Search Results

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, hereinafter 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. Two different product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the number of preloaded fasteners; either 15 or 30. The deployment shaft of the OptiFix™ AT device is 37cm in length and designed for use with 5mm trocars. 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-co-glycolide) and are dyed with D & C Violet No. 2 (<0.15% by weight).

The provided text describes the OptiFix™ AT Absorbable Fixation System with Articulating Technology. The document is a 510(k) premarket notification for a medical device seeking substantial equivalence to already marketed predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a consolidated table of acceptance criteria with corresponding performance data in a dedicated section. However, it states that "All samples tested met the acceptance criteria" for various performance tests. The performance data is scattered throughout Section VII. PERFORMANCE DATA.

Below is a summary of the performance testing and an inferred "met acceptance criteria" outcome:

2. Sample Sizes Used for the Test Set and Data Provenance

• Biocompatibility Testing: The document does not specify the sample sizes (number of devices or biological samples) used for each biocompatibility test.

• Product Testing: The document does not specify the sample sizes for the product tests (Actuation Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing, Mesh Compatibility, Resorption Profile).

• Animal Study: The document does not specify the number of animals used in the study.

• Data Provenance: The studies are described as "preclinical testing" and were conducted to support the 510(k) submission, implying they were prospective studies. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in Warwick, Rhode Island, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Biocompatibility Testing: Ground truth is established by standardized biological evaluation methods (ISO 10993-1). No specific "experts" for ground truth are mentioned beyond the execution of these standardized tests.
• Product Testing: Ground truth is based on engineering specifications and benchmark performance against the predicate device. No specific "experts" (e.g., engineers with a certain number of years of experience) for ground truth establishment are detailed within the narrative.
• Animal Study: The evaluation included "histological evaluation of the tissue". This would typically involve pathologists, but the number and qualifications of these experts are not provided.

4. Adjudication Method for the Test Set

Not applicable. The tests described are primarily objective, quantitative measurements (e.g., torque, force, gap height, material degradation, histological analysis in the animal study). There is no mention of a human-centric "test set" requiring adjudication or consensus for classification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Clinical studies were not performed for the submission of this proposed device nor were clinical studies performed for the primary predicate device (OptiFix-K142873)." Therefore, no MRMC study, or any clinical study involving human readers, was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This device is a mechanical surgical fixation system, not a software-based diagnostic algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable here. The device itself is the standalone system.

7. The Type of Ground Truth Used

• Biocompatibility: Ground truth is based on the results of standardized biological tests as per ISO 10993-1, indicating biological safety (e.g., non-cytotoxic, non-sensitizing).
• Product Testing: Ground truth is derived from engineering specifications and the established performance characteristics of the primary predicate device, used for equivalence comparison.
• Animal Study: Ground truth involved histological evaluation of tissue (pathology/histology) and objective measurements of mesh contracture, fastener seating, and tissue in-growth in an animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as no training set was used.

Ask a specific question about this device

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer, processed into monofilament fiber, and then knitted into a surgical mesh. Phasix™ Mesh is packaged individually as a sterile, single, flat mesh available in a wide range of shapes and sizes. Phasix™ Mesh provides immediate short-term support, and a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material is essentially complete within 12 to 18 months.

The provided document is a 510(k) Premarket Notification for a medical device called Phasix™ Mesh. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch.

Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training data, etc., is not available within this type of regulatory submission. This document highlights that the proposed device is so similar to an already approved device that extensive new studies are not required.

Here's how to interpret the document in the context of your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The "acceptance criteria" here are implicitly that the proposed Phasix™ Mesh performs similarly or equivalently to the predicate Phasix™ Mesh (K142818) across various physical and biological characteristics. The FDA's substantial equivalence determination means they accepted that the proposed device is just as safe and effective as the predicate.
• Reported Device Performance: The document states that "The proposed Phasix™ Mesh demonstrated equivalent performance in comparison to the predicate device" for the following non-clinical tests:
  • Mesh thickness
  • Mesh knit construction
  • Mesh pore size
  • Mesh density
  • Tensile strength
  • Device stiffness
  • Suture pullout strength
  • Burst strength
  • Tear resistance
• Specific performance values are NOT provided. The document only states "equivalent performance," implying that the results fell within acceptable ranges or were statistically comparable to the predicate.

