(313 days)
The Cell-Dyn 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.
The Cell-Dyn 3500 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), mean 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® 3500 System, a multi-parameter automated hematology analyzer, and presents data supporting its substantial equivalence to previously marketed devices. However, it does not contain detailed acceptance criteria or a study proving that the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence rather than explicit performance acceptance criteria with detailed study results against them.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what information is available and note when information is missing.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document states: "The accuracy, precision and linearity data shows performance to manufacturer's specifications. The data supports our claim that the Cell-Dyn 3500 is substantially equivalent to the Coulter S+IV." However, the manufacturer's specifications (i.e., the acceptance criteria) and the specific reported device performance data for these parameters are not provided in the text.
| Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (Not explicitly stated in text) |
|---|---|
| Accuracy: [Specific threshold/range] | Data "shows performance to manufacturer's specifications" |
| Precision: [Specific threshold/range] | Data "shows performance to manufacturer's specifications" |
| Linearity: [Specific threshold/range] | Data "shows performance to manufacturer's specifications" |
| Carryover: [Specific threshold/range] | Data supports claim of substantial equivalence |
| WBC Differential Accuracy: [Specific threshold/range vs. manual method] | "Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." (Specific results not given) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not specified. The document mentions "The data compiled to support the claim...".
- Data provenance: Not specified. (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:
- For the WBC differential accuracy, it states: "The Cell-Dyn 3500 WBC differential has been compared to the NCCLS reference microscopic manual differential method for accuracy." This implies that trained personnel performed the manual differential counts for comparison, which would serve as a form of ground truth.
- Number of experts: Not specified.
- Qualifications of experts: Not specified. (However, performing NCCLS reference microscopic manual differential implies trained laboratory technicians or pathologists).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- No, this is not an MRMC study related to AI assistance. The device is an automated hematology analyzer, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies for image analysis etc. The comparison is between the automated analyzer's results and established manual/other automated methods.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this is effectively a standalone performance study. The document describes the "Cell-Dyn 3500" analyzer's performance (accuracy, precision, linearity, carryover) and its comparison to other instruments and a manual method. This assesses the device's inherent performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For WBC differential accuracy: The "NCCLS reference microscopic manual differential method" was used as a ground truth comparison.
- For other parameters (accuracy, precision, linearity, carryover): The implied ground truth would be accepted laboratory reference methods or established standards against which the device's measurements are validated.
8. The sample size for the training set:
- Not applicable / not specified. This device is from 1996 and uses electrical impedance and laser optical methods, not machine learning or AI models in the modern sense that require a "training set" to learn from data. Its principles are based on physical measurements and established algorithms.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 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.”