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510(k) Data Aggregation
(260 days)
FREND™ TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND™ system.
FREND™ TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.
The FREND™ System is a bench top fluorescence reader containing a simple computerized touchscreen user interface, easily manipulated to order tests, display results and operate the mechanical functions of the instrument. The specimen is added with a transfer pipette to the sample inlet of a single use cartridge by the operator, allowing the appropriate volume of sample (35 uL) to be delivered into the FREND™ TSH cartridge. The cartridge is then placed into the FREND™ system, which is programmed to begin analysis once the sample has reacted with the reagents. All reactions occur in the self-contained plastic cartridge and the reading is done in the cartridge as well. The FREND™ system has a slot that accepts the FREND™ TSH test cartridge containing the reagents and sample, and is programmed to analyze the test when the sample has fully reacted with the on-board in-cartridge reagents. Cartridges are loaded manually one by the operator. The reaction and analysis time is approximately 5 minutes. TSH quantitation is based on the ratio of fluorescence detected by the FREND™ System at the FREND™ TSH test and reference windows in the plastic cartridge compared to a standard curve stored in the TSH Code Chip that is included with each box of the device. A higher ratio of fluorescence is indicative of a higher TSH concentration. In other words, the magnitude of the fluorescent ratio is directly proportional to the amount of TSH in the sample.
The FREND™ TSH device is an in vitro diagnostic test for the quantitative measurement of TSH in human serum and lithium heparin plasma. The study aimed to demonstrate its substantial equivalence to a legally marketed predicate device, the TOSOH ST AIA-PACK TSH (K972586), to support its 510(k) premarket notification.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by equivalence to predicate or clinical guidelines) | Reported Device Performance (FREND™ TSH) |
|---|---|---|
| Accuracy (Linearity) | Linearity over the measurement interval with non-linearity less than allowable (20% up to 1 mIU/L, then 10%). | Linear from <0.06 mIU/L to 25.54 mIU/L. Slope = 0.977, y-Intercept = 0.17, Sw = 0.28, r = 0.999. Non-linearity less than allowable. |
| Accuracy (Comparability to Predicate) | Difference in concentration between test and predicate device less than allowable difference (CLSI EP09-A2-IR, Section 7). Equivalent performance. | Slope of 0.951 (95% CI: 0.940; 0.962), y-Intercept of 0.0266 (95% CI: -0.0258; 0.0790) for concentrations from 0.09 ~ 24.96 mIU/L. Strong correlation (R-squared = 0.9849). Thyroid status equivalent in 98.4% of cases. |
| Precision | Acceptable repeatability, between-run, between-day, and within-laboratory precision throughout the measurement range. | SD (mIU/L) and CV% reported for four TSH concentration levels across repeatability, between-run, between-day, and within-laboratory. E.g., for 0.496 mIU/L, within-laboratory CV% was 9.6%; for 23.763 mIU/L, within-laboratory CV% was 4.1%. |
| Specificity (Cross-Reactivity) | No significant cross-reactivity with structurally similar hormones (LH, FSH, hCG) at specific concentrations. | Insignificant interference (e.g., hCG at 200,000 mIU/mL resulted in 2 x 10^-8 % cross-reactivity at 0.49 mIU/L TSH). |
| Analytical Sensitivity (Limit of Detection - LoD) | Similar to predicate device's sensitivity (0.03 mIU/L). | Determined to be 0.06 mIU/L (using CLSI EP17-A). |
| Interference (Endogenous) | Recovery within 90-110% of expected TSH concentration. | Average TSH recovery: Hemoglobin (98.8%), Bilirubin (100.0%), Total Protein (100.4%), Triglyceride (101.6%), HAMA at 52.5 ng/mL (93.3% - higher concentrations showed interference), RF at 53.8 IU/mL (91.4% - higher concentrations showed interference). |
| Interference (Pharmaceutical) | No significant interference (<10%) from common medications at tested concentrations. | No significant interference found from tested drugs (Acetaminophen, Diltiazem, Erythromycin, Verapamil) at specified concentrations. |
| High Dose Hook Effect | No high dose hook effect within the tested range. | No High Dose Hook effect seen in samples with TSH concentrations up to 2500 mIU/L. |
| Reagent Stability | Stability meets storage and handling conditions. | Cartridges good for at least one year refrigerated; six months at room temperature (22-28°C). |
| Matrix Study (Serum vs. Plasma) | FREND™ TSH can be measured equally well in serum and lithium heparin plasma. | Linear regression of serum (x) vs. lithium heparin plasma (y) yielded y = 0.995x - 0.320 (r = 0.992, r^2 = 0.985). |
| Reference Intervals | Establish a single adult reference interval; no significant racial or gender differences. | FREND™ TSH Reference Interval: 0.49 ~ 3.82 mIU/L (based on 385 healthy adults, 18-71 years old). Similar to predicate (0.47-4.09 mIU/L). |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy (Comparability Analysis): 438 serum samples. Data provenance is not explicitly stated as country of origin, but described as "obtained from subjects both apparently normal and with thyroid conditions as well as other undisclosed diseases and conditions." These samples were stored at -70°C for less than one year. This appears to be retrospective, using banked samples.