2. Sample size used for the test set and the data provenance

• Test Set (Bench Testing): The specific sample sizes for the bench tests listed above are not reported in this summary.
• Data Provenance: The bench testing was conducted by the manufacturer, C.R. Bard, Inc. (Davol Inc. is the submitter). The country of origin for the data is not specified but would typically be the location of the manufacturing and testing facilities. These appear to be retrospective tests designed to compare the proposed device to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of physical/mechanical performance testing, "ground truth" is established through standardized engineering and materials science methods, not expert consensus in the clinical sense.

4. Adjudication method for the test set

• Not applicable. Adjudication is typically for clinical or interpretative tasks, not for objective physical measurements.

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

• No MRMC study was done. This device is a surgical mesh, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a surgical mesh, not an algorithm.

7. The type of ground truth used

• For the bench tests, the "ground truth" is the objective measurement (e.g., actual mesh thickness, measured tensile strength) derived from standardized test methods.
• For biocompatibility and in-vivo studies, the "ground truth" is established through the results of standardized biological and animal tests. In this case, previous studies for the predicate device (K142818) were adopted because the proposed device uses the same materials and knit characteristics. These previous studies would have established biocompatibility based on ISO 10993-1 and characterized mechanical strength and resorption profiles in animal models.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would require a "training set."

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

• Not applicable.

In summary: This document is a regulatory submission for a device seeking substantial equivalence to a predicate. It relies heavily on the fact that the proposed device uses almost identical technology and materials as an already-approved device, therefore adopting prior testing results rather than generating entirely new, extensive clinical or comparative effectiveness data. The "acceptance criteria" are effectively that the new device's physical and biological properties are equivalent to the predicate, as demonstrated through bench testing and by leveraging prior biocompatibility and animal study data.

Ask a specific question about this device

The CapSure ™ Permanent Fixation System 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 CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The shaft of the CapSure™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.

The provided document is a 510(k) premarket notification for the CapSure™ Permanent Fixation System. It focuses on demonstrating substantial equivalence to a predicate device (K142808 CapSure™ Permanent Fixation System) rather than presenting a study for initial market approval. Therefore, the information typically requested for a device's initial acceptance criteria and its demonstration through a study (especially regarding algorithm performance, ground truth establishment, sample sizes for training/test sets, and expert involvement for AI/diagnostic devices) is largely not applicable in this context.

This submission is about minor changes to an already cleared device, asserting that no technological characteristics have changed and that updated instructions for use are supported by adequate performance data from the previous 510(k).

However, I can extract the information related to performance data and acceptance criteria as presented for the original clearance (K142808) and affirmed for this submission.

Here's a breakdown based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The following questions are largely N/A or cannot be answered from this document, as it focuses on demonstrating substantial equivalence for a mechanical/implantable device and not an AI/diagnostic algorithm.

2. Sample size used for the test set and the data provenance:

• Biocompatibility: "All samples tested met the acceptance criteria." Specific sample sizes are not provided in this summary but would have been in the original K142808 submission. Data provenance is implied to be laboratory testing as per ISO 10993 standards.
• Mechanical Testing: "All samples tested met the acceptance criteria." Specific sample sizes are not provided but would have been in the original K142808 submission. Data provenance is laboratory testing.
• Animal Studies: A "Porcine implantation study" was conducted. The sample size (number of pigs, number of fasteners tested) is not specified in this summary. Data provenance is an animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This information is not relevant for biocompatibility, mechanical, or animal studies of a fixation device. Ground truth, in this context, relates to objective measurements or physiological responses, not expert interpretation.

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

• N/A. Not applicable for the types of tests performed.

