(315 days)
The CELL-DYN Emerald 22 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM # , MON%, MON # , NEU%, NEU #, EOS%, EOS # , BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV in K2EDTA anti-coagulated whole blood.
The CELL-DYN Emerald 22 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
The CELL-DYN Emerald 22 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 22 open sampler is equipped to aspirate blood from a collection tube that has been opened and is held under the open sample aspiration probe.
Here's a breakdown of the acceptance criteria and study information for the CELL-DYN Emerald 22 System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for each parameter. Instead, it describes a "substantial equivalence" study where the CELL-DYN Emerald 22 System was compared to the predicate device, the CELL-DYN 3700 System. The study's conclusion is that the device is substantially equivalent.
Therefore, the "acceptance criteria" were implicitly met if the performance of the Emerald 22 was deemed comparable to the legally marketed 3700. The text states:
"The system evaluation included data for background, correlation, precision, linearity and carryover."
Lack of specific criteria is common in 510(k) summaries when demonstrating substantial equivalency to a predicate device. The performance is deemed acceptable if it aligns with the established predicate's performance.
| Parameter | Acceptance Criteria (Implicit: Comparable to CELL-DYN 3700) | Reported Device Performance |
|---|---|---|
| Background | Performance comparable to CELL-DYN 3700 | Data supports substantial equivalence |
| Correlation | Performance comparable to CELL-DYN 3700 | Data supports substantial equivalence |
| Precision | Performance comparable to CELL-DYN 3700 | Data supports substantial equivalence |
| Linearity | Performance comparable to CELL-DYN 3700 | Data supports substantial equivalence |
| Carryover | Performance comparable to CELL-DYN 3700 | Data supports substantial equivalence |
| Overall | Substantially Equivalent to CELL-DYN 3700 | "The CELL-DYN Emerald 22 System is substantially equivalent to the CELL-DYN 3700 (predicate device)." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a clinical trial" where the device was compared to the predicate, but it does not specify the sample size used for this test set.
The data provenance is not explicitly stated regarding country of origin. The submission is to the FDA in the USA, implying US regulatory context. It's likely a prospective study, as it's a "clinical trial" for a new device comparison, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study framework is a comparison of the new device's measurements against a predicate device's measurements, not against an expert-established "ground truth" for individual parameters.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a comparison study between two automated hematology analyzers, an adjudication method for individual parameter values is typically not applicable in the same way it would be for, say, image analysis interpreted by humans. The comparison would involve statistical methods to assess agreement or correlation between the two devices.
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
There was no MRMC comparative effectiveness study done. The CELL-DYN Emerald 22 System is an automated hematology analyzer, not an AI-assisted diagnostic tool that human readers would interact with. The study compares the new automated device to an existing automated device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The CELL-DYN Emerald 22 System is an "automated hematology analyzer" performing quantitative measurements. The study evaluated its performance (background, correlation, precision, linearity, carryover) in comparison to another automated device, without direct human intervention in the primary measurement process itself.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurements obtained from the predicate device, the CELL-DYN 3700 System. The study aims to demonstrate that the new device's measurements are substantially equivalent to those of the predicate, which is already a legally marketed and presumably validated device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. Automated hematology analyzers like the CELL-DYN Emerald 22 are typically built on established physical and chemical principles (e.g., electrical impedance, optical analysis for cell counting, hemoglobin analysis). They do not usually involve "training sets" in the machine learning sense to develop their core algorithms for parameter enumeration. Their algorithms are based on physics and chemistry, not learned from large datasets in the way an AI diagnostic model would be.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated above.
§ 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.”