Search Results

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 OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device 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 design 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 OnFlex™ Mesh 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 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 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 OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

Ask a specific question about this device

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:

1. 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.

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 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.

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 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable and not present.

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 and not present. This device is a surgical mesh, not an AI diagnostic tool.

6. 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.

7. 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.

8. The sample size for the training set

   Not applicable and not present. This device is a physical surgical mesh, not a machine learning algorithm.

9. How the ground truth for the training set was established

   Not applicable and not present.

Ask a specific question about this device

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"):

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.

Ask a specific question about this device