(68 days)
Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.
The Toxammonia Calibrator is a human serum based solution containing various nonhuman constituents at defined concentrations.
The provided document describes a medical device submission for a ToxAmmonia Calibrator and its comparison to a predicate device. It is a calibrator for in-vitro diagnostic assays, not an AI/ML powered device. Due to the nature of the device (a calibrator solution) and the provided text, many of the requested fields are not applicable in the context of an AI/ML device study.
Here's an analysis based on the provided text, indicating "Not Applicable" for fields that do not fit this type of device or for which information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on ADVIA IMS Chemistry systems. | Calibrator is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS chemistry systems. |
| Format | Liquid human serum-based solution with nonhuman constituents. | Liquid human serum albumin base to which appropriate nonhuman constituents have been added. |
| Stability at 2-8°C (Unopened) | Stable until expiration date. | Stable at 2-8°C until the expiration date printed on label. |
| Stability at 2-8°C (Opened) | Stable for 3 days. | Stable 3 days after opening when refrigerated at 2-8°C. |
| Levels | Single Level for all constituents. | Single Level. |
Study Proving Device Meets Acceptance Criteria:
The document states, "The stability of the Toxammonia calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material." This indicates a stability study was performed. The primary acceptance criterion appears to be comparable performance and functional equivalence to the predicate device, specifically regarding its use as a calibrator and its stability characteristics. The submission focuses on demonstrating that the new calibrator has similar characteristics to existing commercial products intended for similar use.
2. Sample size used for the test set and the data provenance:
- Sample Size: "three separate lots of calibrator material" were used for stability validation.
- Data Provenance: Not specified, but likely internal laboratory testing by Bayer Healthcare. This is not
retrospective or prospective data in the clinical sense, but rather a product validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a calibrator, "ground truth" refers to the known, precisely manufactured concentrations of analytes within the calibrator solution itself, established through analytical chemistry methods during production, not by expert interpretation.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods are typically employed in studies involving human interpretation or uncertain outcomes (e.g., medical image reading). For a chemical calibrator, performance is assessed through analytical measurements and stability testing against defined chemical standards.
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/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- Analytical Chemistry Standards / Known Concentrations: The "ground truth" for a calibrator refers to the precisely known concentrations of the target analytes (Acetaminophen, Ammonia, Ethanol, Salicylate) that are formulated into the calibrator solution during manufacturing. These concentrations are established through rigorous analytical chemistry methods.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML model. The calibrator itself undergoes manufacturing and quality control, not a training process.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant. The "ground truth" for the calibrator's stated concentrations is established through the manufacturing process and quality control release testing, ensuring the stated analyte levels are achieved.
§ 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.