- Accuracy (Linearity): Specimens from a high TSH concentration pool were diluted, implying a controlled laboratory experiment rather than patient samples.
- Precision: Four clinical samples were used.
- Specificity: Not specified, but involved samples with various concentrations of interferents.
- Analytical Sensitivity: Not specified, but involved using the CLSI EP17-A protocol with appropriate samples for LoD determination.
- Interference (Endogenous & Pharmaceutical): Not specified, but involved adding known concentrations of interferents to samples.
- Matrix Study: 40 sample pairs (serum and lithium heparin plasma aliquots from the same individuals).
- Reference Intervals: 385 apparently healthy ambulatory adults (195 males and 191 females, ages 18-71). Data provenance is not explicitly stated but implies a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the validation of an in vitro diagnostic (IVD) device for quantitative measurement of TSH. The "ground truth" for such devices typically refers to the true concentration of the analyte (TSH) in samples. This is established through:
- Predicate Device Comparison: The predicate device itself (TOSOH ST AIA-PACK TSH) serves as a gold standard or a highly reliable comparator. The agreement with this device forms a crucial part of the "ground truth" for demonstrating equivalence.
- Reference Methods/Materials: For linearity, sensitivity, and interference studies, samples with known or precisely determined TSH concentrations are used, often prepared based on international standards or reference materials.
- Clinical Characterization: For the reference interval study, "apparently healthy" individuals were selected, but the "truth" here is their health status, not a TSH concentration value. The TSH values themselves are then used to establish the reference range.
Therefore, the concept of "experts" to establish ground truth in the same way it applies to image-based diagnostic AI, for example, is not directly applicable here. The "truth" is based on established laboratory methods, validated predicate devices, and reference materials.
4. Adjudication Method for the Test Set
Not applicable in the context of an in vitro diagnostic immunoassay. The comparison is objective, based on quantitative measurements.
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 is relevant for diagnostic imaging or interpretation tasks where human readers make subjective judgments. For this quantitative immunoassay, the comparison is directly between numerical output of the device and a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the FREND™ TSH device. The FREND™ system automatically performs the analysis once the sample is loaded into the cartridge by the operator, and provides a quantitative TSH result. The performance characteristics (accuracy, precision, sensitivity, etc.) are evaluated based on the device's output itself, without immediate human interpretation or modification of its quantitative result. The device is intended for use in clinical laboratories by "qualified technologists," but the performance metrics are intrinsic to the device's analytical capabilities.
7. The Type of Ground Truth Used
- Comparability: The results obtained from the predicate device (TOSOH ST AIA-PACK TSH) were used as the primary ground truth for the comparability study.
- Analytical Performance (Linearity, LoD, Specificity, Interference): Ground truth was established using known concentrations of TSH, dilution series from high concentration pools, and samples spiked with known amounts of interfering substances or cross-reactants. These are typically based on certified reference materials or established laboratory methods.
- Reference Intervals: The TSH values from a cohort of apparently healthy individuals were used to statistically derive the reference interval.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning, as this is an immunoassay device, not an AI/ML algorithm that undergoes explicit training in the same manner. The studies described are primarily for verification and validation of the device's analytical performance against established standards and a predicate device.
9. How the Ground Truth for the Training Set Was Established
As explained above, the concept of a "training set" for an AI/ML algorithm does not directly apply here. The device's underlying "knowledge" (e.g., standard curve, reaction kinetics) is established during its design and manufacturing based on chemical principles and calibration using reference standards. The studies described are validation studies to ensure this "knowledge" translates into accurate and reliable performance.
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