(25 days)
For in vitro diagnostic use only. The Magnetic TIBC Kit quantitatively measures total iron-biding capacity in serum.
Not Found
The provided document describes a 510(k) submission for the Magnetic TIBC Kit, focusing on its substantial equivalence to a predicate device, the J & S Microcolumn and Iron Saturating reagent kit for TIBC. The evaluation is a correlation study between the two methods rather than a study on a new AI/ML device. Therefore, many of the typical acceptance criteria and study design elements requested, such as human-in-the-loop performance, ground truth establishment for AI, and various expert-related details, are not applicable in this context.
Here's the information that can be extracted or inferred from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Magnetic TIBC Kit vs. J & S microcolumn method) |
|---|---|
| Strong correlation to predicate device | y = 1.02x - 5.7 with a correlation of 0.99 |
2. Sample size used for the test set and the data provenance
- Sample Size: 103 samples
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
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 as the study is a correlation study between two assay methods and does not involve human expert interpretation for establishing a "ground truth" in the context of an AI/ML device. The "ground truth" for the test set is effectively the results obtained from the predicate device (J & S microcolumn method).
4. Adjudication method for the test set
This information is not applicable as the study design is a direct comparison of analytical measurements from two different laboratory methods, not a study involving human interpretation that would require adjudication.
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
This information is not applicable as the device is an in-vitro diagnostic kit, not an AI-powered diagnostic system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm but an in-vitro diagnostic kit. Its performance is evaluated as a standalone analytical method in comparison to another analytical method.
7. The type of ground truth used
The "ground truth" for the purpose of demonstrating substantial equivalence in this context is the results obtained from the predicate device (J & S microcolumn method). The study aimed to show that the new Magnetic TIBC Kit yielded results that were highly correlated with an established, legally marketed method.
8. The sample size for the training set
This information is not applicable. The study described is a direct comparison of analytical methods, not an AI/ML model that requires a distinct training set. The 103 samples were used for the correlation study itself.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.