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For In Vitro Diagnostic Use

For the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) using the VITROS 5600 Integrated System.

Cardiac troponin I is used to aid in the diagnosis of myocardial infarction (MI).

The VITROS hs Troponin I assay is performed using the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack and the VITROS Immunodiagnostic Products hs Troponin I Calibrators on the VITROS 5600 Integrated System. An immunometric immunoassay technique is used. Cardiac troponin I present in the sample reacts simultaneously with streptavidin-conjugated antibody (mouse monoclonal anti- cTnI), bound by biotin-BSA on the wells, and a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-cTnI). The antigen-antibody complex is captured by the antibody 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 system. The amount of HRP conjugate bound is directly proportional to the concentration of cardiac troponin I present.

N/A

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For in vitro diagnostic and laboratory professional use.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiO/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

For use in the calibration of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay performed on the VITROS Systems (VITROS ECi/ECiO Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System) providing fully automated random-access testing.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls on the VITROS Systems.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack is supplied as ready to use and contains:

• 100 wells coated with 100ng/well of recombinant SARS-CoV-2 spike antigen derived from human cells.
• 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent)
• 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator contains:

• 2 vials of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 1gG Calibrator 0 (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative human serum with antimicrobial agent, 1 mL)
• Lot calibration card
• Protocol card
• 8 calibrator bar code labels

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls contain:

• 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL). Control 1 is non-reactive and Control 2 is reactive

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is designed for use on the VITROS Systems. The VITROS Systems use the following ancillary reagents (general purpose reagents):

• VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent

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

Device: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (Chemiluminescent Immunoassay)

Purpose: Qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma, intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the device rather than explicitly stating pre-defined acceptance criteria in a dedicated table. However, we can infer the implicit acceptance criteria from the observed results and the FDA's decision to grant the De Novo request.

2. Sample Size and Data Provenance

• Test Set (Clinical Agreement Study):

  • Total Samples: 642 unique retrospective clinical samples.
  • Population 1 (SARS-CoV-2 Positive): 338 samples from individuals with a prior SARS-CoV-2 positive RT-PCR test result. Collected within the United States between April 2020 and March 2021.
  • Population 2 (Presumed SARS-CoV-2 Negative): 304 samples collected prior to December 2019 (pre-COVID-19 widespread outbreak) within the United States. 30% from blood donor centers.
  • Retrospective: All clinical samples were retrospective.

• Other Analytical Studies:

  • Assay Cut-Off: A collection of pre-COVID-19 negative samples and samples from RT-PCR positive individuals. (Specific count for cut-off determination not explicitly stated beyond "pre-COVID-19 samples" and "samples from individuals with a prior SARS-CoV-2 RT-PCR positive result").
  • Cross-Reactivity: Number of samples tested per category varied (e.g., 10 for Influenza A, 15 for HCV, 21 for OC43, etc.). Total ~300 instances of known interfering substances tested (summing 'Number of Samples Tested' from Table 6).
  • Interference: Tested using 3 reactive (low positive) and 3 non-reactive (negative) samples for each interferent.
  • Specimen Stability: Freshly drawn whole blood from individual donors (number not specified).
  • Analytical Sensitivity (CRM): Serial dilutions of WHO First International Standard for Anti-SARS-CoV-2 Immunoglobulin (human) code 20/136.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts or their qualifications for establishing ground truth. Instead, the ground truth for the clinical study was established based on:

• Population 1 (Positive): Prior SARS-CoV-2 positive RT-PCR test results (FDA-determined appropriate comparator).
• Population 2 (Negative): Samples collected prior to the widespread COVID-19 outbreak (pre-December 2019).

For analytical studies, ground truth was based on:

• Precision/Reproducibility: Defined panel members (control materials, plasma pools).
• Cross-Reactivity/Interference: Samples with known levels/presence of interfering substances.
• Analytical Sensitivity: WHO Certified Reference Material.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The device's results were directly compared to the established RT-PCR status (for positive cases) or pre-COVID-19 status (for negative cases).

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

No MRMC study was performed or described. This device is an automated in vitro diagnostic (IVD) immunoassay, not an AI-assisted imaging device, so MRMC studies involving human readers are not applicable to its evaluation. Its performance is machine-read.

6. Standalone Performance

Yes, the entire evaluation is based on the standalone performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test, as it is an automated IVD platform. There is no human-in-the-loop component for reading the assay results. The performance metrics (PPA, NPA, analytical performance) are all algorithm-only results.

