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The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitative determination of N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma on the Alinity i system.

In the emergency department, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.

The Alere NT-proBNP for Alinity i assay is an automated, two-step immunoassay for the in vitro quantitative determination of NT-proBNP in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample and anti-NT-proBNP coated paramagnetic microparticles are combined and incubated. The NT-proBNP present in the sample binds to the anti-NT-proBNP coated microparticles. The mixture is washed. Anti-NT-proBNP acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of NT-proBNP in the sample and the RLU detected by the system optics.

Despite the request for acceptance criteria and study proving the device meets said criteria, the provided document is a 510(k) summary for a diagnostic test (Alere NT-proBNP for Alinity i Reagent Kit). This type of document focuses on demonstrating substantial equivalence to a predicate device, and thus does not explicitly list "acceptance criteria" for performance in the same way one might find for a new medical device claiming superiority or non-inferiority.

Instead, the document details various performance characteristics of the device, comparing them to relevant standards (CLSI guidelines) and providing statistical data. It aims to show that the new device performs acceptably and similarly to a previously cleared device.

Therefore, I cannot extract a table of "acceptance criteria" as such a table is not explicitly presented. However, I can infer the implied acceptance criteria from the reported performance, specifically from the "No Significant Interference" and "within acceptable performance" statements in the nonclinical performance section, and the effectiveness of the cutoffs for diagnosis in the clinical performance. The "reported device performance" will be the actual numbers provided in the document.

Here's a summary of the available information, structured to address your points as much as possible given the document type:

Implied Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, explicit quantitative acceptance criteria are not stated in a dedicated table format. Instead, the device's performance characteristics are presented as evidence of substantial equivalence to a predicate device and adherence to recognized standards. The implied acceptance criteria are that the device demonstrates acceptable accuracy, precision, and clinical utility for its stated indications for use.

Here's a table summarizing key performance indicators that would implicitly serve as acceptance criteria given standard diagnostic device requirements:

Study Details:

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

   • Clinical Performance Study (test set): 2127 Emergency Department (ED) subjects.
     • Provenance: Multi-center prospective study across 17 collection sites in the US.
     • Demographics: 1030 (48.4%) female, 1097 (51.6%) male, age 19-97 years. Predominantly White (53.1%) and Black/African American (39.5%). 90.9% non-Hispanic/Latino.
   • Nonclinical Performance (examples):
     • Within-Laboratory Precision: 240 replicates (controls/panels).
     • Reproducibility: 360 replicates (controls/panels) per assay (across 3 sites).
     • Lower Limits of Measurement: n ≥ 60 replicates for LoB, LoD, LoQ.
     • Analytical Specificity/Interference: Each substance tested at 2 analyte levels (approximately 125 pg/mL and 2000 pg/mL).

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

   • The ground truth for the clinical study was an "adjudicated diagnosis" determined by a panel of board-certified cardiologists. The exact number of cardiologists on the panel is not specified in the provided text.

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

   • The document states "An adjudicated diagnosis was determined by a panel of board-certified cardiologists." It does not specify the exact adjudication method (e.g., majority vote, sequential review, etc.).

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

   • No, this document describes the validation of a quantitative in vitro diagnostic (IVD) reagent kit for measuring NT-proBNP levels using an automated chemiluminescent immunoassay (CMIA) system. It is not an AI-assisted diagnostic imaging device, so an MRMC study is not relevant to this submission. The "readers" are the automated analyzers and laboratory personnel interpreting numerical results.

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

   • This device is a standalone diagnostic test in the sense that it provides a quantitative NT-proBNP result. The assay itself is a fully automated process on the Alinity i system. The performance data presented (precision, linearity, limits, specificity, clinical performance tables) represent the performance of the device "standalone" in generating these quantitative results, which are then used by clinicians as an "aid in diagnosis." There isn't a "human-in-the-loop" component to the measurement itself, though medical professionals interpret the results in a clinical context.

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

   • For the clinical performance study, the ground truth for Heart Failure (HF) diagnosis was established by expert consensus (adjudicated diagnosis by a panel of board-certified cardiologists).

