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

When used as part of the BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Catheter, and Stingray™ Guidewire), the Stingray™ Guidewire is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.

The modified Stingray™ 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 hydrophilic coated. 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" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.

Here's a breakdown of the acceptance criteria and the study details for the BridgePoint Medical Stingray™ Guidewire, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative performance metrics against predefined acceptance criteria for a new, distinct function. Instead, the "acceptance criteria" are implied by the performance of the predicate device and the design requirements for the modified guidewires. The study aimed to show that the modifications did not negatively impact the performance of the original design.

Therefore, the table below reflects this approach:

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "in vitro bench testing" and "biocompatibility tests" but does not specify the number of test articles or samples used for each test.
• Data Provenance: The studies were in vitro bench tests and biocompatibility tests. The document does not specify the country of origin for the data, but the submission is to the U.S. FDA, implying adherence to relevant US standards. The nature of these tests means they are not retrospective or prospective patient data, but rather controlled laboratory experiments.

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

This section is not applicable for this type of submission. The "ground truth" for this device's performance evaluation is based on engineering specifications, material science, and established biocompatibility standards. It does not involve human interpretation or consensus from clinical experts for the primary performance evaluation. The success is determined by meeting predefined engineering and biological criteria.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., medical imaging reads) to resolve discrepancies. Given that this study relied on objective bench testing and biocompatibility assessments, no human adjudication was required.

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

This section is not applicable. This is a submission for a modified medical guidewire, not an AI software device. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.

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

This section is not applicable. This device is a physical medical guidewire, not an algorithm or AI software. There is no "standalone performance" in the context of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Specifications and Design Requirements: The performance criteria used for the bench tests (tensile, flexibility, torque, etc.) are derived from the original design requirements for the Stingray™ Guidewires, which are established engineering standards for medical guidewires.
• Biocompatibility Standards: The biocompatibility tests are assessed against recognized international standards for biological evaluation of medical devices (e.g., ISO 10993 series).
• Predicate Device Performance: The primary ground truth is the established performance and safety profile of the legally marketed predicate Stingray™ Guidewires (K081187 and K083727), to which the modified device is compared for substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI or machine learning device, so there is no concept of a "training set."

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

This section is not applicable for the same reason as point 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 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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The BridgePoint Medical Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

The modified Mantaray™ 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 peripheral vasculature 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 provided text describes a 510(k) summary for the BridgePoint Medical Mantaray™ Catheter. It outlines the device, its intended use, and a comparison to a predicate device, focusing on modifications made. The document details performance data derived from in vitro bench testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria with specific numerical limits. Instead, it lists a series of performance characteristics that were evaluated to confirm the device meets original design requirements and is substantially equivalent to the predicate. The performance is reported as meeting these requirements through bench testing.

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

The document does not specify exact sample sizes for each bench test. It states that "in vitro bench testing" was used. The data provenance is not explicitly mentioned (e.g., country of origin), and the tests are described as in vitro bench testing, implying a controlled, laboratory setting rather than a clinical study. It is not retrospective or prospective in the clinical sense.

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)

This information is not provided. The evaluation was based on in vitro bench testing, which typically relies on engineers and technicians demonstrating adherence to specifications, rather than clinical experts establishing ground truth in the way medical imaging or diagnosis studies would.

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

This information is not provided. Given the nature of in vitro bench testing for a mechanical device, a formal adjudication method like those used for expert consensus in clinical studies is not applicable or described.

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, an MRMC comparative effectiveness study was not done. This device is a catheter, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical medical catheter, not an algorithm. Performance was evaluated based on its physical characteristics and functionality in a standalone manner (in vitro).

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

The "ground truth" for this device's performance is adherence to established engineering specifications and functional requirements for a percutaneous catheter, as assessed through various in vitro bench tests. The predicate device's performance served as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

This information is not applicable. As stated above, there is no "training set." The "ground truth" for the device's design and manufacturing would have been established through engineering design specifications and quality control procedures, informed by the predicate device's characteristics and clinical needs.

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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 Mantaray™ Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the peripheral vasculature.

The Mantaray™ 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 peripheral vasculature 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.

This document pertains to the 510(k) premarket notification for the BridgePoint Medical Mantaray™ Catheter, a medical device. The information provided is for a traditional medical device (catheter) and does not involve AI/ML technology, thus many of the requested fields are not applicable.

Here's an analysis of the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a conventional medical device, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device through various performance and safety tests. The "reported device performance" indicates that the Mantaray™ Catheter met these established criteria, confirming it performs as intended and is substantially equivalent. Specific quantitative targets or ranges for each test are not explicitly detailed in this summary but are implied to have been met.

