(29 days)
The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.
The AtriClip PRO2 LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains modifications to the AtriClip LAA Exclusion System (PRO2) which are intended to 1.) mitigate inconsistencies of spring return force post deployment of the clip, and 2.) aid in manufacturability of the device.
The provided text is a 510(k) summary for the AtriClip® LAA Exclusion System with preloaded Gillinov-Cosgrove® Clip (PRO2). This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing a detailed study that proves the device meets specific performance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert qualifications, and ground truth establishment is not present in this regulatory submission.
However, I can extract the following information and indicate where details are missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria with reported device performance values. Instead, it states that the modifications "Demonstrated equivalency in performance" and "Did not raise any new issues of safety."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalency in performance to predicate device | Demonstrated equivalency in performance (details of performance metrics not provided) |
| No new safety concerns | Did not raise any new issues of safety |
2. Sample size used for the test set and the data provenance
The document mentions "Non-clinical Bench Testing" including "Mechanical Testing" and "Reliability Testing." However, it does not specify the sample sizes used for these tests. Data provenance (e.g., country of origin, retrospective/prospective) is also not provided as these are described as non-clinical bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the submission describes non-clinical bench testing for mechanical and reliability aspects of the device, not a study involving human assessment or interpretation where experts would establish ground truth.
4. Adjudication method for the test set
This information is not applicable for non-clinical bench testing.
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
An MRMC comparative effectiveness study was not performed as this submission relates to a mechanical implantable clip system, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a mechanical implantable clip system, not an algorithm or AI.
7. The type of ground truth used
For the non-clinical bench testing, the "ground truth" would be established by objective, verifiable mechanical and reliability testing standards and measurements. The specific standards or methods used to define acceptable performance for these tests are not detailed in this summary.
8. The sample size for the training set
This information is not applicable as the device is a mechanical implantable clip system and does not involve AI or algorithms that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
In summary, this 510(k) submission primarily focuses on demonstrating that minor modifications to an existing device (AtriClip® LAA Exclusion System, PRO2) do not alter its fundamental performance, safety, or effectiveness compared to the predicate device. The evidence provided is based on non-clinical bench testing.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.