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:

• No. This is a mechanical fixation device, not an AI/diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• N/A. Not applicable for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Biocompatibility: Ground truth is defined by objective parameters according to ISO 10993 standards (e.g., cell viability, erythema scores, implant site reactions, toxicological endpoints).
• Mechanical Testing: Ground truth is defined by engineering specifications and objective measurements (e.g., force values, successful deployment rate, MR compatibility measurements, burst pressure).
• Animal Studies: Ground truth is objective pathological and physiological observations (e.g., presence/absence of tissue attachments, statistical significance of differences compared to control).

8. The sample size for the training set:

• N/A. This is not an AI/machine learning device; there is no "training set."

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

• N/A. Not applicable.

Ask a specific question about this device

VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

The ECHO 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.

The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.

VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The uncoated fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The VENTRALIGHT™ ST Mesh described above will be packaged pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.

The provided text is a 510(k) Summary for a medical device (ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh). It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

However, the document does not contain a table of acceptance criteria nor a detailed study description with specific numerical performance metrics, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study proving a device meets acceptance criteria. The performance data section lists the types of tests conducted, but not their results or specific acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request as the specific data regarding acceptance criteria and detailed study results are not present in this 510(k) summary. I can only describe the tests performed, not their outcomes or how they met specific acceptance criteria.

Here's a breakdown of what can be extracted from the text, and what is missing:

What can be extracted:

• Types of performance tests performed: Biocompatibility, Bench-top (simulated use, mesh integrity, ball burst, attachment strengths), Mechanical (nylon peel strength, hoisting loop attachment, crimp integrity), and Porcine Animal Model (simulated use, surgeon feedback).
• Absence of some types of studies: No electrical safety/EMC or software verification/validation were required as the device doesn't have such components. No clinical study was required.
• Intended Use & Indications for Use: The device is for reconstruction of soft tissue deficiencies (hernias), and the Lap System facilitates delivery of prostheses during laparoscopic hernia repair.

What is missing (and therefore cannot be provided in the table or detailed descriptions):

• Specific Acceptance Criteria: The document lists types of tests, but not the quantitative or qualitative criteria for success (e.g., "Ball Burst strength > X Newtons").
• Reported Device Performance: No actual results from the tests are provided, only that they were conducted "in support of the substantial equivalence determination."
• Sample Sizes: While tests were done, e.g., in a "porcine animal model," the number of animals or the number of samples for bench testing is not specified.
• Data Provenance: Not specified for bench tests. For biocompatibility, it states testing was conducted "in accordance with FDA Blue Book Memorandum #G95-1" and "leveraged from the primary predicate device." The animal model is porcine. The origin (country/institution) is not mentioned.
• Number of Experts/Qualifications for Ground Truth: Not applicable as specific ground truth data for performance metrics is not provided. Surgeon feedback was gathered for the porcine model, but details on "experts" or the number of surgeons are not given.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Explicitly states "No clinical study was required." This implies no MRMC study.
• Standalone Performance: While "Performance Testing - Bench" and "Performance Testing - Mechanical" describe tests on the device itself, the results establishing its standalone performance against defined acceptance criteria are not provided.
• Type of Ground Truth Used: For the porcine model, it's "surgeon feedback on product performance." For other tests, it would typically be defined metrics based on engineering specifications or ISO standards, but these are not detailed.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/software device. The document explicitly states "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
• Ground Truth for Training Set: Not applicable.

