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VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.

Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.

VITROS® Automation Solutions is a configurable, scalable laboratory automation system (LAS) designed to streamline pre and post analytical processes in the clinical laboratory. VITROS® Automation Solutions is comprised of personal computer (PC) Kit(s) (including software and hardware), sample conveyors with turns, parallel and perpendicular bypasses, storage module, single-tube entry, rack entry and exit, centrifuge, de-capper modules and clinical analyzers.

In the basic configuration, patient sample tubes are loaded onto the automation track to be centrifuged, de-capped, and sorted for further processing on clinical analyzers such as the VITROS® Systems. Additional modules may be added to enable aliquot capability, sample capping, and refrigerated storage.

Parallel and perpendicular bypasses are extensions of the automation track that link with an analyzer's existing laboratory automation system (LAS) interface. These bypasses support on-track metering at the analyzer based on point-in-space pipetting technology and robotic interface module (RIM). With point in space pipetting, the automation performs the sample bar code read function, presents the sample identification to the connected analyzer, and then signals for direct sampling of the open tube by the connected analyzer at an aspiration point on the automation track. With robotic interface modules, the sample tube is transferred to the analyzer and the analyzer will read the bar code to identify the sample, aspirate sample from the tube and perform the test(s) requested and then return the tube to the LAS.

VITROS® Automation Solutions allows the establishment of a connection with clinical analyzers such as VITROS® Systems to enable sample routing based on reagent and calibration status. The clinical analyzers, such as VITROS® Systems, will perform all functions with respect to result generation, including sample metering, assay processing and reporting for the assays.

The VITROS® Systems are fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers 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 VITROS® Systems operate in conjunction with VITROS® Immunodiagnostic and Chemistry Products, reagents, calibrators and controls designed for use with the systems in the MicroSlide, MicroTip or MicroWell format. Representative assays (carbamazepine, gentamicin and total thyroxine) are used to demonstrate acceptable performance.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a laboratory automation system. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria in the same way a clinical trial for a diagnostic algorithm might. Therefore, some of the requested information (like effect size for MRMC studies, details of expert qualifications, or sample size for training sets) is not directly present as it's not typically required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the VITROS® Automation Solutions as a standalone device with specific performance metrics (e.g., sensitivity, specificity). Instead, it aims to demonstrate substantial equivalence by showing that assay performance characteristics remain consistent whether samples are introduced manually or via the automation system. The acceptance criterion is implied to be that the automated method should produce results comparable to the manual method.

Conclusion from document: "The test results showed no clinically significant difference in assay performance between the two sample processing methods. This data demonstrates substantial equivalence between VITROS® Automation Solutions and the stand-alone analyzer, VITROS® Systems."

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

• Sample Size for Test Set:
  • CRBM: 70 samples
  • GENT: 55 samples
  • Total T4: 57 samples
• Data Provenance: The study used "patient samples." The country of origin is not specified, but the applicant (Ortho-Clinical Diagnostics, Inc.) is based in Rochester, New York, USA. The study design is retrospective in the sense that existing patient samples were used for comparative testing. It is not explicitly stated if these were left-over clinical samples or prospectively collected for the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (number and qualifications of experts) is not relevant or provided for this submission. The "ground truth" here is the result obtained from manual processing on the VITROS® System itself, which is a standardized and validated analytical method, not expert interpretation.

4. Adjudication Method

Not applicable. This study compares analytical results from an automated process versus a manual process using the same analyzer. There's no human interpretation or adjudication involved in establishing the "correct" value, as it's a quantitative measurement compared against another quantitative measurement.

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

No, an MRMC study was not done. This device is a laboratory automation system, not an AI or imaging diagnostic tool that involves human readers. The study focuses on the analytical performance of the automated sample processing system compared to manual processing.

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

Yes, in a sense, the performance shown for the automated system is "standalone" to the degree that it measures the impact of the automation on the analyzer's performance, independent of human intervention beyond loading samples onto the system. The automation itself does not produce a "reading" that a human would then confirm or interpret; rather, it handles the pre-analytical processing to feed into existing, validated analyzers. The data presented demonstrates the performance of tests conducted via the automation solution, which then provides results without further human modification.

7. Type of Ground Truth Used

The ground truth was established by:

• Comparison to manual processing results: The "ground truth" or reference method was the results obtained from samples manually introduced to the standalone VITROS® System (referred to as "off track" in the document). This is a validated and established method on a legally marketed device.

8. Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a laboratory automation system, not a machine learning model that requires a training set. The system's functionality is based on mechanical and software-driven processes, not adaptive learning.

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

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

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The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

In the ACE γ-GT Reagent assay, γ-GT in serum or heparin plasma catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.

