(87 days)
The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).
The provided 510(k) summary for the Aesculap Axial Clip Appliers does not include specific acceptance criteria or details of a study that proves the device meets such criteria.
Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. Here's a breakdown of the information available and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. The document mentions adherence to ASTM Standards F700-93 and Proposed ASTM Standard 1B. These standards likely contain performance requirements, but the specific metrics and targets considered "acceptance criteria" for this submission are not enumerated.
- Reported Device Performance: No specific performance metrics (e.g., clip retention force, applier tip strength, number of application cycles without failure) are reported. The submission states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers... These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification." This implies that the performance is considered similar to the predicate devices, but no comparative data is presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
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):
- This information is not applicable as there is no mention of a study involving expert assessment or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; no test set involving expert adjudication is mentioned.
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. This device is a surgical instrument (clip applier), not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument; there is no algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. There is no mention of a ground truth in the context of device performance in this submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
Summary of the Study (as described in the document):
The document states, "The new Axial clip appliers do not impart any new technological features or characteristics from Aesculap's current aneurysm clip appliers (Yasargil, Caspar and Vario) other than the slightly modified jaw design and the take-apart shaft. These minor modifications, however, do not affect the safety and effectiveness of the new Axial clip appliers, as demonstrated by the information submitted in this premarket notification."
This indicates that the "study" or evidence provided is primarily a justification of substantial equivalence based on design similarities and adherence to existing industry standards (ASTM F700-93 and Proposed ASTM Standard 1B), rather than a detailed performance study with explicit acceptance criteria and corresponding results. The submission implies that because the changes are minor and the device conforms to relevant standards, its safety and effectiveness are considered equivalent to the predicate devices. No specific quantitative performance data or clinical study results are presented in this 510(k) summary.
§ 882.4175 Aneurysm clip applier.
(a)
Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.(b)
Classification. Class II (performance standards).