(167 days)
The ADVIA® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.
The technological and methodological principles of the ADVIA 2120 with Autoslide used for the quantitative measurement of blood cells in whole blood specimens will be used without change except for the addition of a new methodology to quantitate nucleated red blood cells and correct for white blood cells in peripheral whole blood.
The ADVIA 2120 Nucleated Red Blood Cell (nRBC) method is described below:
a) The ADVIA 2120 nRBC Analysis method uses histogram analysis routines to analyze the unstained region of the Peroxidase channel as well as an arithmetic algorithm that combines counts from the Peroxidase and Basophil/Lobularity channels to enumerate nRBCs.
b) The analysis corrects the White Blood Cell Count for the presence of nRBCs, as well as the WBC Differential. It reports the corrected WBC count and the corrected differential.
The new nRBC method will report the following Red Blood Cell Parameters-
- % nucleated Red Blood Cells (% nRBC)
- absolute nRBC (# of nRBC per microliter)
The provided text describes the ADVIA® 2120 with Autoslide and NRBC Method. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The text focuses on explaining the new functionality (nRBC analysis) and its technological characteristics compared to the predicate device. It also includes the FDA's 510(k) clearance letter, which confirms substantial equivalence but does not detail the underlying performance studies or acceptance criteria that led to that determination.
Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided document.
Here's what can be extracted based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance:
- Reports "% nucleated Red Blood Cells (% nRBC)"
- Reports "absolute nRBC (# of nRBC per microliter)"
- Reports nRBC counts for whole blood samples with either 200 or more nRBC/uL, or with at least 2% nRBCs with a WBC count of at least 3,000/ uL.
- Corrects the White Blood Cell Count for the presence of nRBCs.
- Recalculates the WBC Differential, and recalculates %MN and %PMN.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 standalone automated analyzer, not an AI-assisted reader system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device is described as an "Automated Hematology Analyzer," indicating standalone performance. The document states, "The ADVIA 2120 nRBC method uses histogram analysis routines... as well as an arithmetic algorithm that combines counts... to enumerate nRBCs." This describes the algorithm's standalone operation.
7. The type of ground truth used: The text mentions "nRBC counts are performed by manual methods that are well established as reference methods in clinical laboratories and consistent with NCCLS H-20A." This suggests that manual microscopy (per NCCLS H-20A guidelines) would have been used as the ground truth for validation, likely expert consensus through manual review.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not explicitly stated, but likely through manual methods consistent with NCCLS H-20A, as referenced for "reference methods."
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).