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The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.

It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

The acceptance criteria and device performance information provided in the document focuses on the Access Intrinsic Factor Ab assay's performance on the Dxl 9000 Access Immunoassay Analyzer compared to the Access 2 Immunoassay System (predicate device).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate table, but it provides performance metrics that would serve as the basis for such criteria, particularly for method comparison and imprecision. The comparison is against an existing predicate device, implying that performance should be comparable or non-inferior.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Method Comparison: 128 serum samples.
  • Imprecision Study: For each of the 6 samples tested, N=80 measurements were performed (implying 80 duplicate measurements over 20 days or similar).
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective analytical validation studies conducted by the manufacturer, Beckman Coulter, Inc.

3. Number and Qualifications of Experts for Ground Truth

This information is not provided in the document. The studies described are analytical performance validations comparing a new instrument platform to an existing one, and assessing precision. They do not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth for the method comparison is the result obtained from the predicate device (Access 2 Immunoassay System), which itself is a quantitative assay.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The studies focus on objective quantitative measurements (concentration levels, agreement with a predicate assay). There is no mention of subjective interpretation requiring adjudication by multiple readers or experts.

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

This information is not applicable/provided. The device is an in vitro diagnostic immunoassay, not an imaging AI device that would typically involve human reader evaluation or assistance.

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

This information is not applicable. The device is an immunoassay system, not an AI algorithm. Its performance is inherent to the assay and instrument mechanics. The "standalone" performance is effectively what is reported in the method comparison and imprecision studies.

7. Type of Ground Truth Used

• For Method Comparison: The ground truth for evaluating the Access Intrinsic Factor Ab assay on the Dxl 9000 was the results obtained from the predicate device (Access Intrinsic Factor Ab assay on the Access 2 Immunoassay System). This is a comparative analytical performance study.
• For Imprecision: The ground truth is the measured concentration of the intrinsic factor antibody within the samples themselves, with variability around that measurement being assessed.

8. Sample Size for the Training Set

This information is not applicable/provided. As an immunoassay, the device does not employ machine learning or AI algorithms that would require a "training set" in the conventional sense. The "training" for such a system would involve optimizing the assay reagents and instrument parameters during development, not a data-driven training set for an algorithm.

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

This information is not applicable/provided for the same reasons as #8.

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An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.

An enzyme linked immunoassay (ELISA)

This FDA 510(k) clearance letter for the ImmuLisa Intrinsic Factor Antibody ELISA does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and study design. The document is primarily an approval letter, not a full summary of the performance study.

However, based on the information provided, here's what can be extracted and what cannot:

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

This information is not available in the provided document. The 510(k) clearance letter confirms that the device was deemed substantially equivalent to a predicate device, but it does not detail specific acceptance criteria (e.g., sensitivity, specificity thresholds) or the exact performance metrics reported in the submission.

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

This information is not available in the provided document.

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 information is not available in the provided document. For an ELISA test, the "ground truth" would typically come from a reference method or clinical diagnosis based on a combination of factors, not necessarily based on expert interpretation of images.

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

This information is not available in the provided document. Adjudication methods are more relevant for subjective interpretations (e.g., radiology reads) than for quantitative ELISA 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

This information is not applicable and not available in the provided document. The ImmuLisa Intrinsic Factor Antibody ELISA is an in-vitro diagnostic (IVD) test, not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study and
AI-assisted improvement metrics are irrelevant for this type of device.

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

This information is not applicable in the provided document in the way it's framed. The device is a laboratory assay. Its performance is inherent to the assay procedure and relies on laboratory technicians performing the test correctly. There isn't an "algorithm only" component in the sense of a software-driven interpretation without human interaction typically found in AI devices. The "standalone" performance would be the analytical performance of the ELISA system itself (e.g., its sensitivity, specificity, accuracy against a reference method). These specific analytical performance metrics are not detailed in the clearance letter.

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

For an ELISA diagnostic test like this, the ground truth for evaluating its performance would typically be based on:

• Clinical diagnosis of pernicious anemia: This would involve a comprehensive clinical assessment (e.g., B12 levels, clinical symptoms, other lab tests).
• Reference method/gold standard for intrinsic factor antibody detection: This might involve a different, already validated, and often more complex assay for intrinsic factor antibodies.

The specific type of ground truth used is not detailed in the provided document.

8. The sample size for the training set

This information is not available in the provided document. For an ELISA kit, "training set" is not typically a concept used in the same way as machine learning. Instead, there would be studies for assay development, optimization, and validation, but these wouldn't be referred to as a "training set" in the context you're asking.

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

This information is not applicable and not available in the provided document. See the explanation for point 8.

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The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "QUANTA Lite™ Intrinsic Factor ELISA" device. It does not contain information about acceptance criteria, a specific study, or detailed performance metrics. The document only specifies the device name, its indications for use, and confirms its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. It lacks data on:

1. Acceptance criteria and reported device performance: No such table is present.
2. Sample size and data provenance: Not mentioned.
3. Number and qualifications of experts for ground truth: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. MRMC comparative effectiveness study or effect size: Not applicable as this is an in-vitro diagnostic test, not an AI-assisted imaging device.
6. Standalone performance (algorithm only): Not applicable as this is an ELISA kit.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

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The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.

The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.

