Search Results
Found 3 results
510(k) Data Aggregation
(463 days)
TYRX PHARMA, INC.
AIGISRx is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRX contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in-vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.
AIGISRX is a dual component (resorbable and non-resorbable), sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. AIGISRX is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer. AIGISRX bioresorbable polymer coating contains the antimicrobial agents, rifampin and minocycline in concentrations of 86 ug/cm2.
Here's an analysis of the provided text regarding the AIGISRX™ Anti-bacterial Envelope, focusing on acceptance criteria and the supporting study information:
It's important to note that the provided text is a 510(k) summary and not a comprehensive study report. Therefore, some information, particularly detailed methodological aspects typically found in full study publications, is either summarized or not explicitly stated.
Acceptance Criteria and Device Performance for AIGISRX™ Anti-bacterial Envelope
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list formal "acceptance criteria" in the manner of specific pre-defined thresholds for performance metrics (e.g., "sensitivity must be > 90%"). Instead, the document outlines the device's intended functions and then presents performance data demonstrating that these functions are met, thereby supporting its substantial equivalence to predicate devices.
Here's an interpretation of the implicit "acceptance criteria" based on the device's intended use and the reported performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Stability: Securely hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. | "AIGISRX is a dual component (resorbable and non-resorbable), sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body." The permanent polypropylene mesh is "incorporated into the tissue," implying long-term mechanical stability after the resorbable coating is gone. |
| Antimicrobial Agent Delivery: Release antimicrobial agents (rifampin and minocycline) for a sufficient duration to reduce infection risk. | "AIGISRX releases the antimicrobial agents, rifampin and minocycline for a minimum of 7 days to reduce the risk of infection of the implanted pulse generator following surgery." |
| Antimicrobial Efficacy (In Vitro): Demonstrate antimicrobial activity against relevant bacterial strains. | "In in vitro studies, AIGISRX demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes and Proteus mirabilis." (Note: A caveat is mentioned: "the in vitro and in vivo activity of the AIGISR antimicrobials is variable against non-epidermidis strains of coagulase-negative staphylococci.") |
| Antimicrobial Efficacy (In Vivo): Reduce infections in an in-vivo model of bacterial challenge following surgical implantation of the generator or defibrillator. | "AIGISRX™ also demonstrated in vivo effectiveness in reducing infections in a series of studies in which a pulse generator canister placed into a AIGISRX™ pouch and generator canister alone (Control) were implanted into appropriate models of infectivity (dogs or rabbits)." "The bacteria tested included Staph aureus, Staph epidermidis, Acinetobacter baumanii, and E coli which represent a majority of the infections reported in pacemaker-related endocarditis." (Note: The same caveat regarding non-epidermidis strains applies here as well regarding variability.) |
| Bioresorption: The resorbable component functions as a carrier for antimicrobial agents and resorbs within a reasonable timeframe, leaving the permanent mesh. | "The purpose of the resorbable coating is to act as a carrier for the antimicrobial agents. Once placed, the polymer resorbs in approximately 140 days leaving a light-weight permanent mesh incorporated into the tissue." |
| Biocompatibility/Safety: As implied by its 510(k) clearance and classification as "Polymeric Surgical Mesh," the device must be safe for implantation and compatible with the body, similar to predicate devices. (No specific safety data is detailed in this summary). | The device's clearance and classification indicate that it meets the general safety requirements for its type, and no adverse events or safety concerns are highlighted in the summary as a basis for rejection. |
2. Sample size used for the test set and the data provenance
- Test Set Description: The "test set" for the in vivo efficacy was described as "a series of studies in which a pulse generator canister placed into a AIGISRX™ pouch and generator canister alone (Control) were implanted into appropriate models of infectivity (dogs or rabbits)."
- Sample Size: The exact number of animals (dogs or rabbits) used in these in vivo studies is not specified in the provided text.
- Data Provenance: The in vivo data was obtained from animal models (dogs or rabbits). The country of origin is not specified. The studies appear to be prospective experimental studies designed to test the device's efficacy. The in vitro studies were laboratory-based experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the context of this device and studies. The studies described are in vitro antimicrobial tests and in vivo animal infection models. "Ground truth" in these cases would be established by direct observation of microbial growth (in vitro) or clinical signs of infection, bacterial cultures, and potentially histological analysis (in vivo animal models), rather than expert reader interpretations of medical images.
4. Adjudication method for the test set
This information is not applicable and not provided. Given the nature of microbiology and animal model studies, adjudication methods (like 2+1 or 3+1 consensus) are typically used for human retrospective image analysis or clinical endpoint determination from human trials, not for direct laboratory or animal observations.
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 information is not applicable. The AIGISRX™ Anti-bacterial Envelope is a physical medical device (an implantable envelope with antimicrobial agents), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used
- In Vitro Studies: The ground truth for antimicrobial activity was established by direct observation of microbial growth or inhibition in laboratory settings using various bacterial strains.
