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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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The BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. 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 distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides additional push. A torque device, coaxially positioned over the proximal portion of the CrossBoss 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 Stingray Orienting Balloon Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports (identified by radiopaque markers). The side-ports 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 Stingray Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft 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. The core wire (~0.0035" diameter) extends approximately 0.007" distal of the rounded tip.

The provided document is a 510(k) summary for the BridgePoint Medical System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on identical designs, prior bench testing, and biocompatibility tests. It briefly mentions a clinical study to support the system's function, but this study is not presented with acceptance criteria or detailed results in the context of device performance metrics.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample size for test sets directly related to acceptance criteria, ground truth establishment, MRMC studies, standalone performance) are not present in this type of regulatory submission.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, asserting that the prior bench testing and biocompatibility of the identical predicate devices are directly applicable. There are no explicit performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) outlined as part of this particular submission for the BridgePoint Medical System.

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

• Test Set (Clinical Study):
  • Sample Size: A "147 patient study" was conducted.
  • Data Provenance: "in the United States."
  • Retrospective or Prospective: Not explicitly stated, but clinical studies for regulatory submissions are typically prospective.

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

This information is not provided. The document states the clinical study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." It does not detail how the success or risk was formally adjudicated or who the experts were.

4. Adjudication Method for the Test Set:

This information is not provided.

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

This information is not provided and is highly unlikely to be applicable to this type of device (catheters and guidewires), which are not typically "AI-assisted reader" devices. The device described is a physical medical instrument, not a diagnostic imaging AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable/provided. The device is a physical catheter system used by a human interventionalist, not an algorithm.

7. Type of Ground Truth Used:

• For the 147-patient study: The "ground truth" or primary outcome likely relates to the successful intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) and patient safety/risk assessment as determined by clinical observation and physician assessment during the procedure. The document states the study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." This implies clinical outcomes and expert judgment as the ground truth.

8. Sample Size for the Training Set:

This information is not provided and is not applicable in the context of this device. This is a physical medical device, not an AI/ML model that requires a "training set."

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

This information is not provided and is not applicable as there is no "training set" for this device.

Summary of what the document does state regarding the study:

• Study Purpose: To demonstrate that the BridgePoint Medical System functions "to enhance medical practice in facilitating the placement of guidewires or other interventional devices beyond chronic total occlusions."
• Study Outcome: The "147 patient study... demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient."
• Context: This study appears to be part of the justification for substantial equivalence, implying that the clinical performance observed was comparable or superior to predicate devices without introducing new safety concerns.

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device to existing predicate devices based on design, prior bench testing, and biocompatibility, supported by a general statement about a clinical study's positive outcome. It does not provide the detailed performance acceptance criteria or granular study details typically requested for AI/ML device evaluations.

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