7. Type of Ground Truth Used

• Clinical Ground Truth:
  • For positive cases: SARS-CoV-2 RT-PCR positive test result (as determined by an FDA-appropriate comparator).
  • For negative cases: Collection prior to the widespread COVID-19 pandemic (presumed negative).
• Analytical Ground Truth:
  • Known concentrations/presence of analytes/interfering substances (e.g., WHO Certified Reference Material for analytical sensitivity, defined control materials for precision, samples with known antibody status for cross-reactivity).

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" for an AI or machine learning model. This device is a chemiluminescent immunoassay, which is a traditional laboratory diagnostic test following established biochemical principles, not a machine learning algorithm that requires a distinct training phase with labeled data in the same sense as an AI for image analysis.

The "assay cut-off" was determined using a collection of negative samples (prior to COVID-19) and samples from RT-PCR positive individuals. This process could be seen as optimizing the device's threshold for qualitative results, but it's not a "training set" for an AI model.

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

As noted above, a distinct "training set" for an AI model is not mentioned for this device. The assay cut-off was optimized using a Receiver Operating Characteristic (ROC) curve analysis on a collection of negative samples (collected prior to the pandemic) and samples from individuals with a prior RT-PCR positive result. This implicitly used the RT-PCR status or pre-pandemic status as the ground truth for establishing the optimal cut-off value.

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For in vitro diagnostic and laboratory professional use.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (K-EDTA. K-EDTA and lithium heparin) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

For use in the calibration of the VITROS ECi/ECiO/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is a qualitative chemiluminescent immunoassay performed on the VITROS Systems (VITROS ECi/ECiQ Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System) providing fully automated random-access testing.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls on the VITROS Systems.

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack is supplied as ready to use and contains:

• . 100 coated wells (streptavidin, bacterial; binds ≥3 ng biotin per well; biotin recombinant SARS-CoV-2 antigen 0.1 ug/mL)
• 6.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent) .
• . 16.2 mL conjugate reagent (HRP-recombinant SARS-CoV-2 antigen) in buffer with bovine protein stabilizers and antimicrobial agent

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator contains:

• . 2 vials of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator (anti-SARS-CoV-2 in anti-SARS-CoV-2 negative human plasma with antimicrobial agent, 1 mL)
• . Lot calibration card
• . Protocol card
• . 8 calibrator bar code labels

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls contain:

• . 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL). Control 1 is non-reactive and Control 2 is reactive.
  The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is designed for use on the VITROS Systems. The VITROS Systems use the following ancillary reagents (general purpose reagents):
• . VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent .

The document describes the evaluation of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator, a chemiluminescent immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2.

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

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

The document does not explicitly state "acceptance criteria" for the clinical performance in a single, clear table with pass/fail thresholds. However, the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) are the key clinical performance metrics presented. The FDA's decision to grant De Novo status implies that the reported performance met their internal criteria for safety and effectiveness for its intended use.

Here's a summary of the reported clinical performance:

Note: The PPA for samples collected early (0-7 days and 8-14 days post-symptom onset) is considerably lower (e.g., 36.00% to 44.00% for 0-7 days), reflecting the time required for antibody development. The indication for use specifies "samples collected on or after 15 days post-symptom onset," making the PPA for ≥15 days the most relevant for the primary intended use.

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

• Test Set Sample Size:

  • PPA (Clinical Sensitivity Equivalent): 296 samples from individuals with prior SARS-CoV-2 positive RT-PCR results were initially acquired. However, the "Number of Subjects Tested" varies slightly per analyzer, typically around 282-286 for individual system reporting, and 237-239 for the ≥15 days post-symptom onset group which is the most relevant for the device's claims.
  • NPA (Clinical Specificity Equivalent): 513 presumed SARS-CoV-2 negative samples collected prior to the COVID-19 pandemic. The "Presumed Negative" count also varies slightly per analyzer, typically around 505-511.

• Data Provenance:

  • Country of Origin: All samples were collected within the United States.
  • Retrospective or Prospective: The samples were collected retrospectively. Population 1 (positive samples) was collected between April 2020 and April 2021. Population 2 (negative samples) was collected prior to December 2019.

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 device for antibody detection, not an imaging AI system. Therefore, the "ground truth" for the clinical study was established by RT-PCR test results for SARS-CoV-2 infection (for positive samples) and collection of samples prior to the COVID-19 pandemic (for negative samples). There is no mention of human experts (e.g., pathologists or radiologists) adjudicating the ground truth for this type of test.

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

Not applicable for this type of in vitro diagnostic test where RT-PCR is the comparator and pre-pandemic samples define the negative group. Discrepancy resolution with expert radiologists would be relevant for imaging-based AI studies, not serology tests.

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 for laboratory use, not an AI-assisted diagnostic tool for human readers (e.g., radiologists interpreting images). Its performance is evaluated as a standalone laboratory test.

