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The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inquinal arteries.

The Auryon ™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inquinal stenoses and occlusions.

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 mJ/mm2 to the occluded or narrowed artery. The laser delivers very short high intensity pulses which travel from the laser, through the fibers, and emerge from the polished ends of the individual fibers. As the UV light emerges from the fiber end, it will be absorbed by the fluid, and create a cavitation bubble within the fluid. The collapse of this bubble results in a photoacoustic shockwave that disintegrates rigid materials such as calcified lesions without relying on thermal degradation to break down the stenotic material.

The Auryon™ Atherectomy System must work over a commercially available guide wire that crosses the lesion intra-luminally. The catheters are available in seven configurations (0.9mm, 0.9mm, 1.5mm, 1.5mm XL, 1.7mm, 2.0mm and 2.35mm), with and without hydrophilic coating.

For the small size catheters (i.e., 0.9mm.1.5mm, and 1.7mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm, 1.5mm, and 1.7mm catheters do not have an aspiration feature and have not been tested in ISR lesions.

The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only. The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions.

The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.

The provided text is a 510(k) summary for the Auryon Atherectomy Catheter 1.7mm. It describes modifications to an existing device (K233668 Auryon™ Atherectomy System) by adding a new catheter size (1.7mm). The key aspect of this submission is demonstrating that the new 1.7mm catheter maintains substantial equivalence to the predicate device.

The document does not describe a study to prove medical device effectiveness or performance in a clinical setting against acceptance criteria for a diagnostic aid or an AI/ML-driven device. Instead, it details engineering and compatibility testing to ensure the new catheter size functions safely and effectively within the established parameters of the predicate device.

Given the nature of the document, the following points address the questions based on the provided information, indicating where the information is not available for a typical AI/ML-driven medical device evaluation:

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

   The document lists the types of tests performed for the new 1.7mm catheter to demonstrate it meets the same standards as the predicate device. However, it does not provide
   a table with specific numerical acceptance criteria and reported performance values for each test. Instead, it states that the new catheter was tested "using the same methods and acceptance criteria as the predicate device."

   Test Type	Acceptance Criteria (Not explicitly stated, assumed to be same as predicate)	Reported Device Performance (No specific data provided in this summary)
   Catheter Shaft OD, ID, Working Length	Conformance to specifications	"The new 1.7mm Auryon Atherectomy System Catheter was tested using the same methods and acceptance criteria as the predicate device." (Implies successful conformance)
   Guard Tube Length	Conformance to specifications	(Implies successful conformance)
   Catheter Trackability (Simulated Use)	Safe and effective navigation in simulated vessels	(Implies successful conformance)
   Shaft Pull Test	Strength and integrity	(Implies successful conformance)
   Inner Blade Pull Test	Strength and integrity	(Implies successful conformance)
   Proximal Section Pull Test	Strength and integrity	(Implies successful conformance)
   Luer Pull vs Handle Pull Test	Secure connection	(Implies successful conformance)
   Distal Tip Evaluation	Conformance to design and functionality	(Implies successful conformance)
   Optical Functionality Test	Proper laser energy transmission	(Implies successful conformance)
   Catheter Torque Strength	Resistance to twisting	(Implies successful conformance)
   Fatigue Test	Durability over repeated use	(Implies successful conformance)
   Catheter Optical Durability	Laser fiber integrity and performance	(Implies successful conformance)
   Evaluation of Hydrophilic Coating	Adhesion, lubricity, and integrity	(Implies successful conformance)
   Bioburden Determination	Sterility levels within acceptance	(Implies successful conformance per sterilization validation)
   LAL Testing	Endotoxin levels within acceptance	(Implies successful conformance per sterilization validation)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   This document focuses on engineering and performance testing of a physical device component (catheter), not a study involving patient data relevant to AI/ML. Therefore, typical "sample size for a test set" and "data provenance" as applied to clinical data or imagery are not applicable or detailed in this context. The testing would involve a sufficient number of manufactured units of the 1.7mm catheter to ensure statistical validity for each engineering test. The document does not specify these sample sizes.

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 ground truth for engineering tests like shaft pull or optical functionality is established by engineering specifications and physical measurements, not clinical expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This concept pertains to clinical studies often involving multiple readers interpreting data or images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This is not an AI/ML-driven device or study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an AI/ML-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the tests mentioned (e.g., Catheter Shaft OD, ID, Working Length, Shaft Pull Test, Optical Functionality Test, etc.) would be established by the device's engineering specifications, design requirements, and industry standards for atherectomy catheters. For sterilization, the ground truth is established by regulatory standards and validated protocols for bioburden and LAL testing.

