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Trapper Exchange Device is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. Trapper Exchange Device is not intended for use outside of the guide catheter.

Boston Scientific Trapper" Exchange Device is an accessory device used to facilitate interventional device exchange while maintaining wire position in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. Trapper" Exchange Device is a fixed wire catheter that has a balloon near the distal tip. The 10mm balloon is designed to secure a 0.014inch wire within a 6F to 8F guide catheter when inflated to 12atm. There is a 1mm radiopaque marker band in the tip and a 2mm marker band at the proximal edge of the balloon to facilitate its placement and identification during catheter exchanges. Trapper" Exchange Device has a single lumen luer hub for inflation and deflation of the balloon. The proximal shaft has markings with an adjustable stop for 90cm and 100cm guide catheter lengths to facilitate balloon placement. The proximal stop is pre-set for a 90cm guide.

Trapper" Exchange Device is designed for use with guide catheters having internal lumen diameters in the range of 6F (0.070inch or 1.7mm) to 8F (0.091inch or 2.3mm) and lengths ≥ 90cm. In 6F guide catheters the PCI catheter to be exchanged must have a shaft OD (Outer Diameter) ≤ 3.2F (0.043inch or 1.1mm).

The set is supplied as a single use sterile device.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification summary for the Trapper™ Exchange Device, which states that clinical studies were not deemed necessary.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical engineering tests and a literature review, rather than presenting results from a study against specific acceptance criteria for performance metrics.

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The GORE® TIPS Set, GORE® TIPS Sheath and GORE® TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.

The GORE® TIPS Set consists of the GORE® TIPS Sheath and the GORE® TIPS Needle, which may be supplied together or individually.

GORE® TIPS Sheath: Transjugular Liver Access Introducer Sheath and Dilator:
The GORE® TIPS Sheath consists of a flexible introducer sheath with a hemostatic valve and a dilator. The introducer sheath includes an inner PTFE layer, a stainless steel coil and an outer jacket. The dilator has a tapered leading end and provides dilatation of the access vessel. The dilator hub has a direction indicator to allow identification of the leading end curvature direction. The dilator hub may be locked into place in the hub of the introducer sheath to prevent the dilator backing out of the sheath.

GORE® TIPS Needle: Transjugular Liver Access Needle and Guiding Catheter:
The GORE® TIPS Needle consists of a stainless steel hollow shaft and a guiding catheter. The needle handle has a direction indicator to allow identification of the leading end curvature direction. The guiding catheter has a tapered leading end and provides protection around the sharp needle tip during vascular access. A white needle status band printed on the trailing end of the needle shaft ensures correct positioning of the guiding catheter around the needle shaft when covering the sharp needle tip. The guiding catheter hub has a direction indicator that identifies the leading end curvature direction.

The set is supplied as a single use sterile device.

The provided document is a 510(k) premarket notification for the GORE TIPS Set, a medical device used for transjugular liver access. It primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies.

Therefore, the document does NOT contain information regarding:

• A table of acceptance criteria and reported device performance: The document lists design verification and validation tests, but it does not specify acceptance criteria (e.g., quantitative thresholds) for these tests or report specific numerical performance results. It only states that the device "meets the requirements in the applicable standards and specifications."
• Sample sizes used for the test set and data provenance: While non-clinical tests were performed, the sample sizes and the origin of any data (beyond the device manufacturer) are not provided.
• Number of experts and their qualifications for ground truth: No expert involvement is mentioned in establishing ground truth for a test set, as no clinical study was performed.
• Adjudication method for the test set: Not applicable as no clinical test set requiring adjudication was used.
• MRMC comparative effectiveness study: No MRMC study was conducted.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Ground truth, in the sense of clinical outcomes or expert consensus for a diagnostic task, is not applicable here as no clinical study for performance was conducted. The "ground truth" for the non-clinical tests would be the established engineering and material standards.
• Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.
• How ground truth for the training set was established: Not applicable.

What the document does describe is an argument for substantial equivalence based on technical principles, materials, intended use, and a review of existing scientific literature and standards, rather than a de novo clinical performance study.

The core of the "proof" is based on:

1. Bench Testing (Non-Clinical Information): A series of design verification and validation tests were performed (listed in Table 5-2 and Table 5-3). These tests assess physical characteristics, mechanical properties, and compatibility with other devices. The document states that the "test results demonstrate that the GORE® TIPS Set meets the requirements in the applicable standards and specifications." While specific numerical acceptance criteria and results are not provided, the implication is that the device performed within acceptable limits defined by those standards.
2. Biocompatibility Testing: Tests were performed in accordance with ISO 10993-1, demonstrating the device is biocompatible. The specific tests performed are listed (Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, Complement Activation Assay, Thromboresistance). This indicates adherence to established safety standards for biological interaction.
3. Comparison to Predicate Devices: The primary argument for substantial equivalence is a detailed comparison (Table 5-1) of the GORE TIPS Set to two legally marketed predicate devices (Cook® Medical Flexor® Check-Flo II® Introducer Set and Cook® Medical Needle Catheter Combination). This comparison covers:
   • Clinical Comparison: Principle of operation, intended use, contraindications, single use, supplied sterile. The document states that the clinical use, designs, principles of operation, and materials are "the same" or "similar."
   • Technical and Biological Comparison: Device description, introducer sheath compatibility, working length, curve angle, composition, dilator ID/guidewire compatibility, material, needle gauge, working length, curve angle, material, needle guide ID/guidewire compatibility, material, and adherence to various ISO standards (ISO 10555-1, ISO 11070, ISO 9626, ISO 10993-1, ISO 11607-1, etc.).
   • Conclusion of Equivalence: The document explicitly states, "no significant difference in clinical, technical and biological parameters was identified between the GORE® TIPS Set and the Cook® Medical Flexor® Check Flo® Introducer Set and Cook® Medical Needle Catheter Combination."

In summary, the "study" proving the device meets criteria is primarily a non-clinical, comparative assessment against established predicate devices and relevant industry standards, rather than a clinical trial with a defined test set, expert ground truth, or statistical performance metrics as typically seen for (e.g., AI/diagnostic) devices.

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