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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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For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.

The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.
The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.

This document describes the performance data for several VIDAS assays when used on the VIDAS 3 instrument, comparing them to their performance on the predicate VIDAS instrument. The tests are primarily for establishing substantial equivalence for the new VIDAS 3 instrument and do not typically include detailed acceptance criteria for the assays themselves, which are already established for the predicate devices. The studies focus on method comparison, precision, linearity, and detection limits.

Here's a breakdown of the requested information based on the provided text, focusing on the VIDAS H. pylori IgG assay as a primary example, and generalizing for others where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for method comparison. Instead, it demonstrates "correlation" and "equivalency" between the new device (VIDAS 3) and the predicate device (VIDAS). For precision, specific CV% ranges are reported.

Here's an example for the VIDAS H. pylori IgG assay's method comparison:

Note: For quantitative assays like VIDAS RUB IgG, VIDAS HCG, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II, method comparison relies on slope, intercept, and correlation coefficient, implying acceptance criteria for these values (e.g., slope close to 1, intercept close to 0, high correlation coefficient). Precision for these assays also includes CV% for various components.

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

• VIDAS H. pylori IgG:

  • Test Set Size: 250 serum samples (positive, equivocal, and negative).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study compares performance between two instruments, implying samples are run on both.

• VIDAS Lyme IgG II:

  • Test Set Size: 220 serum samples (positive and negative).
  • Data Provenance: Not explicitly stated.

• VIDAS RUB IgG:

  • Test Set Size (Quantitative Method Comparison): 112 serum samples (ranging from 0 to 225 IU/mL).
  • Test Set Size (Qualitative Method Comparison): 220 serum samples (positive, equivocal, and negative).
  • Test Set Size (CDC Reference Panel): 100 specimens (50 pairs of sera).
  • Data Provenance: Not explicitly stated for general samples. The CDC panel implies a curated and standardized set.

• VIDAS TOXO IgM:

  • Test Set Size: 198 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Human Chorionic Gonadotropin (hCG):

  • Test Set Size: 113 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS T4:

  • Test Set Size: 105 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Testosterone:

  • Test Set Size: 172 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS TSH:

  • Test Set Size: 179 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS D-Dimer Exclusion II:

  • Test Set Size: 219 plasma samples.
  • Data Provenance: Not explicitly stated.

Across all assays, the studies are described as "Method Comparison" and "Precision" studies, which are typically retrospective analyses of patient samples to compare device performance to an established method.

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

This information is not provided in the document. For in vitro diagnostic devices, ground truth is typically established by comparative methods (e.g., predicate device, reference methods, clinical diagnosis, or other laboratory gold standards) rather than expert consensus on individual cases. The document states that performance was evaluated against the predicate device (e.g., "VIDAS H. pylori IgG assay on the VIDAS 3 to the VIDAS H. pylori IgG assay on the VIDAS"). The "ground truth" for these studies is the result obtained from the predicate VIDAS instrument using its established methodology.

For the VIDAS RUB IgG, a "CDC reference panel" and "CDC low-titer rubella antibody standard" are mentioned, where the reference panel sera were "titered by Hemagglutination Inhibition." This implies that the ground truth for this specific part of the study was established by a recognized reference method (Hemagglutination Inhibition) and certified reference materials from the CDC.

4. Adjudication Method for the Test Set

This information is not explicitly provided. For method comparison studies, typically, discordant results between the new device and the predicate device (or reference method) are investigated. However, the exact adjudication process (e.g., by a third, more definitive test, or expert review of patient clinical history) is not detailed. The phrase "results were evaluated according to CLSI EP12-A2" or CLSI EP9 suggests standard statistical methods for agreement or correlation, which do not necessarily involve expert adjudication of individual discrepancies beyond reporting them.

For quantitative assays where method comparison statistics (slope, intercept, correlation coefficient) are used, "outliers" were removed in some cases (e.g., VIDAS RUB IgG quantitative comparison), implying some form of review or statistical exclusion, but not necessarily expert "adjudication" in the sense of clinical decision-making.

