(134 days)
The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.
The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6AI4V. This alloy was chosen for the new clip because of its excellent compatibility with magnetic resonance imaging (MRI) devices. Titanium and its alloys cause much less artifact and are subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties. The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.
The provided document is a 510(k) summary for the Sugita Titanium Aneurysm Clip, detailing its substantial equivalence to previously marketed devices. It focuses on mechanical properties and MRI compatibility. The document does not contain information about a study involving human readers, AI assistance, or expert consensus for establishing ground truth in the context of image analysis or diagnostic performance. Therefore, I cannot fully complete the table and answer all points as some of the requested information is not present in the provided text.
Here's the information that can be extracted and a clear indication of what is missing:
Acceptance Criteria and Device Performance for Sugita Titanium Aneurysm Clip
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Goal / Benchmark) | Reported Device Performance (Sugita Titanium Aneurysm Clip) |
|---|---|
| Retention of original closing force after 500 openings and closings (compared to predicate device) | Retains 98.5% of original closing force (Yasargil Titanium Clips retain 97.1%) |
| MR safety and compatibility | Safe for use in MR environment up to 10 T |
| Artifact on MR images | Artifact on MR images up to 1.5 T does not extend significantly beyond the clip region |
| Streak artifact on CT images | Minimal streak artifact, much less than cobalt-chromium alloy clips |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for test set: Not specified in terms of number of clips tested, but implicitly involves various models from the 55 available clips.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is presented as "laboratory data" and "testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The ground truth for this device is based on physical and mechanical measurements (e.g., closing force, MRI artifact evaluation), not human expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is not a study involving human readers or interpretation requiring adjudication.
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. This document describes a medical device (aneurysm clip) and its mechanical/material properties, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical and Physical Properties Measurement: The ground truth for the evaluation was based on objective laboratory measurements for mechanical properties (e.g., closing force using the ASTM measurement technique) and physical characteristics (e.g., MRI safety, artifact extent on MR and CT images).
8. The sample size for the training set
- Not Applicable. This is not a study involving a "training set" for an algorithm or a diagnostic model.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set in this context.
§ 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).