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For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

The VITROS TIBC assay is performed using the VITROS Chemistry Products TIBC Kit, VITROS Chemistry Products Fe Slides, and the VITROS Chemistry Products Calibrator Kit 4 on VITROS Chemistry Systems.

The VITROS TIBC Kit consists of VITROS TIBC Columns (containing alumina) and VITROS Iron Saturating Reagent.

Total iron-binding capacity is determined by pretreating a sample using the method of Starr. Excess iron citrate reagent is added to the sample to saturate all available apotransferrin sites. After an incubation period of five minutes, the treated sample is applied to an alumina column where iron that is not bound to transferrin is adsorbed.

The transferrin-bound iron contained in the eluate represents the total iron-binding capacity of the sample.

A drop of eluate is deposited on the VITROS Fe Slide and is evenly distributed by the spreading layer to the underlying layers. After the addition of the eluate, the slide is incubated at 37℃. Two reflection density measurements at 600 nm are made at approximately one and five minutes. The difference in reflection density is proportional to the iron concentration in the sample.

Once a calibration has been performed for each slide lot, total iron binding capacity in unknown samples can be determined using the softwareresident two-point rate math model and the change in reflectance calculated for each unknown test slide.

VITROS Calibrator Kit 4 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum and bovine serum albumin to which organic analytes, inorganic salts, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water. Once reconstituted, the standards are used to calibrate VITROS Chemistry Systems for the quantitative measurement of total iron binding capacity in serum. Calibration of the VITROS TIBC assay requires the use of three of the four levels (bottles 1, 3 and 4). For in vitro diagnostic use only.

This prompt describes a 510(k) summary for an in vitro diagnostic device, specifically the VITROS Chemistry Products TIBC Kit and Calibrator Kit 4. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the typical format of an AI/ML device study.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be directly extracted from the provided text. These concepts are primarily relevant to clinical validation studies for AI/ML-driven medical devices, which this document is not.

The provided document describes a chemistry assay, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as number of experts, adjudication method, MRMC studies, effect size with AI, standalone performance, training set data, etc.) are not applicable in this context.

However, I can extract information related to the device's performance characteristics and how its equivalence to a predicate device was demonstrated.

Here's the information that can be extracted and how it relates (or doesn't relate) to your request:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for this submission. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various device characteristics. The "reported device performance" is essentially the modified device's characteristics, assumed to be acceptable because they are substantially equivalent to a legally marketed device.

Study Proving Substantial Equivalence:

The document states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum samples with measured TIBC values spanning the assay range." This is the core of the "study" for this type of submission.

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

• Sample Size for Test Set: The document mentions "human serum samples with measured TIBC values spanning the assay range," but does not provide a specific number for the sample size.
• Data Provenance: The provenance is "human serum samples." The country of origin and whether they are retrospective or prospective is not specified. Given the context of a 510(k) summary for an in-vitro diagnostic, these are typically clinical samples, likely from a diverse population or at least representative of the target user base (e.g., US patients if for US market), but this is not explicitly stated. It is implicitly retrospective as the samples would have been collected prior to the study.

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

This question is not applicable. For a chemistry assay measuring TIBC, the "ground truth" is established by a reference method or validated laboratory procedure, not by a panel of human experts in the way it is for image-based AI/ML devices. The predicate device's performance, and traceability to SRM 937 via NCCLS approved standard methods, serves as the benchmark.

4. Adjudication method

Not applicable for a chemistry assay.

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 chemistry assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

Not applicable. This is a standalone chemistry assay, meaning it provides a quantitative result directly, rather than an "algorithm" augmenting human performance. Its performance is inherent to the assay itself.

7. The type of ground truth used

The "ground truth" for this type of assay is derived from:

• Comparison to the predicate device's performance.
• Traceability to SRM 937 (Standard Reference Material) via NCCLS approved standard methods (H17-A2 for the modified device, H17-P3 for the predicate). This essentially means the accuracy is tied to recognized international standards for iron measurement.
• "Measured TIBC values spanning the assay range" implies these values were determined by a reference method.

8. The sample size for the training set

Not applicable. This is a chemistry assay that does not usually involve a "training set" in the machine learning sense. The assay method is developed and validated through chemical principles and analytical studies, not statistical learning from a dataset.

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

Not applicable for the reasons stated above.

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