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Phasix ST Mesh with Open Positioning System is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

The open positioning system is intended to facilitate the placement, positioning and fixation of the mesh during open ventral hernia repair.

Phasix™ ST Mesh with Open Positioning System is a sterile, single-use device for prescription use only. It is a bi-layer mesh comprised of Phasix™ ST Mesh (K173143, forms posterior layer) and Phasix™ Mesh (K161424, forms anterior layer) stitched together with a 10 mil P4HB monofilament. The combination of the two distinct layers forms a pocket to accommodate a preinserted removable accessory. The subject device is designed for reinforcement of soft tissue deficiencies during open ventral hernia repair. The subject device and reference device have identical intended use for the mesh i.e. soft tissue repair/ reinforcement.

The removable open positioning system is an accessory with polypropylene (PP) handle attached to a Polytetrafluoroethylene (PTFE) guide. The accessory comes preinserted into the mesh pocket to aid with placement, positioning, and fixation. The center marking on the positioning guide will aid with proper centering and orientation over the defect. The accessory is removed following the initial fixation and then discarded. The intended use of the accessory is similar to the SorbaFlex Memory Technology utilized in the Ventrio™ ST Hernia Patch (K101920).

The provided text is a 510(k) summary for the Phasix ST Mesh with Open Positioning System, a surgical mesh device. The document details the device's characteristics, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:

No specific acceptance criteria table or quantitative performance metrics are explicitly stated in the provided document beyond qualitative "Pass" results for biocompatibility and statements that performance tests "successfully met the established acceptance criteria." The document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices through various tests rather than setting and meeting independent quantitative acceptance criteria for device performance.

However, we can infer the types of acceptance criteria that were likely in place based on the tests conducted and the general regulatory framework for medical devices. The "study" proving the device meets these (largely implied) acceptance criteria refers to the various performance tests and animal studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a specific table of quantitative acceptance criteria with corresponding performance values. Instead, it reports qualitative "Pass" results for biocompatibility and states that "performance test results demonstrate that subject device successfully met the established acceptance criteria."

Here's a conceptual representation based on the tests mentioned:

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

• Biocompatibility Testing: The specific sample sizes for each in vitro biocompatibility test (e.g., number of cells for cytotoxicity, number of animals for systemic toxicity/sensitization) are not explicitly stated in the summary.
• Product (Bench) Testing: The specific sample sizes (n-values) for each mechanical test (e.g., number of meshes tested for tear strength, number of accessories for removal force) are not explicitly stated.
• Animal Studies: The study was "a comprehensive 4 week GLP study in a porcine model." The number of porcine subjects is not specified.
• Data Provenance: All data appears to be prospective testing conducted specifically for this 510(k) submission. The country of origin for the data generation (where the tests were performed) is not specified, but given the submitter (Davol Inc., C. R. Bard, Inc. located in Warwick, RI, USA), it's highly likely the studies were conducted in the USA or by labs compliant with US regulations.

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

• This information is not applicable in the context of this 510(k) summary. The device is a physical surgical mesh, not an AI/software device that requires ground truth derived from expert consensus for image interpretation or diagnosis. The "ground truth" for the performance sections is established through validated laboratory testing methods and histological/mechanical evaluation in the animal study.
• For the "Design Validation Usability Test," it implicitly involves users (likely surgeons or medical professionals) to validate the device's usability, but the number or their qualifications are not specified.

4. Adjudication Method for the Test Set

• This information is not applicable as it typically refers to the process of reconciling disagreements among multiple human readers for diagnostic interpretation (e.g., in AI studies).
• For the bench and animal studies, "adjudication" would involve standard laboratory practices for data collection, analysis, and statistical evaluation, overseen by internal quality systems. The specific mechanisms for resolving data discrepancies, if any, are not detailed.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging AI devices where the performance of human readers with and without AI assistance is evaluated. The Phasix ST Mesh is a physical surgical device, not a diagnostic tool.

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

• No, this is not applicable. The device is a surgical mesh; it does not involve algorithms or AI that would have a standalone performance. Performance is evaluated through bench testing and preclinical animal models.

