(20 days)
The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen.
The provided document describes the ATAC Calibrator Kit and its performance in demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria for the regression statistics (e.g., specific ranges for slope and y-intercept). However, the implicit acceptance criterion is that the regression statistics demonstrate substantial equivalence to the comparative method, indicating accurate calibration.
| Analyte | Comparative Method | Reported Device Performance (Regression Statistics) |
|---|---|---|
| Albumin | Hitachi 704 / Roche Albumin Reagent, product 1970569 | |
| Roche c.f.a.s Calibrator, product 759350 | y = 0.25 + 0.908x, n = 59 | |
| Magnesium | Beckman Synchron CX Magnesium Reagent, product 445360 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = 0.03 + 0.967x, n = 55 | |
| Phosphorus | Beckman Synchron CX Phosphorus Reagent, product 465145 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = - 0.10 + 0.992x, n = 58 | |
| Total Bilirubin | Beckman Synchron CX Total Bilirubin Reagent, product 442745 | |
| Beckman Synchron Bilirubin Calibrator, product 465915 | y = - 0.06 + 1.031x, n = 54 | |
| Total Protein | Beckman Synchron CX Total Protein Reagent, product 442740 | |
| Beckman Synchron Multi Calibrator, product 442600 | y = 0.00 + 1.000x, n = 52 |
Additionally, for reconstituted stability:
- Acceptance Criteria (Implicit): Statistically insignificant changes or changes less than round-off error/minimal clinical significance.
- Reported Device Performance:
- Changes in albumin, magnesium, bilirubin, and total protein over 3 days at 2°C to 8°C were statistically insignificant or less than the round-off error of the assay.
- Observed change for phosphorus over three days was less than 0.2 mg/dL.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Albumin: 59 sera
- Magnesium: 55 sera
- Phosphorus: 58 sera
- Total Bilirubin: 54 sera
- Total Protein: 52 sera
- Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve assaying "at least 50 sera" for comparison with existing methods. It does not indicate the data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of study does not involve "experts" establishing ground truth in the way a medical imaging study might. Instead, the "ground truth" for the calibrator's performance is established by comparing its calibration results to those obtained using established, commercially available comparative methods with their respective calibrators and reagents. The document does not specify the qualifications of the individuals who performed these laboratory assays, but it would typically be trained laboratory personnel.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative laboratory calibration study comparing results to established methods, not a subjective interpretation task requiring adjudication by multiple readers.
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 a calibration study for an in vitro diagnostic device, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study essentially demonstrates the "standalone" performance of the ATAC Calibrator Kit in the context of the ATAC 8000 Random Access Chemistry System. It assesses the calibrator's accuracy by comparing results from the ATAC system (calibrated with the ATAC Calibrator) against established laboratory methods.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is the results obtained from established, commercially available comparative methods (e.g., Hitachi 704, Beckman Synchron CX reagents) which themselves are calibrated with their respective, validated calibrators. This serves as the reference standard for evaluating the accuracy of the ATAC Calibrator Kit.
8. The Sample Size for the Training Set
Not applicable. This is a calibration and method comparison study, not a machine learning study that typically involves distinct training and test sets in the same way. The calibrator itself (ATAC Calibrator Kit) is used to establish reference points, and its accuracy is then validated against other calibrated methods. There isn't an "algorithm" being trained in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. The "ground truth" for the overall system's performance is established by the well-defined, validated methodologies of the comparative reference instruments and reagents.
§ 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.