(33 days)
The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.
The Elecsys® Parathyroid Hormone CalCheck is a lyophilized product manufactured using a human serum base, synthetic PTH, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
This document is a 510(k) summary for the Elecsys® Parathyroid Hormone CalCheck, a calibration verification material. It does not describe an AI/ML device or a study involving human readers or complex algorithms. The information provided is for a diagnostic product used to verify the calibration of an immunoassay. Therefore, it does not fit the criteria requested in the prompt regarding AI performance, human reader improvement, or complex ground truth establishment.
Here's an analysis based on the actual content of the document:
The document describes a diagnostic product (calibration verification material) and its regulatory clearance process, not a device that would require AI/ML performance metrics as outlined in the prompt. Therefore, many of the requested categories are not applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Verification: Used to verify calibration of the Elecsys® Parathyroid Hormone assay. | Performance Characteristics: "The Elecsys® Parathyroid Hormone CalCheck was evaluated for value assignment and stability." (Specific quantitative data is not provided in this summary, but the device received 510(k) clearance, implying successful validation against its intended use.) |
| Levels: Three levels (low, mid, high) with defined PTH concentrations, positioned within the assay's measuring range (near lower detection limit, middle/clinically critical point, and near upper limit). | The product is designed with these three levels according to the description. |
| Material Composition: Lyophilized product using human serum base, synthetic PTH, and preservative. Analyte appropriately spiked. | The device description states this composition. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Given the nature of a calibration verification material, the "test set" would refer to internal validation data for value assignment and stability, which is not detailed here.
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 is not applicable to this type of device. The "ground truth" for a calibration verification material is its assigned value and stability, determined through laboratory methods, not expert consensus interpreting complex data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to this type of device. Adjudication methods are typically for subjective assessments or complex diagnostic interpretations, not for instrument calibration materials.
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
This is not applicable to this type of device. This document describes a calibration material, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this type of device. The device is a physical reagent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device (calibration material) would be the analytically determined and assigned concentration values for parathyroid hormone (PTH) within the material, established through rigorous laboratory methods, likely using a reference method or highly characterized assay. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable to this type of device. There is no "training set" as this is not an AI/ML or statistical modeling device.
9. How the ground truth for the training set was established
This is not applicable to this type of device. As there is no training set, there is no ground truth to establish for it in this context.
Summary of what the document does provide:
- Device Name: Elecsys® Parathyroid Hormone CalCheck
- Intended Use: To verify the calibration of the Elecsys® Parathyroid Hormone assay.
- Device Description: Lyophilized product with human serum base, synthetic PTH, and preservative, spiked to correct CalCheck concentration levels.
- Performance Characteristics Evaluated: Value assignment and stability.
- Predicate Device: Elecsys® CalCheck™ TSH.
- Regulatory Clearance: 510(k) cleared (K993642) as substantially equivalent to the predicate.
§ 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.