In the ACE Lipase Reagent Assay, lipase in serum or heparin plasma acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.

The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NADT) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry Systems using a logarithmic calibration curve established with calibrators, which are provided separately.

The information provided describes the performance of the ACE γ-GT, ACE Lipase, and ACE T4 Reagents on the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. This is not an AI/ML device, however, I will address the other requested points to the best of my ability with the provided text.

Here's a breakdown of the acceptance criteria and study information, where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate table. However, it provides performance data for precision, matrix comparison (serum vs. plasma), detection limits, linearity, and interference. Based on the "Conclusions" section, the goal was to demonstrate "substantial equivalence" of the reagents for lithium heparin plasma samples (compared to serum) and the ACE Alera System (compared to the predicate ACE Clinical Chemistry System). The performance data presented are implicitly intended to support this substantial equivalence.

Implied Acceptance Criteria (based on predicate comparison and performance data) and Reported Performance:

For POL Precision: Similar acceptable %CV values for low, mid, and high samples across different POL sites and in-house, on ACE and ACE Alera systems. | In-House Precision (Serum vs. Plasma):

• γ-GT: Total %CV generally 0.997, Slope 0.960-0.987, Intercept 1.5-4.0 across systems.
  Lipase: Correlation > 0.994, Slope 0.980-1.024, Intercept -2.5 to -0.9 across systems (for ACE and ACE Alera, Axcel missing intercept CI).
  T4: Correlation > 0.984, Slope 0.963-1.007, Intercept 0.01-0.35 across systems. |
  | Method Comparison (POL) | When comparing results from POL sites to in-house results on the same instrument, correlation coefficients should be high (close to 1), slopes close to 1, and with small intercepts, indicating consistency across testing locations. | ACE System:
• γ-GT: Correlation > 0.9997, Slope 0.964-0.976, Intercept -2.7 to 0.7.
• Lipase: Correlation > 0.9966, Slope 0.994-1.031, Intercept -5.3 to 0.0.
• T4: Correlation > 0.9908, Slope 1.010-1.019, Intercept -0.09 to -0.04.

ACE Alera System:

• γ-GT: Correlation > 0.9996, Slope 0.950-1.028, Intercept 1.9 to 2.9.
• Lipase: Correlation > 0.9960, Slope 0.992-1.028, Intercept -3.5 to 3.3.
• T4: Correlation > 0.9868, Slope 1.022-1.048, Intercept -0.31 to -0.10. |
  | Detection Limits (ACE Alera) | Limits of Blank (LOB), Detection (LOD), and Quantitation (LOQ) should be clinically acceptable. | γ-GT: LOB 3 U/L, LOD 5 U/L, LOQ 7 U/L.
  Lipase: LOB 7 U/L, LOD 11 U/L, LOQ 13 U/L.
  T4: LOB 0.3 µg/dL, LOD 0.8 µg/dL, LOQ 1.3 µg/dL. |
  | Linearity (ACE Alera) | The assay should be linear up to the stated measuring range, with a linear regression equation demonstrating good fit. | γ-GT: Linear to 950 U/L ($y = 1.036x + 0.8$).
  Lipase: Linear to 700 U/L ($y = 0.971x + 0.2$).
  T4: Linear to 19.6 µg/dL ($y = 1.057x - 0.09$). |
  | Interferences (ACE Alera) | No significant interference from common exogenous or endogenous substances at physiologically relevant or elevated concentrations. | γ-GT: No significant interference at or below Icterus 14.2 mg/dL, Hemolysis 125 mg/dL, Lipemia 500 mg/dL, Ascorbic Acid 6 mg/dL.
  Lipase: No significant interference below Icterus 12.5 mg/dL, Hemolysis 1000 mg/dL, Lipemia 803 mg/dL, Ascorbic Acid 6 mg/dL.
  T4: No significant interference below Icterus 47.2 mg/dL, Hemolysis 1000 mg/dL, Lipemia 1000 mg/dL, Ascorbic Acid 6 mg/dL.
  Heterophile (T4): HAMA 800 ng/mL, RF 516 IU/mL.
  Cross-Reactivity (T4): 3,3',5,5'- Tetraiodothyroacetic Acid (18.4%), L-Thyroxine (91.6%), D-Thyroxine (68.0%) at 5 µg/dL. |

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

The document does not explicitly use the term "test set" in the context of AI/ML, but rather describes clinical performance studies. The sample sizes for these studies are as follows:

