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The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel.

The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution.

The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.

The provided text describes a 510(k) premarket notification for the Pacific Plus PTA Catheter. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical performance acceptance criteria in the manner one might find for a novel diagnostic or AI-driven decision support tool.

The "acceptance criteria" in this context refer to the benchmark performance of the predicate device and relevant industry standards for similar devices. The "study" proving the device meets these criteria is the bench testing and biocompatibility evaluation performed.

Here's an analysis of the provided information based on your request, keeping in mind the nature of a 510(k) submission for a catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like a PTA catheter, "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics demonstrated by equivalent predicate devices, rather than clinical metrics like sensitivity/specificity for diagnostic AI. The "reported device performance" are the results of bench tests confirming these specifications are met or are comparable to the predicate.

• Ability to withstand rated burst pressure.
• Resistance to fatigue under repeated inflation/deflation.
• Specific balloon compliance (expansion profile).
• Acceptable inflation/deflation times. | - Balloon Preparation, Deployment and Retraction: Demonstrated to function as intended.
• Balloon Rated Burst Pressure: Met specified pressure limits, comparable to predicate.
• Balloon Fatigue: Demonstrated acceptable durability.
• Balloon Compliance: Within expected range, comparable to predicate.
• Balloon Inflation/Deflation Time: Within acceptable limits. |
  | Mechanical Integrity | - Sufficient bond strength between components.
• Acceptable catheter flexibility and kink resistance.
• Adequate torque strength for navigation.
• Integrity of hydrophilic coating. | - Catheter Bond Strength and tip pull test: Met specified strength requirements.
• Catheter Flexibility and Kink Test: Demonstrated acceptable flexibility and kink resistance.
• Catheter Torque Strength: Met specified torque limits.
• Catheter coating Integrity: Confirmed to be intact and functional. |
  | Safety | - Absence of unacceptable particulate matter.
• Biocompatibility (cytotoxicity, pyrogenicity, systemic toxicity, sensitization, intracutaneous reactivity, hemocompatibility). | - Particulate Evaluation: Met acceptable limits.
• Biocompatibility Testing: All tests (Cytotoxicity, Pyrogenicity, Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Haemocompatibility - Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Thromboresistance) were passed, concluding the device is biocompatible for its intended use. |
  | Sterility | Sterility assurance level and method. | Same sterility assurance level and method of sterilization as predicate. |
  | Packaging | Suitable packaging materials. | Similar packaging materials to predicate. |

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench tests. It refers to "internal risk analysis procedures" that determined the extent of testing. For medical device bench testing, the sample size is typically determined by statistical methods or established industry standards to ensure sufficient confidence in the results for each specific test (e.g., a certain number of catheters are tested for burst pressure, fatigue, etc.).
• Data Provenance: The data is "internal" research and development data, generated by Medtronic Vascular, Inc. through their bench testing and biocompatibility assessments. This is not clinical data, but rather engineering and laboratory testing data. The country of origin of the data is implicitly the USA, where Medtronic is headquartered and the submission was made to the FDA. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

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

• Not Applicable in the traditional sense. For a PTA catheter, "ground truth" for bench testing is established by engineering specifications, validated test methods (e.g., ASTM, ISO standards), and the performance characteristics of the legally marketed predicate device. This is not a situation where human experts are adjudicating clinical images or patient outcomes to establish ground truth for an AI algorithm. The "experts" involved would be Medtronic's R&D engineers, quality assurance personnel, and regulatory affairs specialists who designed the tests, conducted them, and interpreted the results against established standards and predicate performance. Their qualifications would be in engineering, materials science, and medical device regulations.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is not a study requiring adjudication by experts to establish ground truth. The results of the bench tests are objectively measured against predefined acceptance criteria (e.g., a specific burst pressure, a certain bond strength, pH levels for biocompatibility assays).

