(42 days)
Temporary placement in the brain to facilitate occlusion of cerebral aneurysms. Clips are only to be applied with V. Mueller titanium coated clip appliers.
The temporary titanium aneurysm clip is bent wire that provides a spring operated, self-closing aneurysm clip of various lengths/sizes.
The document describes the Temporary Titanium Aneurysm Clip. Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Repeat sterilization performance (no adverse effect on closing force) | A "repeat sterilization performance study was conducted to ensure no adverse effect on closing force for the Temporary Titanium Aneurysm Clips and all acceptance criteria were met." |
| Sterilization performance | "Sterilization Performance studies were conducted for the Temporary Titanium Aneurysm Clip and all acceptance criteria were met." |
| Material certification (Titanium to ASTM F136-98) | The device's material is stated to be "Titanium material certification to ASTM F136-98". This is a material specification, implying compliance with this standard is an acceptance criterion. The documentation confirms this as part of its substantial equivalence claim, indicating it meets this criterion. |
2. Sample Size and Data Provenance for Test Set
The provided summary does not specify a sample size for any "test set" in the context of clinical performance or diagnostic accuracy. The studies mentioned are focused on device performance characteristics like sterilization and material properties, not on a patient test set for diagnostic or treatment outcome evaluation.
The data provenance is related to in-vitro testing ("repeat sterilization performance study" and "sterilization performance studies"). No country of origin for this data is explicitly stated, nor is it specified as retrospective or prospective in a clinical sense.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This information is not applicable as the document describes technical/material testing, not a study requiring expert-established ground truth for a clinical test set.
4. Adjudication Method (Test Set)
This information is not applicable as the document describes technical/material testing, not a study requiring adjudication of expert opinions for a clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted. The document describes a medical device (aneurysm clip) and its technical performance, not a diagnostic or treatment effectiveness study involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable as the device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for the studies mentioned appears to be based on technical specifications and established testing protocols. For example, "no adverse effect on closing force" would be measured against a predefined technical standard or original specifications of the clip's closing force. Similarly, "Titanium material certification to ASTM F136-98" means the material was verified against the standards outlined in ASTM F136-98.
8. Sample Size for Training Set
This information is not applicable as the device is a physical medical implant. There is no concept of a "training set" for an algorithm in this context.
9. How Ground Truth for Training Set Was Established
This information is not applicable as the device is a physical medical implant.
§ 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).