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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 atherosclerosis disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).

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 SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenotic materiovenous dialysis fistulae (AV shunt).

The Diamondback 360® Peripheral Orbital Atherectorny 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 OAS SOLID, CLASSIC and MICRO crowns support 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 2.00 Max Crown has not been tested to support removal of stenovenous dialysis fistulae (AV shunt).

The OAS is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The document lists the main components of the OAS, including a reusable saline pump, a single-use orbital atherectomy device, a single-use atherectomy lubricant, and a single-use atherectomy guide wire.

The provided text (K220568 510(k) Summary) describes a medical device, the Diamondback 360® Peripheral Orbital Atherectomy System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to AI or algorithmic performance.

The document outlines:

• Device Description: A percutaneous orbital atherectomy system designed to remove occlusive material from peripheral arteries and arteriovenous dialysis fistulae.
• Comparison to Predicate Device: The current device is "identical" to the predicate device in terms of indication for use, vessel diameter range, principles of operation, sterilization methods, single-use nature, and performance specifications. The only described difference is a change in the diamond size used in the crown coating (from 30-micron to 70-micron diamonds). A minor update to the Indications for Use is mentioned, stating that the 2.00 Max Crown has not been tested for removal of stenotic material from AV shunts.
• Testing Conducted: Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility) and bench testing (stall, tight stenosis, life, coating integrity, tensile verification, orbit characterization, temperature and flow verification, particulate testing, corrosion testing, GLP animal testing). These tests are stated to "verify that the design meets all product specifications and address the potential safety hazards."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving algorithmic performance because the document does not discuss:

• Acceptance criteria for an AI/algorithmic medical device.
• A test set, training set, or data provenance for an AI/algorithmic study.
• Expert involvement for ground truth establishment or adjudication for an AI/algorithmic study.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used in the context of AI/algorithmic performance.

The document is a 510(k) submission for a physical medical device (atherectomy system) that functions mechanically, not through an AI/algorithmic component. The testing described is typical for a mechanical medical device to demonstrate safety and effectiveness and substantial equivalence to a predicate 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 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 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.

Ask a specific question about this device

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 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 Orbital Atherectomy System (OAS) Exchangeable Series is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series 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)

This document describes the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) and its acceptance criteria as proven by a study.

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria values or a direct table comparing them to reported device performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K152694) through a series of performance/bench tests and biocompatibility tests. The conclusion states that the data supports "no new questions of safety or effectiveness...compared to the predicate device" and that "the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions."

Therefore, the acceptance criteria implicitly involve the device successfully passing all listed performance and biocompatibility tests, demonstrating performance comparable to the predicate device, and not raising new safety or effectiveness concerns.

Given the information, a table of acceptance criteria and reported device performance would be structured as follows, with the "Reported Device Performance" reflecting the successful completion of these tests:

Study Information

The document describes performance (bench) testing and biocompatibility testing to demonstrate substantial equivalence, rather than a clinical study with human subjects.

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

   • Test Set Sample Size: Not explicitly stated as a number of devices. For bench testing, typically multiple units are tested to ensure consistency and robustness, but the exact quantity is not detailed in this summary. For biocompatibility tests, samples of materials from the device are used.
   • Data Provenance: The document does not specify the country of origin for the data directly, but the submission is from "Cardiovascular Systems Inc." located in "St. Paul, MN, USA". The testing is described as "bench tests" and "biocompatibility evaluation," indicating laboratory-based studies, not retrospective or prospective human subject data.

2. 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 question is not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence of a medical device like this relies on objective engineering and scientific principles, validated test methods, and compliance with applicable standards and guidance (e.g., ISO standards for biocompatibility). There are no "experts" establishing a subjective ground truth for a test set in the way one might for diagnostic imaging.

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

   • This is not applicable. Adjudication methods are typically used in clinical trials involving human endpoints or expert interpretation of data. For bench and biocompatibility testing, the results are typically objectively measured and evaluated against predetermined pass/fail criteria, not adjudicated by a panel of experts.

4. 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 is not applicable. MRMC studies are specific to diagnostic imaging devices where human readers interpret medical images. This submission is for an atherectomy system, not an imaging device with AI assistance.

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

   • This is not applicable. The Diamondback 360 Peripheral Orbital Atherectomy System is a physical medical device for performing a surgical procedure, not an algorithm.

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

   • The "ground truth" for this submission is based on objective engineering measurements and scientific principles, verified through standardized bench testing and biocompatibility assessments, and evaluated against established performance specifications and regulatory standards. The goal is to demonstrate that the device performs equivalently to the predicate device in terms of safety and effectiveness, based on its physical and biological properties.

7. The sample size for the training set:

   • This is not applicable. There is no mention of a "training set" as this is not an artificial intelligence/machine learning device. The device itself is subject to performance testing, not trained on data.

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

   • This is not applicable, as there is no training set mentioned in the context of this device.

Ask a specific question about this device

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.

Ask a specific question about this device

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 sarface (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 510(k) summary (K152694) for the Diamondback 360 Peripheral Orbital Atherectomy System details the acceptance criteria via performance bench testing and concludes that the device meets these criteria. However, it does not involve a study in the traditional sense of clinical trials or AI/ML evaluations with human experts. Instead, it focuses on verifying the device's physical and functional properties against established specifications.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance bench testing categories that served as the acceptance criteria. The device performance is generally reported as meeting these criteria, implying successful execution within established specifications.

