(24 days)
The AtriClip™ LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial as well as thoracotomy (single or multiple).
The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier. 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. This Special 510(k) does not include any changes to the Clip.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) includes modifications to the Clip Applier including a malleable aluminum alloy shaft.
The provided text pertains to a 510(k) premarket notification for a medical device called the AtriClip™ LAA Exclusion System. This document is a regulatory filing and as such, it does not describe a clinical study in the typical scientific sense with acceptance criteria for device performance in patients, human reader studies, or detailed ground truth establishment.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing and animal model deployment testing. It aims to show that modifications to the clip applier (a delivery tool) do not negatively impact the performance of the actual implantable clip.
Therefore, I cannot provide a table of acceptance criteria for typical device performance metrics (like sensitivity, specificity, accuracy) or details about human reader studies, training sets, or adjudication methods, as these types of studies were not conducted or reported in this 510(k) summary.
However, I can extract the information related to the performance data and "acceptance criteria" as described in the context of a 510(k) submission, acknowledging that these are not clinical performance criteria.
Acceptance Criteria and Device Performance (Based on 510(k) Document)
The "acceptance criteria" in this context are interpreted as the successful demonstration that the modifications to the AtriClip Applier do not compromise the fundamental function of the system, particularly the successful deployment of the Clip.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (as implied by 510(k)) | Stated Performance (from Document) |
|---|---|
| Clip Applier Modification Impact | Modifications to the Clip Applier (malleable aluminum alloy shaft, ability to bend in all directions) were confirmed not to affect the ability to successfully deploy the Clip on the left atrial appendage (LAA). |
| Design Control & Specification Conformance | Modified Clip Applier conformed to design controls and product specifications per 21 CFR 820.30 and AtriCure's Quality System. |
| Mechanical Performance | Non-clinical Bench Testing on "Mechanical Testing" was performed and presumably met internal specifications. |
| Reliability | Non-clinical Bench Testing on "Reliability Testing" was performed and presumably met internal specifications. |
| Transit Performance | Non-clinical Bench Testing on "Transit Testing" was performed and presumably met internal specifications. |
| Equivalence to Predicate | The modified system is equivalent to the previously cleared AtriClip LAA Exclusion System, with no change to intended use, the implant Gillinov-Cosgrove Clip, or the basic design of the Clip Applier. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The document refers to "an animal model" for deployment testing. Specific animal type, number of animals, or quantity of deployment attempts are not provided.
- Data Provenance: The testing appears to be internal to AtriCure, Inc. and is regulatory in nature for a 510(k) submission. No country of origin for external data is mentioned. The testing is prospective in the sense that it was conducted for this specific regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This was a non-clinical/animal model study to assess mechanical function and deployment, not an AI model evaluating diagnostic images or clinical outcomes requiring human expert ground truth. The "ground truth" for successful deployment would be direct observation by the testing personnel.
4. Adjudication Method for the Test Set
- Not applicable. As above, this was a functional test, not a subjective assessment requiring adjudication among multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study (comparing human readers with and without AI assistance) was not performed or reported in this 510(k) summary. The device is a surgical tool, not an AI diagnostic system.
6. Standalone (Algorithm Only) Performance Study
- No. This type of study is not applicable as the device is a physical surgical intervention system, not a standalone algorithm.
7. Type of Ground Truth Used
- For the deployment testing on an animal model, the ground truth was direct observation of successful (or unsuccessful) deployment of the Clip on the LAA by the device during surgical procedures.
- For bench testing, the ground truth was the measured adherence to design specifications and controls (e.g., mechanical properties, reliability, transit functionality).
8. Sample Size for the Training Set
- Not applicable. This document describes testing for a physical medical device, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI algorithm training set, this question is not relevant to this document.
§ 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.