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The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross support catheters have a hydrophilic coating on the distal 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

The provided text is a 510(k) premarket notification regarding a medical device, the ViperCross™ Support Catheter. It outlines the device's intended use, indications for use, technological comparison to a predicate device, and performance testing.

However, it does not contain any information about an AI/ML powered device, associated acceptance criteria, specific study designs (like MRMC), sample sizes for training/test sets for AI, ground truth establishment for AI, or expert adjudication for AI..

The "Performance Testing" section lists various engineering and material tests conducted on the physical catheter, such as working length, leak tests, trackability, kink resistance, etc. These are standard tests for a physical medical device and do not relate to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the provided text, as the document describes a physical medical device and its traditional performance testing, not an AI/ML-powered device.

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0.014"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

0.018" & 0.035"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

014: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral and/or coronary vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm or 70cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

018/035: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm, 70cm, or 40cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The 135cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

The acceptance criteria and study proving the device meets them are:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily states that "All testing met the requirements and passed." Specific quantitative acceptance criteria or numerical performance results are not detailed in the provided text. The performance testing categories are listed below:

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

The document does not specify the sample size for individual tests. It also does not explicitly state the provenance of the test data (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench testing and materials characterization rather than clinical studies with patient data.

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

This information is not applicable and not provided in the document as the testing described is not clinical and does not involve establishing ground truth from expert interpretations.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document, as no human adjudication is mentioned for the described performance 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:

This information is not applicable and not provided in the document. The device is a physical medical device (ViperCross Support Catheters), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

This information is not applicable and not provided in the document, as the device is not an algorithm or AI system.

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

For the performance testing mentioned, the "ground truth" would be established by engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and established test methodologies designed to assess the physical and mechanical properties of the device.

8. The sample size for the training set:

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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The ViperCath™ XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.

The ViperCath XC Exchange Catheter is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is available in the following lengths with a straight tip: 65, 90, 135, and 150 cm as described in this submission. A 200 cm length is also available and was previously cleared under K183000 with a straight tip and an angled tip. There are no accessories for this device. The catheter is compatible with .035" guidewires and has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. The ViperCath XC is supplied sterile with one catheter per box.

The provided text is a 510(k) summary for the ViperCath™ XC Peripheral Exchange Catheter. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information on acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria in terms of clinical performance or diagnostic accuracy.

The "Functional and Safety Testing" section briefly mentions: "Dimensional checks and torque to failure testing were performed to verify the modifications are acceptable and meet specifications over the life of the device." This indicates engineering and mechanical testing, not a clinical study involving human patients or a diagnostic accuracy study.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the elements like sample size, data provenance, ground truth, expert qualifications, or MRMC studies, as these types of studies are not described in the provided document.

The document mainly focuses on establishing substantial equivalence to a predicate device based on similar intended use, technological characteristics, and material properties, and basic functional/safety testing of the device itself rather than its performance in a diagnostic or clinical scenario.

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The ViperCath XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The ViperCath XC Exchange Catheter (ViperCath XC) is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is provided in a 200 cm length, to facilitate the radial access approach, with either a straight or angled tip. There are no accessories for this device. The catheter shaft has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. Two additional printed markers are located 120 cm and 150 cm from the distal tip and are provided to aid with placement.

The provided document is a 510(k) premarket notification for a medical device called the ViperCath XC Peripheral Exchange Catheter. It outlines the device's intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) because the device being reviewed is a physical medical instrument (catheter), not an AI/software device. Instead, the "acceptance criteria" for this type of device are met through demonstrating functional equivalence and safety to a legally marketed predicate device via a series of performance and safety tests.

The table below summarizes the comparison to the predicate device and the types of testing performed on the ViperCath XC, which effectively serve as the criteria for its acceptance by the FDA for substantial equivalence.

