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The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.

The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroid stimulating hormone and thyroxine.

The provided text is a 510(k) summary for the LOCI Thyroid Calibrator, a medical device for in vitro diagnostics. It outlines the device's description, intended use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes for training/test sets, ground truth establishment, or expert involvement.

The document refers to "pre-defined acceptance criteria" in the stability section for the predicate device, but it does not specify what those criteria are or present any study data demonstrating compliance for the new device. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with detailed acceptance criteria and clinical validation.

Therefore, I cannot complete the requested tables and information based on the provided text, as the necessary details are absent.

To illustrate what would be provided if the information were available, here's a conceptual structure.

Conceptual Structure if Information was Present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: [Number of samples/patients]
• Data Provenance (Test Set): [e.g., Country, Retrospective/Prospective, Type of samples (e.g., patient samples, spiked samples, reference materials)]
• Training Set Sample Size: [Number of samples/patients]

3. Ground Truth Establishment for Test Set

• Number of Experts: [Number]
• Qualifications of Experts: [e.g., "Clinical chemists with 10+ years of experience in thyroid hormone analysis," or "Board-certified endocrinologists."]
• Adjudication Method: [e.g., "Consensus discussion," "2-out-of-3 majority vote," "None, single expert determination."]

4. MRMC Comparative Effectiveness Study

• Was an MRMC study done? [Yes/No]
• Effect Size (if Yes): [e.e., "Human readers showed an X% improvement in diagnostic accuracy with AI assistance compared to without."]

5. Standalone Performance Study

• Was a standalone study done? [Yes/No]
• If Yes: The values in the performance table above would typically reflect standalone performance.

6. Type of Ground Truth Used

• For Test Set: [e.g., "Reference method values from an independent lab," "Established true values of spiked samples," "Consensus of expert clinical assessment."]
• For Training Set: [e.g., "Reference method values," "Manufacturer's internal reference materials."]

7. How Ground Truth for Training Set was Established

• [Description of the process, e.g., "Using validated reference methods and commercially available reference materials with certified values," "Internal expert review and consensus."]

Based on the provided text alone, the following is all that can be extracted:

• Device Name: LOCI Thyroid Calibrator
• Intended Use: Calibration of FT4L and TSHL methods on the Dimension® EXL™ with LM system.
• Predicate Device: LOCI Thyroid Calibrator (K073604)
• Key difference from Predicate: The new device also calibrates the TSHL method and contains human thyroid stimulating hormone, and has an additional calibrator level (Level 2).
• Stability Mention: "The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria." (This refers to the predicate device in the comparison table, but implies similar processes for the new device without detailing specific criteria or results).
• Traceability (New Device): Traceable to an internal master pool for FT4 and to the WHO standard for TSH.

Conclusion: The provided 510(k) summary is for a diagnostic calibrator and primarily focuses on demonstrating substantial equivalence. It does not include the detailed performance study results, acceptance criteria, or ground truth establishment information typically found in submissions for AI-powered diagnostic devices or other medical devices requiring extensive clinical validation against specific performance metrics.

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