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The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.

The Bridge Plus Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) or the inferior vena cava (IVC) for the purpose of providing occlusion, emergency control of hemorrhage and perioperative occlusion in the event of an SVC or IVC tear or perforation during a vascular procedure.

The Bridge Plus Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a 12Fr dual lumen nylon shaft. This guidewire lumen is used to pass the catheter over a guidewire. The balloon has a length of 80mm and inflation diameter ranging from 20-29mm. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC or IVC prior to inflation.

This FDA 510(k) clearance letter pertains to a medical device, the Bridge Plus Occlusion Balloon, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance specifications and verification/validation testing described in the submission, rather than clinical study endpoints for AI/software devices. The provided document does not describe a study involving human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various Design Verification and Validation Testing categories. For these types of medical devices, the "acceptance criteria" would be the pre-defined performance specifications for each test, which the device must meet to be considered safe and effective and substantially equivalent to a predicate device. The "reported device performance" indicates that the Bridge Plus Occlusion Balloon met these specifications.

Note: The document does not provide the specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it states that "Performance testing data have demonstrated that the Bridge Plus Occlusion Balloon meets performance specifications to support substantial equivalence to the predicate devices." and that the conducted tests "validate and verify that the subject device met all specifications."

2. Sample Size Used for the Test Set and Data Provenance

The document describes laboratory and bench testing rather than clinical studies with "test sets" of patient data. Therefore, the concept of sample size for a test set of data and data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device's submission. The testing was conducted on the physical device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a physical medical device (occlusion balloon) and not an AI/software device, the concept of "ground truth established by experts" for a test set is not applicable. Device performance was evaluated against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

As this is not an AI/software device or a clinical study with subjective assessments, an "adjudication method" for a test set is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI products where human reader performance is being evaluated with and without AI assistance. The Bridge Plus Occlusion Balloon is a physical medical device for temporary vessel occlusion.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO for sterilization and biocompatibility), and performance benchmarks established by predicate devices. The device's physical and mechanical properties were tested against these pre-defined quantifiable criteria.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this physical medical device. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for this physical device, the method for establishing its "ground truth" is not applicable.

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