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The Total Iron Binding Capacity (TIBC) reagents, product No. FE109-01, FE109-02 and The Total Iron Binding Capacity (TIDO) reagones processor seni-automated, quantitative determination of TIBC in serum, or plasma.

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This document is a 510(k) clearance letter from the FDA for a Total Iron Binding Capacity (TIBC) device. It confirms the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the detailed study information required to answer your questions regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment. The document is primarily an FDA regulatory approval letter and an "Indications For Use" statement.

Therefore, I cannot provide the requested information based on the given input.

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The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which involves a sample pretreatment followed by the analysis of TIBC with the Iron reagents. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution by the saturating solution.

Here's an analysis of the provided 510(k) summary regarding the TIBC assay, detailing acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are established by demonstrating substantial equivalence to the predicate device, the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. The primary performance metrics used for comparison are correlation coefficient, slope, and Y-intercept from a method comparison study, along with precision and linearity data.

The document states that "These data demonstrate that the performance of the TIBC assay is substantially equivalent to the performance of the A-GENT TIBC assay on the ABBOTT SPECTRUM Series II System." This implies that the reported performance metrics met the internal acceptance thresholds for substantial equivalence to the predicate.

Study Information

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

   • Sample Size: Not explicitly stated in the provided summary for the method comparison or precision studies.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The studies were "conducted using the AEROSET™ Analyzer."

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

   • Not applicable/Not mentioned. This is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (TIBC). The "ground truth" for the test set would be the results obtained from the predicate device (A-GENT® TIBC assay), which is itself a laboratory assay. Expert consensus or human reader interpretation is not typically involved in establishing ground truth for such quantitative chemical assays.

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

   • Not applicable/None. As an IVD assay comparing results against a predicate assay, there is no human adjudication process involved in generating or confirming the reference values.

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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or clinical decision support tool that is interpreted by human readers.

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

   • Yes, the performance characteristics provided (correlation, precision, linearity, sensitivity) represent the standalone performance of the TIBC assay on the AEROSET™ Analyzer. This is typical for IVD submissions, where the assay itself is the "algorithm" and its performance is evaluated directly.

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

   • Predicate Device Results: The "ground truth" for the comparative performance study was the quantitative results obtained from the A-GENT® TIBC assay on the ABBOTT SPECTRUM® Series II™ System. This is a common and accepted method for establishing substantial equivalence for new IVD assays.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is a traditional chemical assay, not an AI/machine learning model that requires a training set in the conventional sense. The "development" of the assay involves optimization of reagents and procedures, not a data-driven training process with labeled data.

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

   • Not applicable. See point 7.

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The Total Iron Binding Capacity (TIBC) assay uses TIBC sample pretreatment in conjunction with the Iron assay for the quantitation of the total iron binding capacity of human serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Total Iron Binding Capacity (TIBC) is an in vitro diagnostic assay for the quantitative determination of total iron binding capacity of human serum. The TIBC assay is a clinical chemistry assay which is used in the pretreatment of serum samples for total iron binding capacity analysis with the Iron assay. Ferric chloride saturating solution is mixed with the sample to bind all available apotransferrin binding sites with iron. Alumina adsorbent removes excess iron from the serum mixture. The mixture is then analyzed for total iron and the result is multiplied by the dilution factor to compensate for dilution of the serum by the saturating solution.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new Abbott Laboratories TIBC assay are implicitly defined by its substantial equivalence to the predicate device, the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer. The performance metrics reported are primarily related to this comparison.

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

The document does not explicitly state the sample size used for the comparative performance studies (method comparison). It mentions "comparative performance studies were conducted" and "precision studies were conducted using two levels of control material."

• Sample Size: Not specified for the method comparison or precision studies.
• Data Provenance: Not specified. It's likely retrospective data from laboratory samples, but no country of origin or specific type of samples (e.g., patient samples, spiked samples) is provided. The use of "control material" for precision studies suggests commercially prepared controls.

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

This information is not applicable and is not provided in the document. The study evaluates a quantitative in vitro diagnostic assay, where "ground truth" for individual measurements is established by the reference measurement procedure (the predicate device) or by known concentrations in control materials, not by expert consensus in the way a diagnostic imaging or pathology study might use.

4. Adjudication Method (for the test set)

Not applicable. As described above, this is a quantitative measurement comparison, not a study requiring adjudication of qualitative or subjective interpretations.

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 assay, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

Yes, the performance study describes the standalone performance of the Abbott TIBC assay (which is an enzymatic/colorimetric chemical assay, not an algorithm in the modern AI sense, but functions as a standalone test). The method comparison and precision studies demonstrate the performance of the device without human interpretation or intervention in the measurement process beyond standard laboratory operating procedures.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Reference Method/Predicate Device: For the comparative performance, the Boehringer Mannheim TIBC assay on the Hitachi 717 Analyzer served as the reference or benchmark method.
• Known Concentrations: For precision studies, "control material" at two levels (Level 1/Panel 111 and Level 2/Panel 112) would have known or target concentrations against which the variability of the device's measurements are assessed.
• Spiked Samples/Standards: For linearity and sensitivity, known concentrations of iron would be used to establish the quantitative range and detection limits.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in vitro diagnostic chemical assay, not a machine learning or AI device that requires a "training set." The assay itself is based on established chemical reactions.

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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