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The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.

The MICT® TSH Immunoassay for the quantitative determination of TSH in human serum is designed for use on MICT® Instrument.
MICT® TSH Device Reagents:

1. Solid phase nitrocellulose membrane device with two detection zones:
   a. Control line region containing a polyclonal goat anti-rabbit IgG antibody, and
   b. Test line region containing a monoclonal anti-TSH antibody
2. Lyophilized conjugate tube containing the monoclonal anti-TSH antibody covalently coupled to 300 nm super paramagnetic particles.
   The MICT® Immunoassay is a "sandwich" magnetic chromatographic assay.

The provided 510(k) summary describes the MICT® TSH device and its performance characteristics. This is a medical device for in-vitro quantitative determination of TSH in human serum, not an AI/ML device, and therefore does not have acceptance criteria and a study design in the format requested for AI/ML devices. However, I can extract the relevant performance data as presented.

Here's the information based on the provided text, adapted to the closest relevant categories for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally inferred from a comparison to a predicate device and established analytical performance benchmarks for immunoassays. The study demonstrates substantial equivalence to the predicate device (FastPack® TSH).

1. 0.191 µIU/mL (14.1%CV)
2. 0.29 µIU/mL (9.4%CV)
3. 0.83 µIU/mL (9.4%CV)
4. 3.7 µIU/mL (7.8%CV)
5. 46.7 µIU/mL (8.8%CV)
   Site 2:
6. 0.191 µIU/mL (13.3%CV)
7. 0.29 µIU/mL (10.1%CV)
8. 0.87 µIU/mL (7.8%CV)
9. 4.1 µIU/mL (9.1%CV)
10. 46.6 µIU/mL (9.5%CV)
    Site 3:
11. 0.187 µIU/mL (14.4%CV)
12. 0.29 µIU/mL (9.5%CV)
13. 0.87 µIU/mL (7.6%CV)
14. 3.95 µIU/mL (9.1%CV)
15. 48.4 µIU/mL (7.5%CV)
    (Predicate: Site 1 Total Within Lab: 0.54 µIU/mL (20.0%CV), 1.54 µIU/mL (9.7%CV), 4.69 µIU/mL (7.0%CV), 46.30 µIU/mL (9.5%CV)) |
    | Sensitivity | Comparable or better than predicate device (Predicate Analytical = 0.043 µIU/mL, Functional = 0.13 µIU/mL) | LOB = 0.04 µIU/mL
    LOD = 0.077 µIU/mL
    LOQ = 0.077 µIU/mL |
    | Method Comparison (Correlation with Predicate) | High correlation (e.g., r > 0.95 and slope/intercept close to 1/0) | Site 1: MICT = 0.97 FastPack - 0.27 (n=66, r = 0.99)
    Site 2: MICT = 0.93 FastPack - 0.07 (n=74, r = 0.99)
    Site 3: MICT = 0.98 FastPack 0.00 (n=64, r = 0.99)
    Pooled: MICT = 0.96 FastPack - 0.12 (n=204, r = 0.99) |
    | Interfering Substances | No significant interference at specified concentrations. | Bilirubin: No interference up to 40 mg/dL
    Hemoglobin: No interference up to 1000 mg/dL
    Triglycerides: No interference up to 3200 mg/dL
    Phospholipid: No interference up to 800 mg/dL |
    | Specificity | No significant cross-reactivity with related hormones. | No interference from 500 mIU/mL LH and 500 mIU/mL FSH. |

2. Sample Size Used for the Test Set and Data Provenance
The method comparison study used a total of n=204 samples.

• Site 1: n=66
• Site 2: n=74
• Site 3: n=64

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. As a clinical laboratory device study, these are typically prospective evaluations of clinical samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an immunoassay device, and "ground truth" for TSH levels is established by the comparative measurement of known reference methods or another analytically validated device (the predicate device in this case), not by expert interpretation.

4. Adjudication Method for the Test Set
Not applicable. See point 3.

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
Not applicable. This is an immunoassay device, not an AI/ML device used by human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is an automated immunoassay system; its performance is standalone in the sense that the instrument provides the quantitative reading.

7. The Type of Ground Truth Used
The "ground truth" (or reference method) for the method comparison study was the Qualigen FastPack® TSH device. This is a legally marketed predicate device, implying its results are accepted as a valid reference for TSH determination.

8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not an AI/ML system that requires a "training set." The device's calibration curve is factory-generated.

9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8. The device uses a factory-generated master curve with a single calibration per lot, implying that the "calibration" (analogous to training for an AI model) is established by the manufacturer using a set of known standards.

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