(51 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure total calcium from heparinized whole blood, heparin plasma or serum specimens to aid in diagnosis and treatment of patients with parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. It is intended for professional laboratory use: not for point of care or physician office laboratory use.
CARESIDE™ Calcium cartridges are used with the CARESIDE Analyzer™ to measure calcium concentration in heparinized whole blood, heparin plasma or serum specimens. The CARESIDE™ Calcium cartridge, a single use disposable in vitro diagnostic test carridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of calcium concentration. The film cartridge (patent pending) contains all reagents necessary to measure calcium concentration.
Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ Calcium device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define strict, numerical "acceptance criteria" for precision or accuracy that the device must meet in a pre-defined way. Instead, it presents performance characteristics and concludes that the device is "as safe, effective, and performs as well as or better than the legally marketed predicate device." The comparison is primarily done against the predicate device's characteristics and general expectations for such a device.
However, we can infer some "acceptance" in terms of reported performance:
| Performance Metric | Acceptance Criteria (Implicitly based on comparison or general expectation) | Reported Device Performance (CARESIDE™ Calcium) |
|---|---|---|
| Detection Limit | Comparable to predicate (3 mg/dL) or acceptable for clinical use | 4.2 mg/dL |
| Reportable Range | Comparable to predicate (3 to 14 mg/dL) or acceptable for clinical use | 4.2 to 14 mg/dL |
| Accuracy (Mean Recovery) | Acceptable for clinical use (not explicitly stated for predicate) | 98% |
| Precision (Total CV) | Comparable to predicate (1.6% at 11.9 mg/dL) or acceptable for clinical use | 7.8% at 6.5 mg/dL |
| Method Comparison | Strong correlation (r) to a reference method, slope and intercept close to 1 and 0, respectively. | CARESIDE™ = 0.90 (Reference Method) + 1.09 mg/dL, r = 0.95 |
| Linearity | Slope and correlation coefficient within acceptable limits | Linearity yielded slope and correlation coefficient within acceptable limits. |
| Interference | No significant interference from common substances | No significant interference observed at tested [ |
| Ascorbic Acid, 10 mg/dL | ||
| Bilirubin, 10 mg/dL | ||
| Hemoglobin, 250 mg/dL | ||
| Magnesium 2.5 mmol/L | ||
| Triglycerides 600 mg/dL] |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for any of the performance metrics (accuracy, precision, method comparison, linearity, interference).
The data provenance is also not specified. It's unclear if the data is from a specific country, or if it is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For an in vitro diagnostic device like this, ground truth is typically established by comparing the device's measurements to a recognized "gold standard" laboratory method, rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
This is not applicable and not provided for this type of in vitro diagnostic device study. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation (e.g., radiology reads) where there can be disagreement among experts. For quantitative measurements, the comparison is made directly to a reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant to imaging or diagnostic devices where human readers interpret results, and the AI's impact on their performance is being assessed. The CARESIDE™ Calcium is a diagnostic test kit for quantitative measurement and does not involve human interpretation in the same way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was done. The performance metrics (detection limit, reportable range, accuracy, precision, method comparison, linearity, interference) provided for the CARESIDE™ Calcium directly represent the algorithm’s (device's) performance without human intervention in the measurement process. The CARESIDE Analyzer™ automatically performs the analysis.
7. Type of Ground Truth Used
The ground truth used for performance evaluation appears to be a "Reference Method."
- For the method comparison, the document states: "CARESIDE™ = 0.90 (Reference Method) + 1.09 mg/dL, r = 0.95."
- The "Reference Method for the predicate device is explicitly stated as "Atomic Absorption Spectrophotometry," and for the CARESIDE™ Calcium, it's "2-cresolphthalein complexone colorimetric." While the document doesn't explicitly state that the CARESIDE™ Calcium was compared against Atomic Absorption Spectrophotometry (which is generally considered a gold standard for calcium), it refers to a "Reference Method" in its method comparison, which implies a highly accurate and accepted laboratory method.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. For an in vitro diagnostic device like this, the calibration information is bar-coded on each cartridge and may change with each lot, implying a manufacturing and calibration process rather than a machine learning "training set" in the common sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided or explicitly indicated as being part of an AI model in the modern sense, the method for establishing its ground truth is not applicable based on the provided text. The device uses "lot-specific standard curve to calculate calcium concentration," which implies a traditional calibration process rather than machine learning model training based on a labeled training set.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.