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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 300cm 0.014" guide wire that crosses the lesion intra-luminally. The catheters are available in four sizes (0.9mm, 1.5mm, 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 platinum/iridium marker band within the wall of the 0.9 mm coated and uncoated catheters adjacent to the existing stainless steel inner blade. This marker band will enhance the radiographic contrast of the device.

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

The provided text describes a 510(k) premarket notification for a medical device called the Auryon Atherectomy System. This submission is a "Special 510(k)" to introduce a slight modification to an already cleared device: adding a platinum/iridium marker band to the 0.9 mm catheter for enhanced radiographic image contrast.

The document states that the modified device was tested using the same methods and acceptance criteria as the predicate device (K220116). However, it does not explicitly state the acceptance criteria values nor the reported device performance for each criterion in numerical terms, only that the tests were conducted and support substantial equivalence. It also does not discuss any multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance, or details about training sets, as the modification is to a physical device for improved imaging, not an AI/ML algorithm.

Therefore, the following information is extracted based on what is available in the document, and where information is not present, it is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the modified 0.9 mm Auryon Atherectomy Catheter was tested using the "same methods and acceptance criteria as was done in the predicate device 510(k)." While the specific numerical acceptance criteria and reported device performance are not explicitly detailed in this document, the types of performance tests conducted are listed.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "performance testing" of the modified catheter.

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

This information is not applicable/not provided as the device modification is physical (addition of a marker band) and the testing described relates to mechanical and functional performance, not diagnostic accuracy requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the testing primarily involves objective physical and functional measurements, not subjective interpretation requiring adjudication among experts.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or described. The submission is for a physical modification of an atherectomy catheter, not an AI/ML diagnostic system. The improvement mentioned is enhanced radiographic contrast, which facilitates device visualization rather than directly improving human reader diagnostic accuracy in a comparative study involving AI.

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

No, a standalone (algorithm only) performance study was not done or described. This submission pertains to a physical medical device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/ML validation (e.g., expert consensus, pathology, outcomes data) is not applicable to the type of device modification and testing described in this document. The "tests" are for physical properties and functionality against predefined engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set.

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

This information is not applicable/not provided as the submission is for a physical medical device and does not involve AI/ML algorithms that require a training set and corresponding ground truth.

Ask a specific question about this device

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 Catheters are single use catheters made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The Auryon catheter is connected to the laser of the predicate device Auryon Atherectomy 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 Catheter must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra luminally. The new catheters which are the subject of this 510(k) include a hydrophilic coating on the external distal portion of the catheter shaft.

The predicate device Auryon Atherectomy Catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm, without hydrophilic coating. The subject device Auryon Atherectomy Catheters are available in the same four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm, but with a 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 provided text describes the substantial equivalence of the Auryon™ Atherectomy System (with hydrophilic coating) to its predicate device (Auryon Atherectomy System without hydrophilic coating) and a reference device (Spectranetics Turbo-Elite Laser Atherectomy Catheters). The focus of the submission is the addition of a hydrophilic coating to the catheter shaft.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The hydrophilic coated Auryon Atherectory Catheters were tested using the same methods and acceptance criteria as was done in the predicate device 510(k). In addition, coating performance was tested, with comparison to the performance of the reference device K170059." This implies that all listed tests met the established (but not explicitly detailed in this document) acceptance criteria that were used for the predicate device, and the coating performance was comparable to the reference.

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

The document does not provide details on the specific sample sizes used for each test. It mentions "performance testing" and "additional testing" without quantifying the number of devices or units tested. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective data), as this is a premarket notification for a device, not a clinical study involving patient data. The tests described are bench and functional tests of the device itself.

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

This information is not applicable. The studies described are engineering and performance tests of the device, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The studies described are engineering and performance tests, not clinical evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This submission focuses on the substantial equivalence of a medical device (atherectomy catheter) based on its physical and functional characteristics, particularly the addition of a hydrophilic coating, not on the comparative clinical effectiveness of an AI system with human readers.

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

No, a standalone (algorithm-only) performance study was not done. The device in question is an atherectomy catheter, a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance testing was based on engineering specifications and established test methodologies from the predicate device and relevant industry standards. For coating performance, the ground truth involved comparison to the performance of a legally marketed reference device (Spectranetics Turbo-Elite Laser Atherectomy Catheters).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This information is not applicable, as there is no training set.

Ask a specific question about this device

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 Catheters are single use catheters made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser of the Auryon™ Atherectomy 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 Catheter must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally.

The Auryon™ Atherectomy catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm):

• 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 "offcenter" feature (2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
• . 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 does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would find for a software or AI-powered medical device. Instead, it is a 510(k) premarket notification for the Auryon™ Atherectomy System, a physical medical device.

The document describes Indication for Use for a medical device (Auryon™ Atherectomy System) and asserts its Substantial Equivalence to a predicate device, rather than providing details of an AI-based system's performance metrics against acceptance criteria.

The key points from the document regarding the device and its testing are:

• Device: Auryon™ Atherectomy System (physical device, not AI/software)
• Purpose of 510(k): To revise the Indications for Use for the existing device. No physical or software changes were made to the device itself.
• Revised Indication: Specifically includes the ability for Auryon™ Atherectomy Catheters with aspiration to "aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries."
• Performance Testing for revised indication:
  • Methodology: Fresh thrombus was created in simulated blood vessels and then removed using the Auryon™ Atherectomy System with aspiration.
  • Efficacy Measurement: Thrombus removal efficacy was based on the weight of thrombus removed.
  • Safety Measurement: Confirmation that emboli were not generated during thrombus removal was based on the absence of emboli in an in-line embolic protection device.
  • Conclusion: This testing "confirmed that there are no new questions of safety or effectiveness" with the inclusion of thrombus removal in the Indications for Use.

