(47 days)
The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.
ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase and aspartate aminotransferase from porcine heart.
The provided text is a 510(k) summary for the Siemens Dimension Vista ENZ 2 CAL (KC321) and the FDA's clearance letter. This document focuses on establishing substantial equivalence to a predicate device (Dimension Vista ENZ 2 CAL, KC320) rather than presenting a detailed study proving the new device's performance against specific acceptance criteria for analytical validation.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (as typically found in performance studies) is not present in the provided text.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., specific accuracy, precision, or linearity targets) for the ENZ 2 CAL (KC321) itself. Instead, it focuses on establishing substantial equivalence based on comparative features to a predicate device.
The "performance" reported is inferred from the statement of "substantial equivalence" and the comparative features, which suggest similar functionality and composition to the legally marketed predicate.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | To be substantially equivalent to the predicate's intended use. | Calibrates ALT, ALTI, and AST methods on Dimension Vista®. (Extended from predicate: ALT and AST only) |
| Form | Liquid, bovine serum albumin based. | Liquid, bovine serum albumin based. (Identical to predicate) |
| Constituents | Aspartate aminotransferase and alanine aminotransferase from porcine heart. | Aspartate aminotransferase and alanine aminotransferase from porcine heart. (Identical to predicate) |
| Traceability of ALT/AST | Traceable to Master pool, Dimension® clinical chemistry system values. | Traceable to Master pool, Dimension® clinical chemistry system values. (Identical to predicate) |
| Traceability of ALTI | Traceable to IFCC ALT @ 37°C primary reference method. | Traceable to IFCC ALT @ 37°C primary reference method. |
| Packaging | Glass vials, 1.5 mL/vial, 3 vials of each level/carton. | Glass vials, 1.5 mL/vial, 3 vials of each level/carton. (Identical to predicate) |
| Levels | 2 levels. | 2 levels. (Identical to predicate) |
| Stability and Storage | Stored at 2 to 8°C. | Stored at 2 to 8°C. (Identical to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not provide details on a specific "test set" sample size in the context of analytical performance studies.
- The data provenance, country of origin, and whether it was retrospective or prospective are not mentioned. The submission is from Siemens Healthcare Diagnostics, Inc. in Newark, DE, USA, suggesting the work was performed domestically, but no explicit statement is made.
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 information is not applicable or available in the provided 510(k) summary. "Ground truth" in the context of calibrator performance is typically established through reference methods and internal validation processes by the manufacturer, rather than by an external panel of experts for a test set as might be done for diagnostic image analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or available. Adjudication methods are typically associated with expert review of cases, which is not described for this device's validation.
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 information is not applicable or available. The device is a calibrator for laboratory instruments, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a calibrator, which inherently functions in a standalone manner (it calibrates an instrument). The 510(k) focuses on its equivalence in composition and intended use. There is no explicit "algorithm alone" performance study described beyond the general assurance of substantial equivalence in its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the traceability of constituents, the document states:
- "ALT and AST traceable to Master pool, Dimension® clinical chemistry system values."
- "ALTI is traceable to the IFCC ALT@ 37°C primary reference method."
This indicates that the ground truth for the calibrator's assigned values is based on reference materials and established reference methods (like IFCC standards) and the manufacturer's internal "Master pool" system values, rather than human expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- The document does not explicitly mention a "training set" sample size. As a chemical calibrator, its development involves formulations and reference measurements, not typically machine learning training sets.
9. How the ground truth for the training set was established:
- As a "training set" is not mentioned, the method for establishing its ground truth is not applicable or available. However, as inferred in point 7, the underlying reference values for the calibrator's constituents are based on established reference methods and the manufacturer's internal standards.
§ 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.