7. The sample size for the training set:

   • This document describes a 510(k) submission for an in vitro diagnostic reagent kit. Unlike AI/ML software, such devices typically undergo analytical and clinical validation studies with defined test sets but do not have a "training set" in the sense of machine learning algorithms. The development and optimization of the assay would have involved various internal samples and experiments, but these are not explicitly termed "training sets" and their size is not reported in this context.

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

   • As explained above, the concept of a "training set" with established ground truth, as typically applied to machine learning or AI models, does not directly apply to the regulatory submission type for this diagnostic reagent kit. The assay is based on chemical and biological principles (CMIA) rather than learned algorithms from large datasets.

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The ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay is for in vitro diagnostic use in the quantitative measurement of holotranscobalamin (holoTC) in human serum using the ADVIA Centaur XP system. Active-B12 (holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The ADVIA Centaur AB12 assay is a fully automated, two-step direct immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-transcobalamin antibody as the Lite Reagent. The Solid Phase consists of biotinylated anti-holotranscobalamin antibody coupled to streptavidin-coated magnetic latex microparticles.

Here's an analysis of the provided text regarding the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) assay, structured to address your specific questions about acceptance criteria and the supporting study:

It's important to note that this document is a 510(k) summary, which is a high-level overview. It describes a modification to an already cleared device (K160757), primarily focusing on a change in calibration traceability. Therefore, detailed study protocols and raw data are not typically included in this summary. The summary focuses on demonstrating that the modified device is substantially equivalent to the predicate device and that the modification did not negatively impact its performance.

Since this is a summary of a modification intended to show substantial equivalence, the "acceptance criteria" discussed are largely in the context of ensuring the modification did not degrade performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, the specific numerical acceptance criteria for each test are not explicitly provided in this 510(k) summary. It lists the types of tests performed and implies that the results were satisfactory.

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

The summary does not explicitly state the sample sizes used for the various validation tests (Accuracy, Linearity, Precision, Detection Limits, Recovery, Proficiency, or Reference Range).

• Data Provenance: Not explicitly stated, but the reference range study provides a mean and 95% central reference interval for an "asymptomatic population," implying human serum samples. The device itself is for in vitro diagnostic use in human serum. The data would have been collected in the course of validating the device. The manufacturer is Axis-Shield Diagnostics Ltd. in Scotland, UK, so it's plausible the data collection occurred there or in other regions where they conducted studies. The study is retrospective in the sense that these tests are performed after the device (or its modification) has been developed, but the sample collection itself for the reference range could be prospective.

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

This type of information is not applicable and not provided in the context of this device. This is an in vitro diagnostic (IVD) assay that measures a biomarker (holotranscobalamin) directly. The "ground truth" for the test set is established by the analytical reference methods or reference materials (like the WHO International Standard), not by human experts interpreting images or complex clinical scenarios.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical data where there might be inter-reader variability. For an IVD assay, the result is a quantitative measurement, and the "ground truth" is based on the accuracy and precision of the analytical measurement itself, often against a validated reference method or material.

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 for evaluating human performance, often with and without AI assistance, especially in radiology or pathology. This device is an automated IVD assay, not an AI-assisted human interpretation tool.

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

This device is a standalone algorithm/assay in the sense that it performs the measurement automatically without human intervention during the measurement process. The "performance" mentioned (accuracy, linearity, precision, etc.) are all standalone performance metrics of the assay itself. There is no "human-in-the-loop" once the sample is loaded onto the ADVIA Centaur XP system for this specific measurement.