• Effective Length(s): 200 cm compatible with specified use. | 200 cm (Specific to the subject device for radial access).
• Recommended Guide Catheter Compatibility: 5 Fr | 5 Fr
• Shaft Design: Braid-reinforced for support and pushability. | Braid-reinforced
• Tip Shape: Straight, Angled for navigation. | Straight, Angled
• Maximum Injection Pressure: Ability to withstand pressure during fluid delivery. | 600 psi
• Guidewire Compatibility: 0.035" | 0.035"
• Hydrophilic Coating: Presence/absence as per design. | No (Differentiator from predicate, but not identified as a safety/effectiveness concern).
• Sterility: Sterilized for single use. | Yes
• Single Use: Disposable after one use. | Yes
  Biocompatibility (Safety): |
• Non-toxic to biological systems. | Passed Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity, Pyrogenicity tests.
  Bench Testing (Performance & Safety): |
• Dimensional Verification: Conformance to specified dimensions (luer, shaft, tip). | Performed
• Bond Strengths: Structural integrity of device components. | Performed
• Tracking: Ability to navigate through vasculature. | Performed
• Guidewire Exchange: Facilitates smooth guidewire exchange. | Performed
• Radiopacity: Visibility under fluoroscopy. | Performed
• Wrap/Kink Resistance: Resists kinking or wrapping. | Performed
• Torque Transfer: Efficient transfer of torque from hub to tip. | Performed
• Torque to Failure: Ability to withstand twisting forces. | Performed
• Fluid Flow: Adequate flow rate for injectates. | Performed
• Burst Pressure: Withstands internal pressure without rupture. | Performed
• Leakage: Prevents leakage of fluids. | Performed
  Overall Safety and Effectiveness: |
• No new questions of safety or effectiveness identified compared to the predicate device. | Conclusion: "The ViperCath XC Exchange Catheter data supports that no new questions of safety or effectiveness were identified compared to the predicate device."

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

The document does not specify a "sample size" in terms of patients or a test set, as this is a 510(k) submission for a physical medical device based primarily on bench testing and biocompatibility studies, not a clinical study involving a patient test set for performance metrics like sensitivity or specificity.

• Test Set: Not applicable in the context of a clinical test set. The "test set" here refers to the actual ViperCath XC devices that underwent the various bench and biocompatibility tests. The exact number of devices tested for each parameter is not provided in this summary.
• Data Provenance: The testing was conducted by Cardiovascular Systems, Inc. in accordance with applicable standards and guidance (e.g., FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 2010)). This testing is typically performed in a laboratory setting, not derived from patient data from a specific country or as retrospective/prospective data.

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

• Not applicable. For this type of device submission, "ground truth" is established through engineering specifications, material science, and established laboratory testing protocols and standards, rather than expert consensus on diagnostic interpretations. The "experts" involved would be engineers, material scientists, and toxicologists who design and conduct these tests and interpret the results against predefined safety and performance criteria. Their qualifications are inherent in their roles in a medical device company and adherence to regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. As there is no clinical test set requiring expert interpretation, there is no need for an adjudication method like 2+1 or 3+1. Performance is based on direct measurement and observation during physical and chemical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

• Not applicable. This device is a physical catheter, not an AI or software device. Therefore, no MRMC study involving human readers or AI assistance was conducted.

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

• Not applicable. This device is a physical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the ViperCath XC Peripheral Exchange Catheter is established by:

• Engineering Specifications: The design and manufacturing specifications of the device itself (e.g., dimensions, material properties, bond strengths).
• Industry Standards and Regulatory Guidance: Adherence to recognized national and international standards for medical devices (e.g., ISO standards for biocompatibility, FDA guidance documents for catheters).
• Direct Measurement and Observation: Results from bench tests are directly measured (e.g., burst pressure, fluid flow) or observed to meet established pass/fail criteria (e.g., no leakage, successful guidewire exchange).
• Chemical and Biological Analysis: Results from biocompatibility tests are analyzed against established criteria for toxicity, sensitization, etc.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The engineering design and manufacturing processes are refined through iterative development, but this is distinct from training an algorithm.

