(32 days)
The VesseLink is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
The VesseLink Microvascular Anastomotic Coupler (VesseLink) is a mechanical method for anastomosis, or connection, of small vessels ranging in size from 0.8 mm to 4.3 mm in outer diameter. The VesseLink is intended for use in the end-to-end and end to side vessel anastomosis as well as arterial/venous vein grafts. It is to be used in veins and arteries that are normally encountered in microsurgical and vascular reconstructive procedures. Excluded is the use for coronary artery anastomosis.
The provided document does not contain information about acceptance criteria and a study proving a device meets these criteria in the typical sense of a clinical or analytical performance study with specific metrics, sample sizes, and ground truth establishment.
Instead, the document is a 510(k) premarket notification for the "VesseLink Microvascular Anastomotic Coupler System." The core of this submission is to demonstrate substantial equivalence to a predicate device, not to prove performance against predetermined acceptance criteria through a standalone study.
Here's an breakdown based on the provided text, addressing your points where possible, and highlighting what's not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in the provided document. The overarching "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.
- Reported Device Performance: The document states:
- "Bench testing was performed to demonstrate the product functions as intended and is shown to be substantially equivalent."
- This is a general statement and does not provide specific performance metrics (e.g., burst pressure, patency rates, leakage rates, etc.) or quantitative results from the bench testing.
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 mentions "bench testing" but does not specify any sample size for this testing.
- It does not mention data provenance (country of origin, retrospective/prospective) for any test data.
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 information is not applicable and not present in the document. The substantial equivalence claim is based on technological characteristics and intended use, not on expert-adjudicated ground truth from a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not present. No multi-reader adjudication process is mentioned for any test set.
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
- No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or reported. This device is a mechanical anastomotic coupler, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a mechanical medical device, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For this type of device and submission (510k, substantial equivalence), the "ground truth" essentially refers to documented performance and characteristics of the predicate device, against which the new device's characteristics are compared (e.g., materials, dimensions, mechanism of action, intended use). There is no "ground truth" derived from patient outcomes or expert consensus in the typical sense for this submission.
8. The sample size for the training set
- Not applicable as this is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
In summary:
The provided document details a 510(k) submission for a medical device (VesseLink Microvascular Anastomotic Coupler System) seeking clearance based on substantial equivalence to a predicate device. The "study" mentioned is "bench testing," but no specific quantitative results, sample sizes, or methods for establishing ground truth as would be relevant for an AI or diagnostic device performance study are provided. The focus is on demonstrating similar technological characteristics and intended use to a legally marketed 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.