7. The Type of Ground Truth Used

The ground truth for evaluating the performance of this IVD assay is primarily based on:

• Reference Materials: Specifically, the WHO International Standard for Holotranscobalamin (NIBSC Code 03/178) is highlighted as the new traceability standard for calibration. This serves as a primary ground truth for accurate measurement.
• Comparative Methods: The "Accuracy by correlation" likely involved comparing results from the modified device with those obtained using a reference method or the predicate device.
• Defined Concentrations: For tests like dilution linearity, precision, and detection capability, samples with precisely known or established concentrations of holotranscobalamin are used.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" sample size as this is not a machine learning or AI algorithm in the contemporary sense that would require a separate training phase with a distinct dataset for model building. The calibration process implicitly "trains" the device to measure correctly against known standards. The calibration itself uses "2-point Calibration using 2 level calibrators" (Low – 19 pmol/L, High - 121 pmol/L). However, this is not a "training set" in the context of complex ML models.

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

Given that there isn't a traditional "training set" for a machine learning model, the "ground truth" for the calibration materials (which serve a similar function of establishing correct performance parameters) is established through:

• Reference to the WHO International Standard (NIBSC Code 03/178): The primary modification in this 510(k) is to make the calibration traceable to this international standard. This standard itself would have been value-assigned through a rigorous international collaborative study.
• Internal Reference Material: The predicate device used an "Internal reference material; recombinant holotranscobalamin and phosphate buffer with protein (bovine) stabilizers." This internal standard would have been characterized and assigned values through the manufacturer's own internal assay development and validation processes, likely against an existing recognized reference method or material.

In summary, this 510(k) pertains to a minor modification (calibration traceability) of an existing in vitro diagnostic test. The evaluation focuses on ensuring the modification did not alter the fundamental performance characteristics, and the "acceptance criteria" are implied to be that the modified device performs comparably to the predicate and meets standard analytical performance requirements for IVDs. The "study" refers to a series of analytical verification and validation tests rather than clinical trials with human readers or AI algorithms.

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The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.

Here is a breakdown of the acceptance criteria and study information for the Axis-Shield Active-B12 (Holotranscobalamin) device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Method Comparison: 111 specimens from apparently healthy adults were used. Data provenance not specified, but the description "apparently healthy adults" suggests prospective collection or selection from a healthy cohort.

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

This device is an in-vitro diagnostic assay for quantitative determination of a biomarker (Holotranscobalamin). The ground truth for such assays is typically established through:

• Reference Methods: Comparison to established, clinically validated methods (like the predicate device) or gold standard analytical techniques.
• Known Concentrations: Use of samples with known, spiked concentrations for analytical performance validation (e.g., linearity, detection limits).
• Clinical Diagnosis: Correlating assay results with clinical diagnosis of B12 deficiency (though a direct study for this is not detailed for the subject device beyond the general "aid in diagnosis").

Thus, the ground truth is established through laboratory measurements and comparison to a legally marketed predicate device, rather than through expert consensus on diagnostic images or interpretations. Therefore, there were no human experts establishing the ground truth in the way described (e.g., radiologists interpreting images).

4. Adjudication method for the test set

Not applicable, as this is a quantitative diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or interpretive tasks, often in imaging, where human experts might disagree.

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

Not applicable. This is an immunoassay device, not an AI-assisted diagnostic tool that aids human readers.

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

Yes, this device is a standalone (algorithm only) device if you consider the "algorithm" to be the immunoassay protocol and the detector quantifying the colored end-product. There is no human-in-the-loop for the final quantitative result generation from the assay. The intent is for the device to provide a direct quantitative holotranscobalamin level.

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

The ground truth used for demonstrating substantial equivalence and performance was primarily based on:

• Comparison to the predicate device: The ARCHITECT Active-B12 (Holotranscobalamin) assay served as the reference standard for the method comparison study. This implies the predicate's results were considered the "ground truth" for comparative purposes.
• Analytical validation standards: For metrics like linearity, detection limits, cross-reactivity, and interference, the ground truth is established by carefully prepared samples with known concentrations or compositions, following established analytical chemistry principles.
• Internal reference materials/controls: For precision studies, characterized control samples with established mean values are used.

8. The sample size for the training set

This device is a traditional immunoassay, not a machine learning or AI algorithm in the modern sense that requires a "training set" for model development. Therefore, there is no explicit training set as would be understood in AI/ML validation. The development and optimization of the assay would have involved various experimental batches and iterative improvements, but these do not constitute a formal "training set" in the context of AI regulatory submissions.