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

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

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The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically orbiting sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

1. Orbital Atherectomy Device (OAD)
2. Atherectomy Guide Wire (e.g., ViperWire Advance)
3. Saline Pump (OAS Pump)
4. Atherectomy Lubricant (e.g., ViperSlide)

Additional 1.25 Solid, 1.50 Solid, and 1.75 Solid Diamondback 360 Peripheral Orbital Atherectomy Devices (OADs) with increased drive shaft lengths of 180 cm and 200 cm are proposed as additional length options to accommodate patient vessel anatomy and physicians preferred access methodology, for example radial access. The proposed OADs are designed to maintain 5Fr compatibility. Additional accessories to accommodate the increased drive shaft lengths were necessitated such as additional saline sheaths with increased lengths and additional lengths of ViperWire Advance Peripheral guide wires to accommodate the working length of the proposed OADs. The proposed 0.014 in core guide wires are 475 cm in length and compatible with the 180 cm and 200 cm length drive shafts. The proposed 0.014 in core guide wires are designed with a 0.014 in or 0.018 in distal spring tip options. The proposed dimensions of the 1.75 Solid crown are configured to accommodate the smaller diameter drive shaft while maintaining 5Fr compatibility. Packaging dimensions were increased in comparison to that of the predicate packaging to accommodate for the increased OAD and guide wire lengths.

The provided document describes a 510(k) premarket notification for a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System. This submission is for modifications to an already cleared predicate device, specifically offering additional lengths for the Orbital Atherectomy Devices (OADs) and guide wires.

Since this is a submission for modifications to an existing device, and not a de novo review for a novel AI device, the information typically requested for AI-powered diagnostic or comparative effectiveness studies (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is not directly applicable or present in this document. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than clinical study outcomes.

Therefore, for aspects related to AI performance metrics, ground truth establishment, or clinical study designs (MRMC, standalone), the document would state "Not Applicable" or "Information Not Provided in Document" because these are not within the scope of a 510(k) for device modifications confirmed by bench testing.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Description of the Study:

The study conducted was a series of performance bench tests designed to confirm that the modified Diamondback 360 Peripheral Orbital Atherectomy System (with increased drive shaft lengths) met its established specifications and was substantially equivalent to the predicate device. The tests evaluated various mechanical, physical, and operational characteristics of the device and its components (OADs and guide wires).

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

• Sample Size for Test Set: Not specified in the provided document. The document refers to "bench testing" which typically involves a number of units tested to satisfy engineering specifications and statistical requirements for device validation, but the exact number is not included here.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory and bench testing results conducted by the manufacturer, Cardiovascular Systems, Inc.

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

• Number of Experts: Not applicable. Ground truth, in this context, would be defined by engineering specifications and objective measurements from the bench tests, not by expert clinical interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The tests are objective measurements against predefined specifications.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This document does not describe an AI-powered diagnostic device or a study involving human reader performance.

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

• Standalone Study: No, a standalone algorithm performance study was not done.
• This device is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for this device's performance is based on pre-established engineering specifications, material properties, and functional performance requirements as demonstrated through bench testing. These specifications ensure the device operates as intended and is safe and effective.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable. This document does not describe an AI algorithm that requires a training set.

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The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

• 1. Orbital Atherectomy Device (OAD)
• 2. Atherectomy Guide Wire (e.g., ViperWire Advance)
• 3. Saline Infusion Pump (SIP)
• 4. Atherectomy Lubricant (e.g., ViperSlide)

The provided text describes a 510(k) premarket notification for the Diamondback 360® Peripheral Orbital Atherectomy System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a novel AI/software product. Therefore, much of the requested information regarding AI device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not present in the given text.

However, I can extract the available information regarding performance testing and conclusions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The testing appears to be primarily bench testing of the device's physical and functional characteristics, not clinical data or image-based test sets.
• Data Provenance: Not applicable in the context of an AI device. The data for this medical device submission is from laboratory bench testing.

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

• Not applicable. The "ground truth" for this type of device's performance is established by meeting predefined engineering specifications and regulatory standards through bench testing. There's no mention of clinical experts establishing ground truth in this context.

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

• Not applicable. This is not an AI/software device that requires human adjudication of outputs.

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 not an AI device.

