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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from arterial blood vessels within the body. The FreedomFlow™ Orbital Circumferential Atherectomy System is used together with a compatible introducer sheath and 0.014-inch diameter x 300 cm (minimum length) atherectomy guidewire. The driveshaft is introduced into the patient's vasculature by traditional minimally invasive techniques. The FreedomFlow™ User Handle is available in model numbers that are listed below with vessel size ranges.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) includes an integrated driveshaft with multiple abrasive spheres on a rotating driveshaft. The abrasive spheres are eccentrically mounted onto the driveshaft so that when the driveshaft is rotated, they move outward due to centrifugal force. These abrasive spheres are spaced along the driveshaft in a spiral configuration to optimize plaque modification within a vessel while still maintaining flexibility for treating tortuous arterial anatomy. The User Handle includes two rotational speeds: low speed at 50,000 revolutions per minute (RPM) and high speed at 76,000 RPM.

The FreedomFlow Orbital Circumferential Atherectomy System - Electric (FreedomFlow™) is powered by Cardio Flow Power Supply H7001, which is a hospital-grade portable, reusable component. H7001 provides DC power to rotate the FreedomFlow™ driveshaft. H7001 also provides DC power to a saline pump integrated into the FreedomFlow™ User Handle. During operation the saline pump delivers saline to the distal tip of the driveshaft.

The FreedomFlow™ orbital atherectomy User Handle is supplied single patient use, sterile. The package contents include the following items.

• FreedomFlow™ orbital atherectomy User Handle with integrated electric motor and saline pump
• Saline infusion tubing set

I'm sorry, but your request cannot be fulfilled. The provided document is an FDA 510(k) clearance letter for a medical device (FreedomFlow™ Orbital Circumferential Atherectomy System), not for an AI/ML-driven medical device.

The document describes the physical characteristics of an atherectomy system, its intended use, and bench testing to demonstrate its mechanical and performance characteristics (like plaque removal efficiency, tensile strength, rotational speed, etc.). It does not involve any AI/ML components, nor does it describe a study involving human readers, ground truth establishment by experts, or MRMC studies, which are typical for validating AI/ML-driven medical devices.

Therefore, I cannot extract the information required to describe acceptance criteria and a study proving an AI/ML device meets those criteria from this non-AI/ML medical device submission.

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The Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" and 0.018" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Turbo-Elite laser atherectomy catheters are percutaneous intravascular devices constructed of multiple optical fibers in a concentric array around a guidewire lumen. The optical fibers are enclosed in an outer jacket and the working length of the device is coated with a hydrophilic coating. The distal tip of the catheter includes a Platinum Iridium outer Marker Band which is visible under fluoroscopy. The proximal end consists of a tail tube and a coupler which connects the device to the CVX-300 or PLS laser systems.

Turbo-Elite is designed and intended to be used exclusively with Spectranetics' CVX-300 Excimer Laser System and Philips Laser System (PLS).

The catheters transmit ultraviolet energy from the laser system to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.

During a laser atherectomy, and under fluoroscopic guidance, a physician advances the introducer sheath to the target lesions. The Turbo-Elite catheters are then advanced to the proximal end of the lesion to be treated.

The provided text is a 510(k) summary for the Spectranetics Turbo-Elite Laser Atherectomy Catheter. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially not regarding performance in terms of AI/algorithm effectiveness.

The document states:

• "The subject device has the same technological characteristics as the predicate device with no significant updates to device design, specification, or performance."
• "Other minor changes related to component suppliers and certain adhesives used were supported via applicable design verification and validation testing and related rationales."

These statements imply that testing was performed to demonstrate that the minor changes did not negatively impact performance, and that the device performs equivalently to the predicate. However, it does not provide any specific quantitative acceptance criteria or the results of any clinical or analytical studies proving such performance, nor does it mention any AI or algorithmic components. The device described is a physical medical device (laser atherectomy catheter), not a software or AI-driven diagnostic tool.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets them based on the provided text. The questions are largely centered around AI/algorithm performance and ground truth, which are not relevant to the content of this 510(k) summary.

