(71 days)
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.
The provided text describes a 510(k) premarket notification for a medical device called "Calibration Plasma LMW Heparin," not an AI/ML SaMD product. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts, and adjudication methods) are not applicable to this submission.
However, I can extract information related to the device's performance study and acceptance criteria as presented in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the CV percentages, but it lists the performance data from a precision study. For this type of in vitro diagnostic calibrator, the reported precision (CV%) is the key performance metric. The predicate device's performance would typically serve as an implicit benchmark for substantial equivalence.
| Description | Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Calibration Plasma LMW Heparin Level 1 | Within Run %CV | Not explicitly stated (expected to be low for calibrators, comparable to predicate) | 0.018 (SD) |
| Between Run %CV | Not explicitly stated | 0.008 (SD) | |
| Total %CV | Not explicitly stated | 0.024 (SD) | |
| Calibration Plasma LMW Heparin Level 2 | Within Run %CV | Not explicitly stated | 2.99 % |
| Between Run %CV | Not explicitly stated | 1.47 % | |
| Total %CV | Not explicitly stated | 4.24 % | |
| Calibration Plasma LMW Heparin Level 3 | Within Run %CV | Not explicitly stated | 2.21 % |
| Between Run %CV | Not explicitly stated | 0.00 % | |
| Total %CV | Not explicitly stated | 2.58 % |
2. Sample sized used for the test set and the data provenance
- Sample Size: The precision study was performed "over multiple days with multiple runs (n=60)" for each of the tri-level calibrators. This implies 60 technical replicates were used for the statistical calculation of CVs for each level.
- Data Provenance: The data was generated internally by Instrumentation Laboratory Company, in their labs, using "specific lots of IL reagents on IL instrumentation." The country of origin is implicitly the United States, where the company is located. The study is prospective in the sense that it was conducted specifically to evaluate the performance of this new calibrator.
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 device is an in vitro diagnostic calibrator. "Ground truth" for this device is defined by its manufacturing specifications and metrological traceability, not by expert interpretation. The "truth" is the assigned value of the calibrator.
4. Adjudication method for the test set
Not applicable for a precision study of an in vitro diagnostic calibrator.
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 device is an in vitro diagnostic calibrator, not an AI/ML-driven diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept does not apply to this device. The calibrator itself does not have an "algorithm" or "standalone performance" in the context of AI/ML. Its performance is measured by its precision and ability to establish a calibration curve.
7. The type of ground truth used
The "ground truth" for a calibrator is its assigned value, which is established through a rigorous process of metrological traceability, typically against international reference materials or methods. The document does not detail how the absolute 'Mean IU/mL' values (-0.03, 0.47, 0.80) were assigned, but it's understood to be part of the product's manufacturing and assay development process, following established metrological principles for calibrators.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.