• In-House Matrix Comparison (Serum vs. Plasma):
  • ACE γ-GT Reagent: 100 pairs (ACE), 97 pairs (ACE Alera), 53 pairs (ACE Axcel)
  • ACE Lipase Reagent: 42 pairs (ACE), 43 pairs (ACE Alera), 62 pairs (ACE Axcel)
  • ACE T4 Reagent: 55 pairs (ACE), 55 pairs (ACE Alera), 55 pairs (ACE Axcel)
• Method Comparison (POL vs. In-House):
  • ACE System: 50-54 samples per reagent per POL site (3 POL sites)
  • ACE Alera System: 48-51 samples per reagent per POL site (3 POL sites)
• Precision (In-House and POL): The number of replicates per sample level (Low, Mid, High) is not explicitly stated, but precision studies typically involve multiple runs over several days.
• Detection Limits, Linearity, Interferences, Cross-Reactivity: Sample sizes for these specific experiments are not detailed but are generally conducted with a sufficient number of replicates and concentrations to statistically establish the parameters.

Data Provenance: The studies are described as "In-House" and "POL" (Physician Office Laboratory) studies. This indicates that the data was collected at the manufacturer's facility ("In-House") and potentially at various POL sites. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA, it is likely the studies align with US regulatory requirements and are potentially from US-based labs. The studies are prospective in nature, as they involve newly generated data to demonstrate the performance of the devices.

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

This section is not applicable as the device is a clinical chemistry reagent and not an AI/ML device that generates interpretations requiring expert ground truth for image or diagnostic data. The "ground truth" in this context refers to the measured analyte concentrations obtained from established laboratory methods, calibrators, and reference materials.

4. Adjudication Method for the Test Set

This section is not applicable as the device is a clinical chemistry reagent. Adjudication methods like 2+1 or 3+1 are used in contexts like human reader studies for diagnostic imaging, where discordant interpretations need resolution by additional experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This section is not applicable as the device is a clinical chemistry reagent. MRMC studies are designed to assess the performance of diagnostic devices or AI algorithms by multiple human readers across multiple cases, especially in imaging.

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

This section is not applicable as the device is a clinical chemistry reagent. This term is relevant for AI/ML diagnostic tools. The "performance" of this device is inherently standalone in that the instrument processes samples and generates quantitative results without human intervention in the measurement process itself, beyond sample loading and general operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies presented is based on quantitative chemical measurements of the specific analytes (gamma-glutamyltransferase, lipase, total thyroxine) in control materials, patient samples, and comparison with established reference methods or predicate devices. This includes:

• Known concentrations: For precision, linearity, detection limits, and interference studies, samples with known or spiked concentrations are used.
• Comparison to predicate device: For method comparison studies, the results from the new device/system are compared against the results from the legally marketed predicate device/system.
• Reference materials/calibrators: The accuracy and calibration of the assays depend on traceable reference materials and calibrators.

8. The Sample Size for the Training Set

This section is not applicable as the device is a clinical chemistry reagent and not an AI/ML device. There is no "training set" in the context of machine learning model development.

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

This section is not applicable for the same reasons as #8.

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The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.

The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the GSP Neonatal Thyroxine (T4) kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and ground truth for disease diagnosis in the same way an AI/ML powered device might.

Therefore, the requested information regarding "acceptance criteria" for an AI device, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training/testing" in the context of an AI/ML study does not directly apply to this submission.

However, I can extract the closest analogous information available within this document, focusing on the performance characteristics presented to demonstrate equivalence.

Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" as performance metrics for this diagnostic kit.

1. Table of Acceptance Criteria and Reported Device Performance

For an in-vitro diagnostic kit like this, "acceptance criteria" are typically defined by demonstrating that the new device performs comparably to or within acceptable ranges relative to a predicate device and established analytical performance specifications. The document provides a comparison of various features and performance characteristics between the new GSP Neonatal T4 kit and its predicate device, AutoDELFIA Neonatal T4 Kit.

• Intra-assay variation 14.9 %
• Inter-assay variation 10.0 %
• Total variation 18.0 %
  Control 2; 8.08 µg/dL serum
• Intra-assay variation 10.6 %
• Inter-assay variation 7.1 %
• Total variation 12.7 %
  Control 3; 18.2 µg/dL serum
• Intra-assay variation 8.2%
• Inter-assay variation 4.3%
• Total variation 9.3 % | Sample 1; 2.0 µg/dL
• Within run 1.0%
• Within lot 15.5%
• Total variation 15.8%
  Sample 2; 4.8 µg/dL
• Within run 7.3%
• Within lot 10.7%
• Total variation 11.4%
  Sample 3; 7.5 µg/dL
• Within run 6.5%
• Within lot 8.4%
• Total variation 8.6%
  Sample 4; 16.6 µg/dL
• Within run 4.5%
• Within lot 7.8%
• Total variation 8.5%
  Sample 5; 19.8 µg/dL
• Within run 7.2%
• Within lot 9.9%
• Total variation 10.3%
  Sample 6; 21.4 µg/dL
• Within run 7.1%
• Within lot 9.8%
• Total variation 10.1% |
  | Measuring Range | 1.5 µg/dL to the highest level calibrator | 1.6 to 30 µg/dL serum |
  | Limit of Blank (LoB) |

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The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction.

