(66 days)
The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension® clinical chemistry system with the Heterogeneous Immunoassay Module.
The Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is a liquid product. The kit consists of 10 vials, two each at levels 1 through 5. Level 1 vials contain 2 mL of stripped human serum. Vials for levels 2 through 5, contain 1 mL with concentrations of L-triiodothyronine in a stripped human serum base.
The provided document, K032697, is a 510(k) premarket notification for a medical device (Dimension® Total Triiodothyronine (T3) Calibrator (RC414)). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's an explanation of why the requested information is absent based on the document's content:
- Acceptance Criteria and Reported Device Performance: Instead of performance criteria, the document focuses on comparing the proposed device to a predicate device based on characteristics like intended use, analyte, matrix, form, volume, and levels.
- Study That Proves the Device Meets Acceptance Criteria: No such specific study is described. Substantial equivalence is concluded based on the comparison table and the similarities in intended use.
- Sample Size for Test Set and Data Provenance: Not applicable in a substantial equivalence filing of this type for a calibrator. There isn't a "test set" in the context of evaluating diagnostic accuracy as would be for an AI algorithm.
- Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth for a calibrator is established through its manufacturing process and chemical properties, not by expert interpretation.
- Adjudication Method: Not applicable for a calibrator's performance evaluation.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. These studies are relevant for diagnostic devices where human readers interpret medical images or data, and an AI might assist them. This is a calibrator, a chemical product used to standardize measurements.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this device does not involve an algorithm or AI.
- Type of Ground Truth Used: The "ground truth" for a calibrator is its accurately determined concentration of the analyte (T3 in this case). This is established through analytical chemistry methods during manufacturing, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
- Sample Size for the Training Set: Not applicable. This device is a chemical calibrator, not a machine learning model that requires a training set.
- How the Ground Truth for the Training Set Was Established: Not applicable.
In summary, the provided K032697 document is for a medical device calibrator and demonstrates substantial equivalence to a predicate device. It does not involve AI or diagnostic interpretation, and therefore, the requested information regarding performance studies, ground truth establishment for AI models, and human reader-AI interactions is not present.
The crucial information in the document for K032697 relates to its comparison to a predicate device to establish substantial equivalence.
Here's a table based on the comparison provided in the document:
| Feature | Proposed Device: Dimension® T3 Calibrator (RC414) | Predicate Device: Opus Total T3 Calibrator (K953160) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | T3 | T3 |
| Matrix | stripped human serum base | stripped human serum base |
| Form | liquid | liquid |
| Volume | 2 mL per vial @ level 1; 1 mL per vial @ levels 2-5 | 2 mL per vial @ level 1; 1 mL per vial @ levels 2-6 |
| Levels | 5 levels @ 0, 1, 2, 4, 6.5 ng/ml | 6 levels @ 0, 0.5, 1, 2, 4, 6 ng/ml |
The "acceptance criteria" for this submission are the demonstration of substantial equivalence to the predicate device based on these comparative characteristics. The study demonstrating this is the comparison table and discussion provided in the document, which identifies the similarities and any minor differences. The document concludes that based on this comparison, the Dimension® Total Triiodothyronine (T3) Calibrator (RC414) is substantially equivalent to the Opus Total T3 Calibrators.
§ 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.