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510(k) Data Aggregation
(64 days)
The ADVIA™ 120 Hematology System Complete Blood Count (CBC) method is intended to quantitatively measure the following hematological parameters: White Blood Cell count (WBC) Red Blood Cell count (RBC) Total Hemoglobin concentration (HGBTotal) Cellular Hemoglobin concentration (HGBcell) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Corpuscular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Content (CH) Red Cell Volume Distribution Width (RDW) Hemoglobin Concentration Distribution Width (HDW) Platelet Count (PLT) Mean Platelet Volume (MPV)
The difference between HGBToul and HGBcen can be used to discriminate between cellassociated hemoglobin and cell-free hemoglobin as found in hemoglobin-based blood substitutes.
Cellular hemoglobin is currently a "laboratory use only" parameter on the ADVIA 120 system. There are no changes to software, reagents, calibrators or controls necessary to derive the cellular hemoglobin parameter.
Acceptance Criteria and Device Performance Study for ADVIA 120 Cellular Hgb Method
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria. Instead, it defines acceptance in terms of "equivalence" to the predicate device (ADVIA 120 HgbTotal method, K971998) for several performance characteristics.
| Characteristic | Acceptance Criteria (Stated) | Reported Device Performance (Summary) |
|---|---|---|
| Accuracy | Equivalent to predicate method. | "demonstrate that the ADVIA 120 cellular Hgb Method has equivalent accuracy... substantially equivalent to the ADVIA 120 predicate method." |
| Precision | Equivalent to predicate method. | "demonstrate that the ADVIA 120 cellular Hgb Method has equivalent... precision... substantially equivalent to the ADVIA 120 predicate method." |
| Linearity | Equivalent to predicate method. | "demonstrate that the ADVIA 120 cellular Hgb Method has equivalent... linearity... substantially equivalent to the ADVIA 120 predicate method." |
| Carryover | Equivalent to predicate method. | "demonstrate that the ADVIA 120 cellular Hgb Method has equivalent... carryover... substantially equivalent to the ADVIA 120 predicate method." |
Note: The document states that the predicate method's specifications for Accuracy, Precision, Linearity, and Carryover are "As specified in product labeling." However, these specific values are not included in this 510(k) summary. Therefore, the exact numerical benchmarks for equivalence are not provided in this excerpt.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "test results included in this submission" but provides no details on these aspects.
3. Number and Qualifications of Experts Used to Establish Ground Truth for the Test Set
The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (quantitative measurement of hemoglobin in whole blood), ground truth would typically be established through comparison with a reference method or highly accurate predicate device, not expert human interpretation.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here as the device measures a quantitative parameter, and its performance is assessed against a predicate device or reference method, not through human consensus on image interpretation or complex diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices that rely on human interpretation of images or other subjective data, often to assess the impact of AI assistance on human performance. The ADVIA 120 Cellular Hgb method is a quantitative laboratory instrument, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, the effect size of human readers improving with or without AI assistance is not relevant or reported.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done, as the ADVIA 120 Cellular Hgb method is itself the "algorithm" (or rather, the method of calculation) being evaluated. The submission demonstrates the performance of this method in terms of accuracy, precision, linearity, and carryover, comparing it directly to the predicate device. This evaluation is of the device's inherent capability to measure cellular hemoglobin without human-in-the-loop intervention for the measurement itself.
7. Type of Ground Truth Used
The ground truth for the test set was established by the predicate method, the ADVIA 120 HgbTotal method (K971998). The study aims to demonstrate that the new cellular Hgb method is "equivalent" or "substantially equivalent" to this established and legally marketed predicate device.
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is expected as the ADVIA 120 Cellular Hgb method is based on a deterministic calculation from existing RBC/Plt channel parameters (RBC count, MCV, CHCM) and does not involve machine learning algorithms that typically require a training phase with a distinct training set. The principles of operation describe a direct calculation: "The cellular hemoglobin concentration is then calculated as the product of the RBC count, the MCV, and CHCM, then scaled by a factor of 1/1000 to obtain units of grams per dL of whole blood."
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set or a machine learning algorithm, the concept of establishing ground truth for a training set is not applicable to this device and submission.
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