"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." |
| - Stall Testing | |
| - Introducer Compatibility Testing | |
| - Temperature Testing | |
| - Tensile Testing | |
| - Flexibility Testing | |
| - Delivered Torque Testing | |
| - Orbit Testing | |
| - Guidewire Brake Testing | |
| - Saline Flow Testing | |
| - Track Testing | |
| - Packaging/Simulated Distribution Testing | |
| - Biocompatibility (Cytotoxicity per ISO 10993-5) | |
| - Biocompatibility (ASTM Hemolysis per ISO 10993-4) | |
| - Biocompatibility (Chemical Characterization per ISO 10993-18) | |

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

The document does not specify exact sample sizes for each bench test. The "test set" in this context refers to the manufactured device components or systems subjected to the various physical and chemical tests. The data provenance is internal to the manufacturer (Cardiovascular Systems, Inc.) as these are internal design verification and validation tests. There's no mention of external data or geographic origin beyond the manufacturer's location in Saint Paul, MN. All testing described is retrospective in the sense that it evaluates a designed product, not prospective observational or interventional studies on human subjects.

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

This type of information is not applicable to the presented data. The "ground truth" for bench testing is typically defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and internal quality control criteria. These are established by engineering and quality assurance teams, not clinical experts for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. Bench testing results are compared against predetermined numerical or qualitative specifications, not adjudicated by a panel in the way clinical diagnostic accuracy studies are.

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 submission for a mechanical atherectomy device, not an AI/ML-driven diagnostic or assistive device where MRMC studies with human readers would be relevant.

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

Not applicable. The device is a physical, mechanical medical device.

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

For the bench testing, the "ground truth" is based on:

• Engineering Specifications: Designed parameters and tolerances for device components and system performance (e.g., tensile strength, flexibility limits, torque values, flow rates).
• International Standards: e.g., ISO 10993 for biocompatibility (Cytotoxicity, Hemolysis, Chemical Characterization).
• Test Protocols: Internally developed experimental procedures to evaluate specific performance characteristics.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems 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 atherectomy guide wire is a component that is part of the Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System. The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System (OAS) are 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 and the Diamondback 360 use 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.

In addition to the atherectomy guide wire, the Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: Orbital Atherectomy Device (OAD), Saline Infusion Pump, and Atherectomy Lubricant (e.g., ViperSlide).

The ViperWire Advance Flex Tip Guide Wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft.

This document is a 510(k) premarket notification for a medical device called the "Stealth 360 Orbital PAD System and Diamondback 360 Peripheral Orbital Atherectomy System," specifically addressing a modification to a component: the ViperWire Advance Flex Tip Peripheral Guide Wire.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical table of acceptance criteria with specific numerical targets and matching device performance values. Instead, it lists the types of performance bench tests conducted and states that "All test results demonstrate that the materials chosen, the manufacturing processes, and the design utilized for the ViperWire Advance Flex Tip Guide Wire met the established specifications necessary for consistent performance during its intended use." And "The ViperWire Advance Flex Tip Guide Wire met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs."

Here's a summarized table based on the provided text, indicating the types of tests performed:

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

The document mentions "performance bench testing" and "design verification and validation testing," using phrases like "All test results demonstrate..." which implies that a test set was used. However, specific sample sizes for any of these tests are not provided.

The data provenance is not explicitly stated as country of origin, but these are bench tests conducted by the manufacturer, Cardiovascular Systems, Inc., which is based in Saint Paul, MN, USA. The tests are described as retrospective in the sense that they are laboratory evaluations of the modified device, not clinical trials on patients.

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

This information is not applicable and not provided in the document. The study described is bench testing of a device component's physical and biocompatibility properties, not a study involving human diagnosis or interpretation where expert ground truth would be established. The "ground truth" for these tests would be the established engineering specifications and ISO standard requirements.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies to resolve discrepancies among multiple expert readers. This document describes bench testing, not a reader study.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench testing of a guide wire component, not a study evaluating human reader performance with or without AI assistance.

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

This question is not applicable as the device is a physical medical device (atherectomy system component), not an AI algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance are not relevant concepts for this type of device submission. The performance described is purely device-only (standalone physical device component) performance.

7. The Type of Ground Truth Used:

For the bench testing described, the "ground truth" is defined by:

• Established engineering specifications: Performance requirements set by the manufacturer for the guide wire (e.g., tensile strength, flexibility).
• Applicable standards: Specifically, ISO 10993 series for biocompatibility (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for sensitization and irritation, ISO 10993-11 for systemic toxicity and pyrogenicity, ISO 10993-4 for hemocompatibility).
• Test protocols: Documented procedures detailing how each test was to be performed and what constituted a successful outcome.
• Customer inputs: (Implied: requirements derived from user needs and clinical application).

8. The Sample Size for the Training Set:

This information is not applicable. The document describes a 510(k) submission for a physical medical device component, which involves bench testing and comparison to a predicate device. It does not involve machine learning or AI, and therefore there is no concept of a "training set" for an algorithm.

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

This information is not applicable for the reasons stated above (no training set for an AI algorithm).

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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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