(46 days)
IMMULITE® Vitamin B12 is a chemiluminescent assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative detection of vitamin B12 in human serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in clinical diagnosis and treatment of anemia.
IMMULITE® Vitamin B12 is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer. IMMULITE® Vitamin B12 is a chemiluminescent assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative detection of vitamin B12 in human serum or heparinized plasma.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state pre-defined acceptance criteria for the comparative studies. Instead, it presents the results of method comparison studies and implies that these results were deemed acceptable for regulatory clearance. The "acceptance criteria" are implicitly the statistical measures of agreement shown in the linear regression analysis (slope, intercept, correlation coefficient).
| Acceptance Criteria (Implied) | IMMULITE® vs. DPC SPNB Dualcount® | IMMULITE® vs. Bio-Rad Quantaphase II® |
|---|---|---|
| Linear Regression Slope | 0.99 | 0.91 |
| Linear Regression Intercept | 19.1 pg/mL | 19.5 pg/mL |
| Correlation Coefficient (r) | 0.982 | 0.965 |
| Mean Difference | (IMMULITE® mean = 385 pg/mL, SPNB mean = 371 pg/mL) - Not explicitly stated as a criterion, but means are provided. | (IMMULITE® mean = 396 pg/mL, Quantaphase II® mean = 412 pg/mL) - Not explicitly stated as a criterion, but means are provided. |
2. Sample Size Used for the Test Set and Data Provenance
-
IMMULITE® vs. DPC SPNB Dualcount®:
- Sample Size: 98 patient serum samples.
- Data Provenance: Not explicitly stated, but the samples are referred to as "patient serum samples." It is likely retrospective, collected from a human population, but the specific country of origin or whether it was prospective is not mentioned.
-
IMMULITE® vs. Bio-Rad Quantaphase II®:
- Sample Size: 101 patient serum samples.
- Data Provenance: Not explicitly stated. Similar to the above, these are "patient serum samples," likely retrospective from a human population, with no specific country of origin or prospective/retrospective status mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) assay measuring a quantitative biomarker (Vitamin B12). The "ground truth" for the test set is established by the comparative reference methods (DPC's SPNB Dualcount® and Bio-Rad's Quantaphase II® B12 Radioassay), not by human expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring a biomarker, there is no human adjudication process for the test results. The comparison is between the quantitative values reported by the new device and the reference methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic device that involves human readers or interpretation of complex medical images/data. It is an automated in vitro diagnostic immunoassay for a biomarker.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the IMMULITE® Vitamin B12 device against established reference methods. The device generates quantitative results independent of human interpretation for the measurement itself.
7. The Type of Ground Truth Used
The ground truth used for these studies is the quantitative measurement of Vitamin B12 by two previously cleared and commercially marketed reference immunoassay devices:
- DPC's Solid Phase No Boil Dualcount® (K860815)
- Bio-Rad's Quantaphase II® B12/Folate Radioassay (K933315)
This is a form of comparative reference standard ground truth.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. For IVD devices, development typically involves internal validation and optimization studies (which could be considered analogous to a training phase in AI development, but using different methodologies). The document describes the "Description of Device" and "Technology Comparison," which outlines how the device performs measurements, implying the assay was developed and optimized prior to the comparative tests presented. However, specific numbers for an internal development or training sample size are not provided.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the AI/ML sense is not explicitly discussed, the establishment of its "ground truth" is also not detailed. The ground truth for the performance evaluation (test set) was established by comparison to the two predicate devices. For assay development and optimization, the "ground truth" would typically involve highly characterized samples, gravimetric standards, or other established laboratory reference methods to ensure accurate measurement across the dynamic range.
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.