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Dimension Vista® CDT CAL: CDT CAL is an in vitro diagnostic product for the calibration of the carbohydrate-deficient transferrin (CDT) method on the Dimension Vista® System.
Dimension Vista® CDT CON L: CDT CON L is an assayed, low level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).
Dimension Vista® CDT CON H: CDT CON H is an assayed, high level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of carbohydrate-deficient transferrin (CDT).

Dimension Vista® CDT CAL: CDT CAL is a liquid human serum based product containing carbohydrate-deficient transferrin.
Dimension Vista® CDT CON L: CDT CON L is a low level, liquid human serum based product containing human carbohydrate-deficient transferrin.
Dimension Vista® CDT CON H: CDT CON H is a high level, liquid human serum based product containing human carbohydrate-deficient transferrin.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) summary for the Dimension Vista® CDT CAL, Dimension Vista® CDT CON L, and Dimension Vista® CDT CON H devices, which are calibrators and controls for carbohydrate-deficient transferrin (CDT) measurements. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with explicit acceptance criteria for novel diagnostic performance.

Therefore, the nature of the acceptance criteria and the "study" that proves the device meets them will differ significantly from what one might expect for a new diagnostic assay or an AI-powered medical device. In this context, the "acceptance criteria" revolve around demonstrating that the new devices perform similarly to the predicate devices for their intended use (calibration and quality control).

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices. The study conducted is a comparison study against the legally marketed predicate devices.

• Contents: The new calibrator has 4 vials (2.0 mL each) versus the predicate's 3 x 1mL. The new controls have 4 vials (2.0 mL each) versus the predicate's 3 x 1mL. This is a difference in packaging/volume, not core function.
• Storage Temperature: Both are 2 - 8 °C.
• Shelf life: Both are 24 months.
• Composition: Both are liquid human serum-based products containing carbohydrate-deficient transferrin. |

Details of the "Study" (Comparison for Substantial Equivalence)

Given the nature of the device (calibrators and controls) and the 510(k) submission, the "study" is primarily a comparative analysis of the device's characteristics against the predicate device to establish substantial equivalence. It's not a clinical trial in the traditional sense with patient outcomes.

• 1. Sample sized used for the test set and the data provenance:

  • Test Set Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy for patient samples. Instead, the comparison focuses on the characteristics of the calibrators and controls themselves (e.g., composition, storage, shelf life, intended use). There might have been internal analytical verification studies (e.g., lot-to-lot consistency, stability) for the new devices, but these details are not provided in this 510(k) summary.
  • Data Provenance: Not applicable in the same way as clinical data. The data originates from the manufacturer's characterization of their new products and the known specifications of the predicate device.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. "Ground truth" in this context would typically refer to a gold standard for a diagnostic condition. For calibrators and controls, the "ground truth" is their defined concentration or stability characteristics, which are established by the manufacturer through rigorous analytical methods, not by expert consensus in the clinical sense.

• 3. Adjudication method for the test set:

  • Not applicable. There's no adjudication process described for this type of comparison.

• 4. 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:

  • No. This is not an AI-powered diagnostic device, nor is it a diagnostic device where human "readers" interpret results. Therefore, an MRMC study is not relevant or performed.

• 5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • No. This is not an algorithm or AI device. It's a laboratory reagent (calibrator/control).

• 6. The type of ground truth used:

  • For the calibrators and controls, the "ground truth" (or reference standard) is their defined analytical characteristics (e.g., concentration of CDT, stability over time). This is established through internal analytical testing and certification processes by the manufacturer, ensuring traceability to reference materials where appropriate.

• 7. The sample size for the training set:

  • Not applicable. There is no training set for an algorithm as this is not an AI/ML device.

• 8. How the ground truth for the training set was established:

  • Not applicable for the same reason as above.

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