(96 days)
X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers. Refer to product assay sheet.
X-Cal is a stabilized suspension of human and animal blood, in a solution containing biological salts and anti-microbial preservatives. The product is packaged in plastic vials containing 4.5 ml. The closures are polypropylene screw caps with polyethylene liners. The vials will be packaged in a five welled vacuum formed "clamshell" container. The product must be stored at 2 - 8℃.
The provided text describes a 510(k) summary for the X-Cal™ Assayed hematology calibrator. It focuses on demonstrating substantial equivalence to a predicate device and does not involve typical acceptance criteria related to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the "acceptance criteria" here are implicitly tied to product stability and reproducibility to show it functions similarly to the predicate.
Given the nature of the device (a calibrator) and the provided documentation (a 510(k) summary for substantial equivalence), many of the requested categories for AI/diagnostic studies are not applicable. I will address the relevant points based on the information provided and explicitly state when information is not available or not relevant to this type of device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The device's intended use must be similar to the predicate device. | X-Cal: "X-Cal is used to calibrate Sysmex hematology analyzers." |
| Predicate (Cal-Chex): "Cal-Chex is used to calibrate multi-parameter hematology analyzers." | ||
| (Performance is deemed equivalent for the specified Sysmex analyzers, a subset of the predicate's broader use.) | ||
| Open Vial Stability | The open vial stability should be established and acceptable for its intended purpose. | X-Cal Performance: "24 hours" |
| Predicate (Cal-Chex): "5 days" | ||
| (While different, this is a property of the calibrator, and its 24-hour stability is likely deemed acceptable for routine laboratory use for calibration/verification, as long as it's clearly stated to the user.) Availability of a quantitative metric for this comparison (e.g., % drift from initial values over time) is not explicitly stated but would have been part of the underlying study. | ||
| Closed Vial Stability | The closed vial stability should be established and acceptable, demonstrating shelf-life. | X-Cal Performance: "34 days" |
| Predicate (Cal-Chex): "45 days" | ||
| (Similar to open-vial, a specific stability period is established and deemed acceptable. Actual performance data like % deviation from initial values or target values at 34 days is not explicitly provided in this summary but would be part of the stability study.) | ||
| Reagents | Reagents should be similar in composition to the predicate to support equivalence. | X-Cal Performance: "Same" (as predicate) |
| Predicate (Cal-Chex): "Stabilized Human and Animal Blood" | ||
| (Indicates compositional similarity to predicate was verified.) | ||
| Storage Conditions | Storage conditions should be defined and appropriate for maintaining product integrity. | X-Cal Performance: "2 - 8°C" |
| Predicate (Cal-Chex): "2 - 10°C" | ||
| (Conditions are similar and within acceptable refrigerated ranges.) | ||
| Reproducibility | The device should demonstrate consistent "Run to Run Reproducibility." | "Conclusions Drawn From Tests: Study results show X-Cal to be consistently reproducible..." |
| (Specific quantitative metrics for reproducibility are not provided in this summary, but the study concluded it was "consistently reproducible.") | ||
| Equivalence to Whole Blood | The performance of the calibrator should be comparable to whole blood for the parameters it calibrates. | "Conclusion: ...and Comparison to Whole Blood" |
| (The study assessed this, and based on the overall conclusion of safety and effectiveness, it was deemed adequate. Specific performance data from this comparison is not provided in the summary.) | ||
| Overall Equivalence | The device must be deemed "substantially equivalent" to a legally marketed predicate device, fulfilling its intended use safely and effectively. | "Study results show X-Cal to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. X-Cal is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert." |
| (This is the ultimate conclusion based on all studies performed.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "Three studies of X-Cal were conducted: Run to Run Reproducibility and Comparison to Whole Blood; Open Vial Stability and Closed Vial Stability." However, the number of samples, runs, or batches used in these studies is not provided in this summary.
- Data Provenance: Not explicitly stated. Given the context of a US 510(k) submission for a device manufactured by an Omaha, NE-based company (Streck), it is highly probable the testing was conducted in the USA, but no specific country of origin for the data is mentioned. The studies appear to be prospective in nature, as they involve testing the performance and stability of the newly developed X-Cal product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a calibrator, not an AI or diagnostic device that relies on expert interpretation of images or other data to establish a ground truth. Its performance is measured against instrument readings and stability parameters, which do not inherently require expert "ground truth" in the diagnostic sense. The "ground truth" for calibrators relates to established reference methods or certified reference materials, but these details are not provided in this summary.
4. Adjudication Method for the Test Set
- Not Applicable. As noted above, this type of device does not involve expert adjudication for its performance evaluation.
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
- Not Applicable. This is not an AI diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an AI diagnostic device. The "standalone performance" of the calibrator would refer to its inherent physical and chemical stability and its ability to produce consistent results on hematology analyzers, which is what the "Run to Run Reproducibility" and stability studies address. It does not involve an algorithm.
7. The Type of Ground Truth Used
- For the Open Vial Stability and Closed Vial Stability studies, the "ground truth" would implicitly be the initial measured parameters of the X-Cal product at time zero, against which subsequent measurements at various time points are compared to determine degradation or change within acceptable limits.
- For the Run to Run Reproducibility study, the "ground truth" is the inherent consistency expected from a calibrator, often evaluated by parameters like Coefficient of Variation (CV) or standard deviation across multiple runs.
- For the Comparison to Whole Blood study, the "ground truth" would be the established values or behavior of whole blood samples measured by the analyzer, against which the calibrator's performance (e.g., its ability to set the calibration curve accurately to yield correct whole blood results) is evaluated.
- The comparison to the predicate device (Cal-Chex) uses the known performance characteristics of Cal-Chex as a reference point for demonstrating substantial equivalence.
Specific quantitative "ground truth" values (e.g., target values for specific parameters, acceptable CVs, or deviation limits) are not provided in the summary.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this calibrator 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.