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The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

The Destiny Max instrument performs coagulation testing (clotting, chromogenic and immuno-turbidimetric) using human samples. The system is comprised of an instrument (Destiny Max Analyzer) that performs the tasks necessary to general an assay result together with a Personal Computer (PC) that receives the user's secueeds and provides the results. The assays used with the Destiny Max are generally requences detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations.

The Trinity Biotech Destiny MAX Coagulation Analyzer is a multipurpose system for in vitro coagulation studies. Its acceptance criteria and performance are detailed through a method comparison study and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the performance is reported through method comparison against a predicate device (AMAX Destiny) and precision data, implying an expectation of strong correlation (for method comparison) and low variability (for precision).

Method Comparison (Slope, Intercept, R/R² values):
The device performance is reported across various assays (TriniCLOT PT HTF, TriniCLOT Excel S, TriniCLOT APTT S, TriniCLOT Thrombin Time, TriniCLOT Fibrinogen, TriniCLOT FVII, TriniCLOT FIX, TriniCHROM Antithrombin IIa, TriniLIA D-Dimer) in both optical and mechanical modes (where applicable). The reported R or R² values are consistently high, ranging from 0.88 to 1.00. Slopes are generally close to 1 and intercepts close to 0, indicating strong correlation and agreement with the predicate device.

Linearity (R values):
For linearity, the reported R values are all very high, ranging from 0.993 to 1.000.

Precision (%CV values):
Precision is assessed at different levels for each assay and mode, with "Within Run" and "Total" %CVs reported. The %CV values generally range from 0.6% to 24.2%, depending on the assay, level, and mode. For most clotting assays (PT, APTT, Thrombin Time), the %CVs are often below 5%. For Fibrinogen, FVII, FIX, Antithrombin, and D-Dimer, some %CVs are higher, particularly at lower concentrations or for “Total” precision.

Since specific acceptance criteria were not explicitly stated (e.g., "R² must be > 0.95" or "%CV must be < 10%"), the determination of "meeting acceptance criteria" is inferred from the high reported correlation and acceptable precision for in vitro diagnostic devices. The submission implies these results demonstrate substantial equivalence and acceptable performance.

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

• Method Comparison:
  • The sample sizes (N) for the method comparison study vary by assay and site, ranging from 19 to 117 clinical samples per assay/site combination.
  • The data provenance is described as collected at 3 sites (implying clinical or laboratory settings). The document refers to "a variety of clinical samples," suggesting retrospective or prospectively collected samples from a clinical population. The country of origin is not explicitly stated but implied to be regions where the predicate device (AMAX Destiny) is used.
• Linearity: The sample size for linearity studies is not explicitly stated in terms of number of patient samples, but rather the range of concentrations tested.
• Precision: The sample sizes (N) for precision studies vary by assay, level, and site, with most entries showing N values between 45 and 60 runs. These typically refer to repeated measurements of control materials or pooled patient samples over several days/runs. Data provenance is from 3 sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (coagulation analyzer) does not typically involve human expert interpretation for "ground truth" establishment in the same way imaging or pathology devices do. The "ground truth" for the test set is established by the predicate device, the AMAX Destiny Coagulation Analyzer. Therefore, no human experts were involved in establishing the ground truth for this comparison study. The performance of the predicate device itself is implicitly considered the reference standard.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" or reference method for comparison is the predicate device's measurement. There is no human interpretation or classification that would require an adjudication method.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurements, not a diagnostic imaging or interpretive device that would typically involve human readers.

6. Standalone Performance

Yes, a standalone performance assessment was conducted in the form of linearity and precision studies. These studies evaluate the Destiny MAX's inherent measurement capabilities independent of direct comparison to the predicate device for each individual test.

• Linearity data (Table 3) shows the analytical measurement range and correlation (R value) of the Destiny MAX for various assays.
• Precision data (Tables 4-12) reports the within-run and total precision (%CV) of the Destiny MAX for various assays and at different concentration levels, demonstrating its reproducibility and variability.

7. Type of Ground Truth Used

• For the method comparison study, the "ground truth" was the measurements obtained from the predicate device, the AMAX Destiny Coagulation Analyzer. This establishes substantial equivalence by demonstrating comparable performance.
• For linearity and precision studies, the ground truth is analytical standards, control materials, or known concentrations used to characterize the device's inherent performance.

8. Sample Size for the Training Set

The document does not provide details on a "training set" for the Destiny MAX in the context of machine learning or AI. This device is a quantitative analyzer, and its development would typically involve engineering, calibration, and internal validation steps, rather than traditional "training sets" as understood in AI/ML contexts. The focus of the 510(k) submission is on performance verification against a predicate and analytical characteristics.

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

Not applicable, as there is no mention of a "training set" in the context of AI/ML for this device. The device's operational parameters and calibration are established through standard laboratory practices using reference materials and established assay principles.

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