The ADVIA Centaur T4 assay is for in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum on the ADVIA Centaur and ADVIA Centaur XP systems. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The ADVIA Centaur® is a continuous operation, immunochemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens.

The StreamLAB® Analytical Workcell is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory.

The ADVIA Centaur® with StreamLAB® Analytical Workcell combines the features of both the analyzer and the laboratory automation system.

The StreamLAB routes samples to the Centaur analyzer based on test request information it (StreamLAB) receives from the Laboratory Information System (LIS) and the test map established for the Centaur analyzer. StreamLAB and Centaur communicate sample and analyzer status via Centaur's Laboratory Automation System (LAS) interface. Via its LIS interface, the Centaur analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Centaur's test instructions and test results for each sample are not processed through the StreamLAB.

The StreamLAB performs the following pre and post-analytical functions.

• Sample bar code identification (previously performed by the Centaur) .
• . Sample transport and tracking
• . Sample centrifugation (optional functionality)
• . Sample de-capping (optional functionality)
• Sample transport and tracking
• Tube sealing (optional functionality) .

The Centaur continues to perform the following functions, when connected to the StreamLAB.

• . All functions except reading the sample tube bar code. When Centaur is connected to StreamLAB, samples can be loaded directly onto Centaur and/or loaded onto StreamLAB and routed to Centaur. For samples loaded onto StreamLAB, StreamLAB reads the sample tube bar code (sample identification) and passes it electronically to Centaur via the LAS interface to Centaur.

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

Device: ADVIA Centaur® with StreamLAB® Analytical Workcell

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds as typically seen in modern submissions. Instead, it relies on a "method comparison" study to demonstrate substantial equivalence to a predicate device. The performance is reported in terms of linear regression parameters (slope, intercept, correlation coefficient) comparing the new device to the predicate.

Note: The phrase "CANNO LAND IN COLOR AN CONSULER COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COLLECTION
American and a com a com a proven a management and a pro-" and similar garbled text in the "Method Comparison" table suggests data corruption or OCR errors in the original document. Assuming the numerical values (1.01, -0.03, 0.999) correspond to slope, intercept, and correlation coefficient, these are presented as the "reported device performance."

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

The document does not explicitly state the sample size used for the method comparison study. It only mentions that "Split-sample method comparison studies were conducted using the ADVIA Centaur® T4 Assay."

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were collected and then tested on both systems, but there is no indication of whether these were new prospective samples collected for the study or previously stored retrospective samples. Given the context of a 510(k) for an in vitro diagnostic, samples would typically be clinical specimens.

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

This section is not applicable to this submission. The device is an automated immunoassay analyzer for quantitative determination of Thyroxine (T4). The "ground truth" for such devices is established by comparing its measurements against a recognized reference method or a predicate device, as done in this "method comparison" study. There is no subjective interpretation by human experts involved in establishing the T4 values for the test set.

4. Adjudication Method for the Test Set

This section is not applicable to this submission. The "ground truth" (comparison values from the predicate device) for quantitative diagnostic devices like this is based on the analytical measurement of the predicate device, not on expert adjudication of subjective findings.

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

No, a MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can potentially improve their performance. The ADVIA Centaur with StreamLAB Analytical Workcell is an automated analyzer that performs quantitative immunoassays, with no human interpretation component in the diagnostic process itself.

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

Yes, a form of standalone performance was demonstrated.
The "Method Comparison" study demonstrates the performance of the proposed device (ADVIA Centaur with StreamLAB) in performing T4 assays independently, against the predicate device (ADVIA Centaur) which also operates as an automated system. This comparison evaluates the algorithm's performance in generating the quantitative T4 results. There is no human-in-the-loop component in the T4 measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device, the ADVIA Centaur® (K041133) using the ADVIA Centaur® T4 Assay. The study compares the new device's quantitative T4 results directly to the established, legally marketed predicate device on the same split samples.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set sample size. For in vitro diagnostic (IVD) devices like this, particularly for a 510(k) submission showing substantial equivalence, the focus is typically on analytical and clinical performance studies (like method comparison) rather than an AI/ML model's training phase. While the internal development of assays and instruments involves extensive calibration and validation, this is distinct from "training data" as understood in AI/ML contexts where a model learns from data.