In summary, the provided document does NOT contain the information requested in your prompt regarding acceptance criteria and algorithmic performance studies.

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The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied quidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip.

The provided text is a 510(k) premarket notification for the Rotarex™ Atherectomy System. This document explicitly states that no changes have been made to the subject Rotarex™ Atherectomy System itself. The purpose of this submission is to obtain FDA clearance related to proposed revisions to the existing Rotarex™ Atherectomy System instructions for use (IFU) to clarify and emphasize procedural steps to reduce the risk of catheter breakage events.

Given this, the document clearly states:

"As no changes are being made to the Rotarex™ Atherectomy System associated with this 510(k) notice, no new performance testing was conducted on the subject device."

Therefore, the Acceptance Criteria and Device Performance information you requested, related to new testing proving the device meets acceptance criteria, cannot be extracted from this document because such testing was not performed for this specific 510(k) submission.

This document describes a regulatory filing for an IFU update for an already cleared and existing device. It does not contain information about the original performance data, acceptance criteria, or studies used to clear the initial device.

In summary, none of the requested information (performance table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be provided based on the text you supplied, as the document explicitly states no new performance testing was conducted.

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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as a therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

This looks like a 510(k) summary for a medical device called the "FreedomFlow™ Orbital Circumferential Atherectomy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way one might for a novel AI/software device.

The premise of a 510(k) is that if a new device is shown to be substantially equivalent to a legally marketed predicate device, it does not require a new Pre-Market Approval (PMA) application. Substantial equivalence is often established by demonstrating that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information about acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC, standalone performance, training set details), which are common for AI/software device submissions, are largely not applicable in the context of this specific 510(k) submission.

Here's a breakdown of why this information is largely absent and what is provided:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria/Performance: This document does not provide a table of acceptance criteria and reported device performance in the form typically expected for AI/software evaluations (e.g., sensitivity, specificity, AUC). Instead, it establishes "substantial equivalence" to predicate devices. The "performance" being evaluated here relates to the manufacturing process change (soldering to welding) and a pump head change. The document states: "There are no performances differences incurred as a result of this change." and "Testing verifies all pump related specifications."
• Table of Comparison (from the document): The document includes a large table on pages 6-7 comparing the subject devices (H6001 & H6004 with changes) to predicate devices (H6001 [K231538] & H6004 [K233483]). This table highlights that all key characteristics, including Product Code, Classification, Intended Use, Indications for Use, Mechanism of Operation, System Components, Driveshaft Variations, Rotational Speed, Saline flow rate, Shelf life, Sterility, etc., are "Same." The core acceptance criterion for this 510(k) is demonstrating that these characteristics remain equivalent despite the manufacturing changes.

2. Sample size used for the test set and the data provenance:

• Not Applicable in this context: The document does not describe a "test set" in the sense of a clinical or image dataset for an AI algorithm. The evaluations conducted are likely engineering bench tests, biocompatibility tests, and potentially functional tests related to the manufacturing processes. Details on sample sizes for these types of tests are not typically included in the 510(k) summary provided to the public.
• Data Provenance: Not applicable as there isn't a "data set" originating from specific countries or clinical studies as would be for an AI device. The data provenance would be internal engineering and manufacturing quality control data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: There is no "ground truth" established by experts in this context. The evaluation is against engineering specifications and the established performance of the predicate device.

4. Adjudication method for the test set:

• Not Applicable: There is no "adjudication method" as this is not a subjective diagnostic or interpretative task.

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 a physical medical device (atherectomy system) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is completely irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable: This is a physical atherectomy system; it is not an algorithm.

7. The type of ground truth used:

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's performance is its adherence to engineering specifications, functional requirements, and safety standards, which are themselves benchmarked against the predicate device. For example, biocompatibility testing would be compared against ISO standards, and functional tests (like rotational speed, saline flow) would be compared against their defined operational parameters.

8. The sample size for the training set:

• Not Applicable: There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not Applicable: There is no "training set."

