(72 days)
The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT- Series, providing enumeration of the WBCs and the RBCs.
The XT-Series is an automated hematology analyzer previously cleared by the FDA. The combination of side scatter, forward scatter, and fluorescent intensity of nucleated cells gives an image of each cell detected in the specimen.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table. Instead, it relies on a comparison to a predicate device. The "performance" is implicitly stated as demonstrating "equivalent performance" and "excellent correlation" to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalence to predicate method (Sysmex XE-Series Body Fluid Application) for Intended Use | "Results indicated equivalent performance." |
| Equivalence to predicate method for Methodology | "Same as predicate method." |
| Equivalence to predicate method for Reagents | Some reagents are the same, some differ, but overall performance shown to be equivalent. |
| Equivalence to predicate method for Specimen Type | "Same as predicate method." |
| Accuracy compared to predicate method | "Comparison to the XE-2100 Series Body Fluid Application demonstrated excellent correlation." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Studies were performed to evaluate the equivalency of the automated method to the predicate method," but does not provide details on the number of samples used in these studies.
- Data Provenance: Not explicitly stated. There is no mention of country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The study compares the new device to a predicate device, not directly to expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. The study focuses on comparing the new instrument's performance to an already cleared predicate, rather than using an adjudication process for a new ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for an automated hematology analyzer, not a device that involves human reader interpretation for its primary function. Therefore, there's no mention of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this appears to be a standalone study of the device's performance. The device is an "automated hematology analyzer," and the evaluation is based on its direct measurement capabilities compared to a predicate automated device. There is no indication of a human-in-the-loop component in the performance evaluation.
7. Type of Ground Truth Used
The "ground truth" for this submission is the performance of the predicate device, the "Sysmex XE-Series Body Fluid Application." The study establishes substantial equivalence by demonstrating that the new device's measurements correlate well with those of the already cleared predicate device.
8. Sample Size for the Training Set
This information is not provided. As this is a comparison to a predicate device and not necessarily a machine learning algorithm that requires a separate training set, the concept of a "training set" in the context of AI (as understood today) might not apply directly here. The device is an automated analyzer.
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no explicitly mentioned "training set" in the context of an AI/ML algorithm. The "truth" for the evaluation is the predicate device's performance itself, which would have been established during its own clearance process.
§ 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.”