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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).

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Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.

Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.

The provided document is an FDA 510(k) clearance letter for a medical device called Bard® Mesh. However, this document does not contain the information typically found in a study demonstrating how an AI/algorithm-driven device meets acceptance criteria.

The Bard® Mesh is a surgical mesh, a physical medical device used to reinforce soft tissue, such as in hernia repair. It is a Class II device, and the clearance is based on its substantial equivalence to a preamendment predicate device (meaning it was marketed before May 28, 1976).

The document specifically mentions:

• "As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes. Design verification testing was conducted to support the performance of the pre-shaped configuration." This indicates that for this type of physical device and the nature of the changes (labeling and a pre-shaped configuration), extensive clinical studies or complex performance evaluations are not required in the same way they would be for a novel diagnostic or AI-powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic algorithms, is not present in this 510(k) letter. This clearance is based on the device's established technological characteristics and historical use, demonstrating its equivalence to a long-marketed product, rather than proving performance against specific acceptance criteria through a new study as would be done for an AI device.

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Bard® Soft Mesh is indicated for the repair of ventral, incisional, and inguinal hernias.
Bard® Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernias.

The Bard® Soft Mesh is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with ventral, incisional, and inguinal hernias. The Bard® Soft Mesh Pre-Shaped is a nonabsorbable, sterile mesh designed for reinforcement of soft tissue deficiencies in adults with inguinal hernias. The knit construction allows the mesh to be stretched in both directions, in order to accommodate and reinforce tissue defects. The Bard® Soft Mesh is comprised of knitted polypropylene monofilaments in a rectangular flat sheet ranging from 2" x 4" to 12" x 12" with smooth radiused corners. The Bard® Soft Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair.

This 510(k) clearance letter pertains to a surgical mesh (Bard Soft Mesh), not an AI/software device. Therefore, the detailed questions about acceptance criteria, study design referencing AI performance, expert consensus, MRMC studies, training and test sets, and ground truth establishment are not applicable to this submission.

The 510(k) is for changes to the labeling of an existing device, with no changes to the device itself. The primary purpose of the submission is to align the labeling with European medical device regulations and to document historical product changes (like adding a new size) that were previously handled via internal documentation.

Here's a breakdown of the relevant information provided in the document:

1. Acceptance Criteria and Device Performance:

Since this 510(k) is not for a new device or a functional change, but rather for labeling updates and documentation of previous minor changes, the concept of "acceptance criteria" for a new device performance study (like for an AI model) does not apply. The acceptance criteria here are implicitly related to demonstrating that the labeling changes and historical product modifications do not impact the safety or effectiveness of the device and maintain substantial equivalence to the predicate device.

The document states: "Through the risk analysis conducted, it was determined that the labeling changes described in this 510(k) do not result in any new or increased risks. As there are no new or increased risks identified, no verification or validation activities are required for these labeling changes."

"Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh issued on March 2, 1999. The non-clinical testing supported those historical changes taken under documentation to file, including dimensional line extension, do not impact the safety or effectiveness of the subject device nor do they impact the substantial equivalence between the subject and predicate devices."

Therefore, the "performance" shown is that the device, with its updated labeling and previously documented size extension, continues to meet the physical and mechanical properties expected of a surgical mesh and is substantially equivalent to the predicate.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. This submission is based on non-clinical testing of physical device properties and a comparison to a predicate, not clinical studies with a "test set" of patient data for an AI model. The "test set" refers to the specific mesh samples used for physical and mechanical property testing. The document states "Non-clinical testing including mesh thickness, mesh knit construction, mesh pore size, mesh density, tensile strength, device stiffness, ball burst (strength), tear resistance, device stiffness, and suture pull out were considered," implying relevant samples of the mesh were tested, but specific sample numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of patient data. The "data" pertains to the characteristics of the physical mesh device.

3. Number of Experts used to establish ground truth:

• Not applicable. There is no "ground truth" establishment by experts in the context of an AI model's performance on patient data. The non-clinical testing results establish the performance of the physical device.

4. Adjudication Method:

• Not applicable. No expert adjudication process for an AI model's output is relevant to this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI-assisted diagnostic device study.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is not an algorithm.

7. Type of Ground Truth Used:

• Not applicable in the context of an AI model. The "ground truth" for this device's performance is established by objective non-clinical engineering and material property testing methods as per relevant standards (e.g., those referenced in the 1999 FDA guidance for surgical mesh).

8. Sample Size for Training Set:

• Not applicable. No AI model is being trained here.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

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Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.

