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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 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.

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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 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.

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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 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.

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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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