Search Results

The V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal circuit to provide a volume reservoir, compliance, and assist in removing air during the vacuum assisted venous drainage operating mode.

Not Found

1. Acceptance Criteria and Reported Device Performance:

The provided document does not contain explicit acceptance criteria and corresponding reported device performance metrics in a tabular format. The document is a 510(k) clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

2. Sample Size for Test Set and Data Provenance:

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) because it is a 510(k) clearance letter, not a clinical study report. Such details would typically be found in a separate submission, often summarized in the "substantial equivalence" section or a specific performance testing report.

3. Number of Experts and Qualifications for Ground Truth Establishment:

The document does not mention the number of experts used or their qualifications for establishing ground truth for any test set. This information is not typically part of a 510(k) clearance letter for a device like this, which is a physical medical device (blood reservoir) rather than an AI/software device that requires human interpretation for ground truth.

4. Adjudication Method for Test Set:

The document does not specify any adjudication method for a test set. This is not applicable given the nature of the device and the content of the 510(k) clearance letter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is usually relevant for diagnostic imaging or AI devices where human reader performance is compared with and without AI assistance. This device (V-Bag and Vac-Box) is a cardiopulmonary bypass blood reservoir, not a diagnostic or AI-powered interpretative tool.

6. Standalone (Algorithm Only) Performance Study:

The document does not mention a standalone (algorithm only) performance study. This is not applicable as the device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. For a physical device like a blood reservoir, ground truth would typically refer to objective measurements of device performance, such as volume capacity, air removal efficiency, biocompatibility, and structural integrity, against predefined engineering specifications and international standards. This information would be found in design verification and validation testing reports, not typically detailed in a 510(k) summary letter.

8. Sample Size for Training Set:

The document does not mention a sample size for a training set. This concept (training set) is relevant for machine learning or AI models, which is not applicable to the V-Bag and Vac-Box described.

9. How Ground Truth for Training Set Was Established:

The document does not mention how ground truth for a training set was established, as it is not applicable to this physical medical device.

Ask a specific question about this device