(77 days)
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.
ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.
This document is a 510(k) summary for a Calibrator Material (specifically, a lactate dehydrogenase calibrator) used in a clinical chemistry system. The information provided in the input is about a calibration device, not a diagnostic AI device that would have acceptance criteria and performance metrics for patient diagnosis.
Therefore, many of the requested categories are not applicable to the provided document. I will address the applicable points and note where information is not present or relevant for a calibrator.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary for the "Dimension® clinical chemistry system Enzyme I Calibrator" does not include a table of acceptance criteria and reported device performance in the manner typically expected for a diagnostic device that classifies or predicts. This document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.
The key performance criterion for a calibrator is its traceability and ability to correctly calibrate the assay, which is indirectly addressed by the stated traceability to the IFCC LD method.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a calibrator, not a diagnostic device that uses a test set of patient data. The submission focuses on comparing the new calibrator's characteristics to a predicate calibrator.
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 is a calibrator. The "ground truth" for a calibrator is its accurately assigned value, which is established through traceability to a reference method (in this case, IFCC LD at 37°C primary reference method). This doesn't involve expert readers for a test set in the same way a diagnostic image analysis algorithm would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or human adjudication process for a calibrator's performance.
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 a calibrator, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the calibrator itself, the "ground truth" (or basis for its assigned values) is its traceability to the IFCC LD at 37°C primary reference method. This is a recognized international standard for lactate dehydrogenase measurements.
8. The sample size for the training set
Not applicable. This is a calibrator, not an AI device trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. This is a calibrator, not an AI device.
Summary Table for Applicable Information:
| Category | Description for Dimension® Calibrator (K081789) |
|---|---|
| Acceptance Criteria | Not explicitly stated as "acceptance criteria" for performance in a table for diagnostics. The regulatory acceptance is based on demonstrating substantial equivalence to the predicate device, particularly regarding: |
- Analyte: Lactate dehydrogenase
- Use: Calibration of LDI method
- Matrix: Liquid bovine serum albumin base
- Form: Liquid
- Traceability: IFCC LD at 37°C primary reference method. |
| Reported Device Performance | No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the calibrator itself, as its performance is tied to its ability to accurately calibrate the assay. The report states it is "substantially equivalent" to the predicate. |
| Sample Size (Test Set) | Not applicable (no diagnostic test set). |
| Data Provenance (Test Set) | Not applicable. |
| Number of Experts (Ground Truth) | Not applicable for establishing "ground truth" in the context of diagnostic interpretation. The calibrator's value traceability is established by laboratory practices and international standards. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. |
| Standalone Performance Study (Algorithm Only) | Not applicable. |
| Type of Ground Truth Used | Traceability to IFCC LD at 37°C primary reference method for the calibrator's assigned values. |
| Sample Size (Training Set) | Not applicable (no training set). |
| Ground Truth Establishment (Training Set) | 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.