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The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

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

The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft.

The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.

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 prior to inflation.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (Bridge Occlusion Balloon). It discusses the device's indications for use, comparison to a predicate device, and the basis for its substantial equivalence.

However, it does not contain details about a study that proves the device meets specific acceptance criteria based on performance data. Specifically, the document states:

• "No preclinical or clinical data was needed to support this submission."
• "The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years."

This indicates that any "test data" referred to is related to shelf-life and packaging changes, not a performance study of the device itself with acceptance criteria for a new or modified functionality. There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

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The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

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

The Bridge Occlusion Balloon catheter is constructed of a compliant balloon mounted on a dual lumen shaft. This guidewire lumen is used to pass the catheter over a guidewire.

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 prior to inflation.

This document describes the Bridge Occlusion Balloon, a device intended for temporary vessel occlusion of the superior vena cava (SVC). The purpose of the document is to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally focused on device specifications and performance attributes, rather than specific quantitative metrics with thresholds. This is typical for equivalence claims where the device aims to match the performance of a legally marketed predicate and where the performance itself is described in functional terms.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., how many balloons were tested for burst volume, how many animals were used in the preclinical study). However, it lists various "Design Verification and Validation Testing" categories, along with "Performance Testing," "Sterilization," and "Biocompatibility" tests.

• Preclinical Testing: Mentioned as "preclinical GLP testing." The specific number of animals is not provided.
• Data Provenance: The preclinical study was a prospective study conducted to demonstrate the device's intended use in SVC occlusion. The location of these studies is not specified, but they were conducted by the device manufacturer for regulatory submission in the USA.

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

This information is not applicable in the context of this device and study. The studies described are engineering, materials, and animal studies, not studies involving human interpretation or subjective assessment by experts to establish a "ground truth" as it would be for AI/imaging devices. The "ground truth" for these tests are the objective measurement results and observations of physical performance and biological response.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are primarily objective measurements and observations, not requiring expert adjudication in the manner medical imaging studies might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (balloon catheter), not an AI algorithm for diagnostic interpretation that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the various tests:

• Engineering and Performance Tests: Ground truth is based on the design specifications and measurable physical/chemical properties (e.g., dimensions, material properties, inflation/deflation times, bond strengths, leak detection).
• Biocompatibility Tests: Ground truth is established by standardized biological assays and observation of biological reactions (e.g., cell viability for cytotoxicity, skin reaction for sensitization, blood component analysis for hemolysis).
• Preclinical Animal Study: The ground truth for this segment relates to the objective demonstration of SVC occlusion within the animal model, observed through physiological measurements or imaging.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to the described studies for this physical medical device.

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

Not applicable, as there is no training set for this device.

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