Based on the provided text, here is what can be inferred/extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests (bench, mechanical, or animal model).
• Data Provenance:
  • Biocompatibility: "leveraged from the primary predicate device" and conducted "in accordance with FDA Blue Book Memorandum #G95-1" and ISO 10993-1.
  • Animal Model: Porcine animal model. Country of origin not specified. Retrospective/Prospective not specified, but typically prospective for animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided in detail. For the porcine model, "surveys which captured surgeon feedback on product performance" were used. The number or specific qualifications of these surgeons are not mentioned. For other tests, "ground truth" would be established by engineering specifications or compliance with standards, not expert consensus on performance data.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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:

• No. The document explicitly states: "No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh." This device is a physical surgical mesh and delivery system, not an AI or imaging device, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Yes, various "standalone" performance tests were conducted on the device components and the assembled system. These include:
  • Biocompatibility Testing
  • Bench-Top Simulated Use
  • Mesh Integrity (following simulated use)
  • Ball Burst
  • Connector to Mesh Attachment Strength
  • Connector to Deployment Frame Attachment Strength
  • Nylon Peel Strength
  • Center Hoisting Loop to Deployment Frame Attachment Strength
  • Crimp Integrity
• However, the results of these tests meeting specific acceptance criteria are not detailed in this summary.

7. The type of ground truth used:

• For the performance testing, the ground truth would be based on engineering specifications, material properties, and compliance with recognized standards (e.g., ISO for biocompatibility).
• For the porcine animal model, "surgeon feedback on product performance" acted as a form of experiential ground truth.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/software device that would require a "training set." The document explicitly states: "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."

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

• Not applicable.

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

The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.

When integrated with the Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.

The V2.6 software for the LabSystem™ PRO EP Recording System is a bidirectional software interface that links the Bard LabSystem PRO EP Recording System with the Biosense-Webster CARTO 3 mapping/navigation system. The V2.6 software also incorporates the core recording system functionality of the released V2.4b software for the LabSystem PRO EP Recording System. The joint integrated solution provides a single repository for the resulting CARTO 3D electro-anatomical map and procedure information collected by LabSystem PRO EP Recording System. This interface will enhance the usability of the two systems when used in tandem. This will result in a workflow improvement, more streamlined data management, and simpler review of case details. The information will be shared via a network link using a BWI communication protocol.

The V2.6 software is intended for use with the LabSystem PRO EP Recording System (K031000). The LabSystem™ PRO EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. It does not transmit alarms nor does it have arrhythmia detection capabilities.

This document is a 510(k) summary for the V2.6 software for the Bard LabSystem PRO EP Recording System, which is a programmable diagnostic computer used in electrophysiology procedures. The submission focuses on demonstrating substantial equivalence to predicate devices and does not contain details about specific acceptance criteria or a clinical study in the format requested.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, the specific acceptance criteria (e.g., performance metrics, thresholds) are not detailed in this summary.
   • Reported Device Performance: No specific performance metrics or quantitative results are provided in this summary. The document focuses on demonstrating functional equivalence and adherence to standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This information is not available in the provided 510(k) summary. It describes "Software qualification" being performed "in-house," but does not specify sample sizes for testing or data provenance.

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 information is not available. The document does not describe the establishment of ground truth by experts for a test set.

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

   • This information is not available. No adjudication method is mentioned.

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

   • This is not applicable/not available. The device (LabSystem™ PRO EP Recording System software) is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human readers with and without AI. It's a data acquisition, display, and integration system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not explicitly applicable in the context of an "algorithm-only" performance as one might see for an AI diagnostic tool. The "software qualification" mentioned is an in-house verification and validation process for the software's functionality and integration capabilities. The device itself is a system for acquiring and displaying data for physician analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • This information is not available. The concept of "ground truth" as used in clinical performance studies is not detailed for this type of software verification. The testing would likely focus on functional accuracy (e.g., data transfer integrity, correct display of information, proper integration).

8. The sample size for the training set

   • This information is not available. This device's software (V2.6) for data acquisition and integration does not appear to involve a "training set" in the sense of machine learning algorithms. Its development and testing would involve traditional software engineering verification and validation.

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

   • This information is not available, as no training set (in the machine learning sense) is mentioned or implies.