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

Yes, the clinical performance (PPA and NPA) presented for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is its standalone performance as an automated laboratory assay. There is no human-in-the-loop component for the interpretation or usage of the result beyond the laboratory professional's decision to report the qualitative positive/negative result.

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

• For Positive Samples (PPA): Ground truth was established by prior SARS-CoV-2 positive RT-PCR test results. The document states, "...using a comparator that FDA determined is appropriate (RT-PCR test)."
• For Negative Samples (NPA): Ground truth was established by collection date prior to the widespread outbreak of COVID-19 (i.e., prior to December 2019), deeming them "presumed SARS-CoV-2 negative samples."

8. The sample size for the training set

This document describes the validation of a commercial in vitro diagnostic (IVD) product, not an AI/machine learning model where a distinct 'training set' of patient data in the typical AI sense would be used to train the algorithm. The "training" of this device involves the development and optimization of the chemical reagents, assay parameters, and cutoff values performed internally by the manufacturer (Ortho-Clinical Diagnostics).

The closest equivalent to a "training" activity described in the context of setting the device's operational parameters is the Assay Cut-Off determination study (page 12-13). This study used:

• "a collection of negative samples collected prior to the COVID-19 pandemic"
• "samples collected from individuals with a prior SARS-CoV-2 RT-PCR positive result."

The specific numbers of these samples for the cutoff determination are not explicitly stated, but are implied to be part of the broader pool of samples available to the manufacturer during development. The ROC curve analysis was performed on these samples to optimize sensitivity and specificity at the S/C = 1.00 cutoff.

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

As noted in point 8, this isn't an AI model with a conventional training set. For the "samples" used in the Assay Cut-Off determination (analogous to internal optimization/training data):

• Negative Ground Truth: Established by "negative samples collected prior to the COVID-19 pandemic."
• Positive Ground Truth: Established by "samples collected from individuals with a prior SARS-CoV-2 RT-PCR positive result."

This implies a similar method to the clinical validation set for establishing true positive and true negative status, but performed during the device development phase to define the S/C cutoff.

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For in vitro diagnostic and laboratory professional use.

VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 5600 Integrated System.

Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The VITROS PHBR Slide is a multilayered, analytical element coated on a polyester support. The phenobarbital assay is based on an enzymatic heterogeneous, competitive immunoassay format. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer.

A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Phenobarbital in the sample competes with the phenobarbitalperoxidase conjugate for a limited number of antibody binding sites during Incubation 1. The subsequent addition of 12 µL of VITROS Immuno-Wash Fluid to the slide removes unbound phenobarbital-peroxidase conjugate from the read area, while also providing a substrate for the enzyme mediated oxidation of leuco dye.

The rate of dye formation, as monitored by reflectance spectrophotometry for Incubation 2, is inversely proportional to the phenobarbital concentration in the sample. To determine if an adequate wash has occurred, a wash detection dye is read at 540 nm during Incubation 2.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on the acceptance criteria and study proving the device meets those criteria, formatted as requested:

Device: VITROS Chemistry Products PHBR Slides
Device Type: In vitro diagnostic device for quantitative measurement of phenobarbital (PHBR) concentration in serum and plasma.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary outlines several analytical performance characteristics that serve as acceptance criteria for the VITROS Chemistry Products PHBR Slides. The document doesn't explicitly state "acceptance criteria" for all metrics in the form of numerical thresholds before the study results, but rather presents the study results as meeting acceptable performance for substantial equivalence. For some, like LoQ, a specific goal is mentioned.

2. Sample Sizes and Data Provenance

• Method Comparison: 142 serum samples.
• Precision: 88 observations (2 replicates per run, 2 runs per day over 22 days) using patient pools and quality control materials.
• Linearity: Fourteen proportionally related admixtures of low and high concentration fluids were tested, each in duplicate.
• Specificity (Interference) & Cross-Reactivity: Number of individual samples tested for each interferent/cross-reactant not explicitly stated, but the studies describe adding substances to serum samples.
• Training Set Sample Size: Not applicable based on the provided document. This is an IVD device measuring analyte concentration, not an AI/ML device requiring a training set for algorithm development in the traditional sense. The phrase "training set" is typically used for machine learning models.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). Standard laboratory validation protocols (CLSI guidelines listed) imply controlled, often prospective, collection for such studies.

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

• Not applicable. The "ground truth" for this device (a quantitative diagnostic for phenobarbital concentration) is established by direct chemical measurement in the form of a reference method (the predicate device) or by known concentrations of prepared standards/controls. It does not involve expert interpretation or consensus in the way a diagnostic imaging AI might.

4. Adjudication Method for the Test Set

• Not applicable. This specific study does not involve human readers or interpretations that would require adjudication. Measurements are quantitative and compared to a reference method or known concentrations.

