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510(k) Data Aggregation
(167 days)
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. This kit is for in vitro diagnostic use. High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma. All plate wells contain antibody to PAI-1.
The provided text describes a 510(k) summary for the IMUBIND® Plasma PAI-1 ELISA, a quantitative factor deficiency test. The summary focuses on demonstrating substantial equivalence to a predicate device rather than setting specific acceptance criteria and proving achievement through a detailed study with clinical endpoints.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy against a reference standard). Instead, it demonstrates substantial equivalence to a predicate device through method comparison and precision studies. The "performance" reported is primarily statistical correlation and variability.
| Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (IMUBIND vs. Predicate or IMUBIND's own precision) |
|---|---|---|
| Method Comparison | Positive correlation comparable to the predicate device. | "The regression statistics in Table 1 indicate a positive correlation between the IMUBIND assay and the predicate device." (Specific regression equation and correlation coefficient are present in a table, but the values themselves are not fully rendered in the provided text for "regression" and "correlation"). |
| Intra-Assay CV% | Low variability, comparable to typical ELISA performance. | Lot 1: 5.7%, 4.1% |
| Lot 2: 5.7%, 4.2% | ||
| Inter-Assay CV% | Low variability, comparable to typical ELISA performance. | Lot 1: 5.1%, 2.1% |
| Lot 2: 4.7%, 4.7% |
Note: The table for "Method Comparison" in the original text is malformed and does not clearly present the regression equation or correlation coefficient values. It only states "Regression" and "And 100 Million," making it impossible to extract specific numerical performance for this section. The key takeaway from the text is that a positive correlation was observed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of samples (patients) used for the method comparison study. It only states that "Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA." It also doesn't mention the number of runs for the method comparison.
- Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is a method comparison against a legally marketed predicate device, not a performance study against a clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical adjudication process described for the test set, as it was a method comparison study.
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 in vitro diagnostic (ELISA) kit for measuring a biomarker, not an imaging or interpretive AI device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the assay itself. The performance data presented for "Method Comparison" and "Precision" describe the standalone performance of the IMUBIND® Plasma PAI-1 ELISA.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the method comparison study was the results obtained from the predicate device (TintElize® PAI-1). For precision, the "ground truth" was the expected value of the control samples.
8. The sample size for the training set
Not applicable. This device is an ELISA assay, not a machine learning or AI algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an ELISA assay.
In summary: The submission aims to establish substantial equivalence for the IMUBIND® Plasma PAI-1 ELISA to a predicate device (TintElize® PAI-1). It does so by showing similar method, performance characteristics (correlation, precision), intended use, reagents, storage, stability, specimen types, and limitations. The "study" proving the device meets the (implied) acceptance criteria is the method comparison and precision study, which demonstrated positive correlation with the predicate and acceptable intra- and inter-assay variability for the new device. A precise sample size for the method comparison study is not provided in the summary.
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