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510(k) Data Aggregation
(167 days)
angiOCCLUDE Ligating Clips
angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).
The provided text describes a 510(k) submission for the "angiOCCLUDE Ligating Clips" aiming for substantial equivalence to the Teleflex Medical Horizon Ligating Clips. This document primarily focuses on regulatory approval based on comparison to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical study would for an AI-powered diagnostic device.
However, I can extract the "performance data" that was summarized to show substantial equivalence, which can be thought of as criteria for demonstrating equivalence to the predicate device.
Here's the breakdown based on your request, with an important note that this is not a clinical study of device performance against specific clinical acceptance metrics, but rather a comparison study for substantial equivalence according to FDA 510(k) regulations:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device. In this instance, the criteria are based on direct comparison to the Teleflex Medical Horizon Ligating Clips.
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance (angiOCCLUDE Ligating Clips) |
|---|---|
| Mechanical/Functional Equivalence: | |
| - Closure over vessels | Both will close over vessels. |
| - Clip closure testing (security in applier, release from applier's jaws) | Proven that the clips are secure in the applier and release from applier's jaws equivalent to Horizon. |
| - Mechanism of action (cartridge/clip design, symmetrical leg pivoting) | Same between angiOCCLUDE and Horizon; cartridge and clip design allows for an applier to easily load a clip, and clips are then removed for use. When the clip is closing, the symmetrical legs pivot in from a centered apex as clips are closed. |
| - Dimensional comparison (open and closed state within applier) | Resulted in having the same function as Horizon when clips are applied and closed. |
| - Dimensional/geometry comparisons (using precise overlays) for clip size | Proven that angiOCCLUDE and Teleflex Horizon clips are the same size across the five provided sizes (MC, SML, M, M/L, and LG). |
| Material Equivalence: | |
| - Clip material | Same clip material: implantable grade of titanium. |
| - Material comparisons (formed and sterilized material safety) | Proven that the formed and sterilized material used for the angiOCCLUDE clip is as safe and the same as the material used in Teleflex Horizon. |
| Clinical Application Equivalence: | |
| - Indications and Contraindications | Same clinical application for indications and contraindications. |
| Manufacturing/Convenience Equivalence: | |
| - Cartridge color coding | Cartridges are color coded to match applier ring colors. |
| - Sterilization processing | Uses traditional EO sterilization processing. |
| - Packaging | Uses peel open blister packs with either 6 or 24 clips each. |
| - Clip forming method | Uses 4-slides to form the clips. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or AI performance evaluation. Instead, the "study" is a comparison conducted by the manufacturer against the predicate device. The sample sizes for the quantitative and qualitative performance analyses are not explicitly stated (e.g., number of clips tested for closure, number of units measured for dimensions). The "data provenance" is internal testing and comparison performed by A2 Medical Systems, LLC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The study described is a technical and material comparison, not one requiring expert human interpretation or establishment of ground truth in a diagnostic sense.
4. Adjudication Method
Not applicable as there is no human interpretation or diagnostic ground truth to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This device is a surgical clip, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This device is a physical surgical clip, not an algorithm. Therefore, a standalone performance study without human-in-the-loop performance, in the context of AI/algorithms, is not applicable. The performance studies conducted were mechanical and material comparisons, as outlined in the table above.
7. Type of Ground Truth Used
The "ground truth" here is the established design, material properties, and performance characteristics of the legally marketed predicate device (Teleflex Medical Horizon Ligating Clips), against which the new device is compared. This is based on demonstrable physical properties and existing regulatory acceptance of the predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device. The "ground truth" for the comparison was the predicate device's characteristics.
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