(68 days)
The Perneczky Titanium Aneurysm Clips are devices used to occlude an intracranial aneurysm (a balloon like Sac formed on a blood vessel) to prevent it from bleeding or rebleeding. These clips are intended for use as temporary or permanent devices.
These titanium alloy aneurysm clips will be available as temporary or permanent in STANDARD OR MINI/ MICRO models.
The provided text is a 510(k) Premarket Notification for the Perneczky Titanium Aneurysm Clips. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed acceptance criteria table and the results of extensive clinical trials with specific performance metrics as would be found in a PMA (Premarket Approval) submission.
Therefore, the document does not contain the specific information requested regarding detailed acceptance criteria, a comprehensive study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or ground truth details for testing and training sets.
However, I can extract information related to the demonstration of substantial equivalence if that would be helpful, as it is the primary focus of this type of submission. The document states that the device is substantially equivalent to legally marketed predicate devices, implying that its performance is expected to be similar.
Here's what can be inferred from the document regarding the basis for acceptance, which is "substantial equivalence":
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criterion Type: Substantial Equivalence to predicate devices.
- Performance (Implied): The new device's technological characteristics, material composition, and intended use are considered similar to those of the predicate devices, thereby implying comparable performance. The document explicitly states: "The additional patterns of Perneczky Titanium Alloy aneurysm clips do not incorporate any new technological characteristics when compared to Zeppelin's current Perneczky Titanium aneurysm clips, or to other legally marketed devices."
2. Sample size used for the test set and the data provenance:
- This information is not provided in the 510(k) summary. 510(k)s often rely on bench testing and comparisons to predicate devices rather than large-scale clinical trials for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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:
- This is not applicable as the device is a physical aneurysm clip, not an AI or imaging diagnostic tool that would involve "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical aneurysm clip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. The basis for equivalence relies on comparing the device's technical specifications and material properties against established standards and predicate devices.
8. The sample size for the training set:
- This information is not provided and is not applicable in the context of this type of device submission.
9. How the ground truth for the training set was established:
- This information is not provided and is not applicable in the context of this type of device submission.
Summary of Basis for Substantial Equivalence cited in the document:
- Technological Characteristics: The device "do not incorporate any new technological characteristics" compared to predicate devices.
- Material Composition: The material (titanium alloy Ti6AL4V) and its properties conform to ASTM International standards (e.g., F136-98 & F1472-98).
- Intended Use: The intended use "to occlude cerebral aneurysms in either a temporary or permanent manner" is consistent with predicate devices.
- Predicate Devices: The device is deemed equivalent to several existing aneurysm clips, including:
§ 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).