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510(k) Data Aggregation
(206 days)
The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.
The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Slim Clip Applier, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance | Conclusion |
|---|---|---|---|
| Clip Opening Verification | Minimum opening width of aneurysm clips is met. | Pass | The Aesculap Slim Clip Appliers meet the test acceptance criteria. |
| Biocompatibility (Cytotoxicity) | Reactivity grade of 0. | Reactivity grade of 0. | Non-cytotoxic |
| Biocompatibility (Sensitization) | No evidence of delayed dermal contact sensitization. | No evidence of sensitization. | Non-sensitive |
| Biocompatibility (Pyrogenicity) | Temperature rise below 0.5 °C. | Below 0.5 °C. | Non-pyrogenic |
| Biocompatibility (Irritation) | Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0. | Difference of 0.0. | Normal |
| Biocompatibility (Systemic Toxicity) | No mortality or evidence of systemic toxicity. | No mortality or systemic toxicity. | Non-Toxic |
| Biocompatibility (Hemolysis) | Hemolytic index of 0.0%. | Hemolytic index of 0.0%. | Non-Hemolytic |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the mechanical "Verification test for clip opening." It merely states "Pass" for the test.
For biocompatibility testing, the sample sizes are implied by the test descriptions:
- Cytotoxicity: "Test articles were extracted for 24 hours per ISO 10993-5." (Specific number of test articles not given).
- Sensitization: "in the guinea pig." (Specific number of guinea pigs not given).
- Pyrogenicity: "following intravenous injection in rabbits." (Specific number of rabbits not given).
- Irritation: "All animals appeared normal throughout the study." (Specific number of animals not given).
- Systemic Toxicity: "extracts injected into mice." (Specific number of mice not given).
- Hemolysis: "The test article extract was tested in vitro." (Specific number of test articles or replicates not given).
The data provenance is not explicitly stated regarding country of origin or whether it's retrospective/prospective. However, given that these are bench and biocompatibility tests conducted for a 510(k) submission, they are typically conducted prospectively in a controlled laboratory setting by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and testing. The ground truth for mechanical performance is based on engineering specifications and physical measurements. The ground truth for biocompatibility is based on established ISO standards and observed biological reactions in animal models or in vitro tests, rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. This document describes bench testing and biocompatibility testing against defined physical and biological parameters, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. The Aesculap Slim Clip Applier is a surgical instrument, and its evaluation focuses on mechanical performance and biocompatibility.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
Yes, the studies described are essentially "standalone" in the sense that they evaluate the device's intrinsic mechanical properties and biocompatibility without a human operator's performance being the primary subject of the test (beyond the execution of the test itself). The "Verification test for clip opening" directly assesses the applier's mechanical function, and the biocompatibility tests evaluate the material's interaction with biological systems. There isn't an "algorithm" per se, but the device's performance is tested independently.
7. Type of Ground Truth Used
- For Clip Opening Verification: Engineering specifications and physical measurements of the clip's opening width.
- For Biocompatibility Tests: Established biological endpoints and standards (e.g., ISO 10993 series) for cytotoxicity, sensitization, pyrogenicity, irritation, systemic toxicity, and hemolysis.
8. Sample Size for the Training Set
Not applicable. The Aesculap Slim Clip Applier is a mechanical surgical instrument, not an AI/machine learning device that requires a training set of data. The "training" in manufacturing would relate to process validation and quality control, not a data-driven model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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