(35 days)
VALIDATE Thyroid Calibration Verification Test Set solutions are for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in chemistry systems for the following analytes: Triiodothyronine (T3), Thyroxine (T4), human Thyroid Stimulating Hormone (TSH), and Cortisol.
VALIDATE Thyroid Calibration Test Sets are human serum based calibration verification / linearity materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. Each test set consists of one bottle each of six (6) levels including zero. Each bottle of Levels 0 through 5 contains 3.0 milliliters. There exists a linear relationship among each set of solutions.
The provided text is a 510(k) Summary for the VALIDATE® Thyroid Calibration Verification Test Set. It is a pre-market notification for an in vitro diagnostic device, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and training data are not typically included in a 510(k) summary for this type of device. The document primarily confirms that the new device performs similarly to an already approved device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for the device's performance in the typical sense (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through its "substantial equivalence" to a predicate device in terms of "form and function."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrates "substantial equivalence" to the predicate device (DOCUMENT Thyroid CAL VER, K992034) in "form and function." | The pre-market notification states, "The information provided in this pre-market notification demonstrates that the performance of VALIDATE Thyroid Calibration Test Sets is substantially equivalent in form and function to the predicate device for its stated intended use." |
| Establishes a "linear relationship" among each set of solutions. | "There exists a linear relationship among each set of solutions." |
| Capable of quantitative determination of linearity, calibration verification, and verification of reportable range for T3, T4, TSH, and Cortisol in chemistry systems. | The "Intended Use" and "Indications For Use" sections confirm this capability. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient samples. The device itself consists of "one bottle each of six (6) levels including zero." These levels are used to test the linearity and calibration of chemistry systems, not to diagnose patients.
- Data Provenance: Not applicable in the context of clinical patient data. The "test set" in this case refers to the six levels of the VALIDATE Thyroid Calibration Verification Test Set itself, which is designed to be run on chemistry systems. The study involves demonstrating the performance of this control material, not data from a patient cohort. It is an in vitro diagnostic device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The "ground truth" for a calibration verification material is its known analytical concentration at different levels. This is typically established through precise analytical methods and quality control procedures during manufacturing, not by human expert consensus or interpretation of patient data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "test set" (the calibration verification material) has known values. Its performance is evaluated by how accurately and linearly a chemistry system reads those known values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human readers interpreting medical images or data (e.g., radiologists interpreting AI-assisted mammograms). The VALIDATE Thyroid Calibration Verification Test Set is an in vitro diagnostic quality control material; it does not involve human readers interpreting patient cases in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable as this is not an algorithm or AI-based device. It is a physical chemical solution designed for calibration verification. Its "performance" is whether it exhibits the expected linear relationship across its different concentration levels when measured by a diagnostic instrument.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for this device would be the assigned target values/concentrations of each of the six levels of the calibration verification material, established through precise analytical methods and quality control during manufacturing. These are known, reference values.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a chemical reagent, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set Establishment: 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.