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

• No. An MRMC study is typically performed for AI-assisted diagnostic imaging or similar scenarios where human readers make subjective interpretations. This document describes the analytical performance of an in vitro diagnostic device for measuring a chemical analyte, which is not subject to human reader variability in the same way.

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

• Yes, indirectly. The entire document describes the standalone analytical performance of the VITROS Chemistry Products PHBR Slides on the VITROS 5600 Integrated System. The device provides a quantitative measurement directly, without human interpretation in the loop that would alter the result itself. The measurements obtained are then used by laboratory professionals to aid in diagnosis and treatment, but the device's performance itself is evaluated as a standalone analytical instrument.

7. Type of Ground Truth Used

• Reference Method / Known Concentrations:
  • For Method Comparison, the ground truth is established by the results from the legally marketed predicate device (ARCHITECT iPhenobarbital Assay) on the same patient samples.
  • For Precision, Detection Limits, Linearity, Specificity, and Cross-Reactivity, the ground truth is established by using prepared samples with known, controlled concentrations of phenobarbital and/or interfering/cross-reacting substances.

8. Sample Size for the Training Set

• Not applicable. As explained in section 2, this is an IVD device for quantitative measurement, not an AI/ML device that requires a "training set" for algorithm development.

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

• Not applicable. No training set in the AI/ML sense. For analytical validation, ground truth is established by precisely prepared standards and controls, or by comparison to a validated reference method (like the predicate device).

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For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

The ALB test is a multilayered, analytical element coated on a polyester support.

For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.

The provided document describes the analytical performance of the VITROS XT Chemistry Products ALB-TP Slides for measuring albumin (ALB) concentration, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study data:

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

The document does not explicitly state formal "acceptance criteria" for each performance metric in a dedicated table. Instead, performance is demonstrated through studies and compared against established clinical laboratory guidelines (CLSI protocols) or by showing strong correlation to the predicate device. For some metrics, an implied acceptance based on clinical relevance and comparison to the predicate can be inferred.

Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of the studies:

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

• Test Set Sample Sizes:
  • Method Comparison: 127 patient samples.
  • Matrix Comparison: Not explicitly stated as a number of unique patient samples, but various collection devices (serum: glass red top, plastic red top, SST; plasma: Na-heparin, Li-heparin, PST) were evaluated. The comparison used two replicates for the reference serum and two replicates for each feature tube.
  • Precision: Patient pools and quality control materials. "80 observations (2 replicates per run, 2 runs per day over 20 days)" were used for the precision study, which implies that a smaller number of initial patient pools were tested multiple times.
  • Linearity: A series of seventeen proportionally related admixtures of low and high test fluids were tested in quadruplicate.
  • Specificity: Not explicitly stated as a number of unique patient samples; it likely used spiked samples or patient samples with known levels of interferents.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to "patient samples" and "patient pools" but provides no further details on their source.

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 (IVD) device for quantitative measurement of albumin. "Ground truth" is established by the analytical method itself (measurement against a reference standard or validated method) rather than by expert consensus on qualitative interpretation of images or clinical findings. The predicate device (VITROS Chemistry Products ALB Slides) serves as the reference for method comparison.

4. Adjudication method for the test set

Not applicable. As this is an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring an adjudication process for a "test set" in the way it would be applied to, for example, image-based diagnostic systems. The performance is assessed by comparing quantitative results against reference methods or established analytical performance criteria.

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 for quantitative measurement of a biochemical analyte. It does not involve human readers interpreting images or data, nor does it involve AI assistance for such interpretation.

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

Yes, in essence, the performance studies described are for the standalone device (VITROS XT Chemistry Products ALB-TP Slides on the VITROS XT 7600 Integrated System) measuring albumin concentration. The device operates as a laboratory instrument without direct human-in-the-loop interpretation of the measurement itself. Human involvement is in operating the instrument and interpreting the quantitative result in a clinical context, but the device's analytical performance (accuracy, precision, linearity, etc.) is assessed independently.

7. The type of ground truth used

The "ground truth" for the performance studies is primarily established by:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products ALB Slides (K023875) on the VITROS 5600 Integrated System served as the reference for the method comparison study.
• Reference standards and established analytical methods: Precision, linearity, and detection limit studies rely on the inherent accuracy of the measurement procedure itself against known concentrations (e.g., patient pools, quality control materials, spiked samples, or reference materials).
• Clinical Laboratory Standards Institute (CLSI) protocols: The studies specifically cite adherence to CLSI EP09-A3 (Method Comparison), EP05-A3 (Precision), EP17-A2 (Detection Limits), EP06-A (Linearity), EP07-A3, and EP37 (Interference), which are widely accepted guidelines for validating IVD performance.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that requires a "training set" in the conventional sense. It is a traditional in vitro diagnostic chemical assay. Its development involves chemical and engineering principles, not statistical learning from a data set.

