(82 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure magnesium from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with hypomagnesemia or hypermagnesmia. It is intended professional laboratory use: not for point of care or physician office laboratory use.
CARESIDE™ Mg cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure magnesium in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Mg cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of plasma or serum to a dry film to initiate the measurement of magnesium concentration. The film cartridge (patent pending) contains all reagents necessary to measure magnesium concentration.
Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ Mg, based on the provided text:
CARESIDE™ Mg Acceptance Criteria and Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | CARESIDE™ Mg Performance | Predicate Device (Vitros Mg DT Slides) Performance |
|---|---|---|---|
| Detection Limit | 0.2 mg/dL | 0.2 mg/dL | 0.2 mg/dL |
| Reportable Range | 0.2 to 7.0 mg/dL | 0.2 to 7.0 mg/dL | 0.2 to 7.0 mg/dL |
| Accuracy | Not explicitly stated, but clinical equivalency to predicate is the goal. | Mean recovery 97% | Not provided |
| Precision | Not explicitly stated, but comparable to predicate is the goal. | Total CV, 1.2 mg/dL, 4.3% | Total CV, 1.1 mg/dL, 3.6% |
| Method Comparison | High correlation (r) with predicate and reference methods. | CARESIDE™ Mg = 0.98 (Hitachi 902/BMD) – 0.086 mg/dL, r = 0.99 | |
| CARESIDE™ Mg = 0.82 (Vitros DT 60 II) + 0.31 mg/dL, r = 0.99 | Not applicable (it is the predicate) | ||
| Linearity | Slope and correlation co-efficient within acceptable limits. | Linearity yielded slope and correlation coefficient within acceptable limits. | Not provided |
| Interference | No significant interference at specified concentrations. | No significant interference observed at tested concentrations of: | |
| Ascorbic Acid, 10 mg/dL | |||
| Bilirubin, 60 mg/dL | |||
| Calcium, 20 mg/dL | |||
| Inorg. Phosphorus, 9 mg/dL | |||
| Total Protein, 9 g/dL | |||
| Triglycerides, 2000 mg/dL | Calcium 20 mg/dL | ||
| Inorg. Phosphorus 9 mg/dL |
Notes on Acceptance Criteria:
- Implicit Nature: The acceptance criteria are largely implied by the claim of substantial equivalence to the predicate device (Vitros Mg DT Slides). The studies are designed to demonstrate that the CARESIDE™ Mg performs "as well as or better than" the predicate.
- Specific Values: For detection limit and reportable range, the acceptance criteria are a direct match to the predicate. For precision, the CARESIDE™ Mg is slightly higher (4.3% vs 3.6%), but is presented as acceptable. For method comparison, high correlation coefficients (r=0.99) demonstrate agreement with established methods.
- Interference Test: The CARESIDE™ Mg tested against a broader range of interferents than the predicate, demonstrating non-inferiority or superiority in this aspect.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of samples for each test (accuracy, precision, method comparison, linearity, interference).
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, not necessarily in a 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This device is an in vitro diagnostic (IVD) for quantitative measurement of magnesium. The ground truth for such devices is established through reference methods, calibrated instruments, and known sample concentrations, not human expert consensus like in image interpretation tasks.
4. Adjudication method for the test set:
- Not Applicable: Given that the ground truth is established by objective laboratory methods, there is no need for human adjudication for the test set measurements.
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 an in vitro diagnostic device, not an AI-powered diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this is a standalone device/algorithm. The CARESIDE™ Mg cartridge, in conjunction with the CARESIDE Analyzer™, is designed to quantitatively measure magnesium without human intervention in the result generation beyond operating the analyzer. The comparative performance characteristics (Accuracy, Precision, Method Comparison, Linearity, Interference) are all measures of the algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the CARESIDE™ Mg performance evaluation is established through:
- Reference methods: Primarily indicated by the method comparison against the Hitachi 902/BMD and Vitros DT 60 II systems, which serve as established, accepted methods for magnesium measurement.
- Known concentrations: For tests like linearity and interference, samples with precisely known magnesium levels or known concentrations of interfering substances would be used.
8. The sample size for the training set:
- Not Applicable: This document describes an in vitro diagnostic device that uses enzymatic reactions and reflectometry, not a machine learning model that requires a "training set" in the conventional sense. The "lot-specific standard curve" mentioned in the device description serves a similar purpose to calibration in traditional analytical chemistry, which is distinct from large-scale data-driven machine learning training.
9. How the ground truth for the training set was established:
- Not Applicable: As there is no "training set" in the machine learning sense, this question is not relevant. The device relies on chemical principles and a calibrated measurement system. The "standard curve" for each lot of cartridges is established using reference materials with known magnesium concentrations (though the details of this process are not provided in this summary).
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.