(27 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 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 PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, articulation controls, and deployment end-effector containing the Clip.
This document is a 510(k) premarket notification for a medical device and therefore does not contain all the typical information one would expect from a full study report. The acceptance criteria and "study" described herein are primarily focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or safety in a clinical setting in the way a clinical trial would.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary from this document) |
|---|---|
| Reliability Testing | Met predetermined acceptance criteria. |
| Mechanical Testing | Met predetermined acceptance criteria. |
| Confirmatory Biologic Testing | Met predetermined acceptance criteria. |
| Fundamental Design | Substantially equivalent to the previously cleared PRO-V device. |
| Technology | Substantially equivalent to the previously cleared PRO-V device. |
| Function | Substantially equivalent to the previously cleared PRO-V device. |
| Device Materials | Substantially equivalent to the previously cleared PRO-V device (still titanium and polyester). |
| Packaging | Substantially equivalent to the previously cleared PRO-V device (no changes). |
| Sterilization | Substantially equivalent to the previously cleared PRO-V device (no changes). |
| Operating Principle | Substantially equivalent to the previously cleared PRO-V device (no changes). |
| Intended Use/Indication for Use | Substantially equivalent to the previously cleared PRO-V device (same). |
Explanation of the "Study":
The "study" referenced in this document is a series of non-clinical bench tests designed to demonstrate that minor modifications to the AtriClip® LAA Exclusion System with Preloaded PRO-V™ Clip (K173031) did not affect its safety, effectiveness, or fundamental characteristics compared to its predicate device (K153500). The purpose was to prove substantial equivalence, not necessarily to establish new performance metrics against a clinical standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document refers to "bench testing," which typically involves a number of units tested to statistical confidence levels, but the exact number is not detailed here.
- Data Provenance: Not explicitly stated as "country of origin," but "bench testing" implies laboratory-based testing conducted by the manufacturer (AtriCure, Inc.) or a contracted lab. This is retrospective in the sense that it evaluates a manufactured product, but it's not based on patient data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / Not provided. For this type of 510(k) submission, the "ground truth" for bench testing is typically adherence to engineering specifications, material properties, and functional performance as outlined in test protocols, rather than expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or expert review of medical images/cases. For bench testing, the "adjudication" is typically a pass/fail against predetermined engineering and performance specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is a type of clinical comparative study, often used for diagnostic imaging devices to assess how human readers' performance improves with or without artificial intelligence (AI) assistance. This document describes a 510(k) for an implantable clip system and non-clinical bench testing, not an AI-assisted diagnostic device, and therefore no MRMC study was conducted or is relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This device is a physical, implantable medical device (an implantable clip and applicator), not a software algorithm or an AI product with standalone performance. Its function is to physically occlude the left atrial appendage, and its application inherently involves a human surgeon.
7. Type of Ground Truth Used
- Engineering Specifications and Performance Standards: For bench testing, the ground truth is established by design specifications, material standards, and functional performance requirements that the device must meet. This is verified through specific tests (reliability, mechanical, biologic compatibility). It is not expert consensus, pathology, or outcomes data, as those relate to clinical performance in patients.
8. Sample Size for the Training Set
- Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms. This device is a physical implantable device, and thus does not have a training set in the context of AI or data-driven model development. The design and manufacturing process involve various validated methods, but not a "training set" like an AI model would.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. As there is no training set for this type of device, the method for establishing its ground truth is not relevant. Ground truth for the device itself (its design, materials, and functional performance) is established through established engineering principles, regulatory standards, and internal design controls.
§ 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.