(51 days)
IL Test™ Iron is intended for the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry systems. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.
IL Test™ Iron permits the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry instruments. Measurements of the levels of iron are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis and chronic renal disease. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.
The provided text is a 510(k) summary for the IL Test™ Iron device, which is an in vitro diagnostic test. The document describes how the device compares to predicate devices and provides a summary of performance data.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets. Instead, it demonstrates substantial equivalence to predicate devices through correlation studies. The implicit acceptance criterion is a high correlation coefficient, indicating comparable performance to the established predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Monarch System) | Reported Device Performance (ILab System) |
|---|---|---|---|
| Iron Correlation (r) | High correlation (e.g., >0.99) | 0.9933 (vs. predicate) | 0.9986 (vs. predicate) |
| TIBC Correlation (r) | High correlation (e.g., >0.99) | 0.9920 (vs. predicate) | 0.9988 (vs. predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size for Iron Test: 105 serum samples
- Sample Size for TIBC Test: Not explicitly stated but implied to be the same or similar to the iron test as it's part of the same "comparison study."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "in a method comparison study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For in vitro diagnostic devices like the IL Test™ Iron, the "ground truth" for method comparison studies is typically established by the predicate device's results, which are considered the reference against which the new device is measured. This does not involve expert readers or adjudication as would be the case for image-based diagnostic aids.
4. Adjudication method for the test set
Not applicable and not provided. As noted above, this type of study does not involve adjudication by experts.
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. This is an in vitro diagnostic device for quantitative determination of iron in serum/plasma using a clinical chemistry instrument, not an AI-powered diagnostic aid involving human readers. Therefore, an MRMC study and AI assistance are not relevant to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance presented is standalone. The IL Test™ Iron is designed to perform quantitative measurements without human-in-the-loop diagnostic interpretation of the results from the device itself. The results are generated by the instrument (Monarch or ILab Clinical Chemistry System) using the described method.
7. The type of ground truth used
The "ground truth" for this method comparison study was the results obtained from the predicate IL Test™ Iron device. The new device's performance was compared against the established performance of the legally marketed predicate device.
8. The sample size for the training set
This information is not applicable and not provided. The IL Test™ Iron is a chemical reagent-based diagnostic test, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical formulation and validated manufacturing process.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of in vitro diagnostic device in the context of AI/ML.
§ 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.