(196 days)
The Cell-Dyn 3000 is a multi-parameter, hematology walyzer designed for In-Vitro diagnostic use in clinical laboratories.
The Cell-Dyn 3000 is a table-top analyzer consisting of the main analyzer, data station, and printer. An optional Sample Loader can be attached to the analyzer to transport samples in racks for automated processing.
The instrument has two sampling modes: Open Sample Aspiration Mode and Closed Sample Aspiration Mode. The instrument has the capability of diluting a sample for a CBC including a 5-part WBC differential for a total of 20 parameters. The 20 reportable parameters are as follows:
White blood cells (WBC), red blood cells (RBC), platelets (PLT), percent of neutrophils (%N), number of neutrophils (NEU), percent of lymphocytes (%L), number of lymphocytes (LYM), percent of monocytes (%M), number of monocytes (MONO), percent of eosinophils (%E), number of eosinophils( EOS), percent of basophils (%B), number of basophils(BASO), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), nean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW) and mean platelet volume (MPV).
The provided text describes the Cell-Dyn® 3000 Multi-Parameter Automated Hematology Analyzer and its substantial equivalence to previously marketed devices. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics in the format requested.
The document states that "The accuracy, precision and linearity data shows performance to manufacturer's specifications" and that "The Cell-Dyn® 3000 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." This indicates that studies were performed, but the results of those studies and the specific acceptance criteria are not provided in this summary.
Therefore, I cannot populate the table or answer all the questions in detail based solely on the provided text. I will extract what information is present and indicate where information is missing.
Here's a breakdown of the available information and what's missing:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target/Specification) | Reported Device Performance |
|---|---|---|
| Accuracy | Manufacturer's specifications | Met manufacturer's specifications |
| Precision | Manufacturer's specifications | Met manufacturer's specifications |
| Linearity | Manufacturer's specifications | Met manufacturer's specifications |
| Carryover | Not specified | Not specified (Data presented but results not detailed) |
| WBC Differential | Compared to NCCLS reference method | "Compared to" - Specific quantitative results not provided. |
Missing Information: Specific numerical acceptance criteria (e.g., % agreement, correlation coefficients, range of error) for each parameter. Specific numerical performance results for accuracy, precision, linearity, and carryover.
2. Sample Size and Data Provenance for Test Set
Sample Size: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It can be inferred that it would likely be from a clinical laboratory, as it's an "in-vitro diagnostic use in clinical laboratories."
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Number of experts: Not specified.
Qualifications of experts: Not specified.
Method used: "NCCLS reference microscopic manual differential method" implies trained laboratory personnel performing manual microscopy, who would be considered experts in that field.
4. Adjudication Method for the Test Set
Adjudication Method: Not specified. The comparison is stated as being "to the NCCLS reference microscopic manual differential method for accuracy," implying a comparison against this single established method, rather than an adjudication process between multiple readers of the device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Was an MRMC study done? No, the text does not describe an MRMC study. The comparison is for a standalone device's performance against a reference method, not human readers with or without AI assistance.
Effect size of human readers with AI vs. without AI: Not applicable, as no MRMC study was described.
6. Standalone (Algorithm Only) Performance Study
Was a standalone study done? Yes, the document describes the evaluation of the Cell-Dyn® 3000 analyzer's performance in terms of accuracy, precision, linearity, and carryover. The WBC differential was specifically compared to the NCCLS reference microscopic manual differential method. This represents the standalone performance of the device.
7. Type of Ground Truth Used
Type of Ground Truth: The ground truth for the WBC differential accuracy study was established using the "NCCLS reference microscopic manual differential method." This is a form of expert consensus/reference method based ground truth, executed manually.
8. Sample Size for the Training Set
Sample Size for Training: Not specified. The document describes the device and its testing for equivalence but does not detail the development or training of any underlying algorithms (if applicable, beyond basic instrument calibration). Given the time period (1996), "training set" in the modern AI sense might not have been a direct concept for this type of device.
9. How Ground Truth for the Training Set Was Established
Ground Truth for Training: Not specified. As mentioned above, details about a "training set" are absent.
§ 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.”