(179 days)
The 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 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 ONFLEX™ Mesh has an anatomical shape designed to cover potential defect areas. The ONFLEX™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.
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 lavers of mesh with polytetrafluoroethylene (PTFE) monofilament.
The ONFLEX™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The ONFLEX™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.
The ONFLEX™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The proposed 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 document is a 510(k) summary for a medical device called ONFLEX™ Mesh. It does not present acceptance criteria or a study proving the device meets specific acceptance criteria in the way one would describe for an AI/ML powered device.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Indications for Use: The ONFLEX™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias, which is similar to the predicate devices.
- Technological Characteristics: The device has similar construction materials (polypropylene monofilament),
large pore knit, anatomical shape, and other features, with some modifications from its predicates. - Performance Data: This includes biocompatibility testing, mechanical testing, and animal studies, all used to show similar performance to the predicates.
Therefore, I cannot fulfill the request as it pertains to acceptance criteria and study details for an AI/ML device. The document describes a traditional medical device (surgical mesh) and its regulatory clearance process, which relies on demonstrating substantial equivalence rather than meeting pre-defined performance acceptance criteria for an AI/ML algorithm.
However, I can extract information about the performance data used to support the substantial equivalence claim, which can be seen as analogous to demonstrating that the device performs similarly to its predecessors.
Here's a breakdown of the performance data presented, formatted to align with your request where possible, but with the understanding that it's not a study proving meeting acceptance criteria in the AI/ML sense:
1. A table of performance characteristics reviewed (not "acceptance criteria"):
| Performance Characteristic | Reported Device Performance/Comparison |
|---|---|
| I. Biocompatibility Testing | |
| Cytotoxicity | Leveraged from predicate devices (Bard® 3DMax™ Light Mesh and Bard® Ventrio™ Hernia Patch) |
| Sensitization | Leveraged from predicate devices |
| Intracutaneous reactivity | Leveraged from predicate devices |
| Acute systemic toxicity | Leveraged from predicate devices |
| Subchronic toxicity | Leveraged from predicate devices |
| Genotoxicity | Leveraged from predicate devices |
| Implantation | Leveraged from predicate devices |
| II. Electrical Safety/EMC | Not applicable – no electrical or metal components. |
| III. Software V&V | Not applicable – does not contain software. |
| IV. Mechanical Testing | Performed to compare proposed ONFLEX™ Mesh to predicates (3DMax™ Light Mesh and Ventrio™ Hernia Patch), showing similar characteristics. |
| Mesh weave characteristics | Measured and compared to predicates. |
| Mesh thickness | Measured and compared to predicates. |
| Mesh pore size | Measured and compared to predicates. |
| Mesh density | Measured and compared to predicates. |
| Mesh stiffness | Measured and compared to predicates. |
| Ball burst strength | Measured and compared to predicates. |
| Suture pullout strength | Measured and compared to predicates. |
| Tear strength | Measured and compared to predicates. |
| PDO monofilament tensile strength | Measured and compared to predicates. |
| Simulated deployment test | Measured and compared to predicates. |
| V. Animal Study | In vivo and in vitro resorption studies performed to characterize mechanical strength and resorption of PDO monofilament in SorbaFlex™ Memory Technology. Studies were originally conducted for predicate Ventrio™ Hernia Patch (K081777) and adopted for ONFLEX™ Mesh (which contains the same PDO monofilament). |
| VI. Clinical Study | No clinical study was required. |
2. Sample sized used for the test set and the data provenance:
- Test Set Size: Not specified in terms of fixed sample sizes for a 'test set' as would be done for an AI/ML evaluation. The mechanical testing was performed on the ONFLEX™ Mesh and predicate devices. Biocompatibility and animal studies were leveraged from the predicate devices.
- Data Provenance: Not explicitly stated as retrospective or prospective for the mechanical tests, but implied to be conducted for the submission. Biocompatibility and animal studies were previously conducted for the predicate devices. The country of origin of data is not specified but implicitly US for regulatory purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/ML device relying on expert-established ground truth. The "ground truth" for substantial equivalence is based on established scientific principles for material properties, biocompatibility, and mechanical performance, often standardized through guidance documents and international standards.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described for this type of 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:
- Not applicable. This is not an AI-powered diagnostic/interpretative device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical mesh; it does not have an algorithm.
7. The type of ground truth used:
- For Biocompatibility: Compliance with FDA Blue Book Memorandum #G95-1 / ISO 10993-1 standards (biological evaluation through established tests for cytotoxicity, sensitization, etc.).
- For Mechanical Testing: Comparison of physical and performance characteristics against predicate devices, based on "FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, issued March 2. 1999." The "ground truth" is established engineering and material science principles and the performance of existing, cleared predicate devices.
- For Animal Study (Resorption): In vivo and in vitro studies establishing the mechanical strength and resorption profile of the PDO monofilament, referenced from the predicate device submission.
8. The sample size for the training set:
- Not applicable. There is no training set for this device in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.