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510(k) Data Aggregation
(90 days)
This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml.
This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml.
Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the study that proves the device meets them:
K960195 - ThyroChek TSH Immunoassay
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (ThyroChek) |
|---|---|
| Discrimination of TSH > 5 µIU/ml vs. < 5 µIU/ml (Quantitative Recovery): Ability to distinguish serum samples with TSH concentrations slightly above 5 µIU/ml from those slightly below. | Successfully distinguished samples: - 5.2, 5.7, 6.5 µIU/ml (above 5) - 4.1, 4.5 µIU/ml (below 5) |
| Ability to distinguish TSH > 5 µIU/ml from diluted samples below 5 µIU/ml (Serial Dilution): | Successfully distinguished samples. |
| Intra-Assay Precision (Coefficient of Variation): Reproducibility of results within the same assay run. | - 4 out of 5 sets of 30 replicates showed 30 identical results. - 1 out of 5 sets showed 29 of 30 replicates agreed. - 25 samples in duplicate showed 100% agreement. - Implies an intra-assay coefficient of variation of less than 3%. |
| Accuracy / Agreement with Predicate Device (Parallelism): Correctly identifying TSH levels > 5 µIU/ml and < 5 µIU/ml compared to a legally marketed predicate device. | For TSH > 5 µIU/ml (positive cases): - Predicate identified 66 cases. - ThyroChek correctly identified 65 out of 66 (98.5% sensitivity). For TSH < 5 µIU/ml (negative cases): - Predicate identified 262 cases. - ThyroChek correctly identified 262 out of 262 (100% specificity). |
| Lack of Cross-Reactivity: No interference from high concentrations of structurally similar hormones (hCG, LH, FSH). | - hCG (up to 150,000 mlU/ml) did not produce false negative/positive results or affect TSH determination. - LH / FSH (> 40 mlU/ml from 17 postmenopausal women) did not produce false negative/positive results or affect TSH determination. |
| Lack of Interference: No interference from common physiological substances (glucose, uremic metabolites, lipids, hemolyzed red blood cells). | Elevated concentrations of glucose, uremic metabolites, lipids, or hemolyzed red blood cells did not interfere with device performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Quantitative Recovery: Number of samples not explicitly stated, but includes samples determining 5 TSH concentrations (5.2, 5.7, 6.5, 4.1, 4.5 µlU/ml).
- Serial Dilution: Number of samples not explicitly stated.
- Coefficient of Variation:
- 5 sets of 30 replicates (total 150 replicates from 5 samples).
- 25 samples measured in duplicate (total 50 replicates from 25 samples).
- Parallelism:
- Total: 328 patient samples.
- Positive (TSH > 5 µIU/ml): 66 samples (as determined by predicate).
- Negative (TSH < 5 µIU/ml): 262 samples (as determined by predicate).
- Cross-Reactivity:
- Number of samples containing hCG (not specified).
- 17 postmenopausal women for LH/FSH.
- Interference: Number of samples not specified.
Data Provenance: Not explicitly stated, but the "328 patient samples" suggests human patient data. The country of origin and whether it's retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The ground truth (or reference standard) for the "Parallelism" study was established by a single predicate device (Immunolite Third Generation TSH Assay, K930007).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. This study is for an immunoassay device, which typically outputs a single value rather than requiring human interpretation of an image or signal. The "Parallelism" study compares the device's performance to another device, not to human readers.
6. Standalone Performance Study
Yes, the studies described, particularly the "Parallelism" study, represent a standalone (algorithm only without human-in-the-loop) performance evaluation. The ThyroChek device's output (TSH > 5 µIU/ml or < 5 µIU/ml) is directly compared to the output of the predicate device.
7. Type of Ground Truth Used
The primary ground truth (or reference standard) used for the "Parallelism" study was the predicate device, Immunolite Third Generation TSH Assay (K930007). This means the device's performance was evaluated against the measurements of another already-approved TSH immunoassay.
8. The Sample Size for the Training Set
The document does not mention a training set or the sample size for one. This device is an immunoassay, which typically doesn't involve "training" in the machine learning sense. Its performance is based on its chemical and biological design.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this immunoassay, this question is not applicable.
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