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The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Fathom™-16 Steerable Guidewires are hydrophilic coated, steerable guidewires intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. They are not intended for use in the cerebral or coronary vasculatures. The devices provided are non-pyrogenic, sterile, and intended for one procedure only. The device shaft is coated with a thin hydrophilic coating over the distal section to provide lubricity, which aids in the navigation of distal, tortuous vasculature. Accessories include a torque device, guidewire introducer and torque device. They are not intended to enter the body and have no patient contact.

The provided document is a 510(k) summary for the Boston Scientific Fathom™-16 Steerable Guidewire. This type of submission is for medical devices, specifically guidewires, not for AI/ML-driven diagnostic or assistive software. Therefore, the document does not contain information related to acceptance criteria, ground truth, expert consensus, or study designs like MRMC or standalone performance evaluations as they would apply to an AI device.

The "Performance Data" section in the document indicates that the testing was conducted to demonstrate equivalence to a predicate device, focusing on physical and mechanical properties of the guidewire. The tests listed are:

• Total Length
• Particulate
• Tip Shape Retention
• Torsional Strength
• Pre-Shape Tips

The document states, "The Fathom™-16 Steerable Guidewires met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing." However, it does not provide the specific "acceptance criteria" values or the "reported device performance" values for these tests.

Therefore, I cannot populate the requested table or answer the questions related to AI/ML device study methodologies using the provided text. The information is simply not present in this type of regulatory submission for a physical medical device like a guidewire.

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

The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).

The provided text describes a 510(k) premarket notification for a medical device, the Tatara Vascular, LLC PW Guidewires. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive human-in-the-loop or standalone AI studies.

Therefore, the information regarding acceptance criteria and performance is primarily focused on non-clinical laboratory testing to show that the new device performs as intended and is comparable to predicate devices. There is no mention of studies involving human readers, AI assistance, or complex diagnostic accuracy metrics as typically seen in AI/ML device submissions.

Here's a breakdown based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance

Since this is a guidewire, the acceptance criteria are based on physical and mechanical properties and material safety, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

   The document lists the types of non-clinical laboratory tests performed. While it states "met the required acceptance criteria," it does not provide a specific table with numerical acceptance criteria values or the quantitative reported device performance for each test. It only lists the tests performed and a general statement of compliance.

Study Details (Relevant to Device Substantial Equivalence, Not AI/ML)

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

   • Sample Size: Not specified in the document. The tests performed are non-clinical bench tests; thus, "sample size" would refer to the number of guidewires tested for each physical property. This information is typically detailed in the full test reports, not usually in the 510(k) summary.
   • Data Provenance: The data originates from non-clinical laboratory testing (bench testing) of the Tatara Vascular, LLC PW Guidewires. It is not patient data, and therefore, concepts like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.

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

   • This question is not applicable to this type of device submission. Ground truth for a guidewire's mechanical properties is established through standardized engineering and materials testing methods using calibrated equipment, not by human expert consensus on images or outcomes.

4. Adjudication Method for the Test Set:

   • Not applicable. As described above, there's no human interpretation or adjudication involved in establishing the performance of a guidewire in bench tests.

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

   • No. This type of study is relevant for diagnostic devices, particularly those involving AI/ML for image interpretation. The PW Guidewires are a mechanical interventional device, and their substantial equivalence is demonstrated through engineering performance and material safety, not by comparative effectiveness studies with human readers.

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

   • No. This question is specific to AI/ML algorithms. The device described is a physical guidewire, not an AI algorithm.

7. Type of Ground Truth Used:

   • The "ground truth" for the performance of the guidewire in non-clinical testing is based on engineering specifications, material science principles, and established international standards (e.g., ISO 10993-1 for biocompatibility). Performance is measured objectively via test equipment.

8. Sample Size for the Training Set:

   • Not applicable. There is no "training set" in the context of a physical medical device like a guidewire. Training sets are used for machine learning models.

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

   • Not applicable. As there is no training set, this question is irrelevant to this device submission.

In summary, the provided document details the regulatory pathway for a conventional medical device (a guidewire) seeking 510(k) clearance by demonstrating substantial equivalence. The focus is on showing the device meets established engineering, material, and safety standards through non-clinical testing, rather than complex clinical studies involving human interpretation or AI performance metrics.

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The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those within transcatheter aortic valve procedures. This guidewire is not intended for use in the cerebrovasculature or coronary arteries.

The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of stainless steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE). The coil and core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.

This document describes the qualification testing for a "Pre-Formed Guidewire" and compares it to a predicate device for a 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "applicable bench tests performed at baseline and aging," and states that "Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes." It also states, "All test results support the claim of substantial equivalence." However, specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the exact numerical results obtained for each test are not provided in this summary. The table below represents the categories of tests performed and the general statement of performance.

