(47 days)
Clinical Chemistry - The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" assays to establish points of reference that are used in the determination of values in the measurement of Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" in human specimens.
The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucainedi in a lyophilized human serum matrix. This material is stable until the date printed on the label when stored as directed.
The provided text is a 510(k) summary for the Sentinel Clin Chem Cal, a multiparameter calibrator. It describes modifications to an existing device, adding new analytes. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of typical diagnostic device performance metrics like sensitivity, specificity, or accuracy.
The document focuses on the calibration process for assigning values to the calibrator itself, rather than evaluating the performance of a diagnostic device that uses the calibrator. Therefore, many of the requested categories for a diagnostic device study are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer based only on the provided text, noting where information is absent or not relevant for this type of device:
1. A table of acceptance criteria and the reported device performance
The document describes the process for assigning values to the calibrator analytes and the quality control steps during that assignment process. It doesn't present acceptance criteria for a diagnostic device's performance (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria (for Calibrator Value Assignment) | Reported Performance (for Calibrator Value Assignment) |
|---|---|
| Reconstituted vial weight acceptability | 2.970-3.030 g |
| % recovery of each control material (single run) | within 85% - 115% |
| % recovery of Internal Master lot (single run) | within 95%-105% |
| Imprecision of measurements (for target value calculation) | 3SD |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is for the calibrator value assignment process, not a diagnostic device's test set.
- Sample Size: 30 randomly selected vials of calibrator material were used for value assignment.
- Data Provenance: Not explicitly stated. The submitter is from Milano, Italy, but the location where the testing was performed is not specified. It's an internal process for calibrator characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes the process of assigning values to a calibrator using an instrument (Abbott ARCHITECT® c8000 System) and predefined internal protocols. It does not involve human experts establishing ground truth in the context of, for example, image interpretation or clinical diagnosis. Traceability to certified reference materials/organizations (DGKC, IFCC, NIST) is mentioned for the analytes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The value assignment process involves calculations of mean, standard deviation, and %CV, with outlier detection, based on instrument readings.
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 document is for a chemical calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply. The "standalone" performance here refers to the calibrator's assigned values being determined by an automated analytical instrument (Abbott ARCHITECT® c8000 System) following a defined protocol, without human interpretive input for the final value.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the calibrator, the "ground truth" (assigned values) is established through a rigorous internal process involving:
- Measurement on a qualified instrument (Abbott ARCHITECT® c8000 System).
- Calibration against an Internal Master Lot.
- Confirmation using control materials.
- Traceability to recognized international and national standards: Deutsche Gesellschaft für Klinische Chemie (DGKC), International Federation of Clinical Chemistry (IFCC), and NIST, SRM 909b.
8. The sample size for the training set
Not applicable. Calibrators are characterized, not "trained" in the machine learning sense. The process described is for determining the values of a batch of calibrators.
9. How the ground truth for the training set was established
Not applicable. As above, there's no "training set." The ground truth for the calibrator's values is established by measuring reconstituted vials on a calibrated instrument against an Internal Master Lot, with traceability to external reference standards, and applying statistical analysis (mean, SD, %CV, outlier detection).
§ 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.