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

As noted above, the document does not provide information about a specific "training set" or how its ground truth was established, as the submission focuses on demonstrating equivalence through direct method comparison rather than an AI/ML model's training process.

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The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.

AccuBind™ Neo-Natal T4 Microplate EIA

The provided text is a 510(k) premarket notification approval letter for a medical device (AccuBind™ Neo-Natal T4 Microplate EIA) and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This type of regulatory document confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed scientific study data or performance metrics you've requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information (points 1-9) would typically be found in a separate submission document or a scientific publication related to the device's validation.

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The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems. The Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.

The Access® Total T4 assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffers.

Here's an analysis of the provided text regarding the Access® Total T4 assay's acceptance criteria and studies:

Based on the provided 510(k) summary, the device Access Total T4 is being cleared based on substantial equivalence to a previously cleared Access Total T4 assay (K926475). The primary change in this new submission is the expansion of sample type to include human plasma samples. Therefore, the acceptance criteria and the study focus primarily on demonstrating that the performance of the assay with plasma samples is comparable to its performance with serum samples.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific numerical acceptance criteria (e.g., correlation coefficient thresholds, bias limits, or ranges of agreement) for the method correlation study. It only states a qualitative outcome.

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

• Sample Size for Test Set: The exact number of paired plasma and serum samples used in the method correlation study is not specified in the provided document. It only states "paired plasma and serum samples."
• Data Provenance: The country of origin is not specified. The study is a prospective method correlation study where paired samples were collected and tested.

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

This information is not applicable as the study described is a method correlation study for an in vitro diagnostic (IVD) assay, not a study requiring expert readers to establish ground truth for image or clinical interpretation. The ground truth for this type of assay is derived from the established analytical performance of the predicate device and the new device.

4. Adjudication Method for the Test Set

This information is not applicable for a method correlation study of an IVD assay. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aids that involve human interpretation. This submission concerns an in vitro diagnostic assay with a quantitative output.

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

Yes, in spirit. The study described is an analytical performance study of the device itself (the Access Total T4 assay) generating quantitative results. There is no human interpretation involved in the final result generation by the device. The study demonstrates the device's performance in analyzing plasma and comparing it to serum.

7. The Type of Ground Truth Used

The ground truth for the method correlation study is implicitly the results obtained from the predicate device (or the same device running on the serum sample). The objective is to show the new sample type (plasma) yields results comparable to the established sample type (serum) using the same assay.

8. The Sample Size for the Training Set

This information is not applicable as the Access Total T4 assay described is an IVD assay (a chemical assay), not an AI/ML algorithm that requires a "training set" in the computational sense. The device is a direct measurement system.

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

This information is not applicable for the same reason as point 8.

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The BioCheck Total T4 EIA is intended for the quantitative determination of total thyroxine (T4) in human serum. This test is useful in the diagnosis and treatment of thyroid diseases.

Not Found

The provided text is an FDA 510(k) clearance letter for the BioCheck Total T4 Enzyme Immunoassay Test Kit. It primarily focuses on the regulatory approval and indications for use. It does not contain the specific details about the acceptance criteria or the study that proves the device meets those criteria, as typically found in a clinical study report or a more detailed technical submission.

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

In general, for a medical device seeking regulatory clearance, a submission would include:

1. Acceptance Criteria: Predetermined performance thresholds the device must meet (e.g., sensitivity, specificity, accuracy, precision, linearity, stability) compared to a predicate device or a gold standard.
2. Study Design and Results: Detailed descriptions of the studies conducted to demonstrate that the device meets these criteria. This would typically include:
   • Sample Size: Number of patients or samples used in the study.
   • Data Provenance: Where the data came from (e.g., specific hospitals, geographical regions) and whether it was retrospective or prospective.
   • Ground Truth Establishment: How the true status (e.g., presence or absence of a disease) was determined. For diagnostic tests, this might involve confirmed clinical diagnosis, pathology, or expert consensus.
   • Expert Qualifications: If experts were used, their experience and specialization.
   • Adjudication Method: How disagreements among experts were resolved.
   • MRMC Study: If applicable, to assess reader performance with and without the device.
   • Standalone Performance: The algorithm's performance without human intervention.
   • Training Set Details: Information about the data used to train any AI or algorithm component, including size and ground truth establishment.

Since this information is not in the provided document, I cannot fill out the requested table or answer the specific questions.

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A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a device called "OptiCoat T, EIA Kit" (also referred to as "T4 EIA Kit"). This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, it's a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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