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The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

The BigBoss™ Catheters are single use, over-the-wire, disposable percutaneous catheters consisting of a full length coiled stainless steel shafts with PEBAX exteriors. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The device will be available in two models that are differentiated by the distal shaft stiffness. The distal shaft stiffness is specified by the distal grind dimensions of the coiled shaft component. The distal shaft transitions to an enlarged (Imm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The BigBoss Catheter is hydrophilic coated to enhance lubricity. A torque device. coaxially positioned over the outer shaft at the proximal portion of the BigBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.

The Mantaray™ Catheters are single use, over-the-wire, disposable, dual lumen percutaneous catheters that facilitate the placement, support and steering of guidewires through the central guidewire lumen or through one of two sideports (identified by radiopaque markers). The sideports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft. The device will be available in two models that are differentiated by their balloon dimensions.

The Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of full-length stainless steel shafts with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035" 0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip. The device will be available in four models that are differentiated by their distal tip stiffness and/or core wire diameter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BridgePoint Medical Peripheral System:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state pre-defined acceptance criteria for the clinical study with numerical thresholds (e.g., "technical success rate must be > X%"). Instead, it reports the observed performance metrics from the human clinical study. The acceptance for this submission appears to be based on demonstrating substantial equivalence to predicate devices and acceptable safety and effectiveness in the human clinical trial.

Note: The regulatory submission and subsequent FDA letter confirm acceptance based on substantial equivalence and the presented performance data being deemed acceptable for the intended use and safety profile.

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

• Sample Size for Clinical Study (Treated Subjects): 66 subjects
• Total Subjects Screeened (including screen failures): 105 subjects
• Data Provenance: United States (17 investigators at 10 investigational sites). The study was prospective as it's described as a "human clinical study...conducted to confirm the BridgePoint Medical System would perform as intended."

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

The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical study endpoints. Clinical outcomes (MAE, technical success, perforations) are typically assessed by the treating physicians at the investigational sites and potentially reviewed by an independent clinical events committee or data safety monitoring board, but this level of detail is not provided.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study outcomes. Clinical studies often employ independent adjudication committees, but this information is not present in the provided text.

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:

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a mechanical catheter and guidewire system, not an AI-powered diagnostic tool, so such a study would not be applicable.

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

No. This is a medical device (catheters and guidewires), not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used:

For the human clinical study, the "ground truth" was based on clinical outcomes data reported from the study subjects. This includes:

• Safety Endpoints: Occurrence of Major Adverse Events (MAE) such as death, unplanned major amputation, perforation requiring repair, or target lesion revascularization due to procedural complications, within 30 days.
• Effectiveness Endpoints: Overall technical success rate (successful placement of guidewires beyond stenotic peripheral lesions).
• Specific Clinical Observations: Reported perforations.

8. The Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The development and validation of mechanical medical devices involve various engineering tests and pre-clinical studies. The "training" for such devices would be the iterative design and testing process, informed by internal engineering data, bench testing, and animal studies, which are described in the "Performance Data" section.

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

Since this is not an AI/ML algorithm, there isn't a "training set ground truth" as understood in that context. However, the performance of the device's components was established through:

• Bench Testing (In Vitro): Confirmed performance characteristics against established criteria for: Tensile, Burst, Fatigue, Inflation & Deflation Time, Dimensional, Hydration, Guidewire Insert & Withdrawal, Flexibility, Trackability, Guidewire Re-Direction, Markerband Movement & Removal, Markerband & Guidewire Interaction, Kink Resistance, Coating, Torque, Surface Defects, Balloon Protector Removal, Device Shaft Tip Deflection, Corrosion Resistance, Luer and Hub Tests, Radiopacity, and Packaging.
• Animal Studies (In Vivo): Functional performance and safety evaluated in a porcine animal model (6 animals). Outcomes assessed via angiography, histology, pathology, hematology, serum chemistry, and gross necropsy.
• Biocompatibility Testing: Established per ISO standards, including various cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and thrombogenicity evaluations.

These pre-clinical and bench tests serve as the basis for confirming the device's technical specifications and safety profile before human clinical trials.

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The BridgePoint Medical BigBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.

The BigBoss™ Catheter is a single use, over-the-wire, disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with Pebax exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The device will be available in two models that are differentiated by the distal shaft stiffness. The distal shaft stiffness is specified by the distal grind dimensions of the coiled shaft component. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The BigBoss Catheter is hydrophilic coated to enhance lubricity. A torque device. coaxially positioned over the proximal portion of the BigBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the use remains within the torsional operating strength of the catheter shaft.

Here's a breakdown of the acceptance criteria and study information for the BigBoss™ Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details in vitro bench testing and in vivo animal testing that confirm the performance characteristics relative to the predicate device. However, it does not explicitly state specific quantitative acceptance criteria (e.g., "tensile strength greater than X N") for each test, nor does it provide exact numerical measured performance values for the BigBoss™ Catheter. Instead, it concludes that "All test results demonstrated the materials, manufacturing processes, and design of the BigBoss™ Catheters met the established performance criteria and will perform as intended."

Therefore, here's a table based on the types of tests conducted and the general performance outcomes described:

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

• In Vitro Bench Testing: The specific sample sizes for each bench test (e.g., number of catheters tested for tensile strength) are not explicitly provided.
• In Vivo Testing:
  • Sample Size: 6 animals (porcine model). In each animal, BigBoss™ Catheters were inserted into four arteries, totaling 24 insertions.
  • Data Provenance: Prospective animal study (porcine model). The country of origin is not specified but is implicitly within the scope of Good Laboratory Practices (GLP) for nonclinical laboratory studies.

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

• In Vitro Bench Testing: Not applicable in the context of expert ground truth as these are mechanical/physical property tests.
• In Vivo Testing: The assessment involved:
  • Angiographic evaluation.
  • Histology and pathology.
  • Hematology and serum chemistry.
  • Gross necropsy.
  • The number and specific qualifications of the experts (e.g., veterinarians, pathologists) conducting these evaluations are not specified in the provided text.

4. Adjudication Method for the Test Set

• In Vitro Bench Testing: Not applicable. Results are typically quantitative measurements against defined specifications.
• In Vivo Testing: The text does not describe a specific adjudication method like "2+1" or "3+1" for interpreting findings. The assessments (angiography, histology, pathology, etc.) would typically be performed by relevant specialists, but a formal adjudication process involving multiple independent reviewers for discordant findings is not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance (with and without AI assistance) and is not relevant to a medical device like a catheter.

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

No, a standalone algorithm performance study was not done. The BigBoss™ Catheter is a physical medical device, not a software algorithm, so this type of study is not applicable.

7. The Type of Ground Truth Used

• In Vitro Bench Testing: Ground truth is established by engineering specifications and comparative data against the predicate device for physical and mechanical properties.
• In Vivo Testing: Ground truth was established through a combination of:
  • Angiographic evaluation: Visual assessment of vessel status.
  • Histology and pathology: Microscopic and macroscopic examination of tissues for injury or abnormalities.
  • Hematology and serum chemistry: Lab tests for physiological impacts.
  • Gross necropsy: Post-mortem examination for overall health and specific organ assessment.
  • This is a form of empirical observation and scientific measurement in an animal model.
• Biocompatibility Testing: Ground truth is established by validated laboratory assay results (e.g., ISO and ASTM standards) that demonstrate the biological safety of the materials.

8. The Sample Size for the Training Set

Not applicable. The BigBoss™ Catheter is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. (See point 8).

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