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

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

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Rx Only For in vitro diagnostic use only

The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal destruction of red blood cells, are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.

The ALKP test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS XT 7600 Integrated Systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Not Found

This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically for VITROS XT Chemistry Products TBIL-ALKP Slides. The provided text is a regulatory communication and does not contain the acceptance criteria or study details for the device's performance.

To answer your request, I would need access to the actual 510(k) summary, often referred to as a "510(k) Premarket Notification." This document typically includes the performance data, acceptance criteria, and study designs to demonstrate substantial equivalence to a predicate device.

The information you've provided only states:

• Device Name: VITROS XT Chemistry Products TBIL-ALKP Slides
• Intended Use: Quantitative measurement of total bilirubin (TBIL) and alkaline phosphatase (ALKP) in serum and plasma using VITROS XT 7600 Integrated Systems.
• Regulatory Class: Class II
• Product Code: CIG (Bilirubin (total or direct) test system), CJE (Alkaline phosphatase test system)
• Date of Clearance: April 26, 2019

Without the 510(k) summary or a similar technical document, I cannot extract the specific acceptance criteria, study details, sample sizes, or ground truth information you've requested.

Therefore, I cannot provide the requested table and study details based solely on the provided text.

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For in vitro diagnostic use only

The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders mellitus. neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Special conditions for use statement: For prescription use only.

The new device, the VITROS XT Chemistry Products GLU-Ca Slides is a single device that contains both a GLU test and a Ca test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

For glucose measurement, a drop of patient sample is deposited on the GLU test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light. The dye system used is closely related to that first reported by Trinder. ' The chemistry of the glucose slides has been described by Curme, et al.

For calcium measurement, a drop of patient sample is deposited on the Ca test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. There, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample.

The provided document describes the analytical performance of the VITROS XT Chemistry Products GLU-Ca Slides for measuring Glucose (GLU) and Calcium (Ca) concentrations. Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to show substantial equivalence to predicate devices and acceptable performance based on established clinical laboratory guidelines (CLSI protocols). The "reported device performance" is summarized from the tables in the document.

Table of Acceptance Criteria (Implied by Study Design) and Reported Device Performance

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

• Method Comparison:
  • GLU Serum: N=116
  • GLU Urine: N=103
  • GLU CSF: N=149
  • Ca Serum: N=112
  • Ca Urine: N=119
• Precision:
  • GLU (Serum, Urine, CSF): 80 observations (2 replicates per run, 2 runs per day over 20 days) for each fluid type.
  • Ca (Serum, Urine): 80 observations (2 replicates per run, 2 runs per day over 20 days) for each fluid type.
• Detection Limits (LoQ, LOB, LOD): Not explicitly stated as a number of patient samples, but the determination was based on CLSI EP17-A2.
• Linearity: Not explicitly stated as a number of patient samples, but involved "A series of twenty proportionally related admixtures of low and high test fluids" for each test and sample type, each tested in quadruplicate.
• Specificity (Interference): Not explicitly stated as a number of patient samples. Involves testing of "substances" at specified concentrations in serum, urine, and CSF.

Data Provenance: The document does not specify the country of origin of the data. The studies are non-clinical analytical performance studies, which typically use well-characterized, banked samples or prepared control materials rather than 'retrospective' or 'prospective' patient data in the clinical sense. The samples for method comparison are referred to as "patient samples."

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

This document describes the analytical performance of an in vitro diagnostic device. The "ground truth" here refers to the reference method measurements for Method Comparison studies or the known concentrations of control materials for Precision, Detection Limits, Linearity, and Specificity studies.

• No human experts (e.g., radiologists) are involved in establishing ground truth for chemical analyte measurements.
• The ground truth is established by the predicate devices (VITROS Chemistry Products GLU Slides and VITROS Chemistry Products Ca Slides on the VITROS 5600 Integrated System) for method comparison studies, and by the known values of patient pools and quality control materials for precision, detection limits, and linearity. For specificity, the ground truth is the known concentration of the interferent and the analyte in the prepared samples.

4. Adjudication Method for the Test Set

Not applicable. This is an analytical performance study for an in vitro diagnostic device, not a study involving human interpretation or adjudication of diagnostic findings.

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

No. This is an analytical performance study for an in vitro diagnostic device, not an MRMC study comparing human reader performance.

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

Yes, this entire document describes studies of the standalone performance of the VITROS XT Chemistry Products GLU-Ca Slides on the VITROS XT 7600 Integrated System. The performance metrics presented (method comparison, precision, linearity, detection limits, specificity) are all measures of the device's analytical capabilities without human intervention in the result generation or interpretation beyond operating the instrument and collecting the samples.

