the system. There is no concept of an "algorithm only" in the context of human-in-the-loop for this device.

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

• The document implies that performance was assessed against "manufactured reagents, positive and negative controls and testing human samples." For human samples, the ground truth for cortisol levels would typically come from a well-established reference assay or a clinically validated method, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable. This is an immunoassay, not a machine learning algorithm requiring a distinct "training set."

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

• Not applicable.

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VITROS Immunodiagnostics NT-proBNP Reagent Pack: For the in vitro quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) to aid in the diagnosis of congestive heart failure and for the risk stratification of acute coronary syndrome and congestive heart failure. The test is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease. The test can also be used in the assessment of heart failure severity in patients diagnosed with congestive heart failure.

VITROS Immunodiagnostic Products NT-proBNP Calibrator For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).

VITROS Immunodiagnostic Products NT-proBNP Range Verifiers For the in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products NTproBNP Reagent Pack, the VITROS Immunodiagnostic Products NT-proBNP Calibrators, and the VITROS Immunodiagnostic Products NT-proBNP Range Verifiers (which are combined by the VITROS Immunodiagnostic system to perform the VITROS NTproBNP assay) and VITROS Immunodiagnostic Products High Sample Diluent B. The VITROS Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits. Common reagents used by the VITROS System in each assay.

The provided document is a 510(k) summary for the VITROS Immunodiagnostic Products NT-proBNP Reagent Pack, Calibrator, and Range Verifier. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for novel device performance.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical performance study for an AI-powered device. Instead, it relies on demonstrating comparable performance to an already cleared predicate device.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• No explicit acceptance criteria or performance study for device novelty: Since this is a substantial equivalence submission for an in vitro diagnostic (IVD) device, the "acceptance criteria" are implicitly met by demonstrating that the new device's performance characteristics (e.g., measuring range, analytical sensitivity, functional sensitivity, intended use) are substantially equivalent to a legally marketed predicate device. There isn't an independent study outlined to "prove" the device meets specific (novel) acceptance criteria, but rather a comparison to an established device.
• No AI component: This device is an immunoassay system for measuring NT-proBNP, not an AI-powered diagnostic tool. Therefore, questions related to AI-specific elements (like test sets, training sets, adjudication, MRMC studies, or standalone algorithm performance) are not applicable.

Despite these limitations, I can extract and infer some information based on the comparison tables provided.

Inferred Acceptance Criteria and Reported Device Performance (Based on Predicate Device Comparison)

The acceptance criteria for this device are implicitly tied to demonstrating performance comparable to the predicate device (Roche Elecsys proBNP Immunoassay K051382 for the Reagent Pack and Calibrator, and VITROS Immunodiagnostic Products CEA Range Verifiers K990984 for the Range Verifiers).

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VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA assay. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than novel performance metrics against acceptance criteria in a clinical study.

Therefore, many of the requested categories for a typical medical device performance study, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable in the context of this 510(k) submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the traditional sense, as it aims to show substantial equivalence. Instead, the performance is demonstrated by comparing the characteristics of the new formulation device to the predicate device. The conclusion of the study is that the performance is "substantially equivalent."

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

The document states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range."

• Sample Size: Not specified. The number of "human samples" used is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not Applicable: This is an IVD device measuring an analyte concentration. Ground truth would typically be established by reference methods or clinical outcomes, not expert interpretation of images or clinical findings.

4. Adjudication Method for the Test Set

• Not Applicable: Not relevant for an IVD assay measuring analyte concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

• Not Applicable: This is an IVD assay, not an imaging or diagnostic device requiring human reader interpretation in the context of MRMC studies.

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

• Done (implicitly): The device (VITROS CEA assay) is the standalone "algorithm" or system that quantitatively measures CEA. Its performance is compared to the predicate device. The performance data presented (e.g., precision, accuracy, linearity—though not detailed in this summary) are inherently "standalone" in the context of an IVD.

7. The Type of Ground Truth Used

• The summary indicates that "equivalent performance was demonstrated... testing human samples near the low end of the assay range." For an IVD, the "ground truth" would typically be established through:
  • Reference methods: Comparing results to a recognized gold standard method for CEA measurement.
  • Clinical correlation: Showing that the measured CEA levels correlate with clinical status or outcomes as expected, similar to the predicate device.
  • Known concentrations: Using samples with accurately known CEA concentrations (e.g., controls, spiked samples).

The summary does not explicitly detail the type of ground truth, but implies comparison against the predicate device's established performance, and potentially reference methods for accuracy.

8. The Sample Size for the Training Set

• Not Applicable: This is a traditional immunoassay, not a machine learning or AI-based device requiring a separate "training set" in the computational sense. The "training" of the device is through its manufacturing and calibration processes.

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

• Not Applicable: See point 8.

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For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.

For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin).

Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.

The Vitros Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

• 1. The Vitros Immunodiagnostic Products range of immunoassay products: Vitros Immunodiagnostic Products Myoglobin Reagent Pack, the Vitros Immunodiagnostic Products Myoglobin Calibrators and the Vitros Immunodiagnostic Products Myoglobin Range Verifiers, (which are combined by the Vitros Immunodiagnostic System to perform the Vitros Myoglobin assay), and Vitros Immunodiagnostic Products High Sample Diluent B.
• 2. The Vitros Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits.
• 3. Common reagents used by the Vitros System in each assay.

