(24 days)
The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.
The Coalescent Surgical PG-CLIP™ device is a self-closing clip for peripheral vascular anastomosis and tissue approximation/attachment applications. The PG-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or 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 text is a 510(k) summary for the Coalescent Surgical PG-CLIP™ device. It's a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing a new device to an existing one, rather than proving the new device's performance against specific acceptance criteria through extensive new studies.
Therefore, the document does not contain the kind of information requested regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way a clinical trial or algorithm validation study would.
Here's why the requested information cannot be extracted and what the document does state:
- No new performance data was acquired for this specific submission. The crucial sentence is: "No test data has been acquired related to this restricted indication for use." This means the submission relies on the existing performance data and substantial equivalence demonstrated for the predicate devices.
- The submission is based on "substantial equivalence." This regulatory pathway avoids the need for a full clinical trial to establish new safety and effectiveness criteria if the device is sufficiently similar to an already cleared device.
Given this, I cannot fill out the requested table and answer the specific questions about performance studies. However, I can explain why based on the provided text.
Reason For Inability to Fulfill Request:
The provided 510(k) summary explicitly states: "No test data has been acquired related to this restricted indication for use." (Section: Test Data). This means that for this particular submission (K040821), no new studies, performance data, or acceptance criteria beyond those established for the predicate devices were used or provided to the FDA. The submission relies on establishing "substantial equivalence" to previously cleared devices (Coalescent Surgical U-CLIP™ K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588).
Therefore, specific information regarding:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How training set ground truth was established
is not available within this document because such studies were not conducted or reported for this specific 510(k) submission. The FDA clearance for K040821 was based on the substantial equivalence to predicate devices, leveraging their existing pre-market notification data.
§ 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.