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DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.

DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.

Here's a breakdown of the acceptance criteria and study information for the DOCUMENT® Thyroid CAL•VER™ device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

It's important to note that the provided document is a 510(k) summary for a premarket notification. These summaries generally focus on establishing substantial equivalence to a predicate device rather than detailing comprehensive clinical efficacy studies for the device itself. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not explicitly present in this type of document.

The document primarily states the device's characteristics and its intended use for calibration verification and linearity studies. The "Performance Characteristics and Data" section merely describes the device's attributes, not the results of a formal study to prove those attributes met a predefined acceptance criteria with a specific sample size, ground truth, or expert involvement.

Based on the provided text, here's what can be inferred or explicitly stated:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated. The document mentions the device has "8 levels" and "targets cover the clinical reference range," but it doesn't describe a specific "test set" in the context of a validation study with a defined sample size. The provenance of any underlying data is also not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not explicitly stated. This device is a calibration verification material. Its "ground truth" (i.e., the theoretical values for each analyte at each level) would be established during its manufacturing process and quality control, not by expert consensus in the way a diagnostic imaging device's ground truth would be. The document does not describe the process of establishing these theoretical values or the experts involved.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not explicitly stated. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the primary function of this calibration material.

4. 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. This device is a calibration verification material, not an AI-powered diagnostic tool. MRMC studies are not relevant to its function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This device is a physical reagent, not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For a calibration verification material, the "ground truth" would be the assigned, theoretical concentration values for each analyte at each of the 8 levels. This is established through rigorous gravimetric and/or volumetric preparation, followed by extensive analytical testing using reference methods and/or highly characterized reference materials within the manufacturer's quality control process. The document does not specify how these theoretical values were assigned.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. This device is a material for verifying the performance of other instruments, not a learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no "training set" for this type of device.

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DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical ana volificalled on the following analytes: Thyroxine (T4), Triiodothyronine (T3) and Thyroid Stimulating Hormone (TSH).

DOCUMENT Thyroid CAL • VER contains assayed solutions of the following analytes: Thyroxine (T4), Trilodothyronine (T3) and Thyroid Stimulating Hormone (TSH) in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. d Thyroid CAL • VER contains 8 levels, 1 bottle per level, 5.0 millliters per bottle.

The provided text describes a medical device called "DOCUMENT Thyroid CAL • VER™", which is a calibration verification quality control material. It contains assayed solutions for measuring Thyroxine (T4), Triiodothyronine (T3), and Thyroid Stimulating Hormone (TSH) in a serum matrix.

However, the document is a 510(k) summary for a calibration verification quality control material. This type of device is used to check the accuracy and linearity of other diagnostic instruments, not for direct diagnosis of patients. Therefore, the concept of "device performance" in terms of clinical accuracy (like sensitivity, specificity, or AUC) as expected for an AI diagnostic device, or a study proving its clinical efficacy, is not applicable here.

The "Performance Characteristics and Data" section in the summary refers to the stability and coverage of the target range for the calibration material itself, not the diagnostic performance of a system using it.

Consequently, much of the requested information (like acceptance criteria for clinical performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not relevant or present for this specific type of device (calibration verification material).

However, I can extract the relevant performance characteristics mentioned for this device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for a calibration verification material are typically related to its stability, accuracy of target values, and ability to cover the analytical measurement range of the instruments it's intended to verify. The document does not explicitly state numerical acceptance criteria (e.g., ±X% of target value), but rather describes the characteristics of the product. The "reported device performance" are the described characteristics of the product.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a calibration verification material, not a diagnostic test evaluated on patient samples. Its performance is assessed through its manufacturing quality, stability, and calibration against reference methods, not by testing it on a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the context of an AI diagnostic device, refers to the definitive diagnosis or condition for patient samples. For a calibration verification material, the "ground truth" would be the assayed target values of the analytes within the material, established through rigorous analytical methods and traceability to international standards, not by expert medical opinion on patient cases.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed to assess the performance of diagnostic systems (often AI-assisted) by comparing human reader performance with and without AI assistance on a set of patient cases. This is not relevant for a calibration verification material.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

No. This is not an algorithm or an AI device. It's a physical control material.

7. The Type of Ground Truth Used

For a calibration verification material, the "ground truth" refers to the assigned values of the analytes within the material. These values are established through:

• Reference measurement procedures: Highly accurate and precise analytical methods, traceable to international standards (e.g., NIST, WHO).
• Consensus values: Often determined through inter-laboratory studies using reference methods.

The document does not detail the specific methodology for establishing these assigned values, but it's implicit in a "calibration verification quality control material" that these values are robust and well-defined.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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