(84 days)
Each VALIDATE® THY Calibration Verification / Linearity Test Set consists of two sets of bottles, a THY Set and a FT4 Set. The THY set consists of five (5) levels of the following four analytes: triiodothyronine (T3), thyroxine (T4), human thyroid stimulating hormone (TSH), and cortisol, and the FT4 set consists of five (5) levels containing Free T4.
VALIDATE® THY Calibration / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range in automated, semi automated, and manual chemistry systems.
Quality control material (assayed and un-assayed)
VALIDATE®THY Calibration Verification 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 Levels 1 through 5. One bottle of Base Matrix is also included. There exists a linear relationship among Levels 1 through 5.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VALIDATE® THY Calibration Verification Test Set:
The provided document is a 510(k) Summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance criteria as a new, de novo device might. Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of demonstrating substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for the new device as separate from its predicate. Instead, it states that the device is "substantially equivalent in form and function to the predicate device for its stated intended use." This implies that the 'acceptance criteria' for the new device are inherently met if its performance is comparable to the predicate device, which is already legally marketed.
Therefore, we can infer the "acceptance criteria" are the established performance characteristics (e.g., linearity, calibration verification, reportable range verification) demonstrated by the predicate device, and the "reported device performance" is that the new device functions equivalently for these purposes.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Demonstrated linearity for T3, T4, TSH, Cortisol, and Free T4. | Substantially equivalent in form and function to the predicate device for its intended use, which includes the quantitative determination of linearity. |
| Verification of calibration for T3, T4, TSH, Cortisol, and Free T4. | Substantially equivalent in form and function to the predicate device for its intended use, which includes calibration verification. |
| Verification of reportable range for T3, T4, TSH, Cortisol, and Free T4. | Substantially equivalent in form and function to the predicate device for its intended use, which includes verification of reportable range. |
| Suitable for use in automated, semi-automated, and manual chemistry systems. | Explicitly stated intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The 510(k) summary does not provide details about a specific test set, its sample size, or data provenance used to demonstrate substantial equivalence. The summary focuses on the intended use and device description, and then makes a general statement about equivalence. In such submissions, detailed performance data is often summarized or referenced rather than fully detailed in the publicly available summary.
3. 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)
This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable or stated in this 510(k) summary. This device is a quality control material used for analytical performance verification (linearity, calibration, reportable range). The 'ground truth' in this context would likely be established through robust analytical methods, highly precise reference materials, and established metrological traceability, rather than expert review of clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or stated. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple expert readers. This is a quality control material for laboratory instruments, where analytical rigor replaces such human-centric adjudication.
5. 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
Not applicable or stated. MRMC studies are used to evaluate diagnostic imaging devices or AI-assisted diagnostic tools where human readers are involved in making clinical decisions. This device is a calibration verification material for in vitro diagnostic assays, not a diagnostic imaging or AI-assisted reading device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable or stated. This is not an algorithm or AI-based device. It is a physical chemical quality control material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of "ground truth" used. However, for a calibration verification and linearity material, the 'ground truth' for the analytes (T3, T4, TSH, Cortisol, Free T4) would typically be established through:
- Reference measurement procedures: Highly accurate and precise analytical methods, often traceable to international reference standards.
- Certified reference materials: Materials with assigned values derived from definitive methods.
- Gravimetric/Volumetric preparation: Precise preparation of the different levels (1-5) to create a known linear relationship across concentrations.
8. The sample size for the training set
Not applicable or stated. As this is a quality control material and not an AI/ML or a complex diagnostic algorithm, there isn't a "training set" in the traditional sense. The device is manufactured to specific specifications and then analytically tested for its characteristics.
9. How the ground truth for the training set was established
Not applicable or stated. See point 8. The 'ground truth' for the material itself (i.e., the actual concentration of analytes at each level and their linearity) would be established through the manufacturing process and subsequent analytical characterization using highly precise and accurate laboratory methods.
§ 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.