(39 days)
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.
The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
The provided text describes a 510(k) summary for the Coalescent Surgical U-Clip™. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and the specific study proving the device meets them. The document states that "in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations." This is a high-level summary and lacks the specifics you're asking for.
Here's an attempt to answer based on the available text, with explicit notes where information is missing:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally claims that "All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."
| Acceptance Criteria (Not explicitly stated, inferred requirements for equivalence) | Reported Device Performance (Summary statement) |
|---|---|
| Functional characteristics substantially equivalent to predicate device | Data confirmed substantial equivalence |
| Met internal specification requirements | All data fell well within |
| Met external standard requirements | All data fell well within |
| Met predicate performance expectations | All data fell well within |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "in vitro studies" but does not specify the sample size for any test set or the data provenance. It only states these were "in vitro test data." -
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 information is not provided in the document. The testing described is "in vitro data," implying laboratory or bench testing rather than human subject testing requiring expert ground truth establishment in a clinical context. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given the "in vitro" nature, clinical adjudication methods are unlikely to be relevant here. -
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:
No MRMC study was mentioned. This device is an implantable surgical clip, not an AI/software diagnostic tool, so such a study would not be applicable. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was mentioned. This device is a physical surgical implant, not an algorithm. The "in vitro" testing implies standalone device performance, but not in the context of an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For "in vitro data," the "ground truth" would likely be established engineering specifications, material properties, mechanical test standards, and comparison to the predicate device's known performance characteristics. The document does not explicitly state the type of ground truth beyond fulfilling "internal specification requirements" and "external standard requirements." -
The sample size for the training set:
This information is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set. -
How the ground truth for the training set was established:
This information is not applicable as the device is a physical medical device, not a machine learning algorithm.
§ 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.