(19 days)
VITROS Chemistry Products Mg Slides For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine.
VITROS Calibrator Kit 1 For in vitro diagnostic use only. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/ UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.
The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide. The system is comprised of two main elements: 1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products Mg Slides, VITROS Chemistry Products Calibrator Kit 1, which are combined by the VITROS Chemistry System to perform the VITROS Mg test. 2. The VITROS Chemistry System - instrumentation, which provides automated use of the chemistry slides.
The provided text describes a 510(k) submission for a modified medical device, the VITROS Chemistry Products Mg Slides and VITROS Chemistry Products Calibrator Kit 1. The submission aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy, precision targets). Instead, it relies on demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing the characteristics and overall performance of the modified device to the predicate device.
| Device Characteristic | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Device Model / Name | Equivalence to VITROS Chemistry Products Mg Slide (current) and VITROS Chemistry Products Calibrator Kit 1 | VITROS Chemistry Products Mg Slides (modified) and VITROS Chemistry Products Calibrator Kit 1. |
| Intended Use | No Change from Predicate Device | No Change. For in vitro diagnostic use only. VITROS Mg Slides quantitatively measure Magnesium (MG) concentration use in serum, plasma, and urine. VITROS Calibrator Kit 1 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA. Ca. CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC. |
| Basic Principle | No Change from Predicate Device | No Change. Dry, multilayered slide utilizing reflectance spectrophotometry. |
| Sample Type | No Change from Predicate Device | No Change. Serum, plasma, urine. |
| Reportable Range (Serum, Plasma) | No Change from Predicate Device | No Change. 0.20 - 10.00 mg/dL. |
| Reportable Range (Urine) | No Change from Predicate Device | No Change. 1.20 - 60.00 mg/dL (after multiplying by a 6X dilution factor). |
| Instrumentation | No Change from Predicate Device | No Change. VITROS 250, 500, 750 and 950 Series Analyzers. |
| Incubation time and temperature | No Change from Predicate Device | No Change. Approximately 5 minutes at 37°C. |
| Sample volume | Demonstrated equivalence despite change from predicate | Modified Device: 5 µL. Predicate Device: 10 µL. While this is a change, the study would have shown that despite this change, the performance (e.g., accuracy, precision) remains equivalent to the predicate. |
| Quantity of Reactive Ingredients per slide (test) | Demonstrated equivalence despite change from predicate | Modified Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 272.1 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 46.19 µg. Predicate Device: 1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 542.3 µg and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 92.06 µg. Similar to sample volume, this changes, but overall performance is still shown to be equivalent. |
| Concentrations of Slide Reactive Ingredients per cm-squared | No Change from Predicate Device | No Change. This is a crucial point, suggesting that while the total quantity of reactive ingredients changed due to the reduced sample volume, the concentration per unit area remained the same, implying a consistent reaction environment despite the reduction in overall analyte. |
| Overall Performance | Substantially equivalent to cleared predicate device | "The performance of the VITROS Mg Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical value. The document mentions "patient and quality control samples."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as using "patient and quality control samples with measured Magnesium values spanning the assay range," implying real-world or simulated clinical samples. It is a retrospective or prospective study as it involves testing the modified device against the predicate using samples. The nature of the study (e.g., in-house validation or multi-site trial) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore, not provided. For this type of in-vitro diagnostic device (a chemistry assay), the "ground truth" for Magnesium concentration is established by a reference method or a highly accurate, previously validated method, rather than expert consensus on images or clinical assessments. The reference values for calibrators/controls would typically be determined by highly accurate analytical chemistry techniques.
4. Adjudication Method for the Test Set
This information is not applicable and therefore, not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human readers and subjective interpretations (e.g., radiology studies). For a quantitative diagnostic assay, the "adjudication" is inherent in the analytical measurement process and statistical comparison of results with the predicate device or reference method.
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 and therefore, not provided. An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is a key component. This device is a quantitative chemistry assay where the output is a numerical concentration, not an image requiring human interpretation or AI assistance in that interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is partially applicable but not explicitly detailed. The device itself is an "algorithm only" in the sense that it is an automated assay system. The study described compares the performance of the modified assay (the "device") to a predicate assay (the "existing device"). There isn't a "human-in-the-loop" component in the direct measurement of Mg concentration by these devices. The study effectively assesses the standalone performance of the modified device against the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the test set was established by the measured Magnesium values spanning the assay range in both "patient and quality control samples." For quality control samples, the "ground truth" would be pre-assigned target values based on established reference methods. For patient samples, the "ground truth" would likely be values obtained from a comparative method or the predicate device itself, assuming it's considered a highly accurate reference in this context for demonstrating equivalence. It's essentially reference analytics or comparative method data.
8. The Sample Size for the Training Set
This information is not applicable and therefore, not provided. This device is a chemistry assay, not a machine learning or AI model that requires a "training set" in the traditional sense. The development of the assay (e.g., optimizing reagent concentrations) would involve experimental data, but this is distinct from an AI model's training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for a chemistry assay in the context of AI. The "ground truth" for the experimental data used during the development and optimization of the assay would have been established through standard analytical chemistry techniques and reference methods to determine accurate concentrations for various samples.
§ 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.