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

Not applicable, as there is no formal "training set" in the AI/ML sense. The development of the assay involved standard biochemical and immunological research and development processes.

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Reagents: The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients. Calibrators: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.

The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.

The information provided describes the ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators, an in-vitro diagnostic device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device (AxSYM HbA1c). Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate device, demonstrated through specific statistical metrics.

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

• Sample Size: 127 samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "method comparison study" and does not specify if it was retrospective or prospective.

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

This information is not provided in the document. For in-vitro diagnostic devices, the "ground truth" is typically established by comparative analysis against a recognized reference method or a legally marketed predicate device, rather than by human expert review of images or clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology studies) to establish a consensus ground truth. Here, the comparison is between two quantitative assays.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, and is relevant for devices that aid human interpretation (e.g., in medical imaging). This submission is for an in-vitro diagnostic assay that provides a direct quantitative measurement.

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

Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT HbA1c assay is an automated chemiluminescent microparticle immunoassay (CMIA) run on the ARCHITECT i System. The performance metrics presented (slope, intercept, correlation) compare the results obtained directly from this automated system against results from the predicate automated system, without any human-in-the-loop interpretation being evaluated.

7. The Type of Ground Truth Used

The "ground truth" in this context is the results obtained from the legally marketed predicate device (AxSYM HbA1c assay). The study is a method comparison, aiming to show that the new device produces results comparable to an already accepted method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For an in-vitro diagnostic assay like the ARCHITECT HbA1c, the development process likely involves internal validation and optimization, but the submission primarily details the performance evaluation study against the predicate device.

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

Since a dedicated "training set" with established ground truth as typically understood in AI/ML contexts is not explicitly mentioned, this information is not provided. The development of the assay itself would have involved establishing accurate calibrators and quality control materials, which form the basis for accurate measurement, but this is distinct from a "ground truth" used for training an AI algorithm.

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The 3-Reagent Homocysteine Assay for Beckman Coulter SYNCHRON® and UniCel® systems is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Bound or dimerised homocysteine (oxidised form) is reduced to free homocysteine, which then reacts with serine catalysed by cystathionine beta-synthase (CBS) to form cystathionine. Cystathionine in turn is broken down by cystathionine beta-lyase (CBL) to form homocysteine, pyruvate and ammonia. Pyruvate is then converted by lactate dehydrogenase (LDH) to lactate with nicotinamide adenine dinucleotide (NADH) as coenzyme. The rate of NADH conversion to NAD+ is directly proportional to the concentration of homocysteine (delta A340 nm).

Here's a breakdown of the acceptance criteria and study details for the 3-Reagent Homocysteine Assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device. The acceptance criteria are implicitly defined by the performance of the predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) and demonstrated through method comparison metrics.

2. Sample Size and Data Provenance (Test Set)

• Sample Size: 100 samples
• Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "human serum and plasma" samples.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

The concept of "experts" and "ground truth" as typically applied in AI/imaging device studies (e.g., radiologists) is not applicable to this type of chemical assay. For this device, the comparison is against a legally marketed predicate device, where the "ground truth" is essentially the established performance of that predicate using accepted laboratory methods (e.g., a "reference" assay or the predicate itself).

4. Adjudication Method (Test Set)

Not applicable. This is a quantitative chemical assay, not an interpretative task requiring human adjudication of results in the way an imaging study would. The comparison is statistical (Passing & Bablock method comparison and Pearson correlation analysis) between the new device and the predicate.

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

No. This type of study is not relevant for a quantitative chemical assay like a homocysteine test. MRMC studies are used to assess the impact of a device on decision-making or diagnostic accuracy when human interpretation is involved.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The described "method comparison study" implicitly evaluates the standalone performance of the 3-Reagent Homocysteine Assay against the already established performance of the legally marketed predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) when run on different analyzer platforms. There is no human-in-the-loop component for these quantitative results.