7. The Type of Ground Truth Used

• Biocompatibility Testing: Ground truth is established by standard, recognized in vitro and in vivo biological assays with predefined endpoints and pass/fail criteria (e.g., cytotoxicity, systemic toxicity, sensitization).
• Product (Bench) Testing: Ground truth is established by engineering specifications, material science principles, and validated test methods to measure physical and mechanical properties. The "acceptance criteria" for these tests would be derived from these engineering specifications and comparison to predicate device characteristics.
• Animal Studies: Ground truth is established by histopathological evaluation, gross anatomical observation (e.g., tissue attachments, mesh contracture), and mechanical testing of tissue samples (e.g., T-peel analysis) by qualified personnel (e.g., pathologists, veterinary specialists), against predefined biological response expectations and comparative analysis with predicate devices.

8. The Sample Size for the Training Set

• Not applicable. The Phasix ST Mesh is not an AI/machine learning device; therefore, there is no "training set." The testing performed is for device validation and verification, not for training a model.

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

• Not applicable. As there is no training set, this question is irrelevant.

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Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness involving soft tissue repair, such as for the repair of hernias.

The Echo 2™ Positioning System is intended to facilitate the delivery and positioning of the mest during laparoscopic hernia repair.

The Phasix™ ST Mesh with Echo 2™ Positioning System is a sterile single use mesh preattached to the Echo 2™ Positioning System. The subject device is a combination of the FDA cleared Phasix™ ST Mesh (K173143) and the Echo 2™ Positioning System that is cleared by the FDA in the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294). The Echo 2™ Positioning System is removed following the mesh placement and fixation. As with the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294), many sizes of the subject device include an introducer tool accessory.

The subject device is intended for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias and will utilize a positioning system to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair.

Procedures involving "laparoscopic hernia repair" also pertain to those which are conducted under laparoscopic visualization through a trocar, such as robotic assisted laparoscopic ventral hernia repair (LVHR).

The Phasix™ ST Mesh in the subject device is a fully resorbable mesh with a resorbable hydrogel coating and is identical to the secondary predicate device, Phasix™ ST Mesh (K173143). It is co-knitted using Poly-4-hydroxybutyrate (P4HB) and Polyglycolic Acid (PGA) fibers to form two sided mesh. The PGA side of the mesh is coated with a bioresorbable, chemically modified sodium hyaluronate (HA), Carboxymethylcellulose (CMC) and Polyethylene Glycol (PEG) based hydrogel. The fascial P4HB side of the mesh allows for a prompt fibroblastic response through its interstices, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral PGA side of the mesh coated with a bioresorbable hydrogel separates the mesh from underlying tissues and organ surfaces to help 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.

Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers is observed in preclinical studies within 12 to 18 months, indicating loss in mechanical integrity and strength of the mesh. While fiber segments were observed at 18 months, they continued to degrade.

This Phasix™ ST Mesh (K173143) is preattached to the Echo 2™ positioning system on the hydrogel side of the mesh using nylon connectors. The Echo 2™ Positioning System is composed of nitinol wire, encased in a sealed nylon frame. A Polyethylene Terephthalate (PET) center hoisting suture is attached to the nylon frame. The Echo 2™ positioning system utilized in the subject device is identical in materials and construction to the Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294).Once inserted into the abdomen, the positioning system facilitates both deployment and positioning of the mesh. After initial fixation is complete, the Echo 2™ Positioning System is manually detached from the mesh and then removed from the body through a trocar or skin incision.

The provided text describes a 510(k) premarket notification for a medical device called "Phasix™ ST Mesh with Echo 2™ Positioning System." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with strict acceptance criteria and a definitive study to prove the device meets those criteria from scratch.

Therefore, the information you're requesting regarding a detailed breakdown of acceptance criteria met by a specific study is not explicitly provided in the typical format of a clinical trial or performance study report. Instead, the document discusses performance data in the context of demonstrating similarity and equivalence to predicate devices.

Here's an attempt to answer your questions based on the available information, with explanations for what is not present:

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

The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that "All the samples of the subject device successfully met the established acceptance criteria and performed as intended and similar to the predicate devices" for the product testing specified.

The types of tests performed and their general outcomes are summarized below:

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

• Sample Sizes: The document does not specify the exact sample sizes (e.g., number of meshes, animals, or test replicates) used for each individual test or evaluation. It broadly refers to "all the samples of the subject device."
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the focus on bench and animal testing, these are typically prospective laboratory or animal studies, not human clinical trials with geographical 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)

This is not applicable to the type of tests described. The evaluations are primarily engineering, chemical, and biological performance tests (biocompatibility, mechanical, simulated use, animal model performance), not diagnostic or interpretative tasks requiring human expert "ground truth" in the way a medical imaging AI would. The "ground truth" for these tests is based on objective measurements and predefined specifications / predicate device performance.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews of complex data (e.g., medical image interpretation) where there might be disagreement among reviewers. The tests described are laboratory and animal-based, with results determined by objective measurements and passing/failing criteria without such an adjudication process.

