(91 days)
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.
The ADVIA 120 Hematology System consists of the following: An analytical module that aspirates, dilutes, and analyzes whole blood samples. An autosampler that automatically mixes, identifies, and presents samples for processing. A computer workstation that controls the instrument, provides the primary user interface with the instrument, and manages the data produced by the instrument. A printer that optionally generates reports based on the instrument results.
The ADVIA 120 Hematology System reports the following hematological parameters:
White Blood Cell Parameters: WBC, Neut, Lymph, Mono, Eos, Baso, LUC
Red Blood Cell Parameters: RBC, Hct, MCV, RDW, CHCM, HDW
Hemoglobin Parameters: Hgb, MCH, MCHC
Platelet Parameters: Plt, MPV
Reticulocyte Count: retic, MCVg, MCVr, CHCMg, CHCMr, CHg, CHr
The ADVIA 120 Hematology System is considered substantially equivalent to the Technicon H-3 RTC for CBC, WBC differential, and reticulocyte parameters. The submission indicates that the test results demonstrate equivalent accuracy, precision, linearity, and carryover between the two systems.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly define numerical acceptance criteria (e.g., specific thresholds for accuracy, precision, linearity, or carryover). Instead, it states that the ADVIA 120 Hematology System and the H-3 RTC demonstrate equivalent performance in these areas.
| Acceptance Criteria | Reported Device Performance (ADVIA 120 vs. Technicon H-3 RTC) |
|---|---|
| Accuracy | Equivalent |
| Precision | Equivalent |
| Lineartiy | Equivalent |
| Carryover | Equivalent |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified. The document only mentions "test results included in this submission," but doesn't detail where or when these tests were conducted, or if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. Hematology analyzers typically compare results to a reference method, which might involve manual differentials performed by qualified lab professionals, but this detail is absent.
4. Adjudication method for the test set:
- Not specified. The document does not describe any adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is typically for evaluating a medical device's impact on human reader performance for tasks like image interpretation. This device (a hematology analyzer) is an automated system providing quantitative measurements, not directly assisting a human reader in interpreting qualitative data in a "case" setting. Therefore, this type of study is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The ADVIA 120 Hematology System is described as a "quantitative, automated hematology analyzer." The performance evaluation would inherently be of the algorithm/instrument itself, without human-in-the-loop interaction for the core measurement tasks.
7. The type of ground truth used:
- The document implies that the Technicon H-3 RTC serves as the predicate device and implicitly, the "ground truth" or reference for comparison. The study aims to prove equivalence to this established device. While the H-3 RTC itself would have been validated against other methods (e.g., manual microscopy for differentials, reference chemical methods for hemoglobin), those details are not provided here for the ADVIA 120's validation.
8. The sample size for the training set:
- Not applicable / not specified. For an automated analyzer like this, the "training set" concept is usually associated with machine learning models. While there are algorithms involved, the document describes the principles of operation based on well-established methods (laser light scatter, absorption, modified cyanmethemoglobin method). It's unlikely a "training set" in the modern machine learning sense was used for this type of device at the time of its submission (1997).
9. How the ground truth for the training set was established:
- Not applicable / not specified. As above, the concept of a "training set ground truth" in the context of machine learning is not applicable here. The system's "ground truth" for calibration and validation would be established through reference methods and comparisons to a predicate device.
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).