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510(k) Data Aggregation
(316 days)
Biophen Protein C 5 & 2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method. Biophen Protein C 5 & 2.5 Kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.
Biophen Protein C is a chromogenic assay consisting of chromogenic substrate and Protein C activator.
This document describes a 510(k) submission for the "Biophen Protein C 5 & 2.5" device, a chromogenic assay for the quantitative determination of Protein C activity in human plasma. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Coamatic Protein C".
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the Biophen Protein C device. Instead, it presents performance data for "Intra-Assay CV%" and "Inter-Assay CV%", which are common metrics for assay precision. The implication is that these performance characteristics are considered acceptable due to their similarity to the predicate device, which is already legally marketed.
| Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Biophen Protein C 5 & 2.5) |
|---|---|---|
| Intra-Assay CV% | Not explicitly stated; likely < 1.17% (based on predicate) | Sample 1: 0.37%Sample 2: 1.17%Sample 3: 0.84% |
| Inter-Assay CV% | Not explicitly stated; likely < 1.97% (based on predicate) | Sample 1: 1.26%Sample 2: 1.97%Sample 3: 1.51% |
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: The table provides N values for "Inter-Assay CV%", which are listed as 12, 4, and 12 for Sample 1, Sample 2, and Sample 3, respectively. For "Intra-Assay CV%", the N values are not explicitly stated, but for Sample 2 and 3, they are listed as 10. The total number of samples used for testing is not clearly specified beyond these individual sample group N values.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
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 type of information is not relevant or provided in the context of this 510(k) submission. For diagnostic assays like this, ground truth is typically established by the known concentration or activity of an analyte in a reference material or by comparison to a recognized gold standard method, not by expert consensus on individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a quantitative diagnostic assay. Adjudication methods are typically associated with subjective interpretations of images or clinical assessments, neither of which are described here.
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 is a submission for a laboratory diagnostic assay, not an AI-assisted device requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm; it is a laboratory diagnostic assay. The performance described is "standalone" in the sense that it's the performance of the assay itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of assay would typically involve using calibrators and control materials with known Protein C activity concentrations. The document describes the device as for "quantitative determination," implying that the accuracy of the measurements is assessed against these known values. However, the specific method for establishing this "ground truth" for the performance study samples (e.g., if highly characterized clinical samples or spiked plasma were used) is not detailed.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set in that context. The device is a chemical reagent kit.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm.
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