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510(k) Data Aggregation
(33 days)
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
The Aesculap Yasargil Aneurysm Clip Booster Clip is intended to be used for increasing the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms.
The Aesculap Yasarqil Aneurysm Clip Booster Clip is designed to provide additional pressure for occlusion of cerebral aneurysms when used with a standard aneurysm clip during neurosurgical procedures. They are made from Phynox (cobalt alloy) per ISO 5832/7 and are for use with Phynox aneurysm clips only.
This document describes the Aesculap Yasargil Aneurysm Clip Phynox Booster Clip. The device is intended to increase the closing force of standard permanent aneurysm clips to occlude cerebral aneurysms. The performance data for this device primarily relies on biomechanical testing to demonstrate substantial equivalence to a predicate device.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Effective clip force enhancement | Biomechanical testing results demonstrate the Aesculap Yasargil Aneurysm Clip Phynox Booster Clip provides effective clip force enhancement. |
| Substantial equivalence to predicate device (Yasargil Aneurysm Clip Titanium Booster Clip) in clip force enhancement for occluding cerebral aneurysms. | Biomechanical testing results demonstrate the Aesculap Yasargil Aneurysm Clip Phynox Booster Clip is substantially equivalent to Yasargil Aneurysm Clip Titanium Booster Clip currently on the market. The device is also made from Phynox (cobalt alloy) per ISO 5832/7 and is for use with Phynox aneurysm clips only, implying material and compatibility equivalence for its intended use with specific clips. The FDA's 510(k) clearance confirms substantial equivalence. |
| Compliance with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" | All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)" for the Aesculap Yasargil Aneurysm Clip Booster Clip was completed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the biomechanical testing (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It just states "Biomechanical testing results."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device's performance is established through biomechanical testing, not expert interpretation of outputs like images.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions.
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, as this is a medical device for surgical intervention and not an AI/imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The performance described relates to the physical properties and function of the clip.
7. The Type of Ground Truth Used
The ground truth used for this device is based on biomechanical engineering principles and measurements of clip force enhancement, compared against a predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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