(70 days)
Codman Slim Line Standard Clip is used for permanent occlusion of intracranial aneurysm.
Codman Slim Line Mini Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Codman Slim-Line Graft clip is used to encircle an artery in which a hole has developed as a result of a traumatic injury to the vessel or from an aneurysm tearing at its base that cannot be sutured as the hole is in such a position that it is difficult for the surgeon to rotate a needle.
Codman Slim-Line Reinforcing clip is used to reinforce aneurysm clips that may not be of adequate strength to occlude the aneurysm.
Codman Slim-Line Temporary Aneurysm Clip is used for the occlusion of small vessels when controlling bleeding on arteriovenous malformations or other similar venous structure.
Codman AVM Micro Clip System is designed for occlusion of small vessels when controlling bleeding on arteriovenous malformation or other smaller venous structures.
Aneurysm clips have two parts, a spring section and two blades. The spring section determines the strength of the clip. The blades grasp the aneurysm.
The provided text describes a 510(k) premarket notification for various aneurysm clips from Codman & Shurtleff, Inc. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria with a novel study design for AI/ML devices. Therefore, much of the requested information (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or explicitly stated in the document as it pertains to a different type of regulatory submission (medical device approval for physical devices, not AI/ML software).
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the context of this 510(k) submission. A 510(k) for physical devices like aneurysm clips focuses on substantial equivalence to predicate devices, meaning the new device is as safe and effective as a legally marketed device. It does not typically involve pre-defined performance metrics and acceptance criteria in the way an AI/ML device might. The "performance" here is demonstrating that the device functions as intended and is comparable to existing devices.
2. Sample size used for the test set and the data provenance:
Not explicitly stated. The submission mentions "Bench testing has been completed," but does not specify the sample sizes of devices tested or the data provenance (e.g., how many clips were tested under what conditions).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of AI/ML, refers to a validated reference standard against which an algorithm's output is compared. For a physical device like an aneurysm clip, "ground truth" is established through engineering specifications and the functional demonstration of the device (e.g., successful occlusion, strength tests). There's no mention of experts establishing a ground truth for a "test set" in the sense of data labeling.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is relevant for studies involving human interpretation or AI output, where disagreements need to be resolved. For bench testing of physical devices, the results are typically direct measurements or observations.
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:
Not applicable. MRMC studies are used for evaluating diagnostic performance, often comparing human performance with and without AI assistance. This submission is for a physical medical device (aneurysm clips), not an AI/ML diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or software component being evaluated in this submission for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these physical devices would be their conformance to design specifications and mechanical properties that are historically proven safe and effective for aneurysm occlusion or vessel coarctation. This is established through engineering design, material testing, and functional bench testing.
8. The sample size for the training set:
Not applicable. There is no AI/ML model involved in this submission that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
What the study does mention regarding acceptance and proof:
- Acceptance Criteria/Performance Goal (Implied): The implied acceptance criterion is "substantial equivalence" to predicate devices. This means the new devices (Codman Slim-Line Standard Aneurysm Clip, Mini Clip, Graft Clip, Reinforcing Clip, Temporary Aneurysm Clip, Codman AVM Micro Clip System) must perform as safely and effectively as previously cleared devices.
- Study That Proves Substantial Equivalence: "Bench testing has been completed and demonstrates that the device performs according to its description and intended use which is the same as the predicate device."
- Study Outcome: "All test results demonstrated the substantial equivalence of the products to the previously cleared products from the FDA and the safety and effectiveness has not been compromised."
In essence, this 510(k) demonstrates that the Codman aneurysm clips are very similar in design, materials, and intended use to existing, cleared clips, and bench testing confirmed they function comparably.
§ 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).