(75 days)
The Sysmex™ XE-2100 is a multi-parameter hematology analyzer intended to classify the following formed elements in anti-coagulated blood: WBC, Neut%/#, Lymph%/#, Mono%/#, Eo%/#, Baso%/#, NRBC%/#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, RET%/#, IRF, HFR*, MFR*, LFR*, PLT, MPV, PDW*, P-LCR*, PCT* (*Not Reportable in USA).
The XE-2100 is an automated hematology analyzer which consists of four principal units: (1) Main Unit which aspirates, dilutes, mixes, and analyzes whole blood samples; (2) Sampler Unit which supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.
Here's an analysis of the acceptance criteria and study information for the Sysmex™ Automated Hematology Analyzer XE-2100, 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 the performance of the Sysmex™ XE-2100. Instead, it relies on demonstrating substantial equivalence to predicate devices (Sysmex SE/RAM-1 and SF-3000) and established methods (manual differential, flow cytometry).
The reported device performance is described as "performance to manufacturer specifications" for carryover, precision, linearity, and sample stability. For other parameters, performance is considered "similar to the predicate devices."
| Feature/Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Device | Substantial equivalence to predicate devices (SE/RAM-1, SF-3000), manual differential, and flow cytometry. | Performance claims are similar to predicate devices. Supports substantial equivalence. |
| Carryover | Manufacturer specifications | Performance met manufacturer specifications |
| Precision | Manufacturer specifications | Performance met manufacturer specifications |
| Linearity | Manufacturer specifications | Performance met manufacturer specifications |
| Sample Stability | Manufacturer specifications | Performance met manufacturer specifications |
| Correlation Studies (All parameters listed for XE-2100) | Results expected to be similar to predicate devices for relevant parameters. | Specimens from healthy individuals and pathological conditions showed similar results to predicate devices. |
| WBC Differential | Correlation with manual differentials (NCCLS H20A) and flow cytometry. | Correlated to results from manual differentials (NCCLS H20A) and flow cytometry. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of samples used in the correlation studies. It mentions that "specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions." This implies a varied and likely representative sample, but the exact count is not given.
- Data Provenance: The document does not state the country of origin of the data. The studies appear to be prospective as they were conducted to evaluate the performance of the XE-2100 against predicate devices and established methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document does not specify the number of experts used.
- Qualifications of Experts: The document states that the WBC differential of the XE-2100 was correlated to results from "manual differentials performed according to NCCLS H20A." This implies that the manual differentials, which serve as a form of ground truth, were performed by trained laboratory professionals, adhereing to a recognized standard (NCCLS H20A). No specific experience level (e.g., radiologist with 10 years experience) is mentioned for these individuals.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing ground truth. The comparison for WBC differential was made against "manual differentials performed according to NCCLS H20A and to flow cytometry." This suggests a direct comparison to established methods rather than a consensus-based adjudication by multiple independent experts of the device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the device's performance against predicate devices and established laboratory methods, not on how the device assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the study described is a standalone performance evaluation. The Sysmex XE-2100 is an "Automated Hematology Analyzer," and the studies (carryover, precision, linearity, sample stability, and correlation studies) evaluate the device's output directly against reference methods or predicate devices, without human-in-the-loop interaction as part of the primary performance assessment.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Established Laboratory Methods:
- Manual differentials performed according to NCCLS H20A for WBC differential.
- Flow cytometry for WBC differential.
- Predicate Devices: The Sysmex SE/RAM-1 and SF-3000 served as a comparative reference for many parameters. While not strictly "ground truth," their established performance was used as a benchmark for substantial equivalence.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is typical for devices of this era, especially those demonstrating equivalence to predicate devices, where extensive AI/machine learning training sets as understood today were not a primary requirement for 510(k) submission. The device's operation is based on established analytical principles (e.g., flow cytometry, DC detection).
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth would have been established.
§ 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.”