Summary of what is available regarding "acceptance criteria" and "study":

• Acceptance Criteria Mentioned: The document states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."
• Study Described: The core study mentioned is "Software qualification performed in-house." This is not a clinical study but rather a non-clinical verification and validation process.
• Standards Referenced for Software Development/Testing:
  • IEEE Standard 730-1995 Software Quality Assurance Plans
  • IEEE Standard 829-1983 Software Test Documentation
  • IEEE Standard 1012-1986 Software Verification and Validation Plans
  • IEEE Standard 830-1993 Software Requirement Specifications
  • IEEE Standard 1008-1987 Software Unit Testing
  • EN 60601-1-2:2007 EMC, Radiated emissions and Conducted emissions requirements
  • EN 60601-1:2005 Patient Leakage current (Section 19, Table IV, Type CF, 50uA)
• Conclusion of Study: The non-clinical testing confirmed the safety and effectiveness of each functional aspect of the system, supporting the claim of substantial equivalence to predicate devices based on "same Indications for Use, principles of operation, and the technological characteristics."

This 510(k) submission is for a software update to an existing electrophysiology recording system, primarily focusing on integration capabilities. The "study" referenced is standard software verification and validation, not a clinical performance study with "ground truth" and "readers" in the context of diagnostic AI.

Ask a specific question about this device

The Bard LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data.

When integrated with the Philips EP navigator system, the BARD® LabSystem™ PRO EP Recording System is designed to acquire, analyze, and display 3D electroanatomical maps of the human heart. The maps are constructed using intracardiac electrograms with their respective cardiac locations taken from live x-ray overlay on a patient's 3D cardiac anatomy. Maps may be displayed as electrical activation maps, voltage maps, dominant frequency maps and location maps with user defined measurement values.

The LabSystem EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient.

The provided document is a 510(k) Summary for the Bard LabSystem™ PRO EP Recording System, specifically for its V3.1 software. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving device performance against specific acceptance criteria. This type of regulatory submission typically relies on a comparison to existing, legally marketed devices rather than presenting novel performance studies with acceptance criteria, especially for software updates to established systems.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not available in the document. The document does not describe specific acceptance criteria or report quantified device performance metrics (e.g., sensitivity, specificity, accuracy) for the V3.1 software. The submission aims to show "substantial equivalence" to predicate devices, implying that its performance is comparable, but it doesn't present a study with specific targets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the document. There is no mention of a test set, its sample size, or the provenance of the data.

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)

• Not available in the document. Given no test set is described, there's no information on experts establishing ground truth for it.

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

• Not available in the document. No information on an adjudication method for a test set is provided.

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/Not available in the document. This device is an EP recording system for acquiring, analyzing, and displaying cardiac electrophysiologic data and 3D electroanatomical maps during electrophysiology procedures. It does not appear to be an AI-driven diagnostic system that assists human readers in the way an MRMC study typically assesses for AI. The document does not describe any MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available in the document. The device is a "computer and software driven data acquisition and analysis tool" that "facilitate[s] the gathering, display, analysis by a physician." It is inherently designed for use by a physician, not as a standalone, fully autonomous diagnostic algorithm. No standalone performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not available in the document. Since no specific performance study or test set is described, there's no information on the type of ground truth used.

8. The sample size for the training set

• Not available in the document. This document does not discuss a training set. The device appears to be a software update for an existing system, and the submission emphasizes regulatory compliance and substantial equivalence rather than a machine learning model's training and validation process.

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

• Not available in the document. Since no training set is mentioned, there's no information on how its ground truth was established.

Summary of Non-Clinical Testing Section (Relevant to the overall submission but not specific performance metrics):

The document states: "The LabSystem™ PRO EP Recording System is developed and produced in accordance with 21 CFR 820.30 Quality System Regulations. The software product is developed and tested in accordance with the following industry standards." While this indicates quality control and development processes, it doesn't provide specific device performance acceptance criteria or study results against those criteria. The "Summary of Non-Clinical Testing" is a high-level statement about adherence to quality systems and standards, rather than a detailed report of a performance study.

