(221 days)
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. Assayed parameters include:
WBC (103/μL), RBC (108/μL), HGB (g/dL), HCT (%), PLT (103/ μL), and RET (%)
XN CAL™ is an in-vitro diagnostic product that 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 product is packaged in polypropylene plastic vials with screw caps containing 3 ml. The vials will be packaged in (5) welled or (1) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. The product must be stored at 2 - 8° C.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XN CAL™ device, formatted as requested:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results for the XN CAL™ device against such criteria. Instead, it makes general claims about the device's performance relative to the predicate. The "Discussion of Tests and Test Results" section indicates that the studies demonstrated that XN CAL™ is "consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed."
Based on the text, the implicit acceptance criteria would be that the device:
- Is consistently reproducible. (No specific numerical reproducibility target given.)
- Is substantially equivalent to the predicate product (X-CAL™). (No specific equivalence margin or statistical criteria are provided.)
- Is stable for the claimed shelf life. This includes:
- Open-Vial Stability: 4 hours (Claim based on "Comparison to Predicate Device" table).
- Closed-Vial Stability: 35 days (Claim based on "Comparison to Predicate Device" table).
The reported device performance, in the absence of numerical data, is a qualitative statement: "All testing showed that XN CAL™ is consistently reproducible, substantially equivalent to the predicate product and stable for the shelf life claimed."
Table of Implicit Acceptance Criteria and Reported Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Consistent Reproducibility | "consistently reproducible" |
| Substantial Equivalence | "substantially equivalent to the predicate product" |
| Open-Vial Stability (4 hours) | "stable for the shelf life claimed" (supporting the 4-hour open-vial stability) |
| Closed-Vial Stability (35 days) | "stable for the shelf life claimed" (supporting the 35-day closed-vial stability) |
| Safety and Effectiveness | "safe and effective product, which fulfills its intended use when used as instructed" |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the test set in the Open-Vial Stability, Closed-Vial Stability, or Precision Performance studies.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). As the submitter is Streck, a US-based company, and the context is a US regulatory filing, it is highly probable the data was generated in the US or under US guidance, but this is not explicitly confirmed. The studies are described in the past tense ("were conducted"), suggesting they were completed prior to submission, but does not explicitly state if they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. XN CAL™ is a quality control material (calibrator) for hematology analyzers. The "ground truth" for calibrator performance is established through laboratory methods and reference standards, not by expert interpretation of patient data as might be the case for diagnostic imaging or AI devices. The parameters (WBC, RBC, HGB, HCT, PLT, RET) are quantitative measurements.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically refers to resolving disagreements among multiple human readers/experts. Since the "ground truth" for a calibrator is based on instrumental measurements and adherence to specifications, not expert consensus on qualitative interpretation, an adjudication method is not relevant here.
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
A MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret medical cases. XN CAL™ is a calibrator, not an AI diagnostic device. Therefore, AI assistance for human readers is not a component of this device's intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study was not done/is not applicable in the context of an algorithm. XN CAL™ is a physical chemical product (an in-vitro diagnostic product), not a software algorithm. Its performance is evaluated through laboratory stability and precision testing on hematology analyzers, not through an algorithm's standalone accuracy.
7. The Type of Ground Truth Used
The "ground truth" for performance of XN CAL™ would be established through a combination of:
- Reference Methods/Standard Measurements: The concentrations/values of the assayed parameters (WBC, RBC, HGB, etc.) in the calibrator material would be determined using highly accurate and precise reference methods or against established reference materials.
- Predicate Device Performance: A key aspect of the "ground truth" in this 510(k) is the performance of the legally marketed predicate device (X-CAL™), as the newer device (XN CAL™) aims to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable and not provided. XN CAL™ is a physical calibrator material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided as there is no "training set" for this type of 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.