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The CELL-DYN Emerald System is an automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

The CELL-DYN Emerald System is a bench top analyzer consisting of the main analyzer with data module, display station, and printer. The main analyzer, data module, and display station are housed in a single chassis. The printer is a stand-alone module. The CELL-DYN Emerald open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.

The CELL-DYN Emerald™ System is an automated hematology analyzer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a structured table. Instead, it states that the CELL-DYN Emerald System's performance was compared to the predicate device (CELL-DYN 1800 System) and found to be substantially equivalent in terms of:

• Background: Implies that the baseline noise or interference from reagents/instrumentation is acceptable and comparable.
• Correlation: Suggests that the measurements from the Emerald system correlate well with those from the 1800 system across various parameters (WBC, RBC, HGB, HCT, MCV, PLT, etc.).
• Precision: Indicates that the Emerald system provides reproductible results, with variability comparable to the predicate device.
• Linearity: Means the system accurately measures analytes over their clinically relevant range.
• Carryover: Refers to the absence of significant contamination from one sample to the next.

Since specific quantitative targets are not provided in this public summary, we can infer that the acceptance criteria for these performance characteristics were that the CELL-DYN Emerald System performed comparably to, or within acceptable predefined ranges relative to, the established performance of the CELL-DYN 1800 System.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions that the CELL-DYN Emerald System was compared "in both external as well as an internal clinical trial" to the CELL-DYN 1800 System. However, it does not specify the sample size used for these clinical trials.

The data provenance (country of origin, retrospective/prospective) is also not explicitly stated in this summary. Such details would typically be found in the Medical Clinical Summary Report (Attachment F) which is referenced but not provided here.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not contain information about the number of experts used or their qualifications to establish ground truth for the test set. For hematology analyzers, ground truth often involves comparison to reference methods or manual microscopic differentials performed by trained medical technologists or hematopathologists.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set. In clinical studies, adjudication (e.g., by multiple experts) is often used to resolve discrepancies or ensure accuracy of ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how human readers' performance changes with and without AI assistance, is not applicable and therefore not mentioned for this type of device. The CELL-DYN Emerald System is an automated analyzer, not an AI-assisted diagnostic tool that supports human interpretation of images or other complex data. Its equivalency is assessed against another automated device.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "Equivalency Data Summary" section describes a study where the CELL-DYN Emerald System's results were directly compared to those of the predicate device, the CELL-DYN 1800 System. This comparison covered background, correlation, precision, linearity, and carryover, indicating that the algorithm's (device's) performance was evaluated independently.

7. Type of Ground Truth Used

The ground truth for this device's performance evaluation was established through comparison to a legally marketed predicate device (Abbott CELL-DYN® 1800 System). This is a common approach for 510(k) submissions, where substantial equivalence is demonstrated by showing that the new device performs comparably to an existing, cleared device, which itself would have established its performance against reference methods or clinical outcomes. The underlying "ground truth" for the predicate likely involved standard reference methods for cell counting and differentials.

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" sample size. For traditional automated analyzers like this, the development process might involve internal datasets for calibration and algorithm optimization, but these are typically not documented as explicitly as training sets for machine learning models in 510(k) summaries. The clinical trials mentioned (external and internal) would primarily serve as validation/test sets to demonstrate performance.

9. How Ground Truth for the Training Set Was Established

As no specific training set information is provided, there is no explicit description of how ground truth for such a set was established. For development of automated hematology analyzers, the initial ground truth typically comes from:

• Reference materials: Calibrated standards and controls.
• Reference methods: Manual microscopy for differentials, or other established laboratory methods.
• Validated clinical samples: Samples with well-characterized results from established methods.

The algorithms and parameters of the CELL-DYN Emerald would have been developed and optimized using such data to ensure accurate and reliable measurements.

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