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. This type of study is specifically relevant for diagnostic AI or decision support systems where human interpretation of data is a key component. The Pacific Plus PTA Catheter is an interventional medical device, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• No. This question is relevant to AI algorithms. The Pacific Plus PTA Catheter is a physical medical device. The "performance" being evaluated is its physical and mechanical characteristics in a standalone bench testing environment, but this is distinct from an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• For bench testing, the "ground truth" consisted of engineering specifications, international standards (e.g., ISO 10993-1), and the established performance characteristics of the legally marketed predicate device (K123358) and reference devices. These benchmarks define what constitutes acceptable performance for each test. For biocompatibility, the ground truth is established by conformity to the biological safety limits specified in ISO 10993-1.

8. The Sample Size for the Training Set

• Not Applicable. This question is relevant to machine learning/AI models. The Pacific Plus PTA Catheter does not involve a "training set" in the context of AI. The development of the catheter relies on engineering design principles, material science, and prior knowledge from predicate devices, not on training an algorithm with a dataset.

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

• Not Applicable. As there is no AI training set, this question is not relevant.

In summary, the provided document details a 510(k) submission for a physical medical device. The "study" demonstrating performance involved extensive bench testing and biocompatibility evaluation against engineering specifications, international standards, and the characteristics of predicate devices. This is fundamentally different from the evaluation of an AI-driven diagnostic or decision support system, which would involve clinical studies, ground truth established by expert consensus or pathology, and various performance metrics like sensitivity, specificity, or AUC.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides; and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor implants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

This document is a 510(k) summary for the Heli-FX EndoAnchor System, which is an endovascular suturing system. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared device (K171427) by stating that the Heli-FX EndoAnchor System is compatible with the Valiant Navion Stent Graft System.

Based on the provided text, the document states that "no new testing with the Valiant Navion Stent Graft System was needed" because "Adequate rationale was provided to support the compatibility of these systems based on the previously provided testing with the endografts that are currently listed as compatible with the Heli-FX EndoAnchor System in its IFU."

Therefore, the acceptance criteria and study information would refer to the previous submission (K171427) or prior testing, which is not detailed in this specific document. This document only describes the device and its intended use, and then asserts substantial equivalence based on prior testing and rationale.

Since the document explicitly states "no new testing," it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth for a new study.

To provide the requested information, the details from the original 510(k) submission (K171427) would be required.

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The Sentrant Introducer Sheath with Hydrophilic Coating is intended to provide a conduit for the insertion of diagnostic or endovascular devices into the vasculature and minimize blood loss associated with such insertions.

The Sentrant Introducer Sheath is a single-use, disposable, hydrophilic-coated catheter designed to provide a flexible and hemostatic conduit for the insertion of endovascular devices and to minimize blood loss associated with vascular procedures. The system is comprised of a dilator and an introducer sheath. The system accommodates a 0.035 in (0.89 mm) guidewire and is available in 28 and 64 cm lengths and in sizes from 12 to 26 Fr in 2 French increments.

The dilator is radiopaque and has a flexible tapered tip that facilitates atraumatic tracking through the vasculature. There is a dilator grip at the proximal end of the dilator shaft. The dilator grip has a female Luer taper fitting on the proximal end to allow flushing of the device, and a threaded-feature at the distal end to allow the dilator to be secured to the sheath seal housing (dilator locking mechanism).

The introducer sheath is comprised of a hydrophilic-coated, coil-reinforced catheter that is attached to a rigid seal housing containing the hemostatic valve assembly. A sideport extension assembly with a 3-way valve is attached to the seal housing. A radiopaque (RO) marker band is located at the distal tip of the sheath. The device also has a suture loop for attaching it to the patient and a strain relief to minimize kinking of the catheter where it joins to the seal housing.

The provided text is a 510(k) summary for the Medtronic Sentrant Introducer Sheath with Hydrophilic Coating. This document describes the device and its equivalence to a predicate device, but it does not contain information about acceptance criteria and a study proving a specific device performance metric meets those criteria. Instead, it outlines a series of non-clinical performance tests conducted to demonstrate general safety and effectiveness for substantial equivalence to a predicate device, which had a different sterilization method.

