(140 days)
XN CAL PF is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. Assayed parameters include: PLT-F (10^3/ uL)
XN CAL PF contains the following: stabilized red blood cell component(s), and stabilized platelet component(s) in a preservative medium.
This document describes the XN CAL™ PF device, a calibrator for cell indices used with Sysmex XN series analyzers. The primary purpose of the submission (K141955) is to expand the compatible analyzers and extend the closed-vial stability.
Here's an analysis of the provided text in relation to acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the different studies. Instead, it states that "The resultant data set established that XN CAL PF is safe and effective for its intended use and that the product is stable for the entire product dating. The product fulfills its intended use as instructed in the Instructions for Use." and "Study results show XN CAL PF to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."
Based on the studies conducted and the claims made, the inferred performance metrics and outcomes are:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Open-Vial Stability | Maintain stability characteristics for 4 hours. | Demonstrated stability for 4 hours. |
| Closed-Vial Stability | Maintain stability characteristics for at least 49 days (for new claim). | Demonstrated stability for 49 days. |
| Precision Performance | Consistently reproducible results. | Demonstrated consistently reproducible results. |
| Substantial Equivalence | Performance comparable to the predicate device (XN CAL™ PF, K120747). | Demonstrated substantial equivalence to the predicate product in terms of safety and effectiveness for its intended use. |
| Safety and Effectiveness | Safe and effective for its intended use. | Concluded to be safe and effective for its intended use when used as instructed. |
| Fulfillment of Intended Use | Functions as a calibrator and for calibration verification on specified Sysmex XN series analyzers. | Fulfills its intended use as instructed in the Instructions for Use, including with the expanded list of XN-series analyzers (XN-10, XN-11, XN-20, XN-21). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide details on the specific sample sizes used for the Open-Vial Stability, Closed-Vial Stability, and Precision Performance studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Streck collected product performance data for the following studies".
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)
This information is not applicable to this device. XN CAL™ PF is a calibrator for laboratory analyzers, not an diagnostic imaging or AI-driven decision support tool that requires expert human interpretation to establish ground truth for a test set in the traditional sense. The "truth" or reference values for a calibrator are established through manufacturing processes and validation against primary reference methods or standards, not through expert consensus on cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical studies where human interpretation or diagnoses are being compared, often with an AI system. Ground truth for a laboratory calibrator is determined by its intrinsic properties and manufacturing metrology.
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
An MRMC study is not applicable to this type of device. XN CAL™ PF is a calibrator, not an AI system or software that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to XN CAL™ PF. It is a physical calibrator product, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state how the "ground truth" or reference values for the calibrator were established. However, for a calibrator, the ground truth would typically be established through:
- Manufacturer's certified reference values: The company manufactures the calibrator to specific concentrations/values (e.g., PLT-F) and validates these values using highly accurate and precise reference methods or instruments, often traceable to international standards.
- Traceability: The values are likely traceable to a recognized standard or method for cell enumeration, ensuring accuracy and consistency across different batches and against a predicate.
8. The sample size for the training set
This information is not applicable. XN CAL™ PF is a physical calibrator product; it does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
§ 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.