The Vitros System and common reagents are dedicated specifically for use only with the Vitros Immunodiagnostic Products range of immunoassay products.

The provided text describes the 510(k) summary for the Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information typically required for an AI/ML SaMD acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method) does not directly apply in the same way.

However, I can extract information related to the device's performance compared to a predicate device, which serves a similar purpose in demonstrating functional equivalence.

Here's an analysis based on the provided text, adapted for IVD devices:

Acceptance Criteria and Study for Vitros Immunodiagnostic Products Myoglobin Assay

The Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers were shown to be substantially equivalent to predicate devices through various analytical studies. The primary goal was to demonstrate comparable characteristics and performance to legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

For IVD devices, "acceptance criteria" for demonstrating substantial equivalence often involve comparisons of analytical performance characteristics (e.g., calibration range, precision, correlation) with a predicate device.

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

• Test Set Sample Size: The text states, "This relationship was determined from a panel of patient samples from a variety of clinical categories." A specific number for this panel is not provided within the summary.
• Data Provenance: The origin (e.g., country) of the patient samples or whether they were retrospective or prospective is not specified in the provided summary.

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

This is not applicable to this type of IVD device submission. The "ground truth" for an assay is typically established through a reference method or target values assigned to calibrators, not through expert consensus on medical images or clinical judgment. The DADE Dimension RxL Myoglobin Method acts as the reference for comparison studies.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" here refers to patient samples analyzed by two different diagnostic assays for comparison, not a set of cases requiring adjudication by human readers.

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

This is not applicable. This device is an immunoassay, not an AI/ML-driven diagnostic imaging or clinical decision support tool that involves human readers interpreting AI output.

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

This is applicable in the sense that the device's performance as an assay system (analyzer + reagents) was evaluated independently and then compared to the predicate device. The correlation study directly assesses the "standalone" analytical performance of the new Vitros Myoglobin assay compared to the predicate. The reported correlation coefficient of 0.997 and the regression equation demonstrate this standalone analytical performance.

7. The Type of Ground Truth Used

The "ground truth" was established by the results from the predicate device (DADE Dimension RxL Myoglobin Method) when analyzing the same patient samples. This is a common method for demonstrating substantial equivalence for new IVD assays by comparing them to an already cleared and accepted method. Additional studies on precision, analytical sensitivity, specificity, and expected values provide further grounding for the assay's performance characteristics.

8. The Sample Size for the Training Set

This is not applicable. Immunoassays are not "trained" in the same way AI/ML algorithms are. There isn't a defined training set in the context of machine learning. The assay's analytical characteristics are developed and verified through chemical and biological experimentation, calibration, and validation with various samples (including spiked samples, proficiency samples, and patient samples).

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

Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The accuracy of the assay is established through its analytical and clinical performance studies, often referencing established methodologies or certified reference materials.

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VITROS Progesterone Reagent Pack
For in vitro diagnostic use only.
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.

VITROS Progesterone Calibrators
For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Progesterone Reagent Pack, VITROS Immunodiagnostic Products Progesterone Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Progesterone assay).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) premarket notification (K962919/S1).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

This submission describes the VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators (modified), which is a progesterone assay. The device is intended for in vitro diagnostic use to quantitatively measure progesterone concentration in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device (VITROS Immunodiagnostic Products Progesterone Reagent Pack and VITROS Immunodiagnostic Products Progesterone Calibrators).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison of assay characteristics between the predicate and the new device. It does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it focuses on substantial equivalence based on comparable characteristics.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). The submission focuses on comparing the modified device's characteristics to a predicate device, rather than providing detailed clinical study results with a test set.

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

Not applicable. This is an in vitro diagnostic device for quantitative measurement, and the ground truth would typically be established by established reference methods or primary analytical measurements, not by expert interpretation in the same way imaging or diagnostic algorithms are validated. The document does not mention the use of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on analytical performance and comparison to a predicate, not on subjective interpretations 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 in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

The device itself is a standalone immunoassay system. The document implies that the performance of the VITROS Progesterone assay (modified) was evaluated on its own analytical capabilities to demonstrate substantial equivalence to the predicate. There is no mention of human interaction beyond the operation of the instrument.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic device would typically be established through highly accurate and precise analytical reference methods, or by comparing agreement with the predicate device's established performance, rather than pathology, outcomes data, or expert consensus in an observational or interpretive sense. The document states that "the information presented in the pre-market notification demonstrates that the performance of the VITROS Progesterone assay (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device." This implies that the 'ground truth' or benchmark for performance comparison is the predicate device's established performance using recognized analytical methods.

8. The Sample Size for the Training Set

The document does not provide details on a "training set" in the context of machine learning. This device is an immunoassay, not an AI/ML-based algorithm that typically requires a training set. The development of such assays involves analytical validation, linearity studies, precision, accuracy, and interference studies, but these do not fall under the conventional definition of a "training set" for AI.

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

Not applicable, as this device does not utilize a "training set" in the AI/ML sense. The "ground truth" for developing and validating immunoassay performance would be derived from rigorous analytical testing using known concentrations of analytes, reference materials, and comparison with established methods.

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