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The LOCI THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.

The LOCITHYR CAL is a multi-analyte, liquid, bovine serum albumin based product containing triiodothyronine, thyroxine and human thyroid stimulating hormone. The kit consists of ten vials with two vials per level containing 2.0 mL per vial.

The provided text describes a 510(k) summary for the LOCI Thyroid Calibrator, focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets acceptance criteria based only on the provided input.

The document primarily states:

• The device is a calibrator for specific thyroid hormone tests.
• It is substantially equivalent to a previously cleared device (K073604).
• The key difference from the predicate is the addition of calibration for "Free Triiodothyronine (FT3)".

To answer your request thoroughly, I would need a different type of document, such as a full. 510(k) submission, a clinical study report, or a validation study report that details performance characteristics and acceptance criteria.

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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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The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system.

The Dimension® EXL™ with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

The Dimension® EXL™ with LM clinical chemistry system is a floor model, fully automated, microprocessor-controlled, integrated instrument system which uses prepackaged Dade Behring Flex® reagent cartridges to measure a variety of analytes in human body fluids. The system can process samples in random access, batch or stat modes.

The Dimension® FT4L 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 LOCI® Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroxine. There are four calibrator levels with target values of 0.8, 1.6, 4.0 and 8.4 ng/dL.

The provided text describes a 510(k) premarket notification for the Dimension® EXL™ with LM clinical chemistry system, Dimension® FT4L Flex® reagent cartridge, and LOCI® Thyroid Calibrator. The primary study described is a method comparison study between the new Dimension® FT4L Flex® reagent cartridge and its predicate device, the Dimension® Vista FT4 Flex® reagent cartridge.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "slope must be between 0.95 and 1.05 and r > 0.98"). However, the study aims to demonstrate "excellent correlation" and substantial equivalence to the predicate device. The results indicate that this goal was met.

2. Sample Size and Data Provenance

• Sample Size for Test Set: One hundred-and-eighty (180) serum samples.
• Data Provenance: Not explicitly stated whether the data is retrospective or prospective, nor the country of origin. It's common for such studies to use prospectively collected samples or a mix, but this information is absent.

3. Number of Experts and Qualifications for Ground Truth

The study described is a method comparison study between two in vitro diagnostic devices. It does not involve human interpretation or subjective assessment that would require experts to establish a "ground truth" in the traditional sense (like in image analysis or clinical diagnosis). Instead, the "ground truth" in this context is the measurement obtained from the predicate device.

4. Adjudication Method

Not applicable. This was a direct comparison of measurements between two automated analytical methods, not a study requiring adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of an in vitro diagnostic assay, comparing its measurements to a predicate device. It does not assess the diagnostic effectiveness with or without AI assistance for human readers.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily assesses the standalone performance of the Dimension® FT4L Flex® reagent cartridge on the Dimension® EXL™ with LM system by comparing its quantitative measurements to those of the predicate device. The "algorithm" here refers to the entire analytical process of the device, from reagent interaction to signal detection and calculation.

7. Type of Ground Truth Used

The ground truth used for the comparison was the measurements obtained from the predicate device, the Dimension® Vista FT4 Flex® reagent cartridge. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.

8. Sample Size for Training Set

The document does not explicitly mention a "training set" or "training data" in the AI/machine learning sense. For in vitro diagnostic devices, method comparison studies typically use a test set to validate performance against a predicate. If method development and internal validation occurred, they would have used various samples, but these are not referred to as a "training set" in this context and their size is not provided.

9. How Ground Truth for Training Set Was Established

Not applicable, as a "training set" in the machine learning sense is not described. For the general development of such IVD assays, ground truth for initial development and calibration would typically be established using reference materials, certified calibrators, and samples characterized by a reference method or highly accurate established methods. However, these details are not provided in the summary.

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The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.

The provided text describes a Thyroid Calibrator, a liquid bovine albumin-based product designed for calibrating FT4 and TSH methods on the Dimension® RxL clinical chemistry system. The document is a "Summary of Safety and Effectiveness Information" for a 510(k) submission, indicating a comparison to a predicate device for substantial equivalence.

However, the document does not contain information related to acceptance criteria or a study proving device performance in the way requested by the prompt. This document is a summary of safety and effectiveness information and focuses on comparing the new device to a predicate device to establish substantial equivalence, not on detailed performance validation studies with acceptance criteria, sample sizes for test sets, ground truth establishment, or clinical effectiveness studies.

Specifically, the requested information elements are not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document compares features of the new calibrator to predicate calibrators but does not define or report performance against specific acceptance criteria for accuracy, precision, or other analytical characteristics.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a calibrator, not a diagnostic imaging or interpretive device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a calibrator.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document's purpose is to argue for substantial equivalence based on intended use, analytes, matrix, form, volume, and levels, not to report on detailed performance studies against pre-defined acceptance criteria.

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