(70 days)
DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia. ethanol, and lactate. DOCUMENT Ammonia. Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.
DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol. and lactate. The formulation design provides a liquid calibrator intended for use on automated. semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).
The provided text describes a 510(k) summary for the DOCUMENI® Ammonia, Ethanol, Lactate Calibrator. The primary purpose of this document is to establish substantial equivalence to predicate devices, not to present a comprehensive study proving the device meets specific acceptance criteria in the context of a typical AI/medical device study.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the information provided because this is a submission for a calibrator, not a diagnostic or AI-driven medical device.
However, I can extract the relevant information from the document that aligns with your request as much as possible for a calibrator device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., target accuracy, precision thresholds). Instead, the performance is demonstrated by comparing the new calibrator's behavior to that of predicate calibrators through an established protocol. The implicit acceptance criterion is "comparable behavior" or "similar manner" to the predicate devices when used in an analytical system.
| Characteristic / Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance (Summary of results) |
|---|---|---|
| Ammonia Calibration | Comparable to NERL 100µmol/L Ammonia Standard using BMC Ammonia reagents on a Hitachi 717 | "behaves in a similar manner" compared to the predicate |
| Ethanol Calibration | Comparable to Beckman Alcohol Kit Calibrator with Beckman Reagents on a Beckman Synchron CX5 | "behaves in a similar manner" compared to the predicate |
| Lactate Calibration | Comparable to Beckman CX Multi Calibrator using Beckman Lactate reagent on a Beckman Synchron CX5 | "behaves in a similar manner" compared to the predicate |
| Suitability | Suitable for use as a calibrator | "is suitable for use as a calibrator for the listed analytes on those systems tested." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "patient samples" were used in the equivalence study. It states the study followed "NCCLS EP9 Protocol: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline." The NCCLS EP9 guideline typically recommends a minimum of 40 patient samples for method comparison and bias estimation. However, the exact number used in this specific study is not explicitly stated in the provided text.
- Data Provenance: The data provenance is from "patient samples." The country of origin is not specified, and it is a prospective comparison study between the new calibrator and existing predicate calibrators using real patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a calibrator device, not a diagnostic device requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" for a calibrator is its assigned value, verified through analytical methods.
4. Adjudication method for the test set
This is not applicable for a calibrator device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments.
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
No, an MRMC study was not performed. This type of study is relevant for AI-powered diagnostic devices involving human readers, which is not the case for a chemical calibrator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a calibrator, not an algorithm. The "standalone performance" in this context would be the calibrator's assigned values and its stability, which are implied by the comparison to predicate devices and the stability information provided in the table. The study compared the entire analytical system's performance when using the new calibrator versus the predicate calibrators.
7. The type of ground truth used
For a calibrator, the "ground truth" is established by its traceability (for ammonia and ethanol) or assigned value (for lactate), often derived through validated reference methods or comparison to established reference materials. The comparison study itself uses the predicate calibrators as the reference for "ground truth behavior" within the analytical systems.
8. The sample size for the training set
This is not applicable. The device is a chemical calibrator, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.