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

• Sample Size for Test Set: Not explicitly stated for each bench test, biocompatibility test, or the animal study. The document mentions "Test pieces were tested," implying multiple samples, but gives no numbers.
• Data Provenance: The document does not specify the country of origin for any data.
  • Bench Testing: Performed by Lake Region Medical.
  • Biocompatibility Testing: Performed by an unspecified lab.
  • Animal Study: A GLP (Good Laboratory Practice) Animal Study was completed, implying it was conducted under controlled conditions, but the location is not mentioned.
• Retrospective or Prospective: All testing appears to be prospective as it was specifically conducted to demonstrate equivalence for this 510(k) submission.

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

This type of information is generally not applicable to a medical device 510(k) submission for a guidewire. The "ground truth" for guidewire performance is established through objective, quantifiable physical, chemical, and biological testing as performed in the bench and animal studies, not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, rather than subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. This submission describes a physical medical device (guidewire) where performance is assessed through bench and animal testing.

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

Not applicable. This is not an AI (algorithm-only) device. The device itself is a physical guidewire. Human intervention is inherently part of its use (e.g., a physician manipulating the guidewire).

7. The Type of Ground Truth Used

The "ground truth" for the Pre-Formed Guidewire's performance and safety was established through a combination of:

• Bench Testing: Objective measurements against established requirements for visual/tactile, dimensional, and mechanical attributes, often guided by standards like ISO 11070:1998 and FDA guidance.
• Biocompatibility Testing: Compliance with ISO 10993 series standards, involving various biological assays directly measuring material interaction with biological systems.
• GLP Animal Study: In-vivo evaluation of performance and safety, comparing the new device to a predicate device in a living system. This assesses real-world interaction and outcomes, often including histological and physiological assessments.

8. The Sample Size for the Training Set

Not applicable. This is a traditional 510(k) for a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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

Not applicable, as there is no training set.

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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 Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

The Medtronic Archer Super Stiff Guidewire is a PTFE coated stainless steel guidewire. The Archer Super Stiff Guidewire is offered in 200cm and 260cm lengths and incorporates a flexible tip section and inner 8cm radiopaque spring for enhanced visibility. The Archer Super Stiff guidewire is offered in single and double curve tip configurations. The Archer Super Stiff guidewire is sterile, non-pyrogenic, disposable and for single use only.

The Medtronic Archer Super Stiff Guidewire (K101339) is a medical device for facilitating catheter placement and exchange. The acceptance criteria and the study proving it meets these criteria are described below:

1. Acceptance Criteria and Reported Device Performance

The document summarizes non-clinical data, implying that the device's performance was compared to established standards and predicate devices (Cook Lunderquist Wire Guide (K061670) and Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283)). The acceptance criteria are implicitly met if the device demonstrates "substantial equivalence" to these predicates through various bench tests and biocompatibility testing. No specific numerical acceptance criteria (e.g., minimum tensile strength value) are provided in the summary; instead, the overall conclusion states that the test results "verify that the Archer Super Stiff Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use."

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

The provided 510(k) summary does not specify the exact sample sizes for each non-clinical bench test or the animal study. It generally states that "Non-clinical verification and validation...consists of the following in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing was performed."

The data provenance is not explicitly stated in terms of country of origin. The studies are described as "in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing," implying that they were conducted in a controlled environment, likely by the manufacturer (Medtronic Vascular) or a contracted lab. These are prospective studies designed to evaluate the new device.

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 section is not applicable. The device is a guidewire, and its performance evaluation in this 510(k) relies on objective physical and chemical testing (bench tests, biocompatibility tests), and an animal study. There is no mention of human expert assessment or review of images/cases to establish ground truth as would be the case for an AI-powered diagnostic device.

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

This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. The studies described are objective bench tests and animal studies where measurements and observations are made against predefined criteria, not requiring an adjudication process.

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. The device is a guidewire, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed to assess human reader improvement with AI assistance.

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

This section is not applicable. The device is a physical medical instrument (guidewire), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.

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

The "ground truth" for the performance evaluation of the guidewire was primarily based on:

• Engineering Specifications and Industry Standards: For the dimensions and mechanical properties, the "ground truth" would be the engineered specifications of the device and adherence to relevant industry standards for guidewire performance.
• Biocompatibility Standards: Ground truth for biocompatibility was established by recognized international standards (e.g., ISO 10993-1 and ASTM standards).
• Predicate Device Performance: Implicitly, the performance of the legally marketed predicate devices (Cook Lunderquist Wire Guide and Boston Scientific Corporation Back-Up Meier Steerable Guidewire) also served as a "ground truth" or benchmark for demonstrating substantial equivalence. The new device was shown to have "similar materials of construction" and "the same technological characteristics" as the predicates.
• Pre-clinical Animal Study Observations: For the in-vivo evaluation, the ground truth would be observations and measurements of the device's behavior and effects within a living system, assessed against expected physiological responses and safety parameters.

8. The sample size for the training set

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

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

This section is not applicable, as there is no "training set" for this type of device.

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For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)

The provided text describes a 510(k) submission for the TRAILRUNNER™ Guidewires, seeking substantial equivalence to a predicate device. This type of submission does not involve clinical trials with acceptance criteria for device performance in the same way a de novo or PMA submission might. Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to a legally marketed predicate device.

