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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 from artificial arteriovenous dialysis fistulae (AV shunt). The system 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® Peripheral Orbital Atherectorny 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 system 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 Exchangeable Series 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 Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system 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 OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. Each OAS consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

The provided text describes a 510(k) summary for the DIAMONDBACK 360® Peripheral Orbital Atherectomy System, DIAMONDBACK 360® Peripheral Orbital Atherectomy System, Exchangeable Series, and Stealth 360® Peripheral Orbital Atherectomy System.

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

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

The document states:

• "Functional and Safety Testing: Only software verification and associated testing was required as the software updates do not affect the device performance and hardware."
• "The modified devices are different from the predicate device in that the software has been updated to include additional cybersecurity protection. Also, a hypotube was added to the Exchangeable driveshaft and a coupler was updated to accommodate the change. The hypotube and coupler are located within a fully enclosed, non-patient contacting portion of the device inside the cartridge."
• "The hypotube/coupler update does not impact the functionality of the device to ablate the lesion nor its intended use."
• "The subject devices are substantially equivalent to the predicate devices and the devices continue to perform as intended."

Given this, the acceptance criteria are implicitly that the software updates for cybersecurity and the mechanical changes (hypotube/coupler) do not adversely affect the device's original performance specifications and intended use. The performance reported is that the device continues to perform as intended and its functionality for lesion ablation and intended use are not impacted.

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

The document does not specify a separate "test set" in the context of clinical or performance data for the device's atherectomy function. The primary testing mentioned is "software verification and associated testing" and evaluation of the impact of mechanical changes. No sample size for patients or clinical data is provided, nor is data provenance mentioned, as this submission focuses on modifications rather than new clinical claims.

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 submission does not detail an expert-reviewed ground truth for a clinical test set. The evaluation seems to be based on engineering and functional assessments rather than clinical opinion.

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

Not applicable. There is no mention of an adjudication method for a clinical test set.

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 an atherectomy system, 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 is not an AI algorithm. The device has software for cybersecurity, but its primary function is mechanical.

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

The "ground truth" used for this 510(k) submission appears to be regulatory and engineering standards, and the performance characteristics of the previously cleared predicate devices. The modifications were assessed against the existing performance specifications and intended use of the predicate devices.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI model.

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

Not applicable. There is no mention of a training set.

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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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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 system 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® 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 system 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 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.

The OAS consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile)
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

Mechanism of Action
The Diamondback and Stealth OAS mechanism of action is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding
The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced and the diameter of the orbit increases.

The provided text is an FDA 510(k) summary for a medical device (Diamondback 360® Peripheral Orbital Atherectomy System, Stealth 360® Peripheral Orbital Atherectomy System). It details the device's purpose, components, mechanism of action, and comparison to a predicate device.

However, the document does not contain information about the acceptance criteria and the study proving the device meets those criteria in the context of an AI/ML-driven device. The content focuses on the substantial equivalence of a modified atherectomy system to a previously cleared predicate device, based on functional and safety testing of the hardware components (e.g., motor, bearings, grease).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device, as this information is not present in the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms, which is not the subject of this 510(k) summary.

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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 WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.

WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

I am sorry, but the provided text from the FDA 510(k) K210282 letter and summary for the WIRION® Embolic Protection System does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-based or statistical classification system.

The document is a traditional 510(k) submission for a physical medical device (an embolic protection system), not a software or AI-driven diagnostic device that would typically involve acceptance criteria related to sensitivity, specificity, or reader studies.

The "Functional and Safety Testing" section mentions:

• Biocompatibility testing
• Simulated use
• Bond and torque strength testing
• Package testing

These are standard engineering and safety tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert involvement, MRMC study details, etc.) from the provided text because it is not relevant to the type of device described in the document.

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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 system 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® Peripheral Orbital Atherectorny 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 system 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 Exchangeable Series 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 Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system 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 OAS, Stealth 360 Peripheral OAS, and DIAMONDBACK 360 OAS Exchangeable Series are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. Each OAS consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

The provided text is a 510(k) summary for the DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, and Stealth 360 Peripheral Orbital Atherectomy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML medical device.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not present in the provided text.

The document states that the proposed device differs from the predicate device only in its "manufacturing process and supplier of a device component," and that its "intended use, mechanism of action, and indications for use" are the same as the predicate. The performance data presented is limited to bench testing and biocompatibility testing, which are standard for hardware medical devices to ensure safety and functionality, not to assess AI/ML algorithm performance.

