(63 days)
The Wako L-type UIBC test is an in vitro diagnostic assay for the quantitative determination of iron in serum. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies.
The Wako L-type UIBC is a method utilizing bathophenanthroline as a chromogen. When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.
The provided text describes a 510(k) submission for the Wako L-type UIBC test, an in vitro diagnostic assay. The primary study proving the device meets acceptance criteria is a demonstration of its substantial equivalency to the Wako UIBC manual test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalency to Predicate Device | The Wako L-type UIBC assay "is demonstrated by its substantial equivalency to the Wako UIBC manual test." The FDA concurs, stating "We have determined the device is substantially equivalent...to legally marketed predicate devices." |
| Precision (Day-to-day consistency) | "Precision studies indicate acceptable values can be obtained on a day to day basis." |
| Minimum Detectable Level | The minimum detectable level for this method is estimated to be 1.8 mg/dL. |
| Linearity Range | The Wako L-type UIBC assay has been determined to be linear to 600 ug/dL. |
2. Sample size used for the test set and the data provenance
The document mentions "precision studies" and "substantial equivalency" but does not specify the sample size used for these tests. Data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. The "ground truth" for the test appears to be the performance of the predicate device (Wako UIBC manual test) and various analytical performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth, as it's an in vitro diagnostic assay and not a subjective image interpretation task.
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
No MRMC study was performed or is relevant in this context. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an in vitro diagnostic assay, which by nature operates as a "standalone" system in terms of producing a quantitative result from a sample. The device measures "unsaturated transferrin concentration in the sample" and then "determines...by calculating the decrement of iron in the Buffer." This suggests an automated or semi-automated process without a human-in-the-loop performance component beyond sample handling and result interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the Wako L-type UIBC assay is its analytical performance relative to a predicate device (Wako UIBC manual test) and established analytical standards (e.g., linearity, minimum detectable level, precision). The "truth" is based on the chemical measurement of UIBC.
8. The sample size for the training set
The document does not refer to a "training set" as this is not a machine learning or AI-based device in the common sense. It's a chemical diagnostic assay.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the development of any chemical assay would be established through rigorous analytical chemistry principles and reference methods to ensure accurate measurement of the analyte.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.