(63 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 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.
The Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains manufacturing modifications to the proposed AtriClip LAA Exclusion System intended to provide AtriCure with an alternate raw material source for the Polyethylene terephthalate (PET) of the knit braid polyester used in the AtriClip implant.
This document describes a 510(k) premarket notification for the AtriClip LAA Exclusion System, specifically addressing a manufacturing modification related to an alternate raw material source for a component of the implant. This is not a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm validation. Instead, it demonstrates substantial equivalence to a predicate device through engineering and biocompatibility testing for a material change.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for device performance in a diagnostic or clinical efficacy context are not applicable to this submission.
Here's an attempt to answer the questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the nature of this 510(k) submission (a manufacturing modification for an alternate raw material source), the "acceptance criteria" are related to maintaining the performance and safety characteristics of the original device. The document does not provide a table with specific numerical acceptance criteria for a new clinical performance study. Instead, it states that:
| Acceptance Criteria (Implied by submission type) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence: The new raw material (PET for knit braid polyester) for the AtriClip implant must demonstrate equivalent chemical and biocompatibility characteristics to the previously used material. | "Chemical characterization and in vitro biocompatibility screening testing was conducted to demonstrate equivalence of the knit braided polyester sourced from the various suppliers of PET raw material." This indicates successful testing confirming the new material behaves similarly from a chemical and biological perspective. |
| Functional Equivalence: The device with the new material must maintain the same operating principle, specifications of performance, and overall safety as the predicate device. | "No changes were made in operating principle, or specifications of performance." |
| "The results of the verification and validation testing: Demonstrated equivalency in performance... Did not raise any new issues of safety." This implies a range of engineering and functional tests (though not detailed) confirmed the device with the new material still performs as expected without degradation. | |
| "Device biocompatibility remains unchanged." Confirms the material change has not altered the biocompatibility profile. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical performance or algorithm validation. The testing described is chemical characterization and in vitro biocompatibility screening of the raw material. Details on sample sizes for these specific lab tests are not provided, nor is the country of origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This submission concerns a manufacturing material change for a surgical implant, not a diagnostic device or AI algorithm requiring expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the material equivalence and functional equivalence, the "ground truth" would be established using validated chemical analysis techniques (e.g., spectroscopy, chromatography) and standard in vitro biological assays (e.g., cytotoxicity, sensitization tests) to compare the new material to the established material. For functional performance, it would involve engineering test standards and specifications. Clinical outcomes data or expert consensus on clinical findings are not the primary "ground truth" for this type of submission.
8. The sample size for the training set
This is not applicable. The device is a physical surgical implant, not an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.