(20 days)
The Creatine Kinase MB Isoenzyme Verifier is an in vitro diagnostic product for verification of the Creatine Kinase MB Isoenzyme (CKMB) method on the Dimension® clinical chemistry system and Dimension Vista™ System.
CKMB Verifier is a lyophilized human serum base product. Level 1 contains no CKMB, Levels 2 and 3 contain CKMB from a simian heart source. The kit consists of six vials, two vials per level. The volume per vial is 1.0 mL.
The provided text describes a 510(k) submission for the Dimension® Creatine Kinase MB Isoenzyme Verifier (CKMB Verifier - DC27). This product is a calibrator material used for verifying the CKMB method on Dimension® and Dimension Vista™ clinical chemistry systems.
It's crucial to understand that this submission is for a calibrator material, not a diagnostic device that directly measures a patient's CKMB levels or diagnoses a condition. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance of the verifier itself in its intended role of QC/calibration, not the diagnostic accuracy of a clinical test. The study described focuses on demonstrating substantial equivalence to a predicate device, and the specifics around clinical performance (e.g., sensitivity, specificity, accuracy against a gold standard in patient samples) are not applicable or detailed for a calibrator.
Based on the provided information, here's an attempt to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a direct "performance" study in the sense of a diagnostic device. The primary "performance" aspect highlighted is its substantial equivalence to a previously cleared device (K863840) with an expanded intended use. For calibrators, performance is typically tied to stability, homogeneity, and its ability to act as a stable reference for the assay.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Verification of CKMB method on Dimension® and Dimension Vista™ Systems. | The device meets this intended use, which is an expansion of the previous 510(k) (K863840) without changes to the product features. |
| Analyte: Creatine Kinase MB Isoenzyme | Contains CKMB. |
| Form: Lyophilized | The device is lyophilized. |
| Traceability: Dimension® clinical chemistry system values. | The device traces to Dimension® clinical chemistry system values. |
| Matrix: Human serum based product containing CKMB from simian heart source. | The device is a human serum based product containing CKMB from simian heart source. |
| Levels: Three levels. | The device has three levels (Level 1: no CKMB, Levels 2 & 3: with CKMB). |
| Substantial Equivalence: To predicate device K863840, with expanded intended use. | The FDA found the device substantially equivalent to the predicate device (K863840) for its expanded intended use. This implies the device performs comparably to the predicate in its role as a verifier. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" or a quantified sample size for a performance study in the way one would for a diagnostic device. The assessment is based on the characteristics of the calibrator material itself and its comparison to the predicate device. Therefore, details about data provenance (country, retrospective/prospective) are not provided as it's not a clinical data-driven submission in that sense.
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 material, "ground truth" doesn't involve clinical expert consensus. Its value is established through manufacturing processes, analytical testing, and traceability to reference methods or standards, usually by the manufacturer's own qualified personnel using established laboratory practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described as this is not a diagnostic device relying on interpretation of clinical data.
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 a calibrator material, not an AI-powered diagnostic tool, and involves no human interpretation of images or clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical calibrator material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a calibrator like the CKMB Verifier, the "ground truth" or reference values are established through:
- Analytical methods and certified reference materials: The concentrations of CKMB in the verifier levels are determined by rigorous analytical testing using validated methods and, ideally, traceable to established reference materials or methods.
- Manufacturer's internal quality control and validation: The manufacturer performs extensive testing to ensure the lot-to-lot consistency, stability, and assigned values of the calibrator material.
8. The sample size for the training set
Not applicable. There is no training set as described for an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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.