(255 days)
Vas-Q-Clip™ ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Nanova Biomaterials Inc.'s Vas-Q-Clip™ causes hemostasis through vessel ligation. The technological characteristics are the same as or equivalent to the predicate device. The non-absorbable polyacetal material used in the clips is the same as the predicate device and the clips are manufactured in a similar manner.
The clips are housed in a cartridge and package in a ridged plastic plaster with Tyvek coated lidding and is sold sterile. The method of sterilization is EtO with a SAL of 10-6. The blisters are fitted into a carton in which the clips are sold.
The Vas-O-Clip™ outer structure including legs, bosses, hook and latch mechanism, and hinge are the same as the Hem-o-lok® design (Shape and dimensions are the same for the corresponding sizes). The only difference is the inner closure feature designated as "teeth". Vas-Q-Clip™ triangular protrusions (teeth) are perpendicular to the vessel whereas the Hem-O-Lok teeth are parallel.
The provided document is a 510(k) summary for the Nanova Biomaterials Inc.'s Vas-Q-Clip. This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than describing a study to prove acceptance criteria for a new AI/imaging device. Therefore, much of the requested information regarding AI/imaging study methodology (such as expert adjudication, MRMC studies, training set details, and specific performance metrics) is not applicable or present in this document.
However, I can extract information related to the device's non-clinical performance testing and general acceptance criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Tests performed on Vas-Q-Clip™" and their results, which can be interpreted as the device meeting predefined (though not explicitly stated numerical) acceptance criteria.
| Acceptance Criteria (Test Name) | Reported Device Performance |
|---|---|
| Migration Resistance | Passed |
| Vessel Occlusion | Passed |
| Application Force | Passed |
| Axial Pull-Off Force | Passed |
| USP 85 Bacterial Endotoxins Test | Passed |
| USP 151 Rabbit Pyrogenicity Test | Passed |
| Material Comparison Test | Passed |
| ISO 10993-10 Skin Sensitization | Passed |
| ISO 10993-6 Local Effects After Implantation | Passed |
| Visual Inspection of Seal | Passed |
| Bubble Emission | Passed |
| Dye Penetration | Passed |
| Peel-off Seal Strength | Passed |
| Accelerated and Real Time Aging | Passed |
| Sterility | Passed |
2. Sample size used for the test set and the data provenance
The document states, "Non-clinical testing was completed to assess its performance." It refers to "Internal Testing" for several mechanical properties (Migration Resistance, Vessel Occlusion, Application Force, Axial Pull-Off Force). However, no specific sample sizes or data provenance (country of origin, retrospective/prospective) are mentioned for these tests. The document does not describe imaging data or a test set in the conventional sense for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical performance and biocompatibility testing for a medical device (ligating clip), not an AI/imaging device that requires expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication, as this is not an imaging study requiring human interpretation.
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
Not applicable. This is not an AI-assisted device, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by established laboratory testing procedures (e.g., USP standards for endotoxins and pyrogenicity, ISO standards for biocompatibility, and unspecified internal test methods for mechanical properties). The "Passed" results indicate adherence to the requirements of these test methods.
8. The sample size for the training set
Not applicable. This pertains to an AI/machine learning model, which is not the subject of this document.
9. How the ground truth for the training set was established
Not applicable. This pertains to an AI/machine learning model, which is not the subject of this document.
§ 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.