7. The Type of Ground Truth Used

• Method Comparison: Ground truth was established by the predicate devices (VITROS Chemistry Products GLU Slides [K182072] and VITROS Chemistry Products Ca Slides [K072440]) run on the VITROS 5600 Integrated System.
• Precision and Linearity: Ground truth was established by known concentrations of patient pools and quality control materials.
• Detection Limits (LoQ/LOD/LOB): Ground truth was based on the known concentrations of prepared samples and determined using statistical methods compliant with CLSI EP17-A2.
• Specificity (Interference): Ground truth was based on the known concentrations of the target analyte and the potential interfering substances in prepared samples.

8. The Sample Size for the Training Set

Not applicable. This document describes an analytical validation, not a machine learning study that typically involves "training sets." The device is a chemistry analyzer system, not an AI algorithm that learns from data.

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

Not applicable, as there is no "training set" in the context of this device's validation.

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Rx Only For in vitro diagnostic use only

The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.

The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.

To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.

The provided text describes the analytical performance of the VITROS XT Chemistry Products TRIG-CHOL Slides, an in vitro diagnostic device for quantitatively measuring triglyceride (TRIG) and cholesterol (CHOL) concentrations in serum and plasma.

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

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

The document does not explicitly present a table of "acceptance criteria" but rather reports the analytical performance of the new device and shows its comparison to the predicate devices. The implicit acceptance criteria are that the new device performs at least as well as, and is substantially equivalent to, the predicate devices. The reported performance metrics are detailed in the tables for method comparison, precision, detection capability, and linearity.

TRIG Test

CHOL Test

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

• Method Comparison: 148 serum samples were used for both TRIG and CHOL tests.
• Precision: 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum samples (patient pools and quality control materials).
• Detection Capability (LoQ): 180 determinations for both TRIG and CHOL.
• Linearity: Eighteen proportionally related admixtures of low and high test fluids, each tested in quadruplicate.

The data provenance is not explicitly stated in terms of country of origin or whether the samples were retrospective or prospective. It implies the use of patient samples, but specific details are absent.

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

This document describes the analytical performance of an in vitro diagnostic device, not a device that relies on expert human interpretation for its output (like an AI imaging device). Therefore, there is no mention of "experts used to establish the ground truth" in the way it would apply to a clinical imaging study or a study validating human performance. The "ground truth" for this type of device is established by its quantitative measurements against established analytical standards and reference methods/predicate devices.

4. Adjudication method for the test set

Not applicable. As noted above, this is an analytical performance study for an in vitro diagnostic device, not a human reader study 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 analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this entire study represents a "standalone" performance evaluation of the device (VITROS XT Chemistry Products TRIG-CHOL Slides on the VITROS XT 7600 Integrated System) without human intervention in the result generation. The device quantitatively measures the analytes.

7. The type of ground truth used

The ground truth for this in vitro diagnostic device is established through:

• Comparison to a legally marketed predicate device: The VITROS Chemistry Products TRIG Slides and VITROS Chemistry Products CHOL Slides. This implies that the predicate devices serve as the established reference standard for performance.
• Established analytical methods and materials: CLSI protocols (EP09c, EP05-A3, EP17-A2, EP06-A, EP07-03) are referenced, which dictate the methodology for evaluating analytical performance parameters.
• Quality Control Materials and reference pools: Used in precision and linearity studies.
• Clinically established guidelines: NCEP guidelines are referenced for expected values/classification of TRIG and CHOL, indicating alignment with clinical understanding of these analytes.

8. The sample size for the training set

This document describes pre-market validation studies for a diagnostic test kit and instrument system. It does not refer to a "training set" in the context of machine learning or AI. The development of such a device involves internal optimization and development work, but the data presented in this 510(k) summary are for the validation of the finalized product.

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

Not applicable, as this refers to a diagnostic test kit and instrument's analytical validation, not an AI or machine learning model that would involve a "training set" with ground truth established through expert annotation.

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For in vitro diagnostic use only

The UREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures urea concentration, reported either as urea nitrogen or as urea (UREA), in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases

The CREA test within the VITROS XT Chemistry Products UREA-CREA Slides quantitatively measures creatinine (CREA) concentration in serum, plasma, and urine using the VITROS XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

Special conditions for use statement: For prescription use only.

The new device, the VITROS XT Chemistry Products UREA-CREA Slide is a single device that contains both a UREA test and a CREA test multilayered, analytical element coated on a polyester support separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

To perform the UREA test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Water and nonproteinaceous components then travel to the underlying reagent layer, where the urease reaction generates ammonia. The semipermeable membrane allows only ammonia to pass through to the colorforming layer, where it reacts with the indicator to form a dye. The reflection density of the dye is measured and is proportional to the concentration of urea in the sample.

