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510(k) Data Aggregation
(53 days)
YASARGIL TITANIUM ANEURYSM CLIPS
The Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.
These titanium alloy aneurysm clips will be available as temporary or permanent devices.
The provided text is a 510(k) summary for Yasargil Titanium Aneurysm Clips. This document asserts substantial equivalence to previously marketed devices and describes the product's intended use and technological characteristics. However, it does not contain any information regarding performance studies, acceptance criteria, or specific metrics typically associated with device performance evaluation.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence rather than detailed performance study results.
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(324 days)
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
The Yasargil Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.
These titanium alloy aneurysm clips will be available in mini and standard sizes, and as temporary or permanent devices.
The provided text describes a 510(k) summary for Yasargil Titanium Aneurysm Clips, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria as might be found in a performance study for a diagnostic AI.
However, I can extract information related to the device's characteristics and the studies performed to support its safety and effectiveness, interpreting them as a form of "acceptance criteria" and "study results" within the context of a medical device submission focused on material and mechanical properties, and biocompatibility.
Here's an attempt to structure the information according to your request, acknowledging that it's not a typical AI performance study.
Device Name: Yasargil Titanium Aneurysm Clips
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Conforms to ISO Standard 5832/3 and ASTM standard F136 for titanium alloy (Ti6AL4V). | Material composition and properties conform to ISO Standard 5832/3 and ASTM standard F136. |
| Biocompatibility | No significant neurotoxicity or adverse clinical observations after implantation in cerebrum and subarachnoid space. | Neurological implantation study (albino rabbits) showed no significant clinical observations, neurobehavioral findings, or weight changes over 180 days. Consistent with predicate device (Spetzler TI 100 Aneurysm Clips). |
| Mechanical & Metallurgical Integrity (Production Process) | Production process does not affect mechanical/metallurgical integrity; no surface/subsurface cracks after grinding, bending, adjustment; good mechanical properties at laser welding site; no significant changes in heat-affected zone; adequate removal of thin oxide layers. | Scanning electron microscopy, metallography, and energy dispersive x-ray analysis show production process does not affect integrity. No cracks observed. Laser welding site has good mechanical properties. Metallographic studies show no significant changes. Surface studies indicate adequate oxide layer removal. |
| Closing Force | Comparable to currently marketed predicate (Yasargil Phynox aneurysm clips). | Closing force tested and found comparable to Yasargil Phynox aneurysm clips. |
| MRI Compatibility | Non-ferromagnetic; weaker paramagnetic properties than predicate (Phynox) or stainless steel; no detectable deflections/torsions at magnetic field strengths up to 4.7T; reduced artifacts in nuclear spin resonance and CT scans; no measurable heating effect. | All materials non-ferromagnetic; titanium alloy had detectable weaker paramagnetic properties than Phynox or non-martensitic stainless steel. No detectable deflections/torsions at 4.7T. Artifacts substantially reduced in nuclear spin resonance and CT scans. No measurable heating effect. |
| Design Comparison | Similar or identical to current Yasargil Phynox clip patterns; expanded to include additional temporary clip patterns. Similar features, dimensions, and styles to other legally marketed predicate devices. | Yasargil titanium aneurysm clips are very similar or identical to current Yasargil Phynox clip patterns. Product line expanded for temporary clips. Shares similar features, dimensions, and styles with other listed predicate devices (Spetzler Ti 100, Codman, Sugita Aneurysm clips). |
2. Sample Size for the Test Set and Data Provenance
- Biocompatibility Study: Albino rabbits were used. The exact number of animals is not specified, but it refers to "test or control implanted animals." The study was conducted in animals, not humans.
- Mechanical, Metallurgical & MRI Testing: The sample size for these tests (e.g., number of clips tested) is not specified. The provenance would be internal laboratory testing of the manufactured devices.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study requiring expert readers to establish ground truth for clinical cases. The ground truth for biocompatibility was established through histological and clinical observations in animal models, and for mechanical/material properties through various engineering and material science analyses.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving expert adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This submission focuses on material properties, biocompatibility, and mechanical performance of the device itself, not on human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
No, this is not an AI/algorithm. This refers to the intrinsic performance of the physical aneurysm clip in terms of its material, mechanical, and biological properties. The studies described are essentially "standalone" performance evaluations of the device's physical characteristics.
7. Type of Ground Truth Used
- Material Composition: Conformance to established ISO and ASTM standards, verified through analytical chemistry and material science techniques.
- Biocompatibility: Histological analysis and clinical observations of animal tissues and behavior (lack of neurotoxicity, lack of adverse clinical findings).
- Mechanical/Metallurgical: Results from scanning electron microscopy, metallography, energy dispersive x-ray analysis, and direct mechanical force testing (closing force).
- MRI Compatibility: Direct measurements of magnetic properties, deflection, artifact generation, and heating effects in various magnetic field strengths.
8. Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in the context of this traditional medical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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