Therefore, many of the requested details about acceptance criteria, reported device performance (in terms of specific clinical or technical metrics for an AI/device performance study), sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this document.

However, I can extract the information that is available:

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

The document states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence" for the following non-clinical performance data. It does not provide specific numerical acceptance criteria or quantitative performance results for each test.

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

The document does not describe specific "test sets" in the context of clinical performance or algorithm evaluation with data provenance. The tests listed are non-clinical (e.g., sterilization, packaging, biocompatibility).

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

Not applicable. The document describes non-clinical tests, not expert-adjudicated ground truth for a clinical dataset.

4. Adjudication method for the test set

Not applicable. The document describes non-clinical tests.

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. This document does not pertain to an AI-assisted device or a multi-reader multi-case study.

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

No. This document does not describe an algorithm or AI performance.

7. The type of ground truth used

Not applicable in the context of clinical accuracy or algorithm performance. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for validating those specific device characteristics (e.g., ISO standards for sterilization, biocompatibility, packaging).

8. The sample size for the training set

Not applicable. The document does not describe an AI or machine learning model with a training set.

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

Not applicable. The document does not describe an AI or machine learning model with a training set.

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The SilverHawk and TurboHawk Peripheral Plaque Excision System are intended for use in atherectomy of the peripheral vasculature. The SilverHawk and TurboHawk Catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk Catheter (THS-LS-C, THS-LX-C) is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions.

The SilverHawk and TurboHawk Peripheral Plaque Excision System consists of a Catheter and Cutter Driver, which are packaged separately, but shipped and used together during the plaque excision procedure. The catheter consists of a flexible shaft designed to track over a 0.014" guidewire. At the distal end of the catheter is a small cutting assembly comprised of a rotating inner blade contained within a tubular housing. The proximal end of the Catheter contains a connector and positioning lever designed to fit into a small, disposable, battery driven Cutter Driver, which powers the device.

The SilverHawk and TurboHawk Peripheral Plaque Excision System each have two switches: 1) the Cutter Driver main power switch and 2) the Catheter thumb switch. The Cutter Driver main power switch supplies power to the device when turned ON. When the thumb switch is fully forward (OFF), the cutting blade is closed and stored in the cutter housing with the motor off. This position is used during delivery of the device to the target lesion. Once the device has been positioned the Catheter thumb switch is pulled proximally to the ON position to activate the drive shaft and engage the cutter. Pulling back on the Catheter thumb switch simultaneously turns on the motor and causes the distal portion of the cutter housing to deflect, forcing the device against the target lesion. At the same time, this motion exposes the inner rotating blade, preparing the device for lesion treatment. With the blade spinning, the Catheter is slowly advanced across the lesion, "shaving" occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the Catheter thumb switch distally, deactivating the drive shaft, disengaging the cutter, and aligning the cutter and housing. The Catheter thumb switch is fully advanced distally to the OFF position in order to move the cutter forward within the tip and pack the excised plaque into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The SilverHawk and TurboHawk Peripheral Plaque Excision System uses the following materials: stainless steel, platinum/iridium, carbide w/ 12% nickel binder, titanium, delrin, polyimide, PET lined tecothane, pebax, nylon, Teflon, tungsten carbide, ABS, PVC, silicone, Santoprene, polycarbonate, polypropylene and hydrophilic coating.

The provided document is a 510(k) summary for the Medtronic SilverHawk and TurboHawk Peripheral Plaque Excision Systems. It describes changes made to the device and the testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested data points related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or available in this document. The document focuses on performance testing in a bench setting to support a 510(k) clearance.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "Test Methods Used to Evaluate Change" and concludes that "The results from these tests demonstrate that the technological and performance characteristics of the proposed SilverHawk and TurboHawk devices perform in a manner equivalent to the predicate devices currently on the market."