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. An MRMC study is designed to evaluate the performance of diagnostic devices, often medical imaging AI, and how it impacts expert human reader performance. The Phasix™ ST Mesh with Echo 2™ Positioning System is a surgical mesh with an associated positioning system, not a diagnostic device or AI software. There is no AI component in this device, nor is it intended for interpretation by human readers.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device (mesh and positioning system) used by a surgeon.

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

The "ground truth" for the tests performed can be characterized as follows:

• Biocompatibility: Established scientific standards (ISO 10993-1) and objective laboratory measurements for cytotoxicity, pyrogenicity, and chemical characterization.
• Mechanical Testing: Objective measurements against predefined engineering specifications and performance profiles of the predicate devices.
• Simulated Use Evaluations (Bench Top Simulator) & Performance Testing (Porcine Model): Observation and objective assessment of the device's functional performance (delivery, support, access/fixation, removal) against expected results and the demonstrated performance of predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. All the data described relates to verification and validation testing of the physical medical device.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the described device.

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The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias, including hiatal hernias.

The Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help 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 provided text describes a 510(k) premarket notification for the "Phasix ST Mesh," a surgical mesh. The document details the device's description, indications for use, technological comparison to predicate devices, and performance data from various studies.

Here's an analysis of the requested information based on the provided text, categorized by the questions asked:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with specific thresholds. Instead, the performance data is presented as a demonstration that the device's characteristics are "comparable" to a predicate device or that differences "do not adversely affect safety and performance."

Therefore, I will interpret "acceptance criteria" as implied benchmarks for comparability to the predicate devices and summarize the reported performance in relation to these comparisons.

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 refers to two retrospective clinical studies. Combining them gives a total number of patients whose data was reviewed.

• Sample Size for the Test Set (Clinical Studies):
  • Study 1: 50 patients
  • Study 2: 180 patients
  • Total: 230 patients
• Data Provenance:
  • Both studies are explicitly stated as retrospective reviews.
  • Both studies were conducted at a single institution. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S. company (Davol Inc., Warwick, RI), making it highly probable the studies were conducted in the United States.

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)

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study data (e.g., for diagnosing recurrences or assessing complications). For retrospective reviews, the data is typically pulled from existing medical records, where diagnoses and assessments would have been made by the treating clinicians. The study design does not specify a separate "ground truth" adjudication panel.

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

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the clinical study data. As indicated in point 3, the studies are retrospective reviews, implying that the outcomes (recurrences, complications) were determined based on existing clinical records by the treating physicians or the physicians performing the follow-up procedures (EGD, UGI, BS).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

The Phasix ST Mesh is a physical surgical implant, not an AI software/device that assists human readers/clinicians in interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device.

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

No, a standalone (algorithm-only) performance study was not done, as the device is a physical surgical mesh and not an algorithm or AI software.

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

For the clinical studies, the "ground truth" for assessing device safety and performance appears to be based on:

• Clinical outcomes data: This includes objective follow-up data (Esophagogastroduodenoscopy (EGD), Upper Gastrointestinal (UGI) series, Barium Swallow (BS)) and non-objective follow-up (unspecified clinical assessments).
• Medical records: The retrospective nature of the studies means that existing medical records were reviewed for reported complications, recurrences, and successful repairs.

For the animal studies, the "ground truth" involved histological and mechanical assessments conducted by researchers to characterize mechanical strength, tissue response, and resorption profile.

8. The sample size for the training set

This question is not applicable in the context of this device submission. The Phasix ST Mesh is a physical medical device (surgical mesh), not an AI algorithm or a device that requires a "training set" in the machine learning sense. The performance data consists of biocompatibility testing, animal studies, bench testing, and retrospective clinical reviews, none of which utilize a "training set."

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

As in point 8, this question is not applicable because there is no "training set" for this physical medical device.

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The Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias.

The proposed Phasix™ ST Mesh is a fully resorbable mesh with a resorbable hydrogel coating. It is a sterile mesh prosthesis designed for the reinforcement and reconstruction of soft tissue deficiencies. Phasix ™ ST Mesh is co-knitted using poly-4-hydroxybuterate (P4HB) and polyglycolic acid (PGA) fibers. P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and then knitted into a surgical mesh. P4HB degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to reinforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected healing period. Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal throughout the 12 week expected healing period and up to 26 weeks post implantation. Significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months indicates loss in mechanical integrity and strength. While fiber segments were observed at 18 months, they continued to degrade. Phasix ™ ST Mesh is coated on the PGA surface with a resorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The visceral side of the mesh is a resorbable hydrogel coating, separating the mesh from underlying tissues and organ surfaces to help 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.

