Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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).

Ask a specific question about this device

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.

Ask a specific question about this device

For the in vitro quantitative measurement of Troponin I (cTnI) in human serum or plasma (EDTA or heparin), to aid in the diagnosis of myocardial infarction.

For use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) 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 Troponin I Reagent Pack, VITROS Immunodiagnostic Products Troponin I Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the ... VITROS Troponin I assay, and VITROS Immunodiagnostic Products High Sample Diluent B). Note: High sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total B-hCG Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG Calibrators 510(k) premarket notification (K970894). 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). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text details the 510(k) summary for the VITROS Immunodiagnostic Products Troponin I Reagent Pack and Calibrators. This document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a full study report with detailed acceptance criteria and performance against those criteria as would be found in a clinical trial.

Based on the provided information, a complete table of acceptance criteria and reported device performance with numerical metrics cannot be fully constructed for independent standalone performance (i.e. algorithm only without human-in-the loop performance). However, I can extract the information related to the comparison study.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):

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

• Sample Size: The document states that the relationship between the VITROS Troponin I assay and the DADE Dimension RxL Cardiac Troponin-I assay was determined from a "panel of patient samples from a variety of clinical categories." However, the specific number of samples (sample size) used for this correlation study is not provided.
• Data Provenance: The text does not explicitly state the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, though the use of "patient samples" for a correlation study often implies retrospective analysis of collected samples.

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

• Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for cardiac markers), the "ground truth" is typically established by the quantitative measurement of Troponin I itself, often through the predicate device or a reference method. It does not involve human expert interpretation (e.g., radiologists assessing images). Therefore, there is no mention of experts establishing a ground truth for a test set in the context of human interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: As the "ground truth" for this device is based on quantitative chemical measurement, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant or discussed. The primary "adjudication" is the chemical measurement itself, and the comparison is statistical.

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 device is an in vitro diagnostic assay (a laboratory test kit), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this submission.

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

• Yes, this is an inherently standalone device. The VITROS Immunodiagnostic System, using the VITROS Troponin I assay, performs the quantitative measurement of Troponin I. This is an automated process without human intervention in the actual measurement or interpretation of the raw signal to produce the Troponin I concentration. The device itself provides the final quantitative result. The study of substantial equivalence directly assessed the performance of this device (algorithm/system) against the predicate device.

7. The type of ground truth used:

• The ground truth for demonstrating equivalence was the quantitative measurement results obtained from the predicate device (DADE Dimension™ RxL Cardiac Troponin-I (TROP) Method). The VITROS Troponin I assay's measurements were compared against these predicate measurements.

8. The Sample Size for the Training Set:

• Not Provided / Not Applicable (in the traditional machine learning sense): As this is an immunoassay device, the concept of a "training set" in the context of machine learning (where an algorithm learns from data) does not directly apply. The device's performance characteristics (calibration range, precision, analytical sensitivity, specificity) are established through analytical validation studies during its development, not by training an algorithm on a dataset in the way an AI would be. The document mentions "currently commercially available reagents" and patient samples for the correlation study, which serves as a validation set.

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

• Not Applicable (as per point 8): Since there isn't a "training set" in the machine learning sense, the establishment of its ground truth is not applicable. The assay's analytical characteristics are determined through standard laboratory procedures and reference materials.

Ask a specific question about this device

VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction.
VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.

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 CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB 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 a 510(k) summary for the VITROS CK-MB assay but it does not contain the specific details about acceptance criteria, detailed performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or MRMC studies that would allow for a complete response to all aspects of your request. It mainly focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract the information that is present:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and a "reported device performance" against those targets in the format requested. Instead, it describes characteristics of the new device and compares them to the predicate device to demonstrate substantial equivalence. The overall conclusion is that the performance is "substantially equivalent."

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

The document states: "Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories." However, it does not specify the sample size used for the test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for measuring CK-MB. The "ground truth" for such devices is typically established through reference methods or quantitative chemical analysis, not by human expert interpretation of images or clinical data in the same way as, for example, a radiology AI device. Therefore, the concept of "experts used to establish ground truth" with their qualifications is not applicable in this context.

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

Not applicable for an in-vitro diagnostic immunoassay. The evaluation relies on quantitative measurements against reference standards, not on human adjudication of ambiguous cases.

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 immunoassay, not an AI or imaging device that assists human readers.

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

This refers to the performance of the immunoassay itself in producing quantitative measurements of CK-MB. The entire submission describes the standalone performance of this diagnostic assay. The device is intended for in vitro quantitative measurement and operates without a human-in-the-loop directly influencing the measurement result once the sample is processed.

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

For an immunoassay like the VITROS CK-MB assay, the "ground truth" is typically established by:

• Reference methods: Highly accurate and precise analytical methods.
• Known concentrations: Samples with precisely known concentrations of the analyte (CK-MB) through gravimetric preparation or using certified reference materials.
• Clinical correlation: While not technically "ground truth" for the measurement itself, the clinical utility of the measurement (i.e., its correlation with myocardial infarction) is a broader context.

The document states that equivalence was demonstrated using "patient samples covering a variety of clinical categories," implying that the measurements from the new device were compared to those from the predicate device on these samples, with the predicate device's results serving as the de facto reference for demonstrating equivalence in clinical performance.

8. The sample size for the training set

This document describes a 510(k) submission for an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.

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

As explained above, the concept of a "training set" is not applicable for this type of device.

Ask a specific question about this device