(296 days)
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:
WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)
XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium.
The medical device in question is the XN CAL, a calibrator for cell indices used with Sysmex XN series analyzers. The provided text, a 510(k) summary, describes its intended use, comparison to a predicate device, and results of performance testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it describes general study objectives and conclusions about reproducibility and stability. The "reported device performance" is given as conclusions derived from tests.
| Parameter/Study | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Multi-Site Precision | Not explicitly stated, but implies meeting reproducibility standards. | "The resultant data set established that XN CAL is safe and effective for its intended use..." and "Study results show XN CAL to be consistently reproducible..." |
| Single-Site Precision | Not explicitly stated, but implies meeting reproducibility standards. | "The resultant data set established that XN CAL is safe and effective for its intended use..." and "Study results show XN CAL to be consistently reproducible..." |
| Open-Vial Stability | Not explicitly stated as a numerical target, but expected to demonstrate stability for the claimed duration. | 4 hours (Claimed and supported by data) |
| Closed-Vial Stability | Not explicitly stated as a numerical target, but expected to demonstrate stability for the claimed duration. | 35 days (Claimed and supported by data) |
| Overall Performance | Demonstrates safety, effectiveness, substantial equivalence, and fulfillment of intended use. | "XN CAL is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use." and "substantially equivalent to the products..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of measurements, number of vials, etc.) used for the multi-site precision, single-site precision, open-vial stability, or closed-vial stability studies.
The data provenance is not explicitly stated regarding country of origin. The studies are described as "Multi-Site" and "Single-Site," suggesting they were conducted at different locations. The studies were likely prospective as they were conducted to substantiate product performance claims for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As XN CAL is a calibrator for automated hematology analyzers, "ground truth" would typically refer to the accurately assigned values for the calibrator, which are then used to calibrate the analyzers. This process usually involves highly controlled laboratory methods rather than expert human interpretation in the way, for example, a radiograph would be interpreted.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of medical images or data is involved and discrepancies need to be resolved. For a calibrator, performance is measured objectively against established reference values or reproducible results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI), not for a laboratory calibrator.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
This question is not directly applicable in the context of XN CAL as it is a physical calibrator solution, not an algorithm. Its performance is evaluated based on its measured values and stability when run on the specified analyzers, which are themselves automated devices. The "algorithm" here would be the instrument's measurement algorithm, and the calibrator helps ensure that algorithm produces accurate results.
7. The Type of Ground Truth Used
The concept of "ground truth" for a calibrator usually refers to the assigned or reference values for the parameters (WBC, RBC, HGB, HCT, PLT, RET) within the calibrator. These values are established through rigorous, highly accurate, and often multi-replicate testing using reference methods or predicate devices, ensuring their accuracy. The document implies that the "intended use" and "consistently reproducible" nature suggest these established values serve as the ground truth.
8. The Sample Size for the Training Set
This information is not provided and is not applicable for this device. The XN CAL is a physical calibration material, not a machine learning or AI algorithm that requires a "training set" of data. The performance studies described (precision, stability) are a form of verification/validation, not model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device.
§ 864.8150 Calibrator for cell indices.
(a)
Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.