This document is a 510(k) premarket notification for the Phasix™ ST Mesh, a surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies. Therefore, the information typically requested in your prompt (acceptance criteria, specific study designs, sample sizes for training/test sets, ground truth establishment for AI/algorithm-based devices, MRMC studies, etc.) is not present in this document, as it pertains more to software or diagnostic device submissions.

However, I can extract the information provided regarding performance data relevant to establishing substantial equivalence.

Here's a summary of the performance data reported:

1. A table of acceptance criteria and the reported device performance
   - This document does not provide a table of acceptance criteria with specific numerical targets and reported performance values. Instead, it lists the types of tests performed to demonstrate substantial equivalence, implying that the results of these tests were deemed acceptable by the FDA for the purpose of 510(k) clearance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   - Not applicable. This document describes pre-clinical (biocompatibility, bench, and animal) studies, not human clinical trials. Sample sizes for these studies are not specified in this summary. Data provenance (country of origin, retrospective/prospective) is not detailed.

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 applicable. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms. This document concerns a surgical mesh.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   - Not applicable. Adjudication methods are relevant for studies involving human interpretation, often in diagnostic contexts.

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. MRMC studies are used for evaluating diagnostic performance, particularly of AI-assisted systems.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   - Not applicable. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   - Not applicable in the context of an AI/diagnostic device. For the animal studies, the "ground truth" would be established by direct observation and analysis of the implanted mesh and surrounding tissues, likely involving histology/pathology conducted by veterinarians and researchers.

8. The sample size for the training set
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

9. How the ground truth for the training set was established
   - Not applicable. This device is a physical surgical mesh, not an algorithm that requires a training set.

Summary of Performance Data (as provided in the document for K143380):

The performance data provided supports the substantial equivalence determination for the Phasix™ ST Mesh. The general approach was to compare the new device to existing predicate devices (TephaFLEX® Mesh and Ventralight™ ST Mesh) that are already legally marketed.

• Genotoxicity
• Sensitization
• Intracutaneous Reactivity
• Local and Systemic Toxicity (4 and 13 week)
• Local Toxicity (4, 8, 13, and 20 week)
• Systemic Toxicity (Acute)
• Pyrogenicity | Demonstrated that the materials (P4HB, PGA, hydrogel coating) are biocompatible, addressing risks associated with component interactions, in accordance with FDA guidance (Blue Book Memorandum #G95-1 and ISO-10993). Implies results met acceptance criteria for biocompatibility. |
  | Electrical Safety / EMC | None required | Not applicable as the device has no electrical or metal components. |
  | Software V&V Testing | None required | Not applicable as the device does not contain software. |
  | Bench Testing | - Mesh weave characteristics
• Device stiffness
• Mesh pore size
• Burst strength
• Mesh density
• Tear resistance
• Mesh thickness
• Suture pullout strength
• In vitro degradation study | Performed to compare the proposed Phasix™ ST Mesh to the predicate TephaFlex® Mesh and Ventralight™ ST Mesh.
  The in-vitro degradation study demonstrated that PGA fibers and hydrogel coating do not impact the resorption profile of the P4HB mesh.
  Implies results demonstrate substantial equivalence for physical and performance characteristics per FDA guidance for surgical mesh. |
  | Animal Studies | In vivo porcine studies at 4, 12, and 24 weeks | Characterized mechanical strength, tissue response, and resorption profile in comparison to predicate devices. The implication is that these studies showed comparable performance to the predicates. |
  | Clinical Study | None required | No clinical study was required to support the 510(k) clearance for Phasix™ ST Mesh, indicating that the preclinical data (biocompatibility, bench, and animal studies) were sufficient to establish substantial equivalence. |

Conclusion:

The document states that "All test results provided in this submission demonstrate that the proposed Phasix™ ST Mesh is substantially equivalent to the cited TephaFlex® Mesh and Ventralight™ ST Mesh predicates." This means the conducted tests (biocompatibility, bench, and animal studies) produced results that satisfied the FDA's requirements for demonstrating that the device is as safe and effective as the predicate devices, despite minor technological differences.

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