(30 days)
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.
| Acceptance Criterion Category | Performance Test/Characteristic Assessed | Reported Device Performance (Implicitly Met) |
|---|---|---|
| Physical Dimensions | Catheter shaft ID, OD, and working length | Met predicate device specifications/tolerances for new longer sizes and slightly increased 0.9mm ID. |
| Mechanical Functionality | Catheter trackability in simulated anatomical shape | Demonstrated comparable trackability to predicate devices. |
| Optical Functionality | Optical Functionality test | Maintained optical performance characteristics. |
| Mechanical Durability | Catheter torque test | Demonstrated acceptable torque resistance. |
| Optical Durability | Catheter optical durability | Maintained optical integrity over its operational lifespan. |
| Sterilization Efficacy | Validation that longer catheters can be sterilized in predicate device sterilization process (O B&F testing, Bioburden recovery rate, Bioburden determination, Comparison of natural product resistance to Biological Indicators, EO Residuals, LAL testing) | Demonstrated that the sterilization process is effective and safe for the new catheter lengths, comparable to the predicate. |
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.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).