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

• Not applicable. This is not an AI device. It's a physical atherectomy system.

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

• For this device, the "ground truth" or acceptability criteria are based on engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. It's demonstrated through successful completion of bench tests.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. There is no training set for this device.

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The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

• 1. Orbital Atherectomy Device (OAD)
• 2. Atherectomy Guide Wire (e.g., ViperWire Advance)
• 3. Saline Infusion Pump (SIP)
• 4. Atherectomy Lubricant (e.g., ViperSlide)

The provided text is a 510(k) Summary for a medical device and does not contain the detailed information typically found in a clinical study report. Therefore, I cannot fully answer all aspects of your request as the information is not present in the document.

However, I can extract the available information regarding acceptance criteria and the type of evaluation performed.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document states that the device was evaluated using performance bench testing and that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Diamondback 360 Peripheral Orbital Atherectomy System met the established specifications necessary for consistent performance during its intended use." It also states, "The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."

However, the specific numerical acceptance criteria for each test and the corresponding reported performance values are not provided in this summary.

Here's a table summarizing the tests performed, as listed in the document, and the general statement of performance:

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

The document describes bench testing, not human clinical studies. Therefore, concepts like "test set sample size" in the context of human data, country of origin, or retrospective/prospective study design are not applicable and not provided. The "sample size" would refer to the number of devices or components tested during the bench tests, which is not specified.

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

This information is not applicable and not provided. The evaluation involved bench testing against established engineering specifications, not expert interpretation of medical data where "ground truth" is established by medical professionals.

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

This information is not applicable and not provided. Adjudication methods are relevant in clinical studies where expert consensus is needed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This summary describes a physical medical device (orbital atherectomy system) and its mechanical performance through bench testing, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. This is for a physical device, not an algorithm.

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

For the bench testing, the "ground truth" would be the established engineering specifications, standards, and test protocols.

8. The sample size for the training set

This information is not applicable and not provided. As this is a physical device undergoing bench testing, there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are iterative, but a formal "training set" as you'd find in AI development is not relevant here.

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

This information is not applicable and not provided for the reasons stated in point 8.

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The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital atherectomy device (OAD)
• 2. Atherectomy guide wire
• 3. Externally operated saline pump
• 4. Atherectomy Lubricant (e.g. ViperSlide)

The provided text describes the regulatory clearance of the Stealth 360° Orbital PAD System and mentions performance data used to support its substantial equivalence to a predicate device. However, it does not contain the requested information regarding acceptance criteria, a detailed study proving the device meets those criteria, or specific performance metrics in the format requested.

The submission is for a modification to an existing device where the "crown blanks" will be molded instead of machined. The primary goal of the submission is to demonstrate that this modified device is substantially equivalent to the predicate device (K110389, also the Stealth 360° Orbital PAD System).

Here's an analysis based on the provided text, highlighting what is missing for each requested point:

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

• Missing. The document states that "performance bench testing" was conducted, specifically "Life/Stall Testing" and "Orbit Testing," to confirm performance characteristics compared to the predicate device. However, it does not provide specific acceptance criteria (e.g., "device must operate for X hours without failure") nor report any quantitative device performance metrics from these tests. It only states that the testing "demonstrate[s] that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device."

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

• Missing. No information on sample sizes for any test sets is provided. The tests mentioned ("Life/Stall Testing" and "Orbit Testing") appear to be bench tests, not clinical studies on human subjects. Therefore, data provenance related to human subjects (country, retrospective/prospective) is not applicable or provided.

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)

• Missing. This information is relevant for studies involving expert review or interpretation, typically in diagnostic or imaging devices. This document describes an atherectomy device and physical bench testing, not a study requiring expert ground truth establishment in this manner.

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

• Missing. As above, this is not applicable for the type of bench testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Missing. This type of study is completely unrelated to the device described (an atherectomy system) and the type of testing performed (bench testing for substantial equivalence of a manufacturing change). This question is typically relevant for AI-powered diagnostic tools.

