(37 days)
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
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Analyte Coverage | Cover reportable range of instrumentation; targets cover clinical reference range | Eight levels provided; targets cover the clinical reference range for T4, T3, and TSH. |
| Shelf Life | Stable for a specified period | 12-month shelf life at frozen temperatures (-10 to -20℃). |
| Matrix | Serum matrix | Serum matrix |
| Number of Levels | Multiple levels to establish linearity | 8 levels, 1 bottle per level |
| Volume per Level | Sufficient for use | 5.0 milliliters per bottle |
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.