Here's what can be extracted based on the provided text:

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

The document does not explicitly state acceptance criteria in a table format for performance metrics relevant to AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it lists performance data based on conventional medical device testing.

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

• Sample size for test set: Not mentioned. The testing described is for physical characteristics and biocompatibility, not for an AI/ML algorithm's performance on a dataset.
• Data provenance: Not mentioned.

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

• Number of experts: Not applicable, as this device is not an AI/ML algorithm requiring expert ground truth for image interpretation or similar tasks. The ground truth for biocompatibility and bench testing would be established by laboratory standards and measurements.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable for the type of 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:

• MRMC study: No, an MRMC study was not done, as this is not an AI/ML-driven device.

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

• Standalone performance: No, this is not an AI/ML algorithm.

7. The type of ground truth used:

• Type of ground truth: For biocompatibility, the ground truth would be established by standardized biological assays and observation of cellular/tissue responses against established safety thresholds. For bench testing, the ground truth is established through physical measurements, engineering specifications, and adherence to relevant industry standards.

8. The sample size for the training set:

• Sample size for training set: Not applicable, as this is not an AI/ML device that requires a training set.

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

• How ground truth was established: Not applicable.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

This document is for an embolic protection system (WIRION™), a medical device, and not an AI/ML powered device. Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm, expert ground truth establishment, MRMC study, training/test set sample sizes, data provenance) are not applicable to this 510(k) submission.

The core of this 510(k) submission is that the WIRION™ device is identical to a previously cleared predicate device (K180023). This means the manufacturer is asserting substantial equivalence based on the device being literally the same as one already on the market, rather than needing to prove performance through new clinical or algorithm-specific studies.

Here's how to address the request based on the provided document:

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

Since this is a substantial equivalence claim based on identity to a predicate device, there are no specific performance acceptance criteria or reported performance data for this specific submission. The acceptance is predicated on the prior clearance of the identical device.

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

• Not Applicable. No new test set or data provenance details are provided because the device is stated to be identical to a previously cleared predicate.

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. No ground truth establishment by experts for a test set was required for this submission.

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

• Not Applicable. No adjudication method for a test set was required for this submission.

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/ML device, and no MRMC comparative effectiveness study was performed or required.

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

• Not Applicable. This is not an algorithm, so no standalone performance evaluation was done.

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

• Not Applicable. No new ground truth types were used or established for this submission, as it relies on the predicate device's prior clearance. The previous clearance would have relied on data and performance demonstrations appropriate for a mechanical medical device, likely including preclinical testing and/or clinical data that established safety and effectiveness.

8. The sample size for the training set

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

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

• Not Applicable. No ground truth for a "training set" was established.

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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 system 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® 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 system 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 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS) are designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown.

The OAS consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile)
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

Mechanism of Action
The Diamondback and Stealth OAS mechanism of action is identical to the predicate device and is defined by:
• Centrifugal force
• Orbital rotation
• Differential sanding
• Bi-directional sanding

The rapidly rotating eccentric crown creates a centrifugal force that presses the diamond-coated crown against the calcified plaque. With each pass of the crown, plaque is reduced, and the diameter of the orbit increases.

This document is a 510(k) premarket notification for the Diamondback 360 Peripheral Orbital Atherectomy System and Stealth 360 Peripheral Orbital Atherectomy System. It compares the proposed device to a predicate device (K152694 - Diamondback 360 Peripheral Orbital Atherectomy System).

The information provided in the document refers to physical and mechanical performance testing of the device, rather than a clinical study evaluating its diagnostic or therapeutic effectiveness using AI. Therefore, most of the requested points regarding acceptance criteria and study details for an AI/device performance study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device submission as described.

The performance data listed (Bench Testing, Track Verification Testing, Stall / Life and Tight Stenosis Verification Testing, etc.) are primarily engineering and hardware verification tests, not clinical performance or AI algorithm performance assessments. The conclusion explicitly states that the device has the "same technological characteristics as the predicate device" and that "testing results demonstrate that the devices perform as intended under the specified use conditions." This focuses on demonstrating equivalence to an existing device through non-clinical means.

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided document. The document describes a medical device with mechanical action for atherectomy, not an AI-powered diagnostic or therapeutic device.

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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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