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 (In vivo): Six animals (porcine model). Each animal had Mantaray™ Catheters inserted into four arteries.
• Data Provenance: The in vivo testing was conducted using a porcine animal model. The country of origin for the data is not specified, but the applicant (BridgePoint Medical) is located in Plymouth, MN, USA. The study was prospective in nature for the in vivo portion. Bench testing data provenance is not specified.

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 for this type of device and study. "Ground truth" in the context of this 510(k) submission refers to objective measurements from bench testing and observations/pathology from the animal study, not expert consensus on medical images. The evaluation involved angiographic assessment, histology, pathology, hematology, serum chemistry, and gross necropsy. These would be performed by qualified veterinary pathologists, angiographers, and laboratory technicians, but their specific number and years of experience are not detailed.

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

Not applicable. The in vivo study involved objective biological and pathological assessments and did not require adjudication of human reader interpretations. Bench testing results are typically objective measurements.

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 is a conventional medical device (catheter) and does not involve AI/ML.

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

Not applicable. This is a conventional medical device (catheter) and does not involve an algorithm.

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

• In vitro (Bench Testing): Objective physical and mechanical measurements according to established testing protocols and ISO standards.
• In vivo (Animal Study): Angiographic evaluation, histology, pathology, hematology, serum chemistry, and gross necropsy. These are objective biological and pathological assessments.

8. The sample size for the training set:

Not applicable. This is a conventional medical device without machine learning components. "Training set" is not relevant here. The manufacturing process and materials were based on the predicate device (Stingray™ Catheter).

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

Not applicable. There is no training set as this is not an AI/ML device.

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The BridgePoint Medical Stingray™ Orienting Balloon Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature

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 provided text is a 510(k) summary for a medical device called the Stingray™ Orienting Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain information about acceptance criteria, a standalone study to prove device performance against those criteria, or details related to human reader performance with/without AI assistance. The evaluations described are primarily engineering/bench tests demonstrating that changes to the device (balloon material, manifold adhesive, wire lumen) do not alter its performance from the predicate device.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of specific acceptance criteria values and reported performance values. The submission instead lists a series of design evaluations that were conducted to demonstrate substantial equivalence to the predicate device. These are engineering/bench tests, not clinical performance metrics. The document states "has demonstrated substantially equivalent performance characteristics as compared to the predicate Stingray™ Orienting Balloon," implying the device met internal specifications for these tests, but the specific numerical acceptance criteria and outcomes are not detailed for public consumption in this summary.

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

This information is not present in the document. The document describes engineering and biocompatibility evaluations, not a clinical test set with human or observational data.

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)

This information is not present in the document. The evaluations described are bench tests and biocompatibility tests, not studies requiring expert ground truth establishment in a clinical context.

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

This information is not present in the document. Adjudication methods are typically relevant for clinical studies or studies using human interpretation, which is not the type of evaluation described.

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

This information is not present in the document. MRMC studies and AI assistance are not relevant to this device or its 510(k) submission, which predates widespread AI in medical devices (2010). The device is a physical catheter, not an AI diagnostic tool.

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

This information is not present in the document. This concept is not applicable to a physical medical device like a catheter.

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

This information is not present in the document. The evaluations described are primarily laboratory/bench tests and biocompatibility assessments, where "ground truth" would relate to meeting predefined engineering specifications and international standards for material safety, rather than clinical outcomes or expert consensus on medical images/diagnoses.

8. The sample size for the training set

This information is not present in the document. This concept is entirely irrelevant to the type of device and submission (physical catheter, 510(k)).

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

This information is not present in the document. This concept is entirely irrelevant to the type of device and submission.

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

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 diamcter) 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 the additional tolerance to push. A torque device, coaxially positioned over the proximal additional toferance to pass: "I reserveded a comfortable user interface for device portion of the CrossDoos Catalors, frinilar to a guidewire torque device) is positionable manipulation: "The torque as the catheter and includes a torsion release safety along the proximal portion of the on insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC studies for the BridgePoint Medical CrossBoss Catheter.

This document is a 510(k) summary for a medical device which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or performance metrics against specific acceptance criteria. The text explicitly states:

"Based upon the intended use and descriptive information provided in this pre-market Dusod upon the BridgePoint CrossBoss™ Catheter has been shown to be substantially equivalent to the currently marketed predicate device."

This indicates that the submission relies on the similarity to an already approved device (K081130), and therefore, a new, extensive study with acceptance criteria, sample sizes, and expert review as you've requested is not typically included in such a submission.

Therefore, I cannot populate the requested table or provide answers to points 2 through 9 based on the given input.

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