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

• Missing. This is also irrelevant to the device and testing described. The Stealth 360° Orbital PAD System is a mechanical atherectomy device, not an algorithm.

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

• Missing. For the "Life/Stall Testing" and "Orbit Testing," the "ground truth" would likely be engineering specifications or performance baselines established by the predicate device's performance. However, these specific "ground truths" or benchmarks are not detailed.

8. The sample size for the training set

• Missing. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing. This is also irrelevant as there is no "training set."

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing to a predicate device, primarily to address a manufacturing change (molded vs. machined crown blanks). It does not provide the detailed study results, acceptance criteria, or expert review/AI-related information requested.

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The Diamondback 360° Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following components:

• 1. Orbital atherectomy device (OAD, air or electric powered)
• 2. Atherectomy guide wire
• 3. Atherectomy saline pump or controller
• 4. Atherectomy lubricant

The provided text describes a 510(k) premarket notification for the "Diamondback 360® Orbital Atherectomy System with ViperSlide® Lubricant", focusing on the addition of an alternate ViperSlide lubricant formulation. The study conducted to prove the device meets acceptance criteria is a performance bench testing and biocompatibility testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for the test set used in the performance bench testing or biocompatibility testing. These appear to be laboratory-based tests rather than human clinical trials. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of patient data, as no patient data is mentioned in relation to these tests.

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

This information is not provided in the document. The ground truth for bench testing and biocompatibility is typically based on predefined engineering specifications, material standards (like ISO for biocompatibility), and established scientific methods, rather than expert consensus on patient cases.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the type of bench and biocompatibility testing described. Adjudication methods are typically used in clinical studies involving multiple readers or assessors of subjective outcomes.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study and no discussion of AI or human reader improvement. The submission pertains to a medical device (orbital atherectomy system and lubricant), not an AI diagnostic tool.

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

There is no mention of a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

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

The ground truth for the performance bench testing appears to be based on established engineering specifications, material properties, and functionality requirements. For biocompatibility, the ground truth is established by international standards (e.g., ISO) for material biocompatibility.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. This document describes testing for a physical medical device, not a machine learning or AI model that typically involves training sets.

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

As there is no mention of a training set, this information is not applicable.

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The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360™ Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital atherectomy device
• 2. Atherectomy guide wire
• 3. Externally operated saline pump
• 4. Atherectomy Lubricant (e.g. ViperSlide)

The provided document describes the Stealth 360™ Orbital PAD System, a peripheral atherectomy device. This 510(k) summary focuses on validating the device's substantial equivalence to previously cleared predicate devices through extensive bench testing and biocompatibility studies, rather than clinical performance studies involving human subjects or AI algorithms. As such, many of the requested criteria, such as MRMC comparative effectiveness studies, ground truth establishment for training sets, or expert adjudication, are not applicable to the information provided.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of biocompatibility assays and comprehensive performance bench tests. The report concludes that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD System met the established specifications necessary for consistent performance during its intended use."

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" and "test results" but does not provide precise sample sizes for each specific test.
• Data Provenance: The data provenance is from laboratory and bench testing performed by the manufacturer, Cardiovascular Systems, Inc. This is not derived from human patient data, therefore, it cannot be classified as retrospective or prospective in that context, nor does it have a country of origin in terms of patient data.

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

• Not Applicable. This device submission relies on engineering specifications, material science, and safety standards rather than clinical expert consensus for establishing ground truth. The "ground truth" here is adherence to these predefined technical and safety standards.

4. Adjudication Method for the Test Set

• Not Applicable. As the evaluation is based on objective measurements against engineering and safety specifications, an adjudication method for a test set (as typically seen in clinical studies with human interpretative components) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance

• No. This type of study is not relevant to the clearance of this mechanical atherectomy device, which does not involve AI or human interpretation of medical images.

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

• No. This device is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to pre-defined engineering specifications, international and national biocompatibility standards (e.g., ISO, ASTM, EN 60601), and the performance characteristics of the predicate devices. The device's performance was compared against these established technical criteria to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable. This is a mechanical device, not an AI model, so there is no training set or associated ground truth establishment process in that context.

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