(44 days)
The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.
The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product packaged as ten vials to a carton, with two vials at each of the 5 levels (A, B, C, D and E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives.
Here's an analysis of the provided text regarding the Dimension Vista® LOCI 9 Calibrator (KC647), structured to address your specific questions.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format you've requested for typical medical device studies (e.g., AI algorithms, imaging devices). Therefore, some of your requested information (like expert qualifications, MRMC studies, standalone performance with specific metrics, and detailed ground truth generation for training data) is not applicable or not present in this type of regulatory document for a calibrator.
Description of the Acceptance Criteria and Study for the Dimension Vista® LOCI 9 Calibrator (KC647)
This document describes the 510(k) submission for the Dimension Vista® LOCI 9 Calibrator, a product used for calibrating the progesterone (PROG) method on the Dimension Vista® System. The primary goal of the submission is to demonstrate substantial equivalence to an existing predicate device, the Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (KC676A).
The acceptance criteria for a calibrator like this revolve around its ability to accurately and reliably provide known concentrations for proper instrument calibration. The study performed focuses on verifying the traceability, value assignment, and stability of the calibrator, aligning with established procedures for such in-vitro diagnostic products.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a calibrator and not a diagnostic algorithm, the "acceptance criteria" and "reported device performance" are slightly different from what you might expect for an image-based AI device. The submission primarily focuses on demonstrating that the new calibrator meets the same standards of quality and function as the predicate device and that its critical characteristics (traceability, value assignment, stability) are appropriately managed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Traceability | Validated following Siemens Healthcare Diagnostics, Inc. procedures. |
| Value Assignment | Validated following Siemens Healthcare Diagnostics, Inc. procedures. |
| Stability | Validated following Siemens Healthcare Diagnostics, Inc. procedures. |
| Substantial Equivalence to Predicate | Determined to be substantially equivalent in design and intended use to KC676A by the FDA. |
| Intended Use | Successfully established as "calibration of the progesterone (PROG) method on the Dimension Vista® System." |
| Physical Characteristics (e.g., Matrix, Form, Levels) | Verified to be aligned with or acceptable differences from the predicate device (e.g., bovine serum albumin based, liquid/frozen, 5 levels). |
| Volume per Vial | 1.5 mL per vial (different from predicate's 1.0 mL, but deemed acceptable). |
| Analyte | Progesterone (different from predicate's Synthetic PBNP, but appropriate for its intended use). |
| Typical Concentration Levels | Five Levels, (0, 1.0, 8.0, 20.0 and 44.0 ng/mL) (different from predicate's levels, but appropriate for its intended use). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify a "test set" in the context of individual patient data or diagnostic cases. For a calibrator, the "test set" would typically refer to internal validation runs and stability studies of the calibrator material itself.
- Sample Size for Test Set: Specific numbers are not provided in this summary. The validation would involve multiple lots and vials of the calibrator under various conditions (e.g., temperature, duration).
- Data Provenance: The studies were conducted internally by Siemens Healthcare Diagnostics, Inc. The data would be prospective, generated during the development and validation of the calibrator. There is no mention of country of origin for the data, but presumably, it would originate from the company's testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to a calibrator. The "ground truth" for a calibrator is established through highly controlled analytical chemistry methods, often tracing back to reference standards. It's about chemical concentration accuracy, not expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic imaging or clinical assessment. For a calibrator, the "truth" is determined by the manufacturing and analytical processes, which are highly controlled and validated.
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. This is not an AI diagnostic device. No human-in-the-loop performance or MRMC study was conducted or relevant for a calibrator.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or an AI device. The "standalone performance" refers to the intrinsic accuracy and stability of the calibrator itself, which is what the traceability, value assignment, and stability validations address.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator like the Dimension Vista® LOCI 9 Calibrator is established through:
- Reference Standards: The concentration values are traceable to higher-order reference materials and/or methods.
- Internal Validation Methods: Siemens Healthcare Diagnostics' own validated procedures for value assignment and characterization of the calibrator's chemical composition and concentration.
- Analytical Chemistry: Highly precise and accurate analytical techniques are used to determine the concentration of progesterone (and other components) in each level of the calibrator.
8. The Sample Size for the Training Set
Not applicable. Calibrators are not "trained" in the machine learning sense. Their properties are determined by their chemical formulation and manufacturing process, and then validated.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for a calibrator in the AI context. The manufacturing and QC processes define the "truth" of the calibrator's assigned values.
§ 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.