(184 days)
The Modified ONFLEX™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.
The proposed Modified ONFLEX™ Mesh is a self-expanding, non-absorbable, sterile (Ethylene Oxide) prosthesis, made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The Modified ONFLEX™ Mesh has an anatomical shape designed to cover potential defect areas.
The Modified ONFLEX™ Mesh also contains two pockets to facilitate insertion and positioning of the device. The positioning pockets are located on the larger medical apex of the mesh and the lateral apex of the mesh. In addition to the pocket, the mesh also contains straps to facilitate positioning and fixation of the device. The Modified ONFLEX™ Mesh comes packaged with an onlay which is available in one size and is optional based on surgeon preference.
The proposed device contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The interrupted ring provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 - 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.
The Modified ONFLEX™ Mesh is offered in two sizes: medium (0115610) and large (0115611). The proposed Modified ONFLEX™ Mesh is considered a tissue contacting permanent implant according to Blue Book Memorandum issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing".
The provided text describes a 510(k) premarket notification for a medical device called "Modified ONFLEX Mesh." This document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices, rather than establishing acceptance criteria or reporting specific device performance metrics in a quantifiable table format.
Therefore, many of the requested details, such as specific numerical acceptance criteria, reported performance values, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types/methods for training sets, are not explicitly mentioned in this document. This type of regulatory submission primarily focuses on comparing the new device's design, materials, and intended use to existing, cleared devices.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
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Table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with specific numerical thresholds for performance. Instead, it states that "Mechanical testing was performed consistent with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2, 1999, to verify that the Modified ONFLEX™ Mesh's performance characteristics are similar to that of the predicate devices." The conclusion states, "The test results provided in this submission demonstrate that the Modified ONFLEX™ Mesh is substantially equivalent to the predicates."
The performance characteristics measured include:
- Mesh weave characteristics
- Mesh thickness
- Mesh pore size
- Mesh density
- Mesh stiffness
- Ball burst strength
- Suture pullout strength
- Tear strength
- PDO monofilament tensile strength
- Strap Attachment Strength
- Simulated deployment test
However, specific numerical acceptance criteria for these characteristics or the reported values for the Modified ONFLEX Mesh are not present in this document. The implicit acceptance criterion is that these characteristics are "similar" to the predicate devices.
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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 does not specify the sample sizes used for the mechanical testing or biocompatibility testing. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
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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 type of information is not applicable and not present in this document. The "ground truth" for a surgical mesh involves physical and biological properties measured through standardized tests, not expert interpretation of data in the way one might see in an AI diagnostic device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not present.
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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
Not applicable and not present. This device is a surgical mesh, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable and not present. This device is a surgical mesh.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference for performance in this context would be the established properties and performance benchmarks of the predicate devices, as well as the standards set forth in "FDA Guidance for the Preparation of Premarket Notification for a Surgical Mesh." For biocompatibility, the ground truth is adherence to ISO 10993 standards and leveraging data from predicate devices. For mechanical tests, the ground truth would be the expected physical properties for surgical mesh and comparison to predicate devices, measured using standardized laboratory methods.
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The sample size for the training set
Not applicable and not present. This device is a physical surgical mesh, not a machine learning algorithm.
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How the ground truth for the training set was established
Not applicable and not present.
§ 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.