Ask a specific question about this device

Bard PTFE Coated Guide Wires are indicated for percutaneous entry of a guiding catheter into a vessel using standard percutaneous methods (Seldinger's Technique). Generally, Guide Wires which are 100cm or longer are indicated for use with vascular catheters and balloon dilatation catheters in angiographic or interventional procedures. The guide wire may be inserted through an [18g] needle, introducer, or catheter. A guide wire with an outer diameter of .018" or smaller may be used with open ended guide wires.

Guide wires which are shorter than 100cm are generally indicated for non-vascular use. Guide wires with an outer diameter of .018" or smaller may be inserted into the target organ through a [22g] needle or an open-ended guide wire (60cm or shorter). Larger guide wires may be inserted through larger gauge needles or an introducer for placement of dilators and/or drainage catheters.

The Bard PTFE (Teflon®) coated guide wires, subject of this 510(k), like their predicate device counterparts, are manufactured from stainless steel wire, tin/silver solder, and PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters, lengths, and coating types. Each guide wire is subsequently packaged, labeled, and sterilized.

The provided text describes a 510(k) summary for Bard PTFE (Teflon®) Coated Guide Wires, which aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a new, significantly different device or an AI/ML product.

The submission focuses on a process change for the Teflon® coating due to environmental concerns regarding PFOA, not a new device design or a novel AI algorithm. Therefore, the information provided does not align with the typical structure for reporting acceptance criteria and a study proving device performance as envisioned for an AI/ML product.

However, I can extract the relevant "performance specifications" and the "testing performed" to address your request as best as possible within the context of this document.

Understanding the Context:
The "acceptance criteria" here are essentially that the modified guide wires maintain the same performance characteristics as the predicate devices, despite a change in the manufacturing process of the PTFE coating. The study's purpose is to demonstrate that this change in coating material does not adversely affect the safety, biocompatibility, and functional performance of the guide wires.

Here's the information structured to fit your requested format, with caveats where the document's content deviates from a typical AI/ML performance study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set. It refers to "representative samples" for inhibition/enhancement testing, "representative products" for coating application, and "representative guide wire items" for functional performance testing.

• Sample Size: Not explicitly stated as a number; referred to as "representative samples/products/items."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Bard or outsourced to labs for specific tests (e.g., biocompatibility to ISO standards). It is retrospective in the sense that the new material's performance is being compared to the established performance of the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable in the context of this 510(k) submission. The "ground truth" for this submission is established through validated laboratory tests and engineering evaluations against existing performance specifications and standards (e.g., ISO, USP, FDA guidelines). There's no clinical "ground truth" established by human experts in the way an AI/ML study would require for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is a scientific and engineering performance study, not a clinical trial requiring expert adjudication of results. Each test (e.g., biocompatibility, friction, durability) has its own pass/fail criteria based on standards and internal specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is relevant for diagnostic devices where human readers interpret results, often comparing AI-assisted vs. unassisted performance. This submission is for a physical medical device (guide wire) and its material change.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, in a conceptual sense. All the testing performed (biocompatibility, chemical analysis, mechanical testing) is "standalone" in that it evaluates the physical properties and safety of the device itself, without human interpretation as part of the performance metric for this type of device. There is no AI algorithm involved.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established Standards: International Standard ISO 10993 for biocompatibility.
• Regulatory Guidelines: FDA-modified testing matrix (G95-1) for biocompatibility.
• Pharmacopeial Standards: USP Physiochemical analysis (replacement material meets USP 604 requirements).
• Internal Product Specifications: Performance specifications (e.g., for coefficient of friction, durability, stiffness, tensile, torque) that are the same as those for the predicate devices.
• Chemical Analysis: FTIR analysis.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML product. The "development" of the new coating process was driven by supplier changes, and the "validation" involves ensuring the finished product performs equivalently.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's performance characteristics (biocompatibility, mechanical properties) was established over time for the predicate devices through robust engineering, testing, and compliance with medical device regulations and standards. The purpose of this submission is to demonstrate that the new process for the coating maintains this existing ground truth.

Ask a specific question about this device