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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 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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