(79 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 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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Covers the reportable range of instrumentation on the market for Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol analytes. | DOCUMENT® Thyroid CAL • VER consists of 8 levels which cover the reportable range of instrumentation on the market. |
| Targets cover the clinical reference range for the analytes present. | Targets cover the clinical reference range for the analytes present. |
| Shelf life at frozen temperatures (-10 to -20℃). | This product has a 12-month shelf life at frozen temperatures (-10 to -20℃). |
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.
§ 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.