(90 days)
The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100 for in Vitro diagnostics is used to enumerate the immature platelet fraction.
The Sysmex XE-2100 uses a gating system in the optical (fluorescence) reticulocyte/platelet channel to quantify the immature platelets. (Note: XE IPF master with XE pro is required to obtain results described.)
The provided text describes the submission of a 510(k) premarket notification for the "IPF (Immature Platelet Fraction) parameter on the Sysmex® XE-2100, Automated Hematology Analyzer." However, it does not contain specific acceptance criteria, detailed study designs, sample sizes for training or test sets, or information about expert panel ground truth adjudication.
The document states that "Studies were performed to evaluate the equivalency of the IPF parameter to the predicate method. Results indicate equivalent performance," and "The performance data demonstrated substantial equivalence." This suggests a comparison study was conducted, but the specifics are not included in the provided text.
Therefore, many of the requested details cannot be extracted from this document. I will provide what can be gleaned from the text and explicitly state where information is missing.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: The document only broadly states "Results indicate equivalent performance" and "The performance data demonstrated substantial equivalence" to the predicate device (FACSCalibur flow cytometric method for reticulated platelet). No specific performance metrics (e.g., accuracy, precision, correlation coefficients) are provided.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
- This information would typically be relevant for studies where expert review is the ground truth, which is often the case for image-based diagnostics. For a blood analyzer, the "ground truth" is typically established by a reference method or validated gold standard, not necessarily by expert consensus in the same way.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified in the provided text. Given the nature of a blood analyzer, an adjudication method (like for image interpretation) is unlikely to be directly applicable in the same way. Instead, the comparison would be against an established reference method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study is not mentioned or implied. This type of study is relevant for AI systems assisting human interpretation, which is not the function of this automated hematology analyzer.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the device (Sysmex® XE-2100 Automated Hematology Analyzer) measures the IPF parameter directly. The study would have evaluated the performance of this automated algorithm (the device itself) in a standalone manner against a predicate method. The text states "Studies were performed to evaluate the equivalency of the IPF parameter to the predicate method."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance study was the predicate method: "reticulated platelet on the FACSCalibur flow cytometric method." The study aimed to demonstrate substantial equivalence to this existing, legally marketed method.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As this device is an automated hematology analyzer, it is not an AI/Machine Learning system that typically requires a large 'training set' in the conventional sense. Its functionality is based on established laboratory principles (gating system in the optical fluorescence reticulocyte/platelet channel). Thus, there's no "training set" as understood in machine learning contexts.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set in the machine learning sense for this device.
§ 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.”