In summary:

This 510(k) pertains to a manufacturing process change and a component change for a physical medical device (Atherectomy System). The regulatory submission demonstrates substantial equivalence to existing predicate devices by showing that these changes do not alter the intended use, indications for use, or fundamental technological characteristics, and do not raise new questions of safety or effectiveness. The detailed study parameters typically associated with AI/software device evaluation are not relevant to this type of submission.

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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 FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere) is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply. The User Handle with the integrated driveshaft is sterile, single use, and disposable. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

The provided text describes a medical device, the FreedomFlow™ Orbital Circumferential Atherectomy System (H6004 5Fr 3-Sphere), and its substantial equivalence determination by the FDA. However, the document does not contain the level of detail requested regarding acceptance criteria and the specifics of a study proving a device meets these criteria in the context of an AI/human-in-the-loop system.

The "study" mentioned in this document refers to performance testing for a mechanical medical device, specifically:

• Dimensional Analysis Testing
• Orbit Characterization Testing (effectiveness of sanding technology, lumen diameter vs. speed vs. time, plaque removal efficiency)
• Simulated Life Test
• Torque Stall and Loaded Start Test
• Joint Tensile Test
• Joint Torque Test
• Particulate Analysis Comparison Test
• Electric System Human Cadaver Pre-Clinical Test

There is no indication that this device incorporates AI or sophisticated software that would necessitate human-in-the-loop performance studies, expert ground truth adjudication, or metrics like sensitivity, specificity, or AUC, which are typically associated with AI-powered diagnostic or assistive devices.

Therefore, I cannot provide the requested information in the format of the questions because the document describes a mechanical atherectomy system, not a device whose performance is measured in the ways implied by the prompt's questions (e.g., AI assistance, expert readers, ground truth establishment for AI training/testing).

If the prompt intended for me to infer or create a hypothetical scenario for an AI-powered atherectomy system, I would need additional context or a different document. Based only on the provided text, the questions are not applicable to the described device and its testing.

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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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The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

The FreedomFlow™ Orbital Circumferential Atherectomy System is a flexible over-the-wire rotational device used to ablate atherosclerotic plaque from peripheral arterial blood vessels within the body. The FreedomFlow™ System consists of three components: User Handle with integrated driveshaft, Tubing Set, and Power Supply.

The User Handle with the integrated driveshaft is sterile, single use, and disposable. Both 5 Fr and 6 Fr variations of the User Handle are available. The User Handle provides the operator interface to control driveshaft rotation (with two speed options) and translation within the vessel. The User Handle also incorporates a guidewire mechanical clamp. The User Handle controls the saline fluid flow down the driveshaft catheter. The User Handle utilizes firmware and hardware to perform these functions. The Tubing Set is sterile, single use, and disposable. The Tubing Set connects a user provided sterile saline supply to the User Handle. The Tubing Set is connected by the operator to the User Handle. The Power Supply is a medical grade AC powered transformer, supplying DC electrical energy to the User Handle. The power supply is reusable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample sizes used for the test set and the data provenance

• FAST II Study (Primary Clinical Study):
  • The exact sample size isn't explicitly stated for this part, but it refers to "patients with symptomatic peripheral arterial disease (PAD) of the lower extremities."
  • Provenance: Prospective, multi-center, single-arm, open-label clinical study. No specific country of origin is mentioned, but "multi-center" implies multiple locations.
• Supplemental Analysis (Matched Comparison):
  • FAST II Cohort: The same patient cohort from the FAST II study.
  • PVI Registry Cohort: Real-world evidence obtained from the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry. This cohort was refined using propensity scoring to identify a control group with well-balanced baseline covariates.
  • Provenance: This involves data from a prospective clinical study (FAST II) and retrospective registry data (VQI PVI). The "real-world evidence" suggests a broader, likely multi-national or U.S.-based, data source.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• For the "raw data (i.e., arteriographic images) from the cohort registry and the FAST II study," an independent angiographic core-laboratory was used for blinded analysis.
• The number and specific qualifications of experts within this core-laboratory are not explicitly detailed in the provided text.

