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The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

The Access Vitamin B12 assay is a competitive binding immunoenzymatic assay. The Access Vitamin B12 reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.

The provided document is a 510(k) Premarket Notification from the FDA for a diagnostic device, the "Access Vitamin B12" assay, manufactured by Beckman Coulter, Inc. It details the device's technical characteristics, its intended use, a comparison to a predicate device, and summaries of performance studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the acceptance criteria and observed performance for several analytical studies conducted to demonstrate substantial equivalence of the new Access Vitamin B12 assay on the Dxl 9000 Access Immunoassay Analyzer to the predicate device.

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

• Method Comparison: N = 122 samples.
• Imprecision: 6 serum samples with varying Vitamin B12 concentrations were assayed. Each sample was assayed in duplicate, twice per day, over 21 days (resulting in 84 replicates per sample, 6 samples x 84 replicates = 504 total assays for imprecision).
• Linearity, LoB, LoD, LoQ: Specific sample sizes for these studies are not explicitly stated as 'N' values in the text, but the studies were performed (e.g., "verification studies") following CLSI protocols.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given it's a clinical laboratory device study for regulatory submission, they are typically prospective analytical validation studies conducted in a controlled lab environment.

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

N/A. This device is a quantitative diagnostic assay (Vitamin B12 levels) rather than an AI/ML-based image analysis or pattern recognition device that would typically rely on expert human consensus for ground truth. The "ground truth" for these analytical performance studies is established by the reference methods (predicate device measurements, defined concentrations for linearity/imprecision, and analytical standards for LoB/LoD/LoQ).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

N/A. Adjudication methods are not applicable here since the "ground truth" is determined by established analytical measurements and reference values, not by human interpretation requiring consensus.

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

N/A. MRMC studies are typically performed for imaging devices or AI-assisted diagnostic tools where human readers interpret cases, and the AI's impact on reader performance is assessed. This is a standalone in-vitro diagnostic (IVD) assay designed to provide quantitative results, not assist human readers in interpreting complex cases. The study effectively compares the new instrument (Dxl 9000) to the predicate instrument (Access Immunoassay System), not human readers.

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

While the term "standalone" is often used in the context of AI algorithms, this device functions as a standalone quantitative diagnostic assay. The performance studies (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) demonstrate the analytical performance of the device itself (the "algorithm" being the assay chemistry and instrument processing) without human intervention in the result determination. The results are quantitative outputs (pg/mL or pmol/L of Vitamin B12).

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies was established through:

• Method Comparison: Comparison against the predicate Access Vitamin B12 assay run on the Access Immunoassay System.
• Imprecision: Known or consistent concentrations of Vitamin B12 samples measured repeatedly.
• Linearity: Serially diluted samples or samples prepared with known, varied concentrations.
• LoB/LoD/LoQ: Use of blank samples, low-concentration samples, and statistical methods (CLSI EP17-A2 protocol) to determine limits.
  Overall, the ground truth relies on analytical reference methods, known sample concentrations, and statistical methods as per industry best practices (CLSI guidelines) for IVD devices.

8. The Sample Size for the Training Set

N/A. This is a specific analytical test kit (immunoassay) that functions based on established biochemical principles, not a machine learning algorithm that requires a "training set" in the conventional sense of AI. Its performance is inherent to its design and chemical reagents, validated through the analytical performance studies described.

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

N/A. As stated above, this device does not utilize a training set in the AI sense. Its "ground truth" for development and validation are based on chemical and analytical principles and reference standards.

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The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and postanalytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

The DxI 800 Access Immunoassay System is a microcomputer controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative or qualitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxI 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and plasma (heparin) or red blood cells using the Access Immunoassay Systems. Folate levels in serum and plasma (heparin) or red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vitamin B12 levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

The DxA system is a high throughput automated sample handling system which can perform the pre and post analytical processing of sample tubes. DxA can identify and track samples, perform centrifugation, decapping, delivery of samples to connected analyzers, recapping, storing in either non-refrigerated or refrigerated storage, and sorting to output racks.

The DxA integrates perianalytic (pre and post analysis) functions with analytical instruments (Beckman Coulter, and other manufacturer's) via a track system to provide fully integrated testing solutions.

This document focuses on the substantial equivalence of the DxA 5000 automated sample handling system and related immunoassay tests (Ferritin, Folate, TSH, Vitamin B12) to previously cleared devices. It describes engineering performance studies rather than clinical efficacy studies. Therefore, many of the typical clinical study criteria requested (like multi-reader multi-case studies, effect size of human improvement with AI, number of experts for ground truth, sample size for training sets) are not applicable or detailed in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document states that "The acceptance criteria were met for all method comparisons thereby demonstrating the following:"

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

• Sample Size: The document does not specify the exact sample sizes used for the method comparison studies. It mentions that the studies utilized CLSI EP09, which is a guideline for method comparison and bias estimation using patient samples, but the number of samples is not disclosed.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for an in vitro diagnostic device, the studies are typically conducted in a controlled laboratory setting, often in a prospective manner or using banked samples that meet specific criteria.

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

This information is not applicable and not provided in the document. The acceptance criteria and performance relate to the comparability of the new automation system and immunoassay tests against predicate devices, not against a "ground truth" established by experts for diagnostic accuracy in a clinical setting in the way an AI imaging device might. The "ground truth" here is the performance of the predicate device/system.

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

This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are interpreting data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is an engineering/analytical performance study for a laboratory automation system and immunoassay tests.

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

This information is not applicable and not provided. MRMC studies are relevant for imaging devices where human readers are involved in the diagnostic process. This document concerns a laboratory automation system and immunoassay tests, not an AI-assisted diagnostic imaging tool.

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

The studies described are for the performance of the integrated system (DxA 5000 connected to the DxI 800 Access Immunoassay System running specific assays). While the system operates largely automatically (an "algorithm only" in the sense that the mechanical and analytical processes are automated), its performance is compared to a human-operated predicate system or another automated system. This is not an "AI algorithm only" study in the context of diagnostic decision support, but rather an automated analytical system comparison.

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

The "ground truth" in this context is the performance of the legally marketed predicate devices/systems:

• Power Processor Sample Processing System (K110413) for the DxA 5000's automation features.
• Beckman Coulter UniCel® DxI 800 Access® Immunoassay System (K023764), Access® Ferritin assay (K926221), Access® Folate assay (K060774), Access® HYPER sensitive hTSH assay (K042281), and Access® Vitamin B12 assay (K955436) for the immunoassay performance in conjunction with the automation system.

The study aimed to demonstrate that the new device system yielded results "within specifications" when compared to the predicate, implying the predicate's performance served as the benchmark or "ground truth" for equivalence.

8. The sample size for the training set

This information is not applicable and not provided. This is a 510(k) submission for laboratory equipment and assays, not a machine learning/AI device requiring a "training set" in the computational sense. The "development" for such systems involves rigorous engineering, analytical validation, and verification based on established chemical, biological, and mechanical principles.

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

This information is not applicable for the reasons stated in point 8.

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The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.

The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.

The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.

The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.

The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.

The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.

A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."

Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:

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

The document does not specify sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.

• Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
• Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.

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

This is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.

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. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.

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

Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.

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

The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:

• Expected software behaviors and outputs.
• Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
• Correct communication protocols with connected instruments and the LIS.
• Adherence to performance metrics like throughput.
• The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.

8. The sample size for the training set

Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.

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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