(18 days)
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G and Prealbumin.
Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing Immunoglobulin A, Immunoglobulin G and Prealbumin.
The provided text is a 510(k) summary for the "Dimension Vista™ Protein 1 Calibrator" and "Dimension Vista™ Protein 1 Control L, M and H." This document describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.
Crucially, this type of 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel diagnostic might. For calibrators and controls, the primary "performance" is often related to their stability, accuracy in assigned values, and ability to perform as expected within the context of the assay they are designed for.
Therefore, many of the requested details like "acceptance criteria," "sample size," "ground truth establishment by experts," "adjudication methods," "MRMC studies," or "standalone performance" (as they would apply to a diagnostic or AI device) are not typically found or relevant in a 510(k) summary for a calibrator and control.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, explicit quantitative "acceptance criteria" and "reported device performance" in the context of a clinical performance study (e.g., sensitivity, specificity) are not provided for this device type within the summary. For calibrators and controls, the "performance" relates to their consistency, stability, and the accuracy of their assigned values relative to an established reference method. The summary simply states that the devices are "substantially equivalent" to the predicate, implying they perform similarly and meet the requirements for their intended use.
| Criterion Type | Acceptance Criterion (Not explicitly stated in the 510(k) summary for this device type) | Reported Device Performance (Implied by substantial equivalence) |
|---|---|---|
| Intended Use | Device functions as a calibrator for IGA, IGG, and Prealbumin methods on the Dimension Vista™ System. | The device is "substantially equivalent in intended use" to the predicate, meaning it performs this function. |
| Intralaboratory Quality Control | Device functions as a quality control for assessment of precision and analytical bias for IGA, IGG, and Prealbumin on the Dimension Vista™ System. | The device is "substantially equivalent in intended use" to the predicate, meaning it performs this function. |
| Composition | Contains Immunoglobulin A, Immunoglobulin G, and Prealbumin (human serum-based). | Device described as "multi-analyte, liquid human serum based product containing Immunoqlobulin A. Immunoglobulin G and Prealbumin." |
| Safety | No new safety concerns compared to predicate. | Implied by FDA's substantial equivalence determination. |
| Effectiveness | Performs its intended function for calibration and quality control. | Implied by FDA's substantial equivalence determination. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. For calibrators and controls, "test sets" in the context of clinical performance are not typically discussed in this manner for a 510(k) submission; rather, validation studies would focus on analytical performance (e.g., linearity, precision, stability).
- Data Provenance: Not specified. The summary does not detail the origin of any data (e.g., country of origin, retrospective/prospective). Studies for these types of devices usually involve analytical testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The concept of "experts establishing ground truth" for test sets is generally relevant for diagnostic devices that interpret complex clinical data (like medical images or pathology slides). For a calibrator or control, the "ground truth" would be the assigned analyte values, established through a rigorous analytical process, often traceable to reference materials, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve disagreements among multiple human readers interpreting data. This is not relevant to the validation of a calibrator or control.
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
- No. This is a calibrator/control device, not an AI-based diagnostic tool. Therefore, MRMC comparative effectiveness studies comparing human readers with and without AI are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical calibrator/control, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For calibrators and controls, the "ground truth" refers to the assigned values for the analytes (Immunoglobulin A, Immunoglobulin G, and Prealbumin) within the calibrator and control materials. These values are typically established through highly accurate and precise analytical methods, often traceable to international reference materials or established reference measurement procedures, rather than expert consensus, pathology, or outcomes data. The summary does not detail the specific method for assigning these values, but this is the standard practice for such in-vitro diagnostic products.
8. The sample size for the training set
- Not Applicable. This is a calibrator/control, not a machine learning model. Therefore, there is no "training set" in the context of AI development.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
§ 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.