(28 days)
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibrator based on a buffered aqueous solution. The concentration of the calibrator The Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control.
This document is a 510(k) summary for a medical device (Ammonia/Ethanol/CO2 Calibrator and Controls) and does not contain information typically found in a study proving a device meets acceptance criteria for an AI or software-based medical device.
The provided text describes a calibrator and controls for in vitro diagnostic devices, which are reagents used to ensure the accuracy and precision of laboratory tests on clinical chemistry analyzers. These are physical products, not software/AI, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "MRMC studies," or "standalone performance" as typically applied to AI/software devices are not directly applicable in the same way.
The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of product. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).
Here's a breakdown of the information in relation to your request, highlighting what's missing due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
This type of table is not present in the document because this is not a performance study of an AI/software device. For a calibrator/control, "performance" relates to its ability to accurately and precisely calibrate and control the analytical process of a clinical chemistry analyzer. The document states:
- Intended Use of Calibrator: "for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet."
- Intended Use of Control: "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet."
The "acceptance criteria" here would generally be related to the stability, homogeneity, and assigned values of the calibrator/control, and their ability to ensure the accuracy of the assay. These details are not within this summary. Substantial equivalence usually means that the new device performs similarly to the predicate in these aspects.
| Acceptance Criteria (Implied for Calibrator/Control) | Reported Device Performance (Implied from substantial equivalence claim) |
|---|---|
| Ability to accurately calibrate quantitative Roche methods | Substantially equivalent to predicate device (K952282) |
| Ability to monitor accuracy and precision for quantitative methods | Substantially equivalent to predicate device (K951595) |
| Performance characteristics (e.g., analyte concentrations, stability) | Equivalent to predicate devices (K952282 and K951595) |
Regarding items 2-9, these are generally not applicable to this type of device and submission:
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/software algorithm. The device itself is a physical calibrator/control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant here. The ground truth for the calibrator/control would be the analytically determined true values of the analytes within the product, established through reference methods or highly accurate assays, not expert consensus on images or similar data.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like diagnosis or detection.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a calibrator/control, the "ground truth" refers to the assigned values or the true concentrations of the analytes (Ammonia, Ethanol, CO2) within the calibrator and control materials. This is typically established through a rigorous analytical process using reference methods and highly accurate instrumentation, not expert consensus, pathology, or outcomes data in the way these terms are used for AI/software devices.
8. The sample size for the training set: Not applicable. No training set for an AI/software algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of what's provided for this type of device and submission:
- Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls
- Intended Use: Calibration and quality control for quantitative Roche methods on Roche clinical chemistry analyzers.
- Predicate Device:
- Regulatory Conclusion: Substantial Equivalence to the predicate devices. This means the FDA has determined the new device is as safe and effective as the existing marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the evidence presented by the manufacturer to the FDA demonstrating this substantial equivalence, which would include data on the formulation, stability, and characterization of the calibrator and controls, demonstrating they perform comparably to the predicate. These detailed data points are not typically included in the 510(k) Summary, but rather in the full 510(k) submission.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 § 862.9.