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Device Name :

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Thermo DMA Data-Cal Calibrator is intended for use in the calibration of clinical chemistry assays.

Device Description

Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the Thermo DMA Data-Cal calibrator, structured to answer your questions.

Description of Acceptance Criteria and Device Performance Study

The primary objective of the studies described in the document is to demonstrate the substantial equivalence of the new Thermo DMA Data-Cal calibrator to its predicate device, the Data Medical Associates (DMA) Data-Cal. This is achieved through comparisons of intended use, format, stability, and most critically, performance in clinical chemistry assays, particularly regarding accuracy and traceability.

The acceptance criteria are implicitly defined by two main aspects:

Substantial Equivalence: The new calibrator's features and performance should be comparable to the legally marketed predicate device. This is assessed through direct comparison of features and performance characteristics.
Accuracy and Traceability: The calibrator's assigned values for various analytes should be accurate and traceable to established standards, primarily NIST (National Institute of Standards and Technology) where available. An explicit criterion for performance verification against a secondary calibrator (Verichem) or NIST SRM #909b was set as "to obtain the set point... within +/- 10%".

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence	Intended use, format, and physical state should match the predicate device.	Met. The new calibrator's intended use ("For the quantitative calibration of clinical chemistry assays"), format ("Pooled human sera with constituents added as required to obtain levels"), and physical state ("lyophilized") are identical to the predicate device.
Stability	* Storage Stability: Stable at 2-8°C until expiration date (implied to be equivalent or better than predicate). * Reconstitution Stability: Stable for set number of days after reconstitution (new device proposed 7 days vs. predicate 5 days).	Met.
* Accelerated Stability (36 months at 2-8°C equivalent to 21.5 days at 37°C): Performance after accelerated aging should be comparable to non-stressed material and maintain proposed reconstitution stability. * Real-Time Stability: Material stored at 2-8°C should remain stable until its expiration date.	* Accelerated Stability: The calibrator was reconstituted and compared to non-stressed material after being stressed at 37°C for 21.5 days (equivalent to 36 months at 2-8°C). The proposed 7-day reconstitution stability was validated. * Real-Time Stability: The manufacturer documents real-time stability for equivalent calibrators, and samples of the new calibrator will be held for real-time testing.
Value Assignment & Variability	Vial-to-vial variability should be properly evaluated and consistent with predicate devices.	Met. Duplicate tests were run on ten vials, and results were consistent with those obtained from equivalent predicate devices.
Accuracy & Traceability	* Analyte values should be traceable to NIST primary standards where available. * Performance verification against secondary calibrator (Verichem) or NIST SRM #909b should be within +/- 10%.	Met (mostly). * Analyte values are traceable to NIST where available (12 specific SRMs listed). Primary standards were produced in-house using NIST SRMs. Where NIST SRMs were unavailable, high purity materials and established clinical chemistry procedures were used, with an established history of known performance. * The +/- 10% criterion was met in all cases during performance transfer, except for instances where the value established fell below one, and specifically for Triglyceride SRM #909b, Level 1 which recovered 14% (outside 10%). Thermo DMA rationalizes that the triglyceride set point is valid because the Verichem material recovered within 6% and the previous lot of calibrator recovered its established set point. * Samples of the predicate calibrator were also included, and their results were consistent with historical performance.
Comparative Performance	Results obtained with the new calibrator should not have significant differences compared to the predicate device in clinical chemistry assays.	Met. "No significant differences exist between the results obtained on tests conducted utilizing the Thermo DMA Data-Cal when compared to those obtained when utilizing the predicate device in these studies."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Value Assignment & Variability: Duplicate tests on ten vials were performed to evaluate vial-to-vial variability.
- Analyte Set Points: Twenty replicates were used to determine the mean analyte set points for the calibrator on the Roche Hitachi 717.
- Performance Transfer: The number of samples for the performance transfer is not explicitly stated as a single number but involved testing the secondary calibrator as an unknown, then using it to calibrate an assay with a primary calibrator (where possible), and including vendor calibrators (Verichem) and NIST SRM #909b. This implies multiple runs for each analyte tested.
- Stability: Not explicitly quantified in terms of "test set" samples, but involved 21.5 days of accelerated aging and comparison to non-stressed material.
Data Provenance: The data appears to be prospective, generated specifically for this 510(k) submission. The tests were conducted by Thermo DMA in their facilities (e.g., "samples of the calibrator material will be held for real time stability testing at Thermo DMA"). The text does not specify the country of origin beyond "Thermo DMA, Inc. 845 Avenue G East Arlington, Texas 76011".

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This submission is for a multi-analyte mixture calibrator, not an imaging or diagnostic device requiring human expert interpretation. Ground truth is established through chemical assays, NIST traceability, and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

Not Applicable. Since human interpretation or consensus is not involved in establishing the performance of a calibrator, there is no adjudication method in the traditional sense. The "adjudication" is based on instrumental measurements and comparison to defined reference values (NIST, predicate, vendor calibrators).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a calibrator for clinical chemistry assays, not a diagnostic device requiring human interpretation, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The studies described focus entirely on the performance of the calibrator itself, independent of human interpretation or "in-the-loop" assistance. The calibrator's performance is assessed through its interaction with clinical chemistry assay systems (e.g., Roche Hitachi 717) and its ability to provide accurate and traceable reference points for measurements.

7. Type of Ground Truth Used

Expert Consensus, Pathology, Outcomes Data: None of these.
Physicochemical and Traceable Standards: The ground truth for the analyte values is established through:
- NIST Primary Standards: Where available, assays were calibrated against NIST primary standards, and Primary Standards were produced in-house utilizing NIST Standard Reference Materials (SRM).
- High Purity Materials and Established Clinical Chemistry Procedures: Where NIST SRMs were not available, standards were prepared using high purity materials according to established analytical procedures with known performance characteristics.
- Comparison to Predicate Device and Vendor Calibrators: The performance was also validated by comparing results to those obtained with the predicate device and a recognized vendor's calibrator (Verichem).

8. Sample Size for the Training Set

Not Applicable. This is a calibrator, not an AI/ML algorithm that requires a "training set" for model development. The product itself is the "reference material".

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set in the context of this device, this question is not relevant. The closest analogy would be how the assigned values for the calibrator were established, which is detailed in point 7 above.

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