(111 days)
This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4.
quantex C4: 8 x 6 mL anti-human C4 P/N 3000-22137; 2 x 100 mL Buffer P/N 3000-22130
This document describes a 510(k) summary for the "quantex C4" device, an in-vitro diagnostic test for C4 levels. However, it does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding acceptance criteria, study design for ground truth establishment, and specific performance metrics often associated with AI/software devices. The provided text describes a comparative performance study against a predicate device.
Here's an analysis of what can be extracted and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria (e.g., minimum correlation coefficient, certain accuracy thresholds) for the quantex C4 device. Instead, it reports the result of a comparative study against a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for specific numerical thresholds. | Correlation (r) of 0.9791 with the predicate device (IL Test™ C4) |
| Substantial equivalence to predicate device in performance, intended use, safety, and effectiveness. | Performance demonstrated by a high correlation coefficient (0.9791) in a method comparison study. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Thirty-eight (38) serum samples.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as a "comparative performance study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the type of device and study described. For C4 immunological test systems, the "ground truth" is typically defined by a reference method or an established, reliable predicate device, not by expert human graders or diagnosticians in the same way it would be for imaging interpretation or clinical decision support AI. The "ground truth" here is effectively the measurement obtained from the predicate device within the context of substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, the "ground truth" is based on a predicate device's measurement, not human interpretation requiring adjudication.
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
- MRMC Study: No. This is an in vitro diagnostic device for C4 measurement, not an AI-assisted diagnostic imaging or clinical decision support system. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone in vitro diagnostic test system (reagents and associated instrument). Its performance is evaluated in a standalone manner (without a human interpreting an "AI output"). The comparison is between two automated measurement systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or reference standard for comparison) was the performance of the IL Test™ C4 predicate device, which is an already cleared C4 immunological test system.
8. The sample size for the training set
Not applicable. This device is an in vitro diagnostic reagent system, not an AI/machine learning algorithm. It does not have a "training set" in the computational sense. Its performance is based on the chemical and immunological principles of the assay.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).