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Elecsys T-Uptake CalSet: T-Uptake CalSet is a lyophilized buffer/protein/TBG matrix with added L-thyroxine. The Elecsys T-Uptake assay is traceable to a clinically defined human serum panel with a mean TBI (thyroxine-binding index) of 1.

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies performed for the Elecsys T-Uptake CalSet, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study / Characteristic	Acceptance Criteria	Reported Device Performance
Value Assignment	Pre-defined acceptance criteria for PreciControl Universal must be met to release Assigned Values for T-Uptake CalSet.	Value assignment testing was conducted and passed pre-defined acceptance criteria. The target values for the two levels are chosen to obtain the best fit with the Reference Standard Curve. For each lot, calibrators are run in duplicate on at least three (3) Elecsys 2010 analyzers and at least three (3) MODULAR ANALYTICS E170 analyzers with all T-Uptake reagent lots available. The assigned value of each calibrator is defined as the median value obtained over at least six (6) runs on at least three (3) analyzers.
Stability at 2-8°C, -20°C, in open vial, and freeze/thaw cycles (after reconstitution)	95-105% signal recovery of the reference material value.	On-test material was reconstituted and stored in closed vials for 85 days at 2-8°C, for 699 days at -15 to -25°C, and for 6 hours at 20-25°C in open vial. Stability for one (1) freeze/thaw cycle was also evaluated. (The document states these conditions were tested, implying they met the criteria, but does not explicitly provide the numerical results or a direct statement of "passed" for each condition, only that the "on-test signal recovery was calculated as percent of the reference value.")
Accelerated Stability (35°C for 3 weeks, lyophilized)	95-105% recovery of the reference material value.	On-test material stored lyophilized at 35°C for 3 weeks was evaluated. (The document states this study was performed with the acceptance criterion, implying passage, but does not explicitly provide numerical results or a direct statement of "passed.")
Real-Time Stability (2-8°C, over shelf life)	95-105% recovery of the reference value (stressed vs. unstressed calibrator).	Real-time stability is being evaluated (planned study), with tests performed in duplicate at specified intervals over the shelf life up to 25 months. The mean value of stressed calibrator is calculated as percent recovery of the unstressed value. (This is a planned/ongoing study, so no final reported performance is available in this document.)
Reconstitution Study (15 min vs. 30 min)	95-105% signal recovery of the reference material value (30 min vs. 15 min reconstitution).	Two sets were reconstituted (15 min and 30 min). Signal recovery after 30 minutes reconstitution was compared to the signal value after 15 minutes. (The document states this study was performed with the acceptance criterion, implying passage, but does not explicitly provide numerical results or a direct statement of "passed.")

Additional Information on the Studies:

Sample size used for the test set and the data provenance:
- Value Assignment: For each Elecsys T-Uptake CalSet lot, calibrators are run in duplicate on at least three (3) Elecsys 2010 analyzers and at least three (3) MODULAR ANALYTICS E170 analyzers. This totals at least 6 analyzers and 12 runs per lot during the value assignment process.
- Stability Studies (Study 1 & 2) and Reconstitution Study: "On-test and reference materials were tested in duplicate." and "One T-Uptake CalSet lot was evaluated in duplicate" on the cobas e 411 analyzer.
- Real-Time Stability (Study 3): CalSets are tested in duplicate at specified intervals.
- Data Provenance: Not explicitly stated, but given the manufacturer (Roche Diagnostics) and the nature of the device (calibrator for immunoassay analyzers), the data is most likely from internal laboratory testing, likely based in Germany (where Roche Diagnostics GmbH is located) or the US. It is prospective testing as part of product development and validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a calibrator, not an interpretative diagnostic tool. "Ground truth" in this context refers to the accuracy and stability of the calibrator's assigned values and its performance characteristics. The document mentions that the Elecsys T-Uptake assay is traceable to a "clinically defined human serum panel with a mean TBI of 1.0." This "clinically defined panel" would have been established by experts, but the number and qualifications of those experts are not detailed in this document. The focus of this 510(k) is on the calibrator itself, not the original T-Uptake assay.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device is a calibrator for an in-vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human readers interpret results and consensus is needed. For this device, performance is measured against predefined analytical values and recovery percentages.
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 device is a calibrator for an in-vitro diagnostic assay, not an AI-powered diagnostic system for human reader interpretation. No MRMC study was performed or is relevant for this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable in the usual sense of AI/algorithm standalone performance. The "performance" of this device is its ability to accurately calibrate the Elecsys T-Uptake assay on automated immunoassay analyzers. These analyzers operate without constant human intervention during the measurement process, but the results are interpreted by human operators. The studies conducted (value assignment, stability, reconstitution) are essentially standalone performance evaluations of the calibrator itself within the automated system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ultimate "ground truth" for the T-Uptake assay to which this calibrator relates is a "clinically defined human serum panel with a mean TBI of 1.0." For the calibrator's own performance, the ground truth for comparison is a "reference material" or "unstressed calibrator" with known, freshly reconstituted values, or the established "Reference Standard Curve" for value assignment.
The sample size for the training set:
Not applicable. This device is a calibrator, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable (no training set for this type of device).

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