(196 days)
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer).
In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
This appears to be a 510(k) summary for an in vitro diagnostic (IVD) device, not a medical device in the typical sense of AI-powered diagnostics. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "number of experts used to establish the ground truth" are not applicable to this type of submission.
Here's the information extracted and formatted to the best of my ability given the nature of the document:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with Legally Marketed Device: (Implicit: High correlation demonstrating equivalence) | Correlation Coefficient: 0.973 |
| Y-intercept (compared to legally marketed device): 3.74 | |
| Slope (compared to legally marketed device): 0.85 | |
| Inter-assay Precision: (Implicit: Low %CV indicating reproducibility) | Range of %CV: 0.89 - 7.73% |
| Intra-assay Precision: (Implicit: Low %CV indicating repeatability) | Range of %CV: 1.31 - 2.89% |
Note: The document implies the acceptance criteria through the presentation of performance data and the claim of substantial equivalence. Specific thresholds for 'acceptable' correlation coefficients or %CVs are not explicitly stated, but the reported values would have been deemed acceptable by the FDA for clearance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Correlation Study: 50 serum samples.
- Data Provenance: Not explicitly stated. Given the manufacturer is in Germany and the distributor in the US, the samples could be from either region or a mix. The document does not specify if the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an IVD device for quantitative measurement, not an AI diagnostic that requires expert interpretation to establish ground truth for image or clinical data. The "ground truth" for this device is based on the performance of a legally marketed, predicate device and established laboratory precision methods.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method (like 2+1, 3+1) is relevant for this type of IVD device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done, as this is an IVD for quantitative measurement and does not involve human readers interpreting results in the way AI diagnostics do.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is an IVD medical device. Its "standalone performance" is represented by its analytical performance characteristics (correlation, precision) when measuring samples. It is inherently a standalone device in that it provides a quantitative result without direct human interpretation of a complex output, unlike an AI algorithm that might flag or diagnose.
7. The Type of Ground Truth Used
The "ground truth" for proving equivalence was the results obtained from the legally marketed predicate device (BIND A RID™ C1 assay) when tested on the same samples. For precision, the ground truth is statistical measurements based on repeated testing of control samples.
8. The Sample Size for the Training Set
Not applicable. This is an IVD device that uses specific antibodies for an immunochemical reaction and nephelometry, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the system involves calibration using standards of known concentration.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no "training set" in the AI sense. For calibration where "standards of known concentration" are used, the ground truth for these standards would be established through highly controlled laboratory procedures, often traceable to reference materials or primary calibrators.
§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).