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: Not explicitly stated for any of the individual bench tests. The document refers to "testing" or "tests" but does not give the number of units or replicates tested.
• Data provenance: Bench testing results. This implies the data was generated in a laboratory or engineering setting, likely within Medtronic. No geographical origin is specified beyond Medtronic Vascular, Inc. is located in Plymouth, MN, USA. The testing is prospective in the sense that it was conducted on the modified devices before market clearance.

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. The "ground truth" for bench testing of a medical device's physical and functional properties is typically defined by engineering specifications, material properties, and comparative performance against predicate devices, not expert human interpretation.

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

Not applicable, as this refers to adjudication for expert consensus in clinical data, which is not present in this document.

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 document describes a 510(k) submission for a peripheral plaque excision system (a physical device for atherectomy), not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable, as this is not an algorithm or AI device. The described tests evaluate the physical device's performance.

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

Not applicable. For this type of device and testing, the "ground truth" is defined by established engineering and material science principles, manufacturing specifications, and the performance characteristics of the predicate devices. The objective is to demonstrate that the modified device performs similarly to or within acceptable limits compared to the original/predicate design.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM and Heli-FX Thoracic EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides, and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor impants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for the Heli-FX EndoAnchor System.

The document is a 510(k) premarket notification decision letter and a 510(k) summary. It primarily focuses on the substantial equivalence of the device to previously cleared predicate devices, particularly due to a change in the sterilization facility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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The HawkOne Directional Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX Embolic Protection Device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.

The HawkOne™ directional atherectomy system (HawkOne catheter and cutter driver) is designed for the treatment of de novo and restenotic atherosclerotic calcified and non-calcified lesions located in native peripheral arteries. When treating complex, hard, calcified lesions, pairing the HawkOne catheter with the SpiderFX™ embolic protection device mitigates risk of distal embolization that can be generated when heavily calcified plaque breaks down. For information about the SpiderFX embolic protection device, reference the Instructions for Use provided with the device.

The HawkOne catheter consists of a flexible shaft designed to track with a 0.36 mm (0.014 in) guidewire. At the distal end of the HawkOne catheter there is a small cutting unit comprised of an inner blade that rotates within a tubular housing. The proximal end of the HawkOne catheter contains a connector and cutter positioning lever (thumb switch) designed to fit into the cutter driver. The cutter driver (catalog number H1-14550) is a battery driven, internally powered device, designed to power the HawkOne directional atherectomy catheter.

The HawkOne directional atherectomy system has two switches: 1) the main power switch on the cutter driver and 2) the cutter positioning lever (thumb switch) on the HawkOne catheter. The main power switch on the cutter driver supplies power to the device when turned On. When the thumb switch is pulled proximally to the On position, the HawkOne catheter activates the drive shaft and the cutter. With the cutter engaged, the HawkOne catheter is slowly advanced across the lesion, shaving occlusive material from the artery. The excised tissue is captured and stored in the tip of the device. The cutting process is completed by advancing the HawkOne catheter thumb switch distally, deactivating the drive shaft and disengaging the cutter. When the HawkOne catheter thumb switch is fully advanced distally to the Off position, excised tissue is packed into the tip. This cutting sequence is repeated as necessary to achieve the desired degree of plaque excision.

The provided text describes a 510(k) summary for the Medtronic HawkOne Directional Atherectomy System, focusing on demonstrating substantial equivalence to predicate devices, particularly a smaller 6F version compared to the existing 7F version. The document details bench testing performed, but it does not include information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of clinical performance or human reader studies (MRMC or standalone AI performance). The testing mentioned (bench tests) is for the device's physical and functional characteristics, not for diagnostic or therapeutic efficacy in a clinical setting in relation to established criteria.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document lists various bench tests but does not provide specific acceptance criteria or reported performance values for these tests. For instance, it mentions "Cutter Height" but not what the acceptable range for cutter height is, or what was measured.

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

This information is not provided. The testing described is bench testing of the device itself, not clinical testing on patient 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 is not applicable as the summary describes bench testing of mechanical properties, not clinical studies requiring expert ground truth.

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

Not applicable.

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 medical device for atherectomy, not an AI software intended to assist human readers in diagnosis.

