(195 days)
The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier, and a Selection Guide to aid in appropriate Clip size selection. The frame assembly of the implantable Clip consists of two springs connecting two opposing tubes which are covered with pressure pads. This assembly is covered with a knit fabric. 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 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, and an end effector which contains the Clip. Both sides of the Clip are free to move within the end effector when activated. Pulling the thumb lever proximally opens the Clip. The bias of the Clip allows both the clip and the lever to return to the closed position when the lever is released.
Here's an analysis of the acceptance criteria and study information provided in the document for the AtriClip LAA Exclusion System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "efficacy must be X% or greater"). Instead, it presents the results of the clinical study and concludes that these results demonstrate excellent performance and support substantial equivalence.
Based on the descriptive statements, we can infer the following:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Efficacy: Complete and consistent LAA exclusion. | - Acute and Long-term Exclusion: Demonstrated complete appendage exclusion both acutely and long-term (up to 90 days) in all animals in non-clinical testing. |
- Clinical Efficacy: 95.1% composite exclusion rate (intra-operative and 3 month).
- Clinical Efficacy (3 Months): 98% exclusion rate at 3-month follow-up. |
| Safety: No device or procedure-related adverse events. | - Animal Safety: No adverse events attributed to the Clip device in non-clinical testing. - Clinical Safety: 0% event rate for the primary safety endpoint. Independent physician adjudication found no events linked to the device or procedure. |
| Biocompatibility: Materials suitable for intended use. | - All materials suitable for intended use, tested per ISO 10993-1. |
| Functional Performance (e.g., proper LAA occlusion). | - Non-clinical testing demonstrated complete appendage exclusion. - Post-implant verification confirmed no communication between LAA and left atrium in all animals (non-clinical). |
| Substantial Equivalence to Predicate Devices | - Concluded to be "as safe, as effective and performs as well as or better than the predicate device," based on technological characteristics, non-clinical, and clinical data. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: 70 subjects
- Data Provenance: The document explicitly states "a controlled clinical study," implying prospective data collection in humans. The country of origin is not specified, but the submission to the FDA for a US market device implies it would be relevant to the US regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states: "Independent physician adjudication has demonstrated that there were no events that were in any way linked to the device or the procedure."
- Number of Experts: Not specified.
- Qualifications of Experts: Described as "Independent physician adjudication," but specific qualifications (e.g., specialty, years of experience) are not provided.
4. Adjudication Method for the Test Set
- The document mentions "Independent physician adjudication" for safety events. The specific method (e.g., 2+1, 3+1, none) is not detailed. It implies a review process by independent physicians to determine the linkage of reported events to the device or procedure.
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
- No, an MRMC comparative effectiveness study was not done.
- This device is an implantable medical device (a clip for LAA exclusion), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance does not apply to this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. As mentioned above, this is an implantable medical device, not an algorithm. The performance is the direct result of the device's physical interaction with tissue, not an independent algorithm.
7. The Type of Ground Truth Used
- Clinical Efficacy/Exclusion: Visual confirmation (intra-operative) and likely imaging modalities (e.g., transesophageal echocardiography) at 3-month follow-up to confirm no communication between the LAA and the left atrium.
- Clinical Safety: Adverse event reporting and subsequent "Independent physician adjudication" to determine causality.
- Non-Clinical (Animal) Efficacy/Exclusion: Direct observation, post-implant verification for communication, and likely pathological examination.
8. The Sample Size for the Training Set
- The document describes "non-clinical testing" on "acute and chronic models ranging from 7 days to 90 days." It refers to "all animals" being tested. However, a specific number for the animal "training" or "pre-clinical" sample size is not explicitly stated beyond "all animals."
- There's no mention of a separate training set for algorithm development, as this is not an AI device.
9. How the Ground Truth for the Training Set Was Established
- For the non-clinical (animal) testing, the ground truth for LAA exclusion and safety was established through:
- Direct observation during surgical procedures.
- Post-implant verification (likely imaging and/or direct inspection) to confirm no communication between the LAA and left atrium.
- Observation for adverse events.
- The document implies that the "training set" (animal data) served as foundational evidence before human clinical trials.
§ 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.