To perform the CREA test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product. Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting change in reflection density is measured at 2 time points. The difference in reflection density is proportional to the concentration of creatinine present in the sample.

This document describes the analytical performance of the VITROS XT Chemistry Products UREA-CREA Slides for quantitatively measuring urea and creatinine concentrations. The information provided is for an in-vitro diagnostic device and does not involve AI assistance, human readers, or image analysis, thus many of the requested elements are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is primarily assessed through method comparison (against predicate devices), precision, detection limits, and linearity. The "acceptance criteria" are implied by the measured performance demonstrating substantial equivalence to the predicate devices and meeting clinical laboratory standards for accuracy and precision.

2. Sample Size and Data Provenance

• Method Comparison Test Set:
  • UREA Serum: 124 samples
  • UREA Urine: 128 samples
  • CREA Serum: 130 samples
  • CREA Urine: 116 samples
• Precision Test Set: Not specified as a separate patient sample set, but rather "patient pools and quality control materials." Each precision study included "a minimum of 80 observations (2 replicates per run, 2 runs per day over 20 days)" for serum and urine pools/controls.
• Detection Limits (LoQ) Test Set: 72 determinations for serum (UREA and CREA) and 64 for urine (CREA). 72 for urine (UREA).
• Linearity Test Set: Twenty proportionally related admixtures of low and high test fluids, each tested in quadruplicate. Specific number of patient samples not stated, as it uses contrived samples.
• Specificity (Interference) Test Set: Not explicitly stated how many patient samples were used, but rather "96 test substances" and "88 test substances" were spiked into serum samples, and "two substances" and "nineteen test substances" for urine.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies used standard clinical laboratory protocols (e.g., CLSI EP09-A3, EP05-A3, EP17-A2, EP06-A) which typically involve fresh or appropriately preserved clinical samples. The reference interval studies mention "an internal study of 3160 apparently healthy adults" and "an external study" (for UREA) or "an external study of apparently healthy adults (serum: 180 males and 180 females)" and "a separate external study" (for CREA).

3. Number of Experts and Qualifications for Ground Truth

• This is an in-vitro diagnostic device (chemistry analyzer) measuring chemical concentrations. The "ground truth" is established by the reference methodology (predicate devices on a different system) and gravimetric/analytical preparation of calibrators and quality controls. It does not involve human expert interpretation of images or other subjective assessments. Therefore, the concept of "experts establishing ground truth" in the context of radiology or pathology (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human reader interpretation requiring adjudication. Performance is assessed analytically against quantitative measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC study was not done. This device is an automated in-vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

• Yes, this study represents a standalone analytical performance evaluation of the device's ability to accurately measure urea and creatinine concentrations. "Algorithm" in this context refers to the chemical reactions and measurement principles of the assay, not a software algorithm that processes medical images or data for interpretation. The performance metrics (method comparison, precision, detection limits, linearity, specificity) directly quantify the device's analytical capabilities without human intervention in the measurement process itself.

7. The type of ground truth used

• The ground truth is established through:
  • Reference Methods/Predicate Devices: For method comparison, the results generated by the predicate devices (VITROS BUN/UREA Slides and VITROS CREA Slides on the VITROS 5600 Integrated System) serve as the comparative ground truth.
  • Analytically Prepared Materials: For precision, detection limits, and linearity, the "ground truth" concentrations of control materials, patient pools, and serially diluted samples are established through precise gravimetric and volumetric preparations, often traceable to certified reference materials.
  • Clinical Laboratory Standards (CLSI Protocols): The studies adhered to widely accepted CLSI guidelines for analytical performance evaluation, implying that the methodologies used to establish "ground truth" for each parameter meet industry standards for accuracy and rigor in a clinical lab setting.

8. The Sample Size for the Training Set

• This is not an AI/machine learning study that involves "training sets" in the conventional sense. The device's performance is based on the inherent chemical and optical principles of the dry-slide technology. There's no AI model being trained with data.

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

• Not applicable, as there is no AI training set.

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1. VITROS Chemistry Products CRBM Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5.1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
2. VITROS Chemistry Products CREA Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Product CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
3. VITROS Chemistry Products TBIL Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block.
4. VITROS XT 7600 Integrated System: Rx Only. For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest.

The VITROS XT 7600 Integrated System is a fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid. The System operates in conjunction with reagents, calibrators and controls designed for use with the System in the MicroSlide, MicroTip or MicroWell format.

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, and VITROS Chemistry Products TBIL Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CRBM, CREA, and TBIL assays.