8. The sample size for the training set:
   Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:
   Not applicable, as this is not an AI/ML device.

In summary, this 510(k) pertains to an engineering modification of an existing medical device, not a new AI/ML-powered diagnostic or treatment device. The "study" described is a series of engineering and performance tests to ensure the new catheter size is substantially equivalent and performs as safely and effectively as the predicate device.

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The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.

The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser console. The Auryon catheter is a single use catheter that is made of an array of optic fibers surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser system via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery.

The Auryon™ Atherectomy System must work over a commercially available 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in six configurations (0.9mm, 0.9mm XL, 1.5mm, 1.5mm XL, 2.0mm and 2.35mm), with and without hydrophilic coating.

For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions.

The larger Auryon catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "off-center" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure. These devices are also indicated for treatment of In-Stent Restenosis (ISR) lesions.

The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.

The modification associated with this submission is to add a second catheter length (225cm) for the size 0.9 and 1.5 mm catheter sizes. The ID of the 0.9mm catheter is also increased slightly.

There are no changes to the Auryon Laser Console unit associated with this submission.

The provided text is a 510(k) Summary for the Auryon Atherectomy System. It describes a medical device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance. However, it does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert involvement, or specific statistical measures (like sensitivity, specificity, or effect sizes for human readers). Instead, it focuses on engineering and manufacturing performance testing related to the physical and functional aspects of the catheter sizes and manufacturing processes.

Therefore, I cannot fulfill the request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics of an AI/algorithm-based device. The document details the technical performance testing for a medical device (atherectomy system) where the "acceptance criteria" are related to physical dimensions, functionality, durability, and sterilization.

Here's how I can address the parts of your request based on the actual content of the document:

The document describes a 510(k) submission for the Auryon™ Atherectomy System, a medical device for treating arterial stenoses. The "study" described is a set of performance tests to demonstrate substantial equivalence to a predicate device, particularly for newly added longer catheter sizes and a slight ID increase.

The acceptance criteria are not broken out into a table with reported performance values in the level of detail requested (e.g., sensitivity, specificity) because this device is a physical atherectomy system, not an AI/algorithm with diagnostic performance metrics. The criteria are related to the physical and functional characteristics of the catheters. The document states that the new devices were tested "using the same methods and acceptance criteria as was done in the predicate device 510(k)." The implication is that the devices met these criteria, as substantial equivalence was concluded.

Here's the information extracted and interpreted based on the provided text, addressing your points where possible, and noting when the information is
not applicable (N/A) given the nature of the device and the content of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, implying that the new device configurations met the established acceptance criteria, which were the same as those for the predicate device. Specific numerical acceptance values and test results are not provided in this summary document. The acceptance criteria are implicitly met for the device to be considered substantially equivalent.

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

The document does not specify the sample sizes (e.g., number of catheters) used for each of the performance tests. The data provenance is implied to be from laboratory testing conducted by the manufacturer, Eximo Medical Ltd. The document does not indicate whether the data was retrospective or prospective in the clinical sense, as these are engineering and bench tests rather than clinical study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is N/A. The "ground truth" for this type of device (an atherectomy system) is established through engineering specifications, material science, and functional performance benchmarks (e.g., does it fit through the artery, does it ablate tissue effectively, is it sterile) rather than expert interpretation of medical images or pathologies. There is no mention of external experts being used for "ground truth" in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This section is N/A. Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation or consensus is required to establish ground truth for diagnostic accuracy, particularly with image-based AI. For the engineering and performance tests described, the "adjudication" would be through standard laboratory testing protocols and adherence to pre-defined passing criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is N/A. The device is an atherectomy system, not a diagnostic imaging AI. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its type of evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This section is N/A. The device is a physical atherectomy system; it does not have a "standalone algorithm" in the diagnostic AI sense. Its performance is intrinsically linked to its use by a human operator in a medical procedure.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Engineering Specifications: Defined dimensions, material properties, and functional requirements.
• Bench Testing Standards: Established protocols for testing trackability, torque, optical function, and durability.
• Sterilization Standards: Regulatory and industry standards for demonstrating product sterility and safety (e.g., bioburden, EO residuals, LAL testing).

There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the device's technical performance in this summary.

8. Sample Size for the Training Set

This section is N/A. This document describes the testing and clearance of a medical device (atherectomy system), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm.

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

This section is N/A for the same reason as point 8.

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