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510(k) Data Aggregation
(23 days)
The Artix Thrombectomy Device is indicated for:
- · The non-surgical removal of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Artix Thrombectomy Device is intended for use in the peripheral vasculature.
The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature.
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and advanced to the thrombus. A self-expanding nitinol element is deployed to engage thrombus by retracting the outer delivery catheter. Artix is then retracted into the sheath to capture the targeted thrombus. Additional clot may be removed by aspiration with a Luer syringe (not provided). After the procedure is complete, the Artix and sheath are removed from the patient.
The provided document is a 510(k) summary for the Artix Thrombectomy Device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set information for an AI/CADe device.
The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Instead, it relies on non-clinical testing to demonstrate substantial equivalence to the predicate device.
Therefore, most of the requested information regarding acceptance criteria and studies for an AI/CADe device cannot be extracted from this document because it describes a medical device (thrombectomy catheter), not an AI/CADe system.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance of the device against those criteria. It only confirms that some acceptance criteria (identified through Design Failure Modes and Effects Analysis) were met by non-clinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly specified in the document) | "All acceptance criteria were met" |
2. Sample size used for the test set and the data provenance
N/A. The document describes non-clinical bench testing for a physical medical device, not a diagnostic AI/CADe system. Therefore, there is no "test set" in the context of image data or clinical data for an AI algorithm. The document mentions "verification and validation testing" but does not specify sample sizes or data provenance for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is not an AI/CADe system, there's no "ground truth" for a test set established by experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for a physical medical device clearance based on non-clinical testing.
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. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No clinical "ground truth" was used for this device clearance, as it relied on non-clinical bench testing to demonstrate substantial equivalence.
8. The sample size for the training set
N/A. This is a physical medical device, not an AI/CADe system, so there is no training set.
9. How the ground truth for the training set was established
N/A. Not applicable.
In summary, the provided FDA 510(k) document is for a physical medical device (thrombectomy catheter) and does not contain the information typically required for an AI/CADe device, as it did not involve clinical trials, expert reviews of diagnostic images, or AI algorithm performance evaluation.
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(123 days)
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.
This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.
| Test Category | Acceptance Criteria (Implicit from "PASS") | Reported Device Performance |
|---|---|---|
| Performance Verification | ||
| Microcatheter Stability | Samples passed established criterion | PASS |
| Coil Detachment Durability & Reliability | Samples passed established criterion | PASS |
| Coil Durability (Coil to DPU) | Samples passed established criterion | PASS |
| Distal Outer Sheath Durability | Samples passed established criterion | PASS |
| Track Force (Delivery) | Samples passed established criterion | PASS |
| Re-Sheathing Reliability | Samples passed established criterion | PASS |
| Fluoro Saver Marker Durability | Samples passed established criterion | PASS |
| Detachment Zone Tensile Strength | Samples passed established criterion | PASS |
| Dimensional Inspection of OD | OD within specification for compatibility | PASS |
| Dimensional Inspection of OAL | Appropriate length for compatibility | PASS |
| Dimensional Inspection of Length from Distal Tip to Radiopaque Marker Band | Appropriately placed marker band | PASS |
| Dimensional Inspection of Distal Fluoro Saver Markers | Correct proximal position | PASS |
| Detachment Zone Microcatheter Surface Temperature Comparison | Equivalent temperatures to predicate, no acute tissue inflammatory response | PASS (equivalent, no inflammation) |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity (Cut DPU3) | PASS | PASS |
| In Vitro Cytotoxicity (Uncut DPU3) | PASS | PASS |
| Guinea Pig Sensitization | PASS | PASS |
| Intracutaneous/Irritation Reactivity | PASS | PASS |
| Acute Systemic Toxicity | PASS | PASS |
| Material Mediated Pyrogenicity | PASS | PASS |
| Endotoxin | PASS | PASS |
| In Vitro Ames Bacterial Reverse Mutation Assay | PASS | PASS |
| In Vitro Mouse Lymphoma Mutagenicity Assay | PASS | PASS |
| In Vivo Mouse Peripheral Blood Micronucleus Assay | PASS | PASS |
| In Vitro Hemolysis | PASS | PASS |
| ASTM Partial Thromboplastin Time | PASS | PASS |
| C3a Complement Activation | PASS | PASS |
| SC5b-9 Complement Activation | PASS | PASS |
| In Vivo Thromboresistance in Dogs | PASS | PASS |
| USP Physicochemical Tests (Aqueous Extracts) | PASS | PASS |
| Determination of Extractable Metals By ICP-OES | PASS | PASS |
| Physicochemical Tests (Non-aqueous Extracts) | PASS | PASS |
| Sterilization Validation | Sterility Assurance Level (SAL) 10⁻⁶ | Achieved SAL 10⁻⁶ |
| Shelf-Life Testing | Will be conducted per FDA guidance | Not yet reported (will be conducted) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.
4. Adjudication Method for the Test Set
This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical device.
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