(210 days)
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PSI Titanium Aneurysm Clip:
It's important to note that the provided documents (K991959 510(k) Summary and FDA clearance letter) are for a legacy device that was cleared in 2000. The regulatory requirements for device clearance, particularly regarding the rigor of performance studies and detailed reporting of clinical evidence, have evolved significantly since that time. Therefore, the level of detail regarding acceptance criteria and study methodology is much less than what would be expected for a modern submission.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and a detailed table of performance are not explicitly stated in the modern format of performance goals (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance claims are qualitative and comparative to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Compatibility/Safety: Conformity to established standards for implantable titanium alloys. | Manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO Standard 5832/3 and ASTM Standard F-136. |
| Functional Equivalence: Performs similarly to predicate devices in occluding cerebral aneurysms. | "functions in the same manner as the predicate device in the occlusion of cerebral aneurysms." When used with appropriate applier. |
| Dimensional Equivalence: Similar specifications to predicate devices. | "manufactured... to equivalent functional and dimensional specifications as the predicate clips." "share similar tolerances." |
| MRI Compatibility/Reduced Artifacts: Safe in MRI environment and provides reduced image artifacts. | "presents no additional risk to the patient or other personnel, is compatible with current diagnostic imaging equipment and provides substantially reduced image artifacts over cobalt-based predicate clips." |
| Safety and Effectiveness: Safe and effective for intended use. | "The Titanium Aneurysm Clip is safe and effective for it's intended use and meets all regulatory requirements to be found substantially equivalent to the predicate device." (This is a conclusion statement rather than a specific performance metric, typical of historical 510(k) summaries for substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of a clinical study or a statistically powered performance evaluation as would be expected today. The "Performance Data" section describes the device's functional and MRI characteristics, likely derived from bench testing, material characterization, and possibly comparison of existing literature or specifications of predicate devices. There is no mention of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as there is no mention of a human-read test set or an expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-read test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or described. This type of study, especially with "AI assistance," is a modern concept that was not relevant to medical device submissions in 1999/2000, particularly for a mechanical implant like an aneurysm clip.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted or described. This device is a passive mechanical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
Based on the information, the 'ground truth' for this device appears to be:
- Material Standards: Conformity to ISO and ASTM standards for the titanium alloy.
- Predicate Device Specifications/Performance: Comparative analysis against the established design specifications and reported performance of the predicate aneurysm clips (Aesculap Titanium Aneurysm Clip, Taka Aneurysm Clip). This would have involved reviewing the predicate device's 510(k) or available technical data.
- Bench Testing: Implicitly, functional testing to confirm the spring-operated, self-closing mechanism, appropriate closure force, and MRI compatibility (e.g., magnetic susceptibility testing).
There is no mention of pathology, outcomes data, or expert consensus in relation to establishing performance criteria for this device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a mechanical implant; it does not involve an "algorithm" or "AI" that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
§ 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).