(219 days)
NEOVEIL™ is indicated for use in surgical procedures in which soft tissue transection or resection with suture or staple line reinforcement is needed. NEOVEIL™ can be used for reinforcement of suture or staple lines during lung resection, liver resection, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, and small bowel procedures.
As packaged, NEOVEIL™ is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL TM are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. 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 Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL™ staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL™ is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m²).
The provided text describes a 510(k) submission for a medical device called NEOVEIL™ Tube/Sheet Type Suture and Staple Line Reinforcement Material. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against acceptance thresholds. Therefore, the concept of "acceptance criteria" as typically applied to performance claims (e.g., specific sensitivity/specificity targets for an AI algorithm) is not present. Instead, the "acceptance criteria" are implied by the comparison of technological characteristics and performance testing against a predicate device.
Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" in the context of substantial equivalence:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Nonwoven polymer surgical mesh structure | 100% bioabsorbable polyglycolic acid (PGA) nonwoven material. |
| Thickness comparable to predicate | Thickness ranges from 0.1 mm to 0.85 mm. |
| Mesh density comparable to predicate (for non-woven, this means basis weight) | Average basis weight ranges from 35 to 225 (g/m²). |
| Tensile strength comparable to predicate | Bench tensile strength testing performed. |
| Suture pullout strength comparable to predicate | Suture pull out strength testing performed. |
| Tear resistance comparable to predicate | Tear strength testing performed. |
| Bioabsorbable properties comparable to predicate | Degradation (in vitro tensile strength loss at 1 & 2 weeks) testing performed; Bioabsorbable PGA. |
| Biocompatibility (as per ISO 10993-1) | All materials evaluated in accordance with ISO 10993-1 and deemed acceptable. |
| Mechanical properties during use (insertion/removal, firing, staple formation, stiffness) comparable to predicate | Insertion/Removal Forces, Firing Force, Staple Formation, Staple Line Stiffness, Buttress Material Stiffness testing performed. |
| In vivo performance (free bleed, air leak, burst, staple formation, resorption) comparable to predicate | Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Staple Formation, Resorption testing performed. |
Study Details
The provided document describes a bench and in vivo animal testing to demonstrate substantial equivalence, not a study involving human subjects or AI performance. Therefore, many of your requested points related to AI algorithms, human readers, and ground truth in a clinical context are not applicable.
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Sample size used for the test set and the data provenance:
- Test set size: Not explicitly stated in terms of number of samples for each test, but general in-vitro and in-vivo testing was performed.
- Data provenance: Not explicitly stated, but it would be from internal lab testing (in vitro) and animal studies (in vivo). No information about country of origin of data is provided beyond the submitting company being from Japan. The studies are prospective in nature (designed to demonstrate equivalence).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device based on material property testing and animal studies, not expert-adjudicated clinical data to establish diagnostic ground truth. The "ground truth" here is the performance of the predicate device and established engineering/biological benchmarks.
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Adjudication method for the test set:
- Not applicable for this type of device submission. Performance is measured against physical and biological parameters, not through expert adjudication of qualitative outcomes.
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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. This is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
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The type of ground truth used:
- For in vitro tests: Physical and mechanical property measurements (e.g., tensile strength, thickness, density, stiffness) are compared against the known properties of the predicate device and/or defined engineering standards.
- For in vivo tests: Biological responses and functional performance in animal models (e.g., free bleed, air leak, burst, resorption rates) are compared against observations with the predicate device or accepted physiological norms for successful surgical repair.
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The sample size for the training set:
- Not applicable. There is no AI model to train.
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How the ground truth for the training set was established:
- Not applicable. There is no AI model to train.
§ 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.