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510(k) Data Aggregation
(77 days)
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a multi-parameter, automated. hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a fully automated hematology analyzer, including reporting of the ImmunoPlt (CD61) count, intended for in-vitro diagnostic use in the clinical laboratory of a hospital, medical clinic, or reference laboratory.
The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, difutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is designed to analyze EDTAanticoagulated whole blood specimens and report the hematological parameters shown in the table on the following page.
The provided text describes the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay, a multi-parameter automated hematology analyzer.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the "Equivalency Data" section "shows performance to manufacturer's specifications." However, the specific acceptance criteria (numerical thresholds) or the detailed reported performance values are not explicitly listed in the provided text. The text only broadly concludes that the data supports substantial equivalence to predicate devices and microscopy for low platelet counts.
| Parameter Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary) |
|---|---|---|
| Overall Performance | (Implied: Substantial equivalence to predicate devices and manual microscopy for platelet counts < 50 K/μL) | Data compiled supports the claim of substantial equivalence. |
| Accuracy | Manufacturer's specifications (Not detailed) | Performance shown to manufacturer's specifications. |
| Precision | Manufacturer's specifications (Not detailed) | Performance shown to manufacturer's specifications. |
| Linearity | Manufacturer's specifications (Not detailed) | Performance shown to manufacturer's specifications. |
| Carryover | Manufacturer's specifications (Not detailed) | Performance shown to manufacturer's specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The data compiled supports the claim..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document mentions "base microscopy (for platelet counts < 50 K/μL)" as a comparative method for equivalency data. This implies that microscopy was used as a ground truth for lower platelet counts. However, the number of experts and their qualifications (e.g., specific experience level of the microscopists) are not mentioned.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It implicitly refers to "base microscopy" for low platelet counts as a reference method but does not detail how potential discrepancies or subjective interpretations in microscopy were handled.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done as this device is an automated hematology analyzer and not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of an effect size for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was done. The entire "Equivalency Data" section details the performance of the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay as an automated device. The comparison is made against existing automated systems (Abbott CELL-DYN® 4000 System) and a manual method (base microscopy). This demonstrates the algorithm's performance without direct human intervention in the interpretation of results beyond standard laboratory operation.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation appears to be a combination of:
- Predicate devices: The Abbott CELL-DYN® 4000 System (for general hematological parameters).
- Manual Microscopy: Specifically for platelet counts lower than 50 K/μL.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set for the device's algorithms or operating parameters. It describes the device's principles of operation but not its development or the data used to train its internal models.
9. How the Ground Truth for the Training Set Was Established:
The document does not explicitly state how the ground truth for the training set was established. Since it is an automated hematology analyzer, the "training" would likely involve calibration using known reference materials and internal algorithms refined through extensive testing with reference methods. However, the specifics of this process are not described in the provided text.
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