(35 days)
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.
The provided text describes a 510(k) submission for an in vitro diagnostic assay called "Iron." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to establish new acceptance criteria or conduct a multi-reader multi-case (MRMC) study. The information provided is characteristic of a clinical chemistry assay, which focuses on analytical performance rather than diagnostic accuracy involving human readers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format. Instead, it presents performance characteristics and asserts substantial equivalence to a predicate device. The primary performance metrics are correlation with the predicate, precision, linearity, and limit of quantitation.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | Expected to be high (close to 1) | 0.9938 |
| Slope | Expected to be close to 1 | 0.973 |
| Y-intercept | Expected to be close to 0 | -2.592 ug/dL |
| Within-run Precision | Expected to be low %CV | Level 1: 0.7% (total %CV) |
| Level 2: 1.7% (total %CV) | ||
| Linearity | Sufficiently wide range to cover clinical needs | Up to 1778.5 ug/dL |
| Limit of Quantitation (Sensitivity) | Sufficiently low to detect clinically relevant concentrations | 3.8 ug/dL |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "comparative performance studies" and "precision studies" but does not specify the sample size for these studies.
The data provenance is not explicitly stated regarding country of origin. The studies appear to be retrospective as they are comparing the new assay to an existing, established predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable and therefore not provided in the document. For a clinical chemistry assay like this, "ground truth" is typically established by the reference method (the predicate device) or by established analytical standards, not by human expert consensus or interpretation of test results.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology for image-based diagnostics) to resolve discrepancies among multiple expert readers. This is not relevant for a quantitative chemical assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study focuses on the impact of a device on human reader performance, typically for diagnostic imaging or similar interpretation tasks. The Iron assay is an in vitro diagnostic for quantitative determination, not an interpretive tool for human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in essence, the entire performance evaluation of the Iron assay is a standalone performance assessment. Clinical chemistry assays are designed to operate independently and provide a quantitative result. The performance characteristics (correlation, precision, linearity, sensitivity) described are the standalone performance of the assay itself, without human interpretation as part of the primary output.
7. The Type of Ground Truth Used:
For the comparative performance studies, the ground truth was the results obtained from the Boehringer Mannheim® Iron assay on the Hitachi® 717 Analyzer (K854298), which served as the reference or predicate method. For precision, linearity, and sensitivity, the ground truth would be based on known concentrations in control materials or spiked samples.
8. The Sample Size for the Training Set:
This information is not provided and is generally not applicable in the context of this device. Clinical chemistry assays like the Iron assay are typically developed and validated using well-established chemical principles and analytical methodologies. While there's an optimization process during development that might involve testing numerous samples, the concept of a "training set" in the machine learning sense (where an algorithm learns from labeled data) is not relevant to this type of device.
9. How the Ground Truth for the Training Set Was Established:
As noted above, the concept of a "training set" with established ground truth, as understood in machine learning/AI, is not applicable to this clinical chemistry assay. The performance is assessed against established analytical methods and standards.
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(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.