Here's an analysis based on the information provided, specifically addressing the points in your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in terms of specific performance metrics with numerical values (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices or diagnostics. Instead, the acceptance criterion for this 510(k) is substantial equivalence to the predicate device, the GUIDANT High Torque BMW Guidewire (K983033).

The "reported device performance" is described qualitatively as:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of clinical outcomes. The non-clinical testing involved "test pieces" for visual/tactile, dimensional, and mechanical attributes. The number of these test pieces is not quantified here.
• Data Provenance: Not applicable in the sense of patient data provenance (e.g., country of origin, retrospective/prospective). This is a physical medical device and the "data" would be from lab-based non-clinical tests.

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

• Number of Experts: Not applicable. For this type of 510(k) substantial equivalence submission, ground truth is established through engineering specifications, material properties, and physical performance testing against established standards or internal benchmarks, rather than expert clinical consensus on patient data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Test results for physical and mechanical properties are typically objective measurements, not subject to expert adjudication of subjective interpretations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for a physical medical guide wire.

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm or a diagnostic device. The performance is intrinsically linked to its physical interaction during a medical procedure, but its evaluation for this submission is based on non-clinical engineering and material properties.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications and Design Documents: The core "ground truth" for the device's design and materials.
  • Predicate Device Characteristics: The established design, materials, and (presumably) validated performance of the legally marketed predicate device served as the primary reference for comparison.
  • ISO Standards (e.g., ISO 10993 for biocompatibility): These provide the ground truth for safety aspects like biocompatibility.
  • Established Test Methods and Performance Requirements: For mechanical and functional tests, the ground truth is the expected performance based on relevant engineering principles and industry norms for such guidewires.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

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The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy. This device is not intended for coronary or cerebrovascular use.

The Medcomp .010" Vascular Guidewires are sterile, single-use devices used to facilitate intravascular medical device insertion. The proposed devices will be packaged and labeled as sterile accessories in individual pouches, or as part of kit configurations. The Medcomp .010" guidewires consist of a stainless steel core wire, which forms the proximal shaft of the guidewire - reducing in size from the proximal to the distal end, with a smooth transition to the coiled floppy distal tip secured to the end of the core. The .010" Vascular Guidewires have an outside diameter of 0.010" and are available in 45, 80 and 120cm lengths, with coil lengths of 4cm or 9.5cm. The .010" Vascular Guidewires are uncoated, or are available with a hydrophilic coating or a silicone fluid coating. The hydrophilic and silicone coatings reduce friction during use. Radiopacity of the distal coil region facilitates fluoroscopic visualization.

Despite the length of the provided document, the crucial information needed to answer the request comprehensively regarding acceptance criteria and the study proving adherence to them is not present.

The provided text is a 510(k) Summary for a medical device (Medcomp .010" Vascular Guidewires). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on performance testing against specific acceptance criteria.

Here's what can be inferred and what is explicitly stated, along with what's missing:

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

• Missing. The document states that "Physical testing was performed on the Medcomp .010" Vascular Guidewires following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) to assure design integrity and performance for the intended use." However, it does not detail:
  • The specific acceptance criteria derived from these guidances.
  • The actual quantitative results or performance metrics of the Medcomp guidewires against those criteria.
  • Inference: It is implied that the device met some unstated criteria, as the submission was successful. However, the specific criteria and performance values are not reported.

2. Sample size used for the test set and the data provenance:

• Missing. The document states "Physical testing was performed," but there's no mention of the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is also not applicable as this was physical testing, not clinical data.
• Inference: For physical testing, the "test set" would typically refer to the number of guidewire units subjected to various tests. This information is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This question pertains to studies involving human interpretation or clinical endpoints. The described testing is physical performance testing of a device's mechanical properties, not clinical or image-based assessment requiring expert ground truth.

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

• Not applicable. Similar to point 3, this relates to human interpretation or clinical studies, not physical device testing.

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 vascular guidewire, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a physical medical instrument, not an algorithm.

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

• Not applicable (in the way it's usually understood for diagnostic devices). For physical performance testing, "ground truth" would be established by the specifications of the tests themselves (e.g., a certain force to cause breakage, a certain friction coefficient limit). The document states testing was done "following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995)," implying these guidances define the "truth" for acceptable physical performance attributes.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of medical device's performance testing, as it is not an AI or machine learning algorithm.

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

• Not applicable. As above, there is no training set.

Summary of available information regarding performance evidence:

• Acceptance Criteria (Implied): Derived from ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) for physical performance, and ISO 10993 for biocompatibility.
• Reported Device Performance: The submission's approval implies the device met these criteria, but specific performance data or numerical results are not provided in this 510(k) summary.
• Study Type: Physical performance testing and biocompatibility testing.
• Rationale for no Clinical Studies: "No clinical studies were performed as part of the 510(k) process as the product is comparable to products currently cleared for marketing and can be applied under the substantial equivalence claim." This is a key aspect of 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through technological characteristics and non-clinical testing.

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