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

No. This document describes performance studies for in vitro diagnostic instruments and assays, not imaging or similar devices that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study, which assesses improvements in human interpretation with AI assistance, is not applicable and was not performed.

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

The studies described are for the standalone in vitro diagnostic instruments and their associated assays. These are standalone tests, meaning the algorithm (or assay chemistry in this case) processes the sample and provides a result without direct human interpretation of raw data for diagnosis. The "human-in-the-loop" here refers to trained laboratory technicians operating the instrument and interpreting the final quantitative or qualitative results according to established cut-offs/guidelines, rather than interpreting complex images or signals. The purpose of these studies is to confirm that the new instrument (VIDAS 3) produces equivalent results to the predicate instrument (VIDAS) for these assays.

7. The Type of Ground Truth Used

The primary type of "ground truth" used in these studies is the results obtained from the predicate device (VIDAS instrument) for the same assays. The goal is to demonstrate "substantial equivalence" of the new instrument (VIDAS 3) to the predicate.

For the VIDAS RUB IgG assay, a CDC reference panel where samples were "titered by Hemagglutination Inhibition" served as an additional, external reference for ground truth in a specific subset of testing. This is a form of reference method/standardized panel data.

8. The Sample Size for the Training Set

This information is not explicitly provided in the document. For in vitro diagnostic assays, "training sets" are usually involved in the initial development and optimization of the assay itself (e.g., establishing reagents, parameters, cut-offs). The studies described in this document are focused on the validation and verification of the new instrument's performance with existing, already developed assays, often referred to as "test sets" or "evaluation sets." The assays themselves were presumably developed and "trained" using various sample sets prior to these studies.

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

Since information on a distinct "training set" for the new instrument's validation isn't provided (as the assays were pre-existing), details on its ground truth establishment are also not available in this document. For the development of the original assays, ground truth would have been established through a combination of clinical diagnoses, established reference methods, and correlation with disease status.

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For in vitro diagnostic use in the quantitative determination of free thyroxine (FTA) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease.

For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.

Not Found

The provided 510(k) summary focuses on the addition of pediatric reference intervals to existing ADVIA Centaur FT4 and T4 assays, rather than the development of a new device or a comparative effectiveness study involving AI. Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as MRMC, standalone performance, ground truth establishment for training, etc.) are not directly applicable or explicitly detailed in this document.

However, based on the information provided, here's a breakdown of the acceptance criteria and the study conducted for the pediatric reference intervals:

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

The "acceptance criteria" here are implicitly tied to the established pediatric reference intervals themselves, and the "reported device performance" is the statistical summary of the patient data used to derive these intervals. The document states that the previously established euthyroid adult reference intervals and analytical measuring ranges already apply. The acceptance criteria for the pediatric reference intervals specifically are:

• The established pediatric reference intervals must be either within or above the previously established euthyroid adult reference intervals.
• The established pediatric reference intervals must be within the analytical measuring ranges of the ADVIA Centaur FT4 and T4 assays.

As stated in the conclusions: "The newly-established pediatric reference intervals are either within or are above the previously-established reference intervals for euthyroid (normal thyroid) adult populations and they are within the analytical measuring ranges of the ADVIA Centaur FT4 and T4 assays." This confirms the device (when interpreted with these new intervals) meets its implicitly defined acceptance criteria.

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

• Sample Size: A total of 454 patients were analyzed: 72 infants, 190 children, and 129 adolescents.
• Data Provenance: Not explicitly stated, but typically reference interval studies use samples collected from healthy individuals within the specified age groups, often from multiple geographic locations to ensure generalizability. It's not specified if this was retrospective or prospective, though the term "analyzed" suggests it could have been retrospective analysis of collected samples.

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

This information is not provided in the summary. For establishing reference intervals, the "ground truth" is typically defined by recruiting a statistically robust population of "healthy" or "euthyroid" individuals based on clinical criteria and medical examination, rather than expert consensus on individual cases. The document refers to CLSI C28-A3c, which is a guideline for establishing reference intervals. This guideline outlines methods for selecting reference individuals and statistical methods for calculating intervals, but not necessarily "experts" in the sense of adjudicating individual cases.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the establishment of reference intervals. The process involves clinical selection criteria for healthy individuals and statistical determination of intervals.

