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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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