(118 days)
The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
The COULTER LH 780 Hematology Analyzer is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 780 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and WBCs in body fluids. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting and sizing, reticulocyte determination, quality control, calibration and cleaning.
Here's a summary of the requested information based on the provided text for the COULTER® LH 780 Hematology Analyzer:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative format with corresponding "reported device performance" values for each parameter. Instead, it states that "Accuracy, precision, linearity and carryover studies were conducted and the data demonstrated compliance with the manufacturer specifications." The key point is that the LH 780's performance specifications are considered "Same as LH750 plus Within-Run precision, Accuracy, and Operating and Reportable Ranges include RDW-SD and a tighter WBC Linearity specification."
This implies that the acceptance criteria are the manufacturer's internal specifications, which were met. Without access to the specific manufacturer's specifications for the LH 750 or the LH 780, it's impossible to create a precise table. However, the performance areas assessed are clearly stated:
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Accuracy | Compliance with manufacturer specifications for CBC, Diff, Retic, and RDW-SD | Demonstrated compliance |
| Precision (Within-Run) | Compliance with manufacturer specifications for CBC, Diff, Retic, and RDW-SD | Demonstrated compliance |
| Linearity | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt, and a tighter WBC linearity specification for LH 780 | Demonstrated compliance |
| Carryover | Compliance with manufacturer specifications | Demonstrated compliance |
| Background | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt | Not explicitly stated but implied in overall compliance |
| Operating and Reportable Ranges | Compliance with manufacturer specifications for CBC, Diff, Retic, NRBC, and RDW-SD | Demonstrated compliance |
| Mode to Mode Comparison | Compliance with manufacturer specifications for WBC, RBC, Hgb, Plt | Not explicitly stated but implied in overall compliance |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states that "Accuracy, precision, linearity and carryover studies were conducted," but it does not specify the sample sizes used for these studies.
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be prospective as they were conducted to demonstrate the device's compliance.
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 device is an automated hematology analyzer, and ground truth for blood counts and differentials is typically established by reference methods or expert manual microscopy, but the details of this process are not described.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The COULTER® LH 780 is an automated analyzer, not an AI-assisted diagnostic tool for human readers in the traditional sense of medical imaging. Its purpose is to automate blood analysis, reducing the need for extensive manual microscopic review in routine cases. Therefore, a study of human improvement with/without AI assistance is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are inherently standalone performance studies. The COULTER® LH 780 Hematology Analyzer is an automated device designed to perform quantitative measurements of blood parameters without human intervention in the primary analytical process. The "Accuracy, precision, linearity and carryover studies" would assess the algorithm's performance directly against established reference methods or known controls.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The document does not explicitly state the specific type of ground truth used. However, for hematology analyzers, ground truth is typically established by:
- Reference methods: Highly accurate and precise laboratory techniques for each parameter (e.g., manual cell counts, spectrophotometry for hemoglobin).
- Known standards/controls: Materials with certified known concentrations of analytes.
- Manual microscopy/expert review: For differential counts, an expert microscopist performs a manual differential count, which serves as the "gold standard" to validate the automated differential.
Given the context of a hematology analyzer, a combination of these methods would have been used.
8. The Sample Size for the Training Set:
The document does not specify the sample size for any training set. This is typical for submissions of this nature, where the focus is on the performance of the final, commercialized device rather than the developmental aspects.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document. As with the test set ground truth, it would likely involve reference methods, known controls, and potentially expert manual review during the development and training phases of the instrument's algorithms.
§ 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.”