(115 days)
The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).
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.
The Iron Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use.
The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.
The provided document is a 510(k) summary for the Sentinel Iron Liquid, an in vitro diagnostic assay. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or a detailed study section with performance data that would allow for a comprehensive answer to all parts of your request.
Based on the information available in the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." However, it does not provide a table of specific acceptance criteria (e.g., target precision values, sensitivity thresholds) nor does it report the actual device performance metrics (e.g., measured sensitivity, CVs for precision, regression statistics for method comparison). It only states that these evaluations were performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance evaluations (test set). It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron. The "ground truth" for such devices is typically established through reference methods or established biochemical standards, not expert interpretations of images or clinical cases. The document does not mention experts being used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for this type of in vitro diagnostic device, where ground truth is based on quantitative measurements rather than expert consensus requiring adjudication. The document does not mention any adjudication method.
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 question is not applicable as the device is an in vitro diagnostic assay for quantitative determination of iron, not an AI-assisted diagnostic tool for human readers. The document does not mention an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Sentinel Iron Liquid is a reagent-based assay for quantitative determination of iron. It operates standalone in the sense that it produces a quantitative result; there isn't a "human-in-the-loop performance" in the same way there would be for an image-based AI diagnostic. The comparative study was against a predicate device (IL Test Iron), indicating a standalone performance comparison. The document confirms that "Performance evaluations included sensitivity, intra- and inter-assay precision and method comparison." This implies a standalone evaluation of the device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an in vitro diagnostic assay like Sentinel Iron Liquid, the "ground truth" would be the true concentration of iron in the samples, likely determined by a precise reference method or by using certified reference materials and calibrators. The document does not explicitly state the specific reference method or approach used to establish the ground truth for the performance evaluations. It only implicitly suggests that the predicate device serves as a comparison for accuracy.
8. The sample size for the training set
The concept of a "training set" is primarily relevant for machine learning or AI models. The Sentinel Iron Liquid is a chemical reagent-based assay. Therefore, there is no training set in the context of an AI model. The document does not refer to a training set.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
Summary of what is present:
- Intended Use: Quantitative determination of iron in human serum and plasma (heparin salts, only).
- Comparison to Predicate Device: IL Test Iron (Instrumentation Laboratory Company, K972363).
- Performance Evaluations Conducted (but not reported in detail): Sensitivity, intra- and inter-assay precision, and method comparison.
- Conclusion: The performance and safety data support a finding of substantial equivalence to the predicate devices.
§ 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.