The document describes the performance of the VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, and the VITROS XT 7600 Integrated System. The main purpose of the study is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study details:

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

The document does not explicitly state acceptance criteria in a dedicated table format for each performance metric, but rather describes how results were evaluated in the "Specificity" section and implies acceptance based on the comparison to predicate devices and established guidelines. For the method comparison, precision, linearity, and detection limits, the "reported device performance" is the direct result of the testing.

Given the nature of the submission (510(k) for substantial equivalence in an in-vitro diagnostic device), the acceptance criteria would typically revolve around demonstrating comparable performance to the predicate devices and adherence to established clinical laboratory standards (CLSI guidelines).

Below is a table summarizing the reported performance, with implied acceptance criteria based on standard practices for demonstrating substantial equivalence for in-vitro diagnostic devices.

Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison Test Set:

  • CRBM: 118 human serum samples.
  • CREA: 116 human serum samples and 122 human urine samples.
  • TBIL: 125 human serum samples.
  • Data Provenance: The document states "human serum samples" and "human urine samples," implying these are clinical samples. The country of origin and whether the data is retrospective or prospective is not specified.

• Precision Test Set: For each assay (CRBM, CREA serum, CREA urine, TBIL), the study involved:

  • 80 replicates (N=80) for each of the multiple fluid levels (e.g., 6 for CRBM, 6 for CREA serum, 6 for CREA urine, 5 for TBIL). The total number of analyses is much higher (e.g., 80 replicates x 6 levels = 480 for CRBM).
  • The samples used were Quality Control fluids and human-based precision fluids.
  • Data Provenance: Not specified.

• Linearity Test Set: A series of eleven proportionally related admixtures of low and high test fluids. Each sample was tested in triplicate.

  • Data Provenance: Not specified.

• Detection Limits (LoB, LoD, LoQ) Test Set:

  • LoB: 4 blank samples, tested in replicates of 6 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 216 observations (72 results per reagent lot).
  • LoD: 4 pools of human samples with analyte concentrations close to the expected detection limit, tested in replicates of 6 over 3 days, using 3 lots of reagents, with the 4 human sample pools every day, for a total of 216 observations (72 results per reagent lot).
  • LoQ: 4 pools of low level samples, tested in replicates of 4 over 3 days, using 3 lots of reagents, 4 samples every day, for a total of 144 observations (48 results per reagent lot).
  • Data Provenance: The LoD and LoQ studies used "human samples." The country of origin and whether the data is retrospective or prospective is not specified.

• Specificity (Interference) Test Set: Chemical interferents, common chemical substances, and claimed non-interferents, including hemoglobin, bilirubin, and intralipid. Testing employed "paired-difference" assessment at a minimum of two analyte levels.

  • Data Provenance: 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)

This device measures quantitative concentrations of specific analytes (Carbamazepine, Creatinine, Total Bilirubin). Ground truth for these types of in vitro diagnostic devices usually refers to the reference method (predicate device in this case) or a highly accurate reference standard rather than expert interpretation in the way it applies to image analysis or clinical diagnosis. The document does not mention human experts establishing ground truth in the context of radiologists or similar clinical diagnosticians. The ground truth for the method comparison study was established by the predicate device, VITROS 5600 Integrated System.

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

None mentioned. Adjudication methods are typically used when there's a subjective element to ground truth establishment, often involving multiple human readers for diagnostic image interpretation. For quantitative measurements in clinical chemistry, the "truth" is established by reference methods, precision, and linearity studies, not by human adjudication of results.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, particularly in radiology or pathology, and often involves AI assistance. This document describes an automated in-vitro diagnostic device for quantitative chemical measurements, where human interpretation of results is direct measurement rather than subjective assessment. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

Yes, the studies described are, in essence, standalone performance evaluations of the VITROS XT 7600 Integrated System itself, with the VITROS Chemistry Products slides, operating automatically without continuous human intervention during the measurement process. The system performs the tests, generates results, and its performance (method comparison, precision, linearity, detection limits, specificity) is evaluated. The comparison is against a predicate device, which is also an automated system.

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

The ground truth for the test set, especially for the method comparison, was established by comparison to the legally marketed predicate device (VITROS 5600 Integrated System), which itself would have been previously cleared based on demonstrating accuracy against established reference methods or accepted gold standards for each analyte. For precision, linearity, and detection limits, the ground truth is established by the known characteristics of reference materials and statistical analysis.

8. The sample size for the training set

The document does not mention a training set. This is because the device described is not an AI/ML-based diagnostic algorithm that learns from data. It is a traditional in-vitro diagnostic instrument with chemical reagent slides. The studies are validation studies for the performance of the integrated system, not for training an algorithm.

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

Since there is no training set mentioned or used for this type of device, this question is not applicable.

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