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the test set is the results obtained from the legally marketed predicate device (Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent) when tested on the Olympus AU400 analyzer. The study design is a method comparison, where the new device's results are compared to the predicate's results for the same samples.

8. Sample Size for the Training Set

Not applicable. This is a reagent-based assay, not a machine learning or AI algorithm that requires a "training set" in the traditional sense. The device's performance is inherent to its chemical reactions and physical characteristics.

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

Not applicable. As stated above, there is no "training set" for this type of device. The development and optimization of the reagent formulations would involve various internal validation steps (e.g., verifying chemical reactions, stability, sensitivity) rather than establishing "ground truth" through a dataset that directly trains an algorithm.

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The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and study information for the ARCHITECT Active-B12 device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are largely implicit in the context of a 510(k) submission seeking "substantial equivalence." The device aims to perform as well as the predicate device (AxSYM Active-B12) across these performance characteristics.

Study Details

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

   • Sample Size: 125 samples
   • Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates "human serum" samples. It's a non-clinical/clinical performance study comparing the new device to a predicate, not a study to establish clinical utility from a population. This type of study is retrospective, as existing samples are used to compare the new device to an established one.

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

   • Not applicable. This is a method comparison study between two quantitative laboratory assays. "Ground truth" is established by the reading of the predicate device (AxSYM Active-B12 (HoloTC) Immunoassay), not by expert opinion.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or imaging studies where expert consensus is needed to define ground truth. For quantitative assays like this, the result from the predicate device serves as the comparator.

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

   • No. This is a comparison between two automated laboratory diagnostic devices, not a study involving human readers.

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

   • Yes, this is implicitly a standalone study. The ARCHITECT Active-B12 assay is an automated immunoassay. Its performance is evaluated independently against another automated immunoassay (AxSYM Active-B12). There is no "human-in-the-loop" component for the measurement itself, only for operating the instruments and interpreting the quantitative results.

6. The Type of Ground Truth Used:

   • Comparator (reference) Method: The AxSYM Active-B12 (HoloTC) Immunoassay served as the "ground truth" or reference method for comparison. The study aimed to show substantial equivalence between the new device and this legally marketed predicate device.

7. The Sample Size for the Training Set:

   • Not applicable. This 510(k) summary describes a performance study for a diagnostic assay, not a machine learning algorithm that requires a "training set." The ARCHITECT Active-B12 is a chemistry-based immunoassay.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set mentioned or implied for a device of this type.

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The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments. For in vitro diagnostic use.

The Axis-Shield Anti-CCP device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with purified synthetic cyclic citrullinated peptide, in a resealable foil pack with desiccant; ready to use calibrators (diluent with or without IqG antibodies against CCP2); positive and negative assay controls (human plasma with or without IgG antibodies against CCP); ready-to-use reference control; goat anti-human IgG horseradish peroxidase conjugate: TMB substrate; sample diluent (5x) wash buffer (10x); ready-to-use stop solution.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

The provided text describes a 510(k) submission for the Axis-Shield Anti-CCP device, claiming substantial equivalence to the DIASTAT™ Anti-CCP Assay. The primary study presented is a method comparison and concordance analysis between the two devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds (e.g., "concordance must be >95%"). Instead, it presents the achieved performance and implies that this level of performance was considered "substantially equivalent" to the predicate.

• Axis-Shield anti-CCP AUC: 0.910 (95% CI: 0.881 to 0.940)
• DIASTAT™ anti-CCP AUC: 0.903 (95% CI: 0.871 to 0.934) (using suggested cut-off of 5.0 U/mL) |

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

• Sample Size for Test Set: 514 samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, demographics of participants). The document only mentions using "human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate)." It's a clinical performance study comparing two assays, implying human samples. The study appears to be retrospective as it involves running existing banked samples on both devices for comparison.

