(21 days)
Control for Elecsys® CK-MB and Troponin-T assays.
Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays.
This document is a 510(k) summary for a medical device called Elecsys® PreciControl Cardiac 1 and 2. It describes the device's characteristics and its comparison to a predicate device, Elecsys® CK-MB and Elecsys® Troponin-T CalSets.
The information provided does not include acceptance criteria for a performance study. It focuses on demonstrating substantial equivalence to a predicate device by comparing features such as matrix, analytes, standardization, storage conditions, application test system, reconstitution methods, manufacturer, and open vial stability. The document explicitly states that the intended use has changed to a quality control material rather than a diagnostic device, which implies that a clinical performance study demonstrating diagnostic accuracy against acceptance criteria, as typically understood for AI/ML devices, is not relevant here.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, sample sizes for test sets, ground truth establishment for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to the content of this 510(k) summary.
Here's an attempt to answer the quantifiable questions based only on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of a performance study proving the device meets those criteria. Instead, it compares features of the new device (Elecsys® PreciControl Cardiac) to a predicate device (Elecsys® CK-MB and Troponin-T CalSets) to demonstrate substantial equivalence, particularly for its new intended use as a quality control material.
| Feature Comparison (PreciControl Cardiac vs. Predicate CalSets) | Predicate Device (CalSets) | PreciControl Cardiac (New Device) |
|---|---|---|
| Similarities Identified | ||
| Matrix | Human serum matrix | Human serum matrix |
| Analytes | CK-MB and Troponin-T | CK-MB and Troponin-T |
| Standardization | CK-MB: commercially available CK-MB test; Troponin-T: highly purified bovine cardiac troponin-T | CK-MB: commercially available CK-MB test; Troponin-T: highly purified bovine cardiac troponin-T |
| Storage conditions | 2 - 8°C | 2 - 8°C |
| Application test system | Elecsys® 2010 | Elecsys® 2010 |
| Reconstitution | 2 mL distilled water | 2 mL distilled water |
| Manufacturer | Boehringer Mannheim Germany | Boehringer Mannheim Germany |
| Differences Identified | ||
| Target concentration (CK-MB) | 0.15 and 500 ng/mL (approx.) | 6.0 and 60 ng/mL (approx.) |
| Target concentration (Troponin-T) | 0.021 and 25 ng/mL (approx.) | 0.2 and 6.0 ng/mL (approx.) |
| Intended Use | Calibration of the Elecsys CK-MB and Troponin-T Assays | Monitoring assays for CK-MB and Troponin-T (Quality control material) |
| Open vial stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |
| Value Assignment (mentioned as Performance Characteristic) | CK-MB: 0.15 and 500 ng/mL (approx.) Troponin-T: 0.021 and 25 ng/mL (approx.) | CK-MB: 6.0 and 60 ng/mL (approx.) Troponin-T: 0.2 and 6.0 ng/mL (approx.) |
| Open Vial Stability (mentioned as Performance Characteristic) | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) summary for a control material, not a diagnostic device requiring a clinical test set to assess performance metrics like sensitivity or specificity. No specific "test set" in the context of clinical performance is mentioned.
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)
Not applicable. Ground truth for a clinical test set is not relevant for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant for this type of device and submission.
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/ML device, nor a diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The device itself is a control material for other assays.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this control material would be its manufactured concentration and stability characteristics, validated through chemical/analytical methods, not clinical ground truth. The document does not detail these validation methods for the control material itself, but rather focuses on comparing its characteristics to a predicate.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and thus does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.