(79 days)
The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.
The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a 26parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
The COULTER® AcT™ 5diff Autoloader (AL) is a moderate cost 5-part differential hematology analyzer with autoloader and external computer workstation.
Here's a breakdown of the acceptance criteria and study information for the COULTER® AcT™ 5diff Autoloader (AL), based on the provided document. Please note that the document is a 510(k) summary, which often provides an overview rather than detailed study results. Consequently, some specific details like exact confidence intervals, full statistical analyses, or the exact improvement effect size in an MRMC study if conducted for this type of device, are not explicitly stated.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table with specific pass/fail thresholds. Instead, it relies on substantial equivalence to predicate devices (Beckman Coulter HmX with Autoloader and Abbott CELL-DYN 4000) for its performance. The "reported device performance" is primarily characterized by the parameters measured and the principles of measurement, which are fundamentally similar to the predicates. The clinical significance also outlines the intended performance: to accurately identify normal patients from those needing further studies.
Here's an attempt to structure what can be inferred as performance benchmarks based on the comparison to predicate devices:
| Characteristic/Parameter | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (COULTER® AcT™ 5diff AL) |
|---|---|---|
| Parameters Measured | Similar range and type of hematology parameters, including 5-part differential, as predicate devices. | 26 parameters: WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, PDW*, Pct*, Lymphocyte % & #, Monocyte % & #, Neutrophil % & #, Eosinophil % & #, Basophil % & #, Atypical Lymphocyte % & # *, Immature cell % & # * |
| Principles of Measurement | Similar measurement technologies for core parameters (WBC, RBC, Hgb, Plt, Differential). | WBC, RBC, Plt: Aperture impedance. Hgb: Spectrophotometric. MCV: Calculated from Hct. Hct: Aperture impedance. Differential: Aperture Impedance, Light Scattering. |
| Sample Volume | Comparable to predicate devices. | CBC profile - 30 µL; CBC/DIFF profile - 53 µL (significantly lower than predicates) |
| Throughput | Comparable to predicate devices. | Closed and Open vial mode - 80 samples/hour (comparable to higher end of predicates) |
| Intended Use | Quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use, distinguishing normal from abnormal for further study. | Identical. |
*These parameters are for Research Use Only (RUO). Not for use in diagnostic procedures.
2. Sample Size Used for the Test Set and Data Provenance
The document is a 510(k) summary, which typically focuses on product characteristics and substantial equivalence, and does not provide details on the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It simply states that "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies..." without elaborating on the studies themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The 510(k) summary does not describe how ground truth was established for any performance studies.
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 Effect Size
This document does not indicate that an MRMC comparative effectiveness study was done. This type of study (human readers with vs. without AI assistance) is more common for diagnostic imaging AI devices, rather than automated lab analyzers like the COULTER® AcT™ 5diff Autoloader (AL), which are typically evaluated for accuracy, precision, and agreement with established methods rather than human performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the device itself, an automated hematology analyzer, inherently operates in a "standalone" fashion as an algorithm-only device (though used in a clinical lab setting with human oversight for interpretation and follow-up). The summary implies that its performance was assessed independently to demonstrate substantial equivalence to existing automated analyzers. The performance data supports a finding of substantial equivalence, meaning its accuracy and reliability were assessed on its own merits against established predicate devices.
7. Type of Ground Truth Used
The specific type of ground truth used is not explicitly stated. For hematology analyzers, ground truth is typically established by:
- Reference methods: Such as manual differential counts performed by highly experienced medical technologists, or other established automated analyzers.
- Clinical outcomes/diagnoses: Though less direct for individual parameter accuracy.
- Split samples: Running samples on both the new device and a predicate/reference device and comparing results.
Given the context of substantial equivalence to predicate devices, it is highly probable that the ground truth was established by comparison to results obtained from the predicate devices or other established reference methods.
8. Sample Size for the Training Set
This information is not provided in the document. The document does not discuss the training of any AI or machine learning models, as the device is an automated hematology analyzer using impedance and light scattering principles, rather than a deep learning AI device. If it were a predictive model, such information would be crucial.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As mentioned above, the document does not suggest the use of a "training set" in the context of machine learning. The device operates based on established physical principles of cell measurement.
§ 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.”