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

The ground truth in this study is based on the results of the predicate device (DIASTAT™ Anti-CCP Assay). This is a comparison study, not a study aiming to establish the accuracy against a gold standard for Rheumatoid Arthritis diagnosis directly. Therefore, there were no human experts establishing a separate ground truth for the test set beyond the predicate device's results.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is typically relevant when establishing a ground truth based on multiple expert opinions. Since the ground truth for comparison was the predicate device's results, no expert adjudication method was used for the test set. The devices were likely run independently and their results compared.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA assay), not an imaging-based AI system that requires human interpretation. Therefore, there is no "human readers improve with AI vs. without AI assistance" effect size to report.

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

• Yes, the study primarily demonstrates the standalone performance of the Axis-Shield Anti-CCP device by comparing its output (antibody levels) directly to the predicate device's output. ELISA assays are inherently standalone tests; human involvement is in performing the lab procedure, not in interpreting the raw results in a way that would classify it as "human-in-the-loop" for the algorithm itself.

7. The Type of Ground Truth Used

The "ground truth" for the comparison study was the results obtained from the legally marketed predicate device (DIASTAT™ Anti-CCP Assay). While the intended use notes the test is an "aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information," the study itself does not directly use a definitive RA diagnosis (e.g., pathology, long-term outcomes, or consensus clinical diagnosis) as its ground truth for evaluation. Instead, it assumes the predicate's results are acceptable and compares the new device's results to them.

8. The Sample Size for the Training Set

The document does not provide information on a training set for the Axis-Shield Anti-CCP device. ELISA assays are typically developed through biochemical optimization and validation, not through machine learning training on a 'training set' in the conventional AI sense. The "clinical performance" study described is a validation or test set study for the finished device.

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

As there is no mention of a training set in the context of an algorithm requiring ground truth, this information is not applicable and not provided in the document.

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The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Test System includes two reagents and two calibrators.

The first reagent (Reag 1) includes Lactate dehydrogenase (LDH), Serine, nicotinamide adenine dinucleotide reduced di-sodium salt (NADH), tris [2-carboxyethyl] phosphine (TCEP) reductant, with buffers and stabilizers (Trizma Base and Trizma Hydrochloride), and preservative (Sodium Azide).

The second reagent (Reag2) includes Cystathionine beta-Synthase (CBS) and Cystathionine beta-Lvase (CBL) cvcling enzymes with preservative (sodium azide).

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent kit will also include two calibrators; Calibrator "0" (0 µmol/L) and Calibrator "28" (28 µmol/L).

Here's a breakdown of the acceptance criteria and the study details for the Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

• Intercept: 0.3165 (95% Confidence interval 0.031 to 0.290)
• r-value: 1.00 (95% Confidence interval 1.00 to 1.00)
• Average Percent Bias: 0.01% (95% Confidence interval -0.10 to 0.07%) |

Study Details

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

   • Sample Size: 94 plasma specimens.
   • Data Provenance: Not explicitly stated, but the submission is from Axis-Shield Diagnostics, Ltd. in the UK, suggesting potential European origin. It is a retrospective comparison study against an existing, legally marketed device.

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

   • This is a quantitative diagnostic assay. The "ground truth" for the test set is established by the predicate device (CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay) measurements rather than expert consensus on images or clinical diagnoses. Therefore, expert involvement for ground truth establishment as in image interpretation studies is not applicable here.

3. Adjudication Method for the Test Set:

   • Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.

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

   • No. This is a study comparing the performance of a new quantitative laboratory assay against a predicate assay, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this is a standalone performance study. The Axis-Shield device is a reagent system for automated laboratory analysis, and its performance is evaluated directly without human interpretation in the loop impacting the result.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context is the quantitative results obtained from the legally marketed predicate device, the CATCH Incorporated Liquid Stable (LS) 2-Part Homocysteine Reagent assay. The study aims to demonstrate that the new device produces results that are substantially equivalent to this established method.

7. The Sample Size for the Training Set:

   • Not applicable. This device is a biochemical reagent system, not a machine learning model that requires a dedicated "training set" in the computational sense. The "development" and "optimization" of the reagent would involve internal testing and validation, but not a formally segregated "training set" like in AI/ML contexts.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" in the conventional AI/ML sense for this type of device.

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