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 submission is for updating reference intervals for an existing IVD assay, not for an AI-based device or a comparative effectiveness study involving human readers or AI assistance.

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

The device is an in vitro diagnostic (IVD) assay, not an algorithm or AI. Its performance is inherent in its analytical capabilities, which were previously established and cross-referenced to earlier 510(k) submissions (K905532, K080167, K971418). The current submission states, "The inclusion of pediatric reference intervals in the Instructions for Use (Package Inserts) does not necessitate the collection of additional analytical performance data." Therefore, no new standalone performance study was conducted for this submission as the analytical performance was deemed sufficient by previous submissions.

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

For this type of study (establishing reference intervals), the "ground truth" is typically an "apparently healthy" or "euthyroid" state for the pediatric population, as defined by rigorous clinical selection criteria (e.g., absence of diseases, medications, or conditions known to affect thyroid function) as per CLSI guidelines. The specific criteria are not detailed but are implied by the reference to CLSI C28-A3c.

8. The sample size for the training set

This study is focused on establishing reference intervals, which typically involves a single dataset used for derivation. There isn't a "training set" in the context of machine learning. The 454 patients (72 infants, 190 children, 129 adolescents) constitute the dataset used to establish these reference intervals.

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

As noted in point 7, the "ground truth" for the individuals included in the study (which acts as the "training set" for interval derivation) would be their status as "apparently healthy" or "euthyroid" pediatric individuals. This status would have been established through a process of screening, clinical assessment, and potentially other diagnostic tests, following the methodologies outlined in the CLSI C28-A3c guideline mentioned in the submission. The specific clinical criteria used for selection are not provided in this summary.

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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 ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of hemoglobin A1c (µmol/L) and total hemoglobin (g/dL) in human EDTA whole blood for the calculation of percent hemoglobin A1c using the ACE Axcel Clinical Chemistry System. The test is intended for use in clinical laboratories or physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.

The ACE CEDIA T Uptake homogenous enzyme immunoassay is intended for the quantitative determination of unoccupied binding sites of thyroxine-binding proteins in serum using the ACE Axcel Clinical Chemistry System. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

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

The ACE Ferritin Reagent is intended for the quantitative determination of ferritin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

Prior to the ACE Hemoglobin A1c (HbA1c) Reagent assay, whole blood samples require a pretreatment step, which is done on-board the analyzer. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the agglutinator (synthetic polymer containing the immunoreactive portion of HbA1c) in the HbA1c Agglutinator Reagent and the antibody-coated microparticles in the HbA1c Antibody Reagent will agglutinate. The presence of HbA1c in the sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monitored monochromatically at 592 nm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution, which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA1c and total hemoglobin are measured, the ratio is calculated and the result reported as percent HbA1c.

The CEDIA T Uptake assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme which, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, enzyme donor thyroxine conjugate binds directly to the unoccupied thyroxine-binding sites in the sample, preventing the spontaneous re-association of the enzyme fragments to form the active enzyme. Thus, thyroxine-binding proteins regulate the amount of β-galactosidase formed from the reassembly of the remaining donor and enzyme acceptor as monitored by the hydrolysis of the substrate o-nitrophenyl-β-galactopyranoside.

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 (NAD+) 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 System using a logarithmic calibration curve established with calibrators, which are provided separately.

In the Ferritin Assay, serum ferritin, in the presence of anti-ferritin conjugated latex micorparticles, and a buffer promoting aggregation, initiates an antigen-antibody reaction, resulting in the agglutination of the latex microparticles. The agglutination is detected turbidometrically by an absorbance change measured at a wavelength of 592 nm. The magnitude of the absorbance change is proportional to the ferritin concentration in the sample.

