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510(k) Data Aggregation
(88 days)
The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:
- The monitoring of heparin therapy.
- The monitoring of fibrinolysis therapy.
- The screening of disorders of fibrin formation.
- The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).
The provided document is a 510(k) summary for the BC Thrombin Reagent. This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive acceptance criteria and a standalone study for novel device performance. However, I can extract the relevant information from the "Comparative Analysis" and "Precision" sections to address your request as much as possible within the context of this submission.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (BC Thrombin Reagent vs. Predicate) |
|---|---|---|
| Correlation | High correlation with predicate device | Correlation coefficient: 0.93 |
| Agreement (Slope) | Slope close to 1.0 (indicating proportional agreement) | Slope: 1.48 |
| Agreement (Y-intercept) | Y-intercept close to 0 (indicating absence of systematic bias) | Y-intercept: -5.5 |
| Precision (Within-run) | Low variability (e.g., <10% CV) | Ranged from 2.2% to 6.2% |
| Precision (Total) | Low variability (e.g., <10% CV) | Ranged from 3.8% to 7.4% |
Note: The document does not explicitly state numerical acceptance criteria for correlation, slope, or Y-intercept. The criteria are implicitly derived from the goal of demonstrating substantial equivalence to the predicate device. For precision, the reported values are within typically acceptable ranges for IVD assays.
2. Sample size used for the test set and the data provenance
- Sample size for comparative analysis: 67 patients.
- Data provenance: The document does not specify the country of origin of the data. It states the samples were from "normal blood donors, patients undergoing heparin therapy, patients with increased fibrin degradation products," which implies they were collected for the purpose of this comparative study, thus being prospective data for this specific comparison, although the samples themselves might have been collected over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a comparative study comparing a new device to a predicate, the "ground truth" is typically established by the predicate device's measurement. The document does not describe any independent adjudication or expert panel to establish a separate ground truth.
4. Adjudication method for the test set
This information is not provided and is not applicable in this context. The study compares the new device's results directly against the predicate device's results.
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
- A MRMC study was not done.
- This is an in vitro diagnostic (IVD) reagent, not an AI-assisted diagnostic imaging or interpretation device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- A standalone performance study was not explicitly detailed as a separate "algorithm only" study. The comparative analysis with the predicate device served as the primary performance demonstration. The precision study can be considered a standalone performance assessment of the reagent's inherent variability.
7. The type of ground truth used
The "ground truth" for the comparative analysis was the results obtained from the predicate device (Behring Test Thrombin Reagent). The study's purpose was to show that the new reagent performs similarly to the established legal predicate.
8. The sample size for the training set
The document does not mention a training set. This is likely because the BC Thrombin Reagent is an IVD reagent, not a machine learning or AI-based device that typically requires a training set. Its performance is evaluated through direct chemical and analytical comparison.
9. How the ground truth for the training set was established
As there is no mention of a training set, this information is not applicable.
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