Phasix™ ST Umbilical Hernia Patch is a sterile, single-use device for prescription use only. It is a self-expanding, fully resorbable mesh with a resorbable hydrogel coating and a positioning pocket and strap. Phasix™ ST Umbilical Hernia Patch is comprised of 2 layers of poly-4hydroxybutyrate (P4HB), with the posterior side being co-knitted with polyglycolic acid (PGA) fibers, identical to the mesh component of the secondary predicate device (Phasix™ ST Mesh with Open Positioning System). P4HB degrades through hydrolysis and a hydrolytic enzymatic digestive process and is essentially completely resorbed in 12-18 months. Phasix™ ST Umbilical Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based hydrogel. The hydrogel is identical to both the primary predicate device (Ventralex™ ST Hernia Patch (K101928) and the secondary predicate device (Phasix™ ST Mesh with Open Positioning System, K190185). The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth. The visceral side of the mesh is the resorbable hydrogel coating, which separates the mesh from underlying tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after hydration in saline, the coating becomes a hydrated gel that is resorbed from the site in less than 30 days. Phasix™ ST Umbilical Hernia Patch contains SorbaFlex™ Memory Technology, which provides memory and stability to the mesh, facilitating ease of initial insertion, proper placement and fixation of the device. The SorbaFlex™ Memory Technology is comprised of an extruded polydioxanone (PDO) resorbable monofilament contained within a knitted P4HB containment sleeve. PDO is resorbed within 24-32 weeks. The PDO ring and hybrid positioning straps (comprised of P4HB and polypropylene materials that are connected by overlapping the materials and sewing them together with clear PP monofilament, with a delineation marker dyed blue with [phthalocyaninato(2-)] copper), are based on the design of the primary predicate Ventralex™ ST Hernia Patch (K101928). The subject device has the identical intended use as the primary and predicate devices; soft tissue repair/reinforcement.

The provided document does not describe acceptance criteria for a software device or a study proving that a software device meets those criteria.

Instead, the document is a 510(k) premarket notification summary for a physical medical device: Phasix™ ST Umbilical Hernia Patch.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for a software device.

The document discusses the following types of testing for the physical medical device:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Many tests were not repeated as the materials were the same as previously cleared predicate devices. Tests included material chemical characterization (gravimetric analysis, GCMS, LCMS-UV-CAD, HS-GCMS, ICPMS, GPC), cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, LAL, subacute/subchronic/chronic toxicity, genotoxicity (AMES, Mouse Lymphoma), and implantation tests.
• Product Testing (Performance Testing): This included "Substantial Equivalency Testing" covering physical characteristics (mesh weave, pore size, thickness, weight per unit area, stiffness, dimensions) and functional characteristics (ball burst strength, suture retention strength, tear strength, PGA pull-out strength, three-tack pluck force, gel disruption analysis). It also included functional testing of the subject device (25-degree recoil, containment sleeve puncture, strap attachment strength, pocket integrity), resorption profile of the ring and containment sleeve (in-vitro degradation of PDO), design validation usability testing, and human factors/simulated testing.
• Animal Studies: No new animal studies were conducted for the subject device. Instead, the safety and performance were evaluated based on animal and histological data from reference devices (Phasix™ Mesh, Phasix™ ST Mesh) and predicate devices (Phasix™ ST Mesh with Open Positioning System, Ventralex™ ST Hernia Patch). The PDO ring material was previously evaluated in a rat model.

If you have a document pertaining to a software device, please provide that, and I will do my best to extract the requested information.

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Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

This submission, K233402, describes a Special 510(k) for the Bard 3DMax Mesh, which focuses solely on labeling changes to align with European medical device regulations and other devices in the Davol Inc. portfolio. The submission explicitly states:

"No non-clinical or clinical testing was provided in support of this Special 510(k)." and "The purpose of this Special 510(k) is to notify FDA of the changes to the Bard® 3DMax™ Mesh labeling. There are no changes to the device itself."

Therefore, based on the provided document, there are no acceptance criteria or studies associated with this specific submission to describe regarding device performance, as the device itself (materials, design, manufacturing, etc.) has not changed from its predicate, K081010.

To provide the requested information, one would need access to the original 510(k) submission (K081010) that established the substantial equivalence of the device itself, rather than just its labeling.

Since the prompt asks for information from the provided input, and the input explicitly states no testing was done, I cannot fulfill the request for acceptance criteria and study details.

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The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The OptiFix™ AT Absorbable Fixation System with Articulating Technology, herein after referred to as "OptiFix™ AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device is available in either 15 or 30 preloaded fasteners. The tip of the shaft can be articulated, and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide and glycolide) and are dyed with D&C Violet No. 2.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum tensile strength, maximum deployment force) or numerical performance metrics for the OptiFix™ AT device. Instead, it uses qualitative statements about the device meeting established requirements.

2. Sample Sizes and Data Provenance

The document does not specify the sample sizes used for the product testing (design verification and validation).

• Test Set Sample Size: Not specified.
• Data Provenance: Not explicitly stated, but given the nature of pre-market submissions in the US, the testing would generally occur in the US or in adherence to US/international standards. It is retrospective in the sense that the testing was completed prior to the submission.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not applicable as the device is a physical medical stapling system, not an AI/software device that requires expert-established ground truth for a test set. The performance is assessed through engineering and biological testing.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a physical medical stapling system. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for setting ground truth in imaging/AI studies, which were not conducted for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device." MRMC studies are typically for evaluating diagnostic devices where human readers interpret results.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not done. This device is a physical medical staple system and does not involve an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For this physical device, the "ground truth" for verifying performance relies on:

• Engineering Specifications: The device's design, materials, and functional performance are compared against predetermined engineering specifications and safety standards.
• Biocompatibility Standards: Performance against established international standards (ISO 10993).
• Packaging Standards: Performance against established international standards (ISO 11607).

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI algorithm, so there is no training set in the AI sense. The manufacturing process and quality control would involve internal testing of components and assemblies that could be analogous to "training" in a broader engineering sense, but not for an "AI training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of such a device is established through engineering design principles, material science, applicable regulatory standards, and risk assessments.

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