(35 days)
The Aesculap T-Bar Aneurysm Clips are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner.
The Aesculap T-Bar Aneurysm Clips are designed for temporary or permanent occlusion of vessels during neurosurgical procedures. They are made from either Phynox (oobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. The clips are a fennstrated design with the jaws at 90 and 45 degree angles. They are applied with previously cleared Aesculap aneurysm clip appliers.
The provided text is a 510(k) summary for the Aesculap T-Bar Aneurysm Clips. This document asserts substantial equivalence to a predicate device rather than presenting a study against specific acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable or cannot be extracted from this document.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Testing | Not explicitly stated (implied to be in line with "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)") | "...demonstrate the Aesculap T-Bar Aneurysm Clips are substantially equivalent to our current aneurysm clips currently on the market." |
| Material Composition | Not explicitly stated (implied to meet ISO standards) | Made from Phynox (cobalt alloy) per ISO 5832/7 or Titanium Alloy per ISO 5832/3. |
| Design Characteristics | Not explicitly stated | Fenestrated design with jaws at 90 and 45-degree angles. |
| Applicability | Compatibility with existing appliers | Applied with previously cleared Aesculap aneurysm clip appliers. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a specific test set. The performance data refers to biomechanical testing, not clinical data from patients. Therefore, information regarding sample size for a test set (e.g., number of patients or images) and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was likely conducted in a lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since this is not a study involving human-interpreted data, there were likely no experts used to establish ground truth in the way envisioned for software performance evaluation. The "ground truth" for biomechanical testing would be defined by engineering standards, test methodologies, and material specifications.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as there was no test set of human-interpreted data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of medical device (physical aneurysm clips). The device is not an AI-assisted diagnostic tool for human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone algorithm study was not performed. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Aesculap T-Bar Aneurysm Clips, based on the description, would be established through engineering standards, material specifications (ISO 5832/7, ISO 5832/3), and biomechanical testing protocols outlined in the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s)". It is not expert consensus, pathology, or outcomes data in the typical sense of a clinical study.
8. Sample Size for the Training Set
There is no training set in the context of this device. This is a physical product, not a machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).