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For the in vitro quantitative immunological determination of human complement C3c in serum and plasma. Measurements of these proteins aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

The Tina-quant Complement C3c ver.2 Test System is based on the activation of the complement system which takes place via a classical and an alternative route. The two pathways come together in a joint terminal path. As a complement factor C3 is a factor common to both pathways, the concentration of C3 and its degradation products (including C3c) can be evaluated as a parameter for activation of the complement system. Human C3c forms a precipitate with a specific antiserum which is determined turbidimetrically.

The provided text describes a 510(k) summary for the Tina-quant Complement C3c ver.2 Test System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a novel study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance studies, and training set details) is not typically included in a 510(k) summary focused on substantial equivalence for an in vitro diagnostic (IVD) device like this one.

However, I can extract the relevant information regarding the acceptance criteria (as implied by comparison to the predicate) and the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

For IVD devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device's performance characteristics demonstrate substantial equivalence to the predicate device. This is shown by comparing key analytical performance parameters.

Study Description:

The study proving the device meets the acceptance criteria (i.e., demonstrates substantial equivalence) is a comparison study against the predicate device, Tina-quant Complement C3c Test System (K951595). The summary states: "The table below indicates the similarities between the modified Tina-quant Complement C3c ver.2 Test System on COBAS Integra analyzers and the predicate, Tina-quant Complement C3c Test System on COBAS Integra analyzers (K951595). In summary, the Tina-quant Complement C3c ver.2 Test System described in this submission is, in our opinion, substantially equivalent to the predicate device."

This comparison highlights that the new device has a broader sample type (includes plasma) and improved analytical sensitivity (lower detection limit) compared to the predicate, while maintaining the same intended use (with expanded sample type), indications for use, wavelength, and analyzer. The measuring range has also shifted to a lower limit, providing a broader range at the lower end.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. For IVD devices comparing performance to a predicate, studies would typically involve a sufficient number of patient samples to demonstrate equivalent or improved performance across various concentrations and clinical conditions. However, the exact number is not detailed in this summary.
• Data Provenance: Not explicitly stated. Given it's a product performance comparison, the data would likely be from laboratory testing. It's not specified if it's retrospective or prospective, nor the country of origin.

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

• This information is not applicable and not included in the provided 510(k) summary. For an IVD device measuring an analyte concentration, "ground truth" is typically established through reference methods, calibrated standards, or validated internal procedures, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable and not included. Adjudication methods like "2+1" or "3+1" are relevant for performance studies where human interpretation of medical images or other complex data is being assessed, often with multiple readers. For an automated IVD test measuring an analyte, this type of adjudication is not part of the performance evaluation.

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 an automated in vitro diagnostic test for measuring an analyte (Complement C3c concentration). It does not involve human readers interpreting images, nor does it incorporate AI assistance for diagnostic interpretation. Therefore, an MRMC study or AI-related effectiveness is irrelevant for this submission.

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

• Yes, implicitly. The device itself is an automated laboratory analyzer for quantitative immunological determination. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement directly, without requiring human interpretation during the measurement process. The study compares the performance characteristics of this automated system to its predicate, also an automated system.

7. The type of ground truth used:

• The "ground truth" for this type of IVD device is generally based on the accurate measurement of the analyte (human complement C3c) using established reference methods, calibrated standards, and quality control materials. The summary does not explicitly state the reference method used to establish the "truth" for the samples tested, but it is implied to be analytical accuracy and precision determined through standard laboratory practices for IVD validation.

8. The sample size for the training set:

• Not applicable. This device is a quantitative immunoassay test system, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. Its performance is based on the chemical and immunological reactions and the associated detection system.

9. How the ground truth for the training set was established:

• Not applicable for the same reasons as #8.

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