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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 additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft 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.

This document describes the BridgePoint Medical Peripheral System: Mantaray™ Guidewires, a Class II Percutaneous Guidewire, and its special 510(k) submission (K121745) for modified models. The submission focuses on demonstrating substantial equivalence to previously cleared Mantaray™ Guidewires (K120881, K120533).

Based on the provided text, the device is a medical guidewire, and the "acceptance criteria" and "device performance" refer to the results of in vitro bench testing and biocompatibility testing used to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified guidewires were to meet the "original design requirements of the currently marketed Mantaray™ Guidewires" as demonstrated through bench tests and to demonstrate biocompatibility.

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

The document does not specify the exact sample sizes for each in vitro bench test or biocompatibility test. It generally states that the "additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing." Given that this is a 510(k) submission for a modification to an existing device, the testing would have been conducted internally by BridgePoint Medical. The data provenance is prospective in the sense that the tests were performed specifically for this submission, using new samples of the modified devices. These are not clinical studies, so country of origin of patient data is not applicable.

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

This information is not applicable (N/A) because the device is a guidewire, and the "ground truth" for its performance is established through in vitro bench testing and biocompatibility assessments against predefined engineering specifications and ISO standards, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable (N/A) for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., radiologist reads) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI-based) on human reader performance in interpreting medical data. The Mantaray™ Guidewires are physical medical devices, and their performance is evaluated through bench testing, not through human interpretation of cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable (N/A). The Mantaray™ Guidewire is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an independent algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the Mantaray™ Guidewires is based on:

• Engineering specifications and standards: The device's physical and mechanical properties (tensile strength, flexibility, radiopacity, etc.) were tested against established design requirements and likely relevant industry standards.
• Biocompatibility standards: The materials used were tested against accepted biocompatibility standards to ensure they are safe for human contact.
• Predicate device comparison: The ultimate "ground truth" for this 510(k) is the demonstration of substantial equivalence to the previously cleared Mantaray™ Guidewires, meaning the modified device performs comparably to a device already deemed safe and effective.

8. The Sample Size for the Training Set

This is not applicable (N/A). There is no "training set" as this is not a machine learning or AI-driven device. The guidewires are manufactured physical products.

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

This is not applicable (N/A) for the same reason as #8.

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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 Mantaray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). The Mantaray™ Guidewires are not to be used in the cerebral blood vessels.

The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steell 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) extrands approximately 0.007" distal of the rounded tip.

The provided text describes a 510(k) premarket notification for the BridgePoint Medical Mantaray™ Guidewire, focusing on modifications to an already cleared device. This submission does not include a study that proves the device meets acceptance criteria in the sense of a clinical trial or a performance study using human or image data.

Instead, this 510(k) is for a modified version of an existing guidewire, and the acceptance criteria and supporting "study" are based on comparative bench testing and biocompatibility testing to demonstrate substantial equivalence to the predicate device. The core idea is that if the modified device performs similarly to the predicate device in key functional and safety aspects, and the changes are minor, then it is considered substantially equivalent.

Here's an analysis of the provided information based on your requested points, recognizing that the "device" here is a guidewire, not a diagnostic or AI-driven system, so some of your points are not directly applicable.

1. A table of acceptance criteria and the reported device performance

The document lists performance characteristics that were evaluated for the modified Mantaray™ Guidewire and states that the device "met the established performance criteria." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table. It only lists the types of tests performed and a general statement of successful completion.

The "established performance criteria" are defined by the predicate device's performance and the general requirements for guidewires of this type. The study demonstrates that the modified device performs comparably to the predicate and meets these safety and performance benchmarks.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of number of guidewires tested for each category. For bench testing, typical "sample sizes" would refer to the number of units tested per configuration/material, which is not provided.
• Data Provenance: The testing was "in vitro bench testing" and "biocompatibility tests," implying laboratory settings. There is no mention of country of origin for data.
• Retrospective or Prospective: Not applicable for bench and biocompatibility testing. These are controlled laboratory tests performed to demonstrate device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a physical medical device (guidewire), not a diagnostic algorithm or imaging system requiring expert interpretation for "ground truth." The performance criteria are objective, physical measurements and biological responses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication was required for the bench and biocompatibility test results.

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

Not applicable. This device is a guidewire, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a guidewire, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established engineering specifications, material science principles, and biological safety standards. Bench tests (e.g., tensile strength, flexibility, radiopacity) have objective, measurable outcomes compared against predetermined ranges or relative to the predicate device's performance. Biocompatibility tests compare material interactions against known safe biological responses.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set was used.

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