(37 days)
Method: The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM System. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.
Diluent: The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM systems.
The Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dimension® EXL™ with LM system.
The TSH Sample Diluent is a liquid, bovine serum albumin based product with preservatives.
Here's a summary of the acceptance criteria and study information for the Siemens Healthcare Diagnostics Inc. Dimension® TSHL Flex® reagent cartridge and TSH Sample Diluent:
Acceptance Criteria and Device Performance
The submission focuses on demonstrating substantial equivalence to a predicate device, the Dimension Vista™ TSH Flex® reagent cartridge. The primary acceptance criterion for the new device, the Dimension® TSHL Flex® reagent cartridge, is to show excellent correlation with the predicate device.
| Acceptance Criteria | Reported Device Performance (Dimension® TSHL Flex® vs. Dimension® Vista TSH Flex®) |
|---|---|
| Correlation Coefficient (r) | 0.997 |
| Slope | 1.05 |
| 95% CI (for Slope) | 1.0442 to 1.0649 |
| y-intercept | -0.04 µIU/mL |
| Sy,x (Standard Error) | 1.708 µIU/mL |
| Assay Range | 0.007-100 µIU/mL (Predicate: 0.005-100 µIU/mL) |
| Intended Use | Quantitative measurement of TSH in human serum and plasma |
| Sample Type | Human serum and plasma |
| Technology | LOCI® technology |
| Sample Size | 12 µL |
| Reagents and Antibody | Same as predicate |
| Uses TSH Sample Diluent | Yes |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Two hundred and ten (210) serum samples.
- Data Provenance: Not explicitly stated, but typically these samples would be clinical samples representing various TSH levels. The document does not specify country of origin or if they were retrospectively or prospectively collected.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is a method comparison study against a predicate device, not a diagnostic accuracy study requiring expert-established ground truth for individual cases. The "ground truth" for the new device's performance is its correlation with the established predicate device's measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a quantitative laboratory measurement comparison, not a qualitative assessment requiring adjudication of results from multiple readers.
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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:
- No, an MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but rather an in vitro diagnostic reagent cartridge assessing TSH levels.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The study evaluates the performance of the TSHL Flex® reagent cartridge as a standalone measurement tool on the Dimension® EXL™ with LM system, comparing its quantitative results directly against the quantitative results of the predicate device (Dimension Vista™ TSH Flex® reagent cartridge). There is no "human-in-the-loop" component being evaluated in this specific comparison beyond the standard operation of the laboratory instruments.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is the quantitative measurement provided by the legally marketed predicate device, the Dimension Vista™ TSH Flex® reagent cartridge. The intent is to show that the new device produces results that are statistically comparable and correlate strongly with the predicate device.
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The sample size for the training set:
- Not applicable. This is a method comparison study for an in vitro diagnostic assay, not a machine learning or AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device and study.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.