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

Not applicable. This is a physical medical device.

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

For the bench testing, the "ground truth" would be engineering specifications and validated test methods. The document does not explicitly state the specific ground truths but implies that the tests were designed to show comparability to predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of available information related to acceptance criteria and device performance (from bench testing):

The document lists the following bench tests performed to demonstrate substantial equivalence:

Study Proving Device Meets Acceptance Criteria:

The study described is a bench testing program aimed at demonstrating substantial equivalence of the proposed HawkOne 6F Directional Atherectomy System to its predicate and reference devices (HawkOne 7F and TurboHawk). The purpose was to show that, despite changes like a reduced crossing profile, smaller driveshaft, cutter, and tip, and a material supplier change, the device performs comparably.

• Type of Study: Bench testing (non-clinical, engineering/materials testing).
• Purpose: To demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F are comparable to the predicate and reference devices.
• Methodology: Various tests listed above were performed using "internal Risk Analysis procedures."

Missing Information: The document explicitly states that the "results from these tests demonstrate that the technological characteristics and performance criteria of the proposed HawkOne 6F devices are comparable to the predicate and reference devices," but it does not provide the specific numerical acceptance criteria or the measured performance values for each test. Instead, it offers a general statement of comparability.

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The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The TrailBlazer™ angled support catheter is an over-the-wire (OTW) single lumen catheter with a tapered angled distal tip. The catheter system is compatible with 0.36 mm (0.014in.), 0.46 mm (0.018 in.), or 0.89 mm (0.035 in.) guidewires. The support catheter has working lengths of 65 cm. 90 cm. 135 cm. and 150 cm depending on the model. All models are compatible with a 4 Fr introducer sheath. The manifold provides proximal access to the lumen which transitions to the catheter shaft and terminates at the angled distal tip. The lumen is used to pass the catheter over a guidewire. The manifold is constructed from elastomer and molded to the catheter proximal shaft. The guidewire compatible diameter and length are marked on the strain relief that is clipped to the manifold post molding. The multi-layer elastomer catheter shaft is designed with a stainless steel braided mesh. Three radiopaque markers starting at the distal tip aid in positioning the catheter. The distal tip of the catheter is molded to a predetermined angle to optimize vessel subselection with a guidewire. The distal 40cm portion of the catheter is coated with a hydrophilic coating. Finished catheters are packaged in hoops, sealed in pouches and provided in 5-pack cartons with an IFU.

The provided text describes the 510(k) summary for the Medtronic TrailBlazer™ Angled Support Catheter (K162384). This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and does not contain information about clinical studies involving human patients or ground truth established by medical experts for diagnostic performance.

Therefore, many of the requested elements related to clinical study design, sample sizes for test and training sets, expert involvement, and comparative effectiveness (MRMC) cannot be answered from the provided text.

Here's an overview of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to demonstrate substantial equivalence. It does not explicitly state numerical acceptance criteria or specific quantitative performance values for each test in a table format. Instead, it generally states "All testing was performed in accordance with recognized standards. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

However, the types of tests conducted can be considered the acceptance criteria categories:

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

The document describes bench testing, not a clinical study with a test set of patient data. Therefore, this information is not applicable.

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

Not applicable as this was a bench study, not a study requiring expert ground truth for diagnostic performance assessment.

4. Adjudication method for the test set

Not applicable as this was a bench study.

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 catheter, not an AI-assisted diagnostic tool, and the studies were bench tests, not MRMC studies.

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

Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the physical and functional aspects of the catheter in isolation, which were assessed through the listed bench tests.

7. The type of ground truth used

For the bench tests, the "ground truth" was defined by recognized standards and specifications for medical devices. For example, a bond strength test would have a specified minimum acceptable force, and the outcome of the test (e.g., whether the bond held) would be compared against that standard.

8. The sample size for the training set

Not applicable. This device is a physical medical device where performance characteristics are often established through engineering design and testing against specifications, rather than machine learning training sets.

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

Not applicable.

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