(41 days)
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.
The provided document, K031623, is a 510(k) summary for the Coalescent Surgical U-CLIP™ and Accessories. It outlines the device's intended use and claims substantial equivalence to previously cleared predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've outlined for AI/ML devices.
The information provided about testing is very high-level and focused on demonstrating substantial equivalence to predicate devices and adherence to USP standards, not on detailed performance metrics as would be expected for a diagnostic or AI-driven system.
Therefore, I cannot fully complete your request based on the provided text. Here's what I can extract and what is missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations." |
| Substantial equivalence to predicate devices (K024366, K023125, K021407, K013664, K012317, . K994160, and K971588) in terms of materials, use, and application. | Confirmed through in vitro and in vivo data. |
| Compliance with applicable USP suture testing requirements. | Confirmed. |
Missing Information as per Request:
The provided document does not include the following information, as it describes a surgical device and not an AI/ML-driven diagnostic or analytical tool. The questions below are tailored for AI/ML performance studies and are not applicable to this 510(k) submission for a surgical clip.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is not an AI/ML diagnostic device with a "test set" of data in the typical sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a surgical device would be its mechanical and biological performance in a physiological environment, not discrete data labels.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document provides regarding testing:
The document briefly states: "In vitro and in vivo data have confirmed that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."
This indicates that a series of tests (both laboratory/benchtop and animal/human studies, usually) were conducted to ensure the U-CLIP performs similarly to existing, legally marketed surgical clips and meets recognized performance standards for surgical materials. However, it does not provide the granular detail about specific performance metrics, sample sizes, or ground truth establishment that would be present in a submission for an AI/ML device.
§ 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.