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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.

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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.

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