Here's a breakdown of the acceptance criteria and study information for the Access Intrinsic Factor Ab assay based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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IMMULITE 2000 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

IMMULITE® 2000 Vitamin B12 is a clinical device for use with the IMMULITE 2000 Automated Immunoassay Analyzer. IMMULITE® and IMMULITE® 2000 Vitamin B12 are chemiluminescent immunoassays. The technology in DPC's IMMULITE® 2000 Vitamin B12 is a unique combination of technologies employed in previously cleared and commercially marketed DPC products. The IMMULITE 2000 Vitamin B12 assay begins with a one-cycle sample treatment of patient serum or plasma with dithiothreitol (DTT) and a sodium hydroxide/potassium cyanide solution (NaOH/KCN) in a reaction tube containing no bead. After a 30-minute incubation, the treated sample is transferred to a second reaction tube containing a vitamin B12-coated polystyrene bead, hog intrinsic factor (HIF) and an alkaline phosphatase-labeled antibody specific for HIF. During a 30-minute incubation, the vitamin B12 released from endogenous binding proteins during sample treatment competes with immobilized vitamin B12 for binding with HIF. Alkaline phosphatase-labeled anti-HIF antibody binds to HIF and is immobilized only if HIF is bound to the B12-coated bead. Unbound enzyme conjugate is removed by centrifugal wash. Substrate is added. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound comblex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of vitamin B12 in the sample.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the IMMULITE® 2000 Vitamin B12 device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 166 patient serum samples for the method comparison study.
• Data Provenance: The document does not specify the country of origin. It does not explicitly state if the data was retrospective or prospective, but the phrasing "patient serum samples" suggests existing samples were used, which would typically be retrospective.

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

This section is not applicable to this type of device. The ground truth for this device is established by a quantitative measurement using a legally marketed predicate device (DPC's IMMULITE® Vitamin B12), not by expert consensus or interpretation of images/data. The predicate device itself acts as the reference standard.

4. Adjudication Method for the Test Set

This section is not applicable. Since the comparison is against an established quantitative assay, there is no need for an adjudication method by experts to resolve disagreements, as would be the case in subjective diagnostic evaluation.

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 section is not applicable. The device is an in-vitro diagnostic (IVD) assay for quantitative measurement of a biomarker (Vitamin B12), not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

Yes, this was a standalone performance evaluation. The IMMULITE® 2000 Vitamin B12 device's performance was compared directly to the predicate IMMULITE® Vitamin B12 device without human intervention influencing the measurement results of either system. The method comparison described is a "standalone" evaluation of the new device's quantitative output against the established device's quantitative output.

7. The Type of Ground Truth Used

The ground truth for the comparison was the quantitative measurement of vitamin B12 in serum samples obtained using the IMMULITE® Vitamin B12 (the predicate device).

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set". For this type of IVD, method comparison studies do not typically involve a training/test set split in the same way machine learning models do. The 166 patient samples were used for the performance comparison. If any internal validation or calibration was performed during development, that information is not provided here.

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

Since a training set is not explicitly mentioned as a distinct component of the regulatory submission (as would be for an AI/ML device), the method for establishing its ground truth is also not described. For an IVD, the development and calibration typically rely on reference materials, calibrators, and internal validation studies, rather than a "ground truth" derived from human experts for a training set. The performance is then validated against a predicate device.

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The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

Here's an analysis of the acceptance criteria and the study used to demonstrate substantial equivalence for the Abbott ARCHITECT™ B12 assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abbott ARCHITECT™ B12 assay are implicitly derived from demonstrating substantial equivalence to a legally marketed predicate device, the AxSYM® B12 Assay. Substantial equivalence is shown through a statistical comparison of results from both assays.

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

• Sample Size: 544 serum specimens.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study used "serum specimens," which implies human samples. The study appears to be retrospective in nature, as it's a comparison of an existing assay (AxSYM B12) with a new assay (ARCHITECT B12) using a collected set of samples.

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

This type of in-vitro diagnostic (IVD) assay comparison study does not typically involve human experts establishing "ground truth" in the same way as, for example, an imaging study. The "ground truth" here is the measurement obtained from the predicate device (AxSYM B12 Assay), which is already an FDA-cleared and accepted method for quantitative determination of B12. Therefore, no human experts were used to establish ground truth for this test set; rather, the predicate device served as the reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, the comparison is directly between two quantitative assays, with the predicate assay serving as the reference. There's no need for human adjudication of results in this context.

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

Not applicable. This is an in-vitro diagnostic device (an assay for vitamin B12), not an imaging or interpretive AI device that assists human readers.

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

Yes, the study described is essentially a standalone performance evaluation of the ARCHITECT B12 assay. It directly compares the results generated by the new assay (which operates without human interpretation of the final B12 value) to an established predicate assay. The human component is limited to collecting the samples and running them on both automated systems.

7. The Type of Ground Truth Used

The ground truth used is the measurements obtained from a legally marketed predicate device, the AxSYM® B12 Assay. This is a form of reference standard comparison, where the established performance of an existing device serves as the benchmark.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. For this type of IVD, the development and initial validation of the assay (e.g., establishing reagents, calibration curves, and internal controls) would typically happen during product development before the 510(k) submission. The 544 specimens described are for the clinical validation/equivalence study (i.e., the test set) comparing the new device to the predicate.

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

Since there is no explicit mention of a "training set" for an AI model in this document, the concept of establishing ground truth for a training set as typically understood in AI development does not directly apply. For the development of the ARCHITECT B12 assay itself, the internal "ground truth" would have been established through rigorous analytical performance studies (e.g., accuracy, precision, linearity, limit of detection, interference studies) using certified reference materials or established laboratory methods, but these details are not provided in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to an existing device rather than the foundational development of the assay's methodology.

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