(55 days)
The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.
The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4.
The provided 510(k) summary for the "Preciset® Serum Proteins" calibrator focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria. This type of submission, common for calibrators and certain other IVDs, often relies on comparing the new device's formulation and intended use to an already cleared predicate.
Therefore, many of the requested details about acceptance criteria, clinical studies, and ground truth establishment are not applicable to this 510(k) submission.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as formal performance acceptance criteria (e.g., accuracy, precision targets). The core "acceptance criteria" for a calibrator in this context is its ability to accurately calibrate the specified immunoturbidimetric assays. This is implied by its composition and comparison to the predicate.
- Reported Device Performance: Instead of performance metrics, the document provides the representative constituent levels for each analyte (IgG, IgA, IgM, C3, C4) at different "levels" (1 through 5, or 4 for C3 and C4). These levels are what the calibrator is designed to provide for calibration, not a measure of its performance against a gold standard. The fact that the device was cleared implies that these levels were deemed appropriate for its intended use.
| Constituent | Level 1 (mg/mL) | Level 2 (mg/mL) | Level 3 (mg/mL) | Level 4 (mg/mL) | Level 5 (mg/mL) |
|---|---|---|---|---|---|
| IgG | 215 | 454 | 982 | 1859 | 3755 |
| IgA | 56 | 108 | 236 | 470 | 941 |
| IgM | 46 | 88 | 181 | 361 | 724 |
| C3 | 40 | 74 | 159 | 330 | NA |
| C4 | 6.5 | 12.8 | 27.5 | 56.0 | 110.6 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a clinical performance study using a test set of patient samples. The device is a calibrator, and its evaluation typically involves analytical studies (e.g., accuracy of manufactured concentrations, stability) rather than clinical studies on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. No test set requiring expert ground truth is described. The "ground truth" for the calibrator's constituent levels would be established through accredited reference materials and methods, as indicated by the "Reference Material: RPPHS" in the table.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method is described.
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
- N/A. This device is a chemical calibrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the calibrator's constituent levels is based on Reference Material (RPPHS). This indicates that the concentrations of the analytes (IgG, IgA, IgM, C3, C4) in the calibrator were determined and traced to a recognized reference standard (Reference Preparation for Human Serum Proteins). This is a common and appropriate method for establishing the "truth" for calibrator values.
8. The sample size for the training set
- N/A. This device does not use a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
- N/A. As above, no training set in the context of machine learning. The "ground truth" for the calibrator's composition is linked to Reference Material (RPPHS).
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.