(95 days)
NEOVEIL® Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. NEOVEIL® Staple Line Reinforcement of staple lines during lung resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.
NEOVEIL® Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid (PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.
This document is a 510(k) summary for a medical device called NEOVEIL® Staple Line Reinforcement. It outlines a Special 510(k) submission, meaning the device is largely similar to a previously cleared predicate device with minor modifications. As such, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing rather than new extensive clinical studies.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with numerical targets. Instead, it states that "The performance testing validated that NEOVEIL® Staple Line Reinforcement meets its product specification and performs as intended. Results confirm that the specification requirements for the subject device have been met."
The performance tests conducted include:
| Test Name | Reported Device Performance |
|---|---|
| GUNZE internal test method for stapler insertion and removal forces with NEOVEIL®™ | Meets product specification and performs as intended. |
| GUNZE internal test method for stapler firing force with NEOVEIL®™ | Meets product specification and performs as intended. |
| GUNZE internal test method for staple formation with NEOVEIL®™ | Meets product specification and performs as intended. |
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 does not specify the sample size used for each of the internal tests. The testing was described as "simulated usability testing on final finished versions of NEOVEIL®™ using a relevant mechanical stapler." The data provenance is "internal GUNZE test methods," implying the testing was conducted by Gunze Limited. The country of origin for the data is not explicitly stated, but Gunze Limited is based in Japan. The testing described is prospective, as it was conducted to validate the modified device.
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 section is not applicable as the evaluation involved non-clinical performance testing of a physical device, not an AI or diagnostic tool where expert ground truth would be established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable as the evaluation involved non-clinical performance testing of a physical device.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a physical medical device (staple line reinforcement), not an AI diagnostic tool. The "usability" mentioned refers to the device's interaction with a stapler, not human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance testing was the product specifications and intended performance as defined by Gunze's internal test methods. The tests verified if the device functioned correctly (e.g., stapler insertion, firing, and staple formation) under simulated conditions.
8. The sample size for the training set
This section is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as above.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.