Therefore, since the request is for details related to acceptance criteria and a study for an AI/software device, and the provided document is for a physical medical device and its updated indications for use, I cannot fulfill the request as specified. The document does not discuss:

1. A table of acceptance criteria and reported device performance (for AI/software).
2. Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, or how ground truth was established for the training set.

These are all metrics and details relevant to AI/software validation, which are not present in this physical device 510(k) submission.

Ask a specific question about this device

The Auryon Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

The Auryon™ Atherectomy System consists of two sub-units: 1) a single use catheter ("Auryon catheter"); and 2) a laser system. The Auryon catheter is a single use catheter that is made of an array of optic fibers and 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 300cm 0.014" guide wire that crosses the lesion intra-luminally. 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. These devices should not be used in ISR cases.

The larger B-Laser™ 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 "offcenter" feature 2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.

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.

Here's an analysis of the provided text regarding the Auryon Atherectomy System, focusing on acceptance criteria and the study proving it meets them:

Device: Auryon Atherectomy System

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document (K202835) is for a modification to an already cleared device (B-Laser Atherectomy System, K181642). Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the modified device performs equivalently to the predicate device and that the changes do not raise new questions of safety or effectiveness. The document states: "The modified 1.5 mm Auryon Atheter was tested using the same methods and acceptance criteria as was done in the predicate device 510(k)."

Therefore, the acceptance criteria are not explicitly detailed as specific numerical thresholds in this document, but rather as successful completion of the listed tests to demonstrate equivalent performance to the predicate device.

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

The document does not provide specific sample sizes (e.g., number of catheters tested) for each of the performance tests listed. Since this is a 510(k) for a modification (changing fiber diameter and subtle length differences in the 1.5mm catheter), the testing would likely involve a statistically appropriate number of units of the modified device to demonstrate equivalence, but this detail is not present in the provided text.

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's for regulatory submission, the testing would be conducted under controlled laboratory conditions, likely at the manufacturer's facility.

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

This information is not provided. The listed tests are primarily engineering and bench-top performance tests, not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as the tests are primarily objective physical and functional performance assessments, not subjective interpretations requiring adjudication.

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 not an AI diagnostic tool and does not involve human readers interpreting AI output. It is an atherectomy system (a physical medical device for removing plaque from arteries).

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

For the engineering and bench-top performance tests, the "ground truth" is typically defined by engineering specifications, international standards (e.g., ISO, ASTM), and the performance characteristics of the predicate device. For example, "trackability" would be assessed against a defined force or successful navigation through a simulated tortuous path. "Fatigue testing" would have a defined duration or cycles to be met without failure.

8. The Sample Size for the Training Set

Not applicable. This device does not have a "training set" in the context of machine learning or AI models. It is a physical medical device.

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

Not applicable. Refer to point 8.

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The B-Laser™ Atherectomy System is intended for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

The B-Laser™ System consists of two sub-units: 1) a single use catheter ("B-Laser™ catheter"); and 2) a laser system. The B-Laser™ catheter is a single use catheter that is made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The B-Laser™ 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 B-Laser™ System must work over a commercially available 300cm 0.014" guide wire (GW) that crosses the lesion intraluminally. - For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a quidewire at the center of the inner blunt blade. Please note that 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions. These devices should not be used in ISR cases.

The larger B-Laser™ 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 "offcenter" feature (2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.

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 B-Laser Atherectomy System is intended for the treatment, including atherectomy, of infra-inguinal stenoses and occlusions, including in-stent restenosis (ISR).

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on safety and effectiveness endpoints rather than defining specific numerical acceptance criteria for each measurement. However, based on the documented "achieved" status of primary endpoints, we can infer the achieved performance.

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

• Pilot Study: 49 subjects (52 lesions). Data provenance is "Europe" (prospective, single-arm, multi-center, open-label, non-randomized clinical study).
• Pivotal Study: 97 subjects (107 evaluable lesions). Data provenance is "US and Europe" (pivotal, prospective, single-arm, multi-center, open-label, non-randomized IDE clinical study).

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

The document mentions that "residual stenosis reduction" in the pilot study was "determined by retrospective evaluation by independent Corelab." While it indicates independent analysis, it does not specify the number of experts from the Corelab or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the clinical studies. It mentions an "independent Corelab" for stenosis evaluation in the pilot study, implying a standardized review process, but details of how disagreements would be resolved are not provided.

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

A MRMC comparative effectiveness study was not done. The studies described are single-arm studies evaluating the performance of the B-Laser Atherectomy System itself, not comparing human readers with and without AI assistance. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance:

The document describes the performance of the "B-Laser Atherectomy System" as a medical device. This is a standalone performance study of the device itself (algorithm only without human-in-the-loop performance is not applicable here as it is a physical device). The "standalone" context for this device refers to its ability to perform the intended atherectomy procedure effectively and safely.

7. Type of Ground Truth Used:

For the clinical studies, the ground truth was established through clinical outcomes data (e.g., successful lesion crossing, reduction in residual stenosis, occurrence of adverse events, MAE rates) as assessed by clinical investigators and an independent Corelab.

8. Sample Size for the Training Set:

The document describes clinical performance testing, meaning these studies were conducted on the finished device to evaluate its safety and effectiveness. It does not mention a "training set" in the context of an AI/algorithm where a separate training dataset would be used. The clinical studies represent validation of the device's performance in human subjects.

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

As there is no mention of a "training set" for an algorithm, this question is not applicable to the information provided about the B-Laser Atherectomy System, which is a physical medical device, not an AI or software algorithm requiring a training phase for its core functionality.

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