4. Adjudication method for the test set

• For the supplemental effectiveness analysis, the "raw data (i.e., arteriographic images)" were "randomized for blinded analysis by an independent angiographic core-laboratory." This implies a blinded, independent review process. The specific number of readers or a 2+1, 3+1 method is not stated, but the "core-laboratory" typically suggests a robust, structured review process.

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed. This submission is for an atherectomy system (a physical medical device) and its associated firmware, not a diagnostic AI system designed to assist human readers in interpreting images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, this is not applicable. The FreedomFlow Orbital Circumferential Atherectomy System is a physical medical device. While it includes firmware (software), the studies described evaluate the device's clinical and non-clinical performance, not the standalone performance of an algorithm that generates an interpretation or diagnosis without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Clinical Outcomes Data: The primary safety endpoint (freedom from MAE) and primary effectiveness endpoints (technical success, Post Atherectomy Stenosis) are based on direct clinical outcomes measured in patients.
• Expert Adjudication: For the effectiveness endpoint, residual diameter stenosis was determined by an "independent angiographic core-laboratory," which implies expert consensus based on angiographic images.

8. The sample size for the training set

• Not applicable/Not provided. This information pertains to machine learning models. The studies described are evaluating a physical medical device, not training a machine learning model for diagnostic or predictive purposes where a distinct training set would be required for the evaluation itself. The "propensity scoring" used in the supplemental analysis to "refine" and "identify a control cohort" from the PVI registry is a statistical matching technique, not a machine learning training process in the sense of an algorithm.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As there is no described training set for a machine learning model in this context, the method for establishing its ground truth is not relevant here.

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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 Pantheris LV System is indicated to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox.

This document is a 510(k) summary for the Pantheris LV Atherectomy Catheter. It outlines the device's indications for use, compares it to predicate and reference devices, and describes the performance data used to demonstrate substantial equivalence.

Based on the provided text, the Pantheris LV Atherectomy Catheter is not an AI/ML enabled device. This conclusion is drawn from the following observations:

• Absence of AI/ML terminology: The document does not mention any terms typically associated with AI or machine learning, such as "algorithm," "model," "deep learning," "neural network," "AI assistance," "inference," "training data," "validation data," "ground truth establishment" for algorithms, or "performance metrics" relevant to AI (e.g., sensitivity, specificity, AUC for an AI-driven diagnostic).
• Focus on mechanical and optical characteristics: The device description and performance data sections primarily detail mechanical properties, optical coherence tomography (OCT) imaging capabilities (which are optical imaging not AI-driven image interpretation), electrical safety, electromagnetic compatibility, and biocompatibility.
• Comparison to existing devices based on physical design: The substantial equivalence argument relies heavily on comparing the Pantheris LV's physical design attributes (e.g., catheter size, tip length, working length, mechanism of atherectomy) and shared operational characteristics with existing cleared devices, rather than any advanced computational functionalities.
• Nature of the device: The device is described as an "atherectomy catheter" used to "remove plaque." Its functionality involves physical plaque removal assisted by OCT imaging for guidance, not AI-driven diagnosis, interpretation, or decision-making. The OCT is explicitly stated as "OCT-assisted orientation and imaging" and "an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies," referring to human interpretation of these images, not AI analysis of them.
• Lack of AI-specific study types: The "Performance Data" section details mechanical, electrical, and biocompatibility testing. There is no mention of studies that would be typical for an AI/ML device, such as those evaluating diagnostic accuracy (e.g., standalone performance, MRMC studies, reader studies). The sections on "Animal Testing" and "Clinical Studies" explicitly state they "were not necessary" for this particular submission, further indicating the absence of complex data-driven (AI) performance validation.

Therefore, the request to describe acceptance criteria and study data for an AI/ML device is not applicable to the Pantheris LV Atherectomy Catheter based on this document. The provided text does not contain information related to AI/ML acceptance criteria or studies.

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