The provided text is a 510(k) summary for the Alfa Wassermann Diagnostic Technologies ACE Axcel Clinical Chemistry System and several associated reagents. It describes the devices, their intended uses, and technological characteristics. However, the document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The content of the document focuses on:

• Identification of the device and reagents: Trade names, classifications, common names, and product codes.
• Predicate devices: Listing the previously approved systems and reagents used for comparison in the 510(k) submission.
• Device descriptions: Detailed explanations of the ACE Axcel Clinical Chemistry System's functionality and the biochemical principles of each reagent (HbA1c, CEDIA T Uptake, T4, Ferritin).
• Intended Use/Indications for Use: What each device/reagent is designed to measure and for what clinical purpose.
• Technological Characteristics: Specifications of the analyzer (throughput, reagent capacity, cooling, sample handling, optical system).
• Regulatory approval notice: A letter from the FDA indicating substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria from the provided text. The requested information about sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance studies is not present in this document.

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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 i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.

• Sodium measurements are used for monitoring electrolyte imbalances.
• Potassium measurements are used for diagnosis and monitoring of diseases and clinical conditions that manifest high and low Potassium levels.
• Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
• Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
• Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
• Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
• pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
• 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.
• The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
• The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
• Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
• The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
• The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
• The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis

The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care. The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability. The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.

This document is a 510(k) summary for the i-STAT 1 Wireless Analyzer, which is a modified version of the i-STAT 1 Analyzer. The submission argues for substantial equivalence primarily based on the fact that the measurement cycle of the device is identical to the predicate device, and the wireless functionality is temporally distinct and does not affect the core measurement performance. As such, the document does not report on a study comparing the diagnostic performance of the i-STAT 1 Wireless Analyzer against specific acceptance criteria for each analyte. Instead, it focuses on the differences and safety aspects related to the addition of wireless communication.

Therefore, much of the requested information cannot be extracted directly from this 510(k) summary because the evaluation approach was not based on a new clinical performance study for the analytes.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This section cannot be fully constructed as a typical acceptance criteria table for diagnostic accuracy because the submission's core argument is that the measurement performance of the i-STAT 1 Wireless Analyzer is identical to the predicate device (i-STAT 1 Analyzer) for all cartridge tests. The only "performance" discussed in relation to the new wireless feature is its safety and data integrity.

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

Not applicable/Not provided for diagnostic accuracy. As noted, no new cartridge tests were performed to compare the diagnostic performance because the measurement cycle is identical to the predicate device. The testing focused on the wireless functionality itself, which does not involve patient samples or diagnostic data in the same way.

The document discusses "Specific Absorption Rate tests conducted by the supplier of the radio frequency module" but does not provide sample sizes or data provenance for these engineering tests.

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

Not applicable. No diagnostic ground truth was established for a new clinical performance test set, as the device's diagnostic measurement capabilities are considered identical to its predicate.

4. Adjudication method for the test set

Not applicable. No new clinical performance test set was conducted that would require adjudication of diagnostic 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

Not applicable. This device is an in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system for human readers. No MRMC study was conducted.

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

Yes, implicitly in the context of the device's core function. The i-STAT 1 Wireless Analyzer, like its predicate, is a standalone device that performs quantitative measurements of various analytes. The output (a numerical value for an analyte) does not require human-in-the-loop for its generation. However, the study supporting this submission did not involve a new standalone performance evaluation for the analytes; it relied on the established performance of the predicate device. The wireless functionality itself is an "algorithm only" in terms of data transmission, operating independently of human intervention during the transmission process once configured.

7. The type of ground truth used

Not applicable for a new clinical performance study. The original ground truth for the predicate i-STAT 1 Analyzer's diagnostic measurements would have been established through methods appropriate for each analyte (e.g., comparison to laboratory reference methods, clinical outcomes where relevant). For this 510(k) submission, the ground truth for the wireless transmission involved verifying signal integrity and proper data transfer, but this is an engineering ground truth, not a diagnostic one.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning algorithm that requires a training set in the conventional sense for diagnostic performance.

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

Not applicable. (See point 8).

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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 Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The Dimension Vista™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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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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