(43 days)
The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) hematological parameters: white blood cells (leukocytes) WBC, red blood cells (erythrocytes) RBC, hemoglobin HGB, hematocrit HCT, mean corpuscular volume MCV, mean corpuscular hemoglobin MCH, mean corpuscular hemoglobin concentration MCHC, red blood cell distribution width RDW, platelets PLT, mean platelet volume MPV, lymphocyte (number) #LYM, lymphocyte (percent of WBC) %LYM, monocyte (number) #MON, monocyte (percent of WBC) %MON, granulocyte (number) #GRA, granulocyte (percent of WBC) %GRA. The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters: 16 parameters, 8 parameters (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT), 5 parameters (WBC, RBC, MPV, HGB, HCT). Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.
The ADVIA 60 Hematology System consists of an analytical module that aspirates, dilutes, and analyzes whole blood samples along with a printer that optionally generates reports based on the instrument results. The ADVIA 60 Hematology System reports the following hematological parameters: White Blood Cell Parameters WBC - white blood cell count GRA - granulocyte count (percentage and absolute counts) LYM - lymphocyte count (percentage and absolute counts) MON - mononuclear count (percentage and absolute counts) Red Blood Cell Parameters RBC - red blood cell count Hct - hematocrit MCV - mean corpuscular volume RDW - red cell volume distribution width Hemoglobin Parameters Hab - hemoglobin concentration MCH - mean corpuscular hemoglobin MCHC - mean corpuscular hemoglobin concentration Platelet Parameters Pit - platelet count MPV - mean platelet volume. The RBC/WBC/Plt parameters are counted based on impedance variation generated by the passage of cells through a calibrated micro-aperture. hemoglobin parameters are based on a modification of the The manual International Committee cyanmethemoglobin method developed by the for Standardization in Hematology. The WBC differential parameters are derived through a volumetric study of leukocytes after the use of a diluent and lysing reagent.
The provided text is a 510(k) Summary of Safety and Effectiveness for the ADVIA 60 Hematology System. It aims to demonstrate substantial equivalence to the ABX MICROS Hematology System based on accuracy, precision, linearity, and carryover. However, the document does not explicitly state acceptance criteria in a table format and the specific studies that prove the device meets these criteria in the way requested. It generally asserts equivalence to the predicate device.
Given the information provided, I cannot fully complete the table as requested, nor can I provide details on sample sizes, ground truth establishment methods, or multi-reader studies. The document describes the device's function and parameter reporting but lacks detailed study protocols and results in the format requested.
Here's an attempt to extract the closest available information to your requested points, highlighting what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria (e.g., specific ranges for accuracy, precision) or quantitative reported device performance values. It only states a conclusion of equivalence in accuracy, precision, linearity, and carryover to the predicate device.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Accuracy | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Precision | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Linearity | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Carryover | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a hematology analyzer, not an imaging device requiring expert interpretation for ground truth. Its ground truth would typically be established by established reference methods (e.g., manual microscopy, highly accurate reference instruments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of a hematology analyzer.
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 not an AI-assisted diagnostic device. It is a standalone automated hematology analyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this appears to be a standalone performance study. The device is a quantitative, automated analyzer, implying its performance is assessed independently against reference methods or another predicate device. The submission explicitly states: "The test results included in this submission demonstrate that the ADVIA 60 Hematology System and the ABX MICROS Hematology System have equivalent accuracy, precision, linearity, and carryover." This suggests a direct comparison of the ADVIA 60's results to the ABX MICROS.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the "ground truth" method for the test set. However, for hematology analyzers, ground truth usually involves:
- Reference methods: Such as manual differential counts by trained technologists (for WBC differentials), or established reference instruments/methods for CBC parameters (e.g., conductivity for Hct, cyanide-free methods for Hgb).
- Predicate device comparison: In this specific submission, the "ground truth" performance for equivalence is the performance of the ABX MICROS Hematology System, since the study aims to show "equivalent accuracy, precision, linearity, and carryover" to that predicate device. The document also mentions for hemoglobin parameters that "a modification of the manual International Committee cyanmethemoglobin method developed by the for Standardization in Hematology" is used, implying this as a reference.
8. The sample size for the training set
Not mentioned. This device is from 1998, predating the widespread use of machine learning models requiring explicit "training sets" in the modern sense. Its development would likely have involved engineering and calibration using blood samples, but these wouldn't typically be referred to as a "training set" in a 510(k) submission from this era.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" with established ground truth as understood in modern AI development is not specified. Device calibration and development would have relied on established hematology standards and comparison to reference methods.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”