(137 days)
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction 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.
The provided information is for an In Vitro Diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication methods, MRMC study, sample size for training set) are not applicable to the information contained within this 510(k) summary.
However, I can extract information related to acceptance criteria (often tied to performance characteristics) and the study details that demonstrate the device meets these criteria.
Here's an analysis of the provided text:
Acceptance Criteria and Reported Device Performance
The 510(k) summary for "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)" describes performance characteristics based on method comparison studies. While explicit "acceptance criteria" (e.g., minimum correlation coefficient or acceptable bias range) are not stated in a tabular form, the equivalency claim to a legally marketed device (K860894) implies that the new device's performance should be comparable.
The device performance is reported in terms of correlation (r) and bias (y-intercept) from method comparison studies, comparing results obtained using the modified N Antisera with results obtained using the current N Antisera (K860894). The goal is to show substantial equivalence.
| Analyte | Sample Type | Sample Size (n) | Correlation (r) | Bias (y-intercept) |
|---|---|---|---|---|
| IgG | Heparinized | 49 | 0.969 | 0.155 |
| IgG | EDTA | 20 | 0.978 | -0.102 |
| IgA | Heparinized | 49 | 1.003 | -0.031 |
| IgA | EDTA | 20 | 0.947 | 0.014 |
| IgM | Heparinized | 49 | 0.988 | 0.001 |
| IgM | EDTA | 20 | 0.920 | 0.024 |
Implicit Acceptance Criteria: The reported correlation coefficients (all above 0.9) and low bias values indicate good agreement between the modified device and the predicate device, suggesting the performance is acceptable for substantial equivalence. For IVDs, strong correlation and minimal bias are standard expectations for method comparison studies to demonstrate equivalency.
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Sizes:
- IgG (Heparinized): 49 samples
- IgG (EDTA): 20 samples
- IgA (Heparinized): 49 samples
- IgA (EDTA): 20 samples
- IgM (Heparinized): 49 samples
- IgM (EDTA): 20 samples
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, for IVD performance studies, samples are typically collected from a relevant patient population and tested prospectively or retrospectively.
- Test Set Sample Sizes:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an IVD device measuring immunoglobulin concentrations. The "ground truth" for such devices is typically the result obtained from a reference method or a legally marketed predicate device. No human expert interpretation is involved in establishing the "ground truth" for quantitative analyte measurement in this context. Therefore, this question is not applicable.
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Adjudication method for the test set:
- Not applicable as the "ground truth" is established by a quantitative assay, not by expert interpretation requiring adjudication.
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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 is an IVD assay, not an AI/ML-driven diagnostic imaging device requiring human reader interpretation or assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone IVD assay. Its performance is evaluated independently by comparing its results to a predicate device. There is no "human-in-the-loop" component in the operational analysis of this quantitative assay.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or reference standard) is the measurement obtained from the legally marketed predicate device (K860894), also "N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) assay" on the BN™ Systems. This is a comparison between two quantitative assays.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. Performance is evaluated on test samples.
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How the ground truth for the training set was established:
- Not applicable as there is no training set for this type of IVD device.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).