Search Results
Found 1 results
510(k) Data Aggregation
(100 days)
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.
The XT-Series is an automated hematology analyzer previously cleared by the FDA (K021241- cleared June 24, 2002). The RET-He parameter determines the hemoglobin of reticulocytes. XT-Pro and RET- Master are required. The IG parameter (Immature Granulocyte) classifies and counts the immature granulocyte cells. The XT-Pro and IG Master are required.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Sysmex XT-Series IG and RET-He parameters:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit acceptance criteria in the typical sense of performance thresholds. Instead, the "acceptance criteria" here is implicitly demonstrated through "excellent correlation" and "performance to the manufacturer's specification" when compared to the predicate device (Sysmex XE-2100). The specific numerical values for manufacturer's specifications for accuracy and precision are not detailed in this summary.
Therefore, the table will reflect the general statements of performance and equivalence rather than specific numeric acceptance criteria.
| Parameter | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Sysmex XT-Series) |
|---|---|---|
| IG Parameter | Substantially equivalent to predicate device (Sysmex XE-2100 IG) in terms of intended use, methodology, and performance (accuracy, precision, sample stability). | Demonstrated excellent correlation and performance to the manufacturer's specification compared to the Sysmex XE-2100 IG. |
| RET-He Parameter | Substantially equivalent to predicate device (Sysmex XE-2100 RET-He) in terms of intended use, methodology, and performance (accuracy, precision, sample stability). | Demonstrated excellent correlation and performance to the manufacturer's specification compared to the Sysmex XE-2100 RET-He. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions that "Data consisting of accuracy, precision and sample stability was collected". However, it does not explicitly state the sample size used for the test set.
- Sample Size: Not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only indicates that the data was collected to show performance, implying it was likely a controlled study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given that this is an automated hematology analyzer, the "ground truth" for the predicate device's performance would typically be established through method comparisons against established reference methods or manual expert review, but this detail is omitted for the current submission.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The study described is a comparison of the new device (Sysmex XT-Series) against a predicate device (Sysmex XE-2100), not a study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance evaluation of the Sysmex XT-Series IG and RET-He parameters. The device is an automated hematology analyzer, and the performance evaluated is the algorithm's ability to classify and count cells and determine reticulocyte hemoglobin, without direct human intervention in the measurement process.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation is implicitly established by comparing the Sysmex XT-Series to the predicate device, Sysmex XE-2100. The document states that the performance was "initially established in XE-2100 510(k) submission" and that the XT-Series "demonstrated excellent correlation" to the predicate. Therefore, the predicate device's results serve as the reference standard or "ground truth" for this substantial equivalence submission.
8. The Sample Size for the Training Set
The document does not specify the sample size used for any training set. As this device is primarily demonstrating equivalence to a previously cleared device, the emphasis is on testing the new device, not on detailing the initial development and training of the algorithms (which would have occurred for the predicate device or a much earlier version).
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established.
Ask a specific question about this device
Page 1 of 1