- In Vivo Studies (Animal Models): The ground truth for infection presence/absence was established by direct evidence of infection in the animal models. This likely involved:
- Bacterial inoculation: Directly infecting the implanted control and device groups.
- Clinical observation: Monitoring animals for signs of infection.
- Microbial culture: Culturing implant sites or tissues from the animals to validate the presence and identify the bacteria causing infection.
- The statement "observed for a minimum of 7 days to validate the presence of infection in the animals" suggests a direct endpoint.
8. The sample size for the training set
This information is not applicable in the context of this device. A "training set" typically refers to data used to train a machine learning algorithm. Since this is a physical medical device, there is no algorithm to train. The preclinical in vitro and in vivo studies are direct performance evaluations, not training phases for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the sense of data used for machine learning.
Ask a specific question about this device
(196 days)
TYRX PHARMA INC
PivitAB™ is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue.
The provided text describes a 510(k) premarket notification for the PivitAB™ surgical mesh. This document focuses on demonstrating the substantial equivalence of the PivitAB™ to legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a study designed to meet those criteria.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) summarizes existing data to show equivalence, rather than detailing a de novo study to establish new performance metrics against pre-defined acceptance criteria.
Here's an attempt to address your request based on the provided text, with explanations for what cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | (Implicitly, comparable to predicate devices and acceptable for human implantation as per FDA guidance for surgical mesh.) | "The PivitAB™ and the polyarylate polymer have been demonstrated to be biocompatible." |
| Tissue Ingrowth | (Implicitly, satisfactory and comparable to commercial surgical mesh, as per FDA guidance for surgical mesh.) | "animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology." |
| Antimicrobial Effectiveness (In Vivo) | (Implicitly, significantly fewer colonized implants compared to a non-antimicrobial control mesh.) | "Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%)." |
| Mechanical Properties / Hernia Repair Performance | (Implicitly, "comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies" as per FDA guidance for surgical mesh.) | "Non-clinical laboratory testing was performed in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies." |
Explanation: The 510(k) submission doesn't explicitly state numerical acceptance criteria in the way a clinical trial protocol would. Instead, it relies on demonstrating comparability to predicate devices and adherence to relevant FDA guidance for surgical mesh. The "reported device performance" is a summary of findings from various non-clinical and animal tests designed to support this comparability and safety.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- For the antimicrobial effectiveness study: The text states "PivitAB™ and a non-antimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 10^5 CFUs of S aureus and implanted into rabbits." While it provides the result (13% vs 43%), it does not specify the number of rabbits or implants used in this study.
- For tissue ingrowth and other non-clinical tests: Not specified.
- Data Provenance: The studies mentioned are referred to as "Non-clinical laboratory testing" and "animal testing."
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: These would typically be prospective studies, especially the animal model for antimicrobial effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the 510(k) summary. "Histopathology" for tissue ingrowth implies expert review by pathologists, but details on their number or qualifications are absent. For the antimicrobial effectiveness, the "ground truth" was the percentage of colonized implants, likely determined through microbiological culture and counting, not expert consensus on an image or clinical observation.
4. Adjudication method for the test set
- This information is not explicitly provided. For the antimicrobial effectiveness study, the method was likely objective measurement (microbial counts), not an adjudication process among human observers.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical imaging) where human readers interpret data. The PivitAB™ is a surgical mesh; its effectiveness is assessed through physical, biological, and antimicrobial performance, not human interpretation of diagnostic output. Therefore, there's no "AI assistance" or "human reader improvement" to measure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. PivitAB™ is a physical surgical implant, not an algorithm. Its performance is inherent to the device itself (materials, design, antimicrobial properties).
7. The type of ground truth used
- For Biocompatibility: Likely based on standardized assays and histopathological examination in animal models, comparing responses to established benign materials.
- For Tissue Ingrowth: "Histopathology" is mentioned, indicating microscopic examination of tissue sections as the ground truth.
- For Antimicrobial Effectiveness: The "ground truth" was the presence and extent of microbial colonization on the implants, quantified through microbiological methods (e.g., CFUs - Colony Forming Units) from the explanted devices. This is an objective, laboratory-derived ground truth.
- For Mechanical Properties: Likely engineering tests and physical measurements according to standards.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device that requires a training set. The data presented are from pre-clinical studies and animal models.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of medical device.
Ask a specific question about this device
(72 days)
TYRX PHARMA INC
Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
This document describes a 510(k) premarket notification for a new surgical mesh and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a diagnostic algorithm or AI device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use.
However, I can extract the relevant information that is available and indicate when specific details are not provided in the document.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria and corresponding performance values for the TyRx Surgical Mesh are not explicitly stated in terms of a table with quantitative metrics. The submission focuses on demonstrating comparability and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated to be biocompatible (TyRx Surgical Mesh and polyarylate polymer) |
| Satisfactory tissue ingrowth | Animal testing demonstrated satisfactory tissue ingrowth compared to control, evidenced by histopathology. |
| Comparability to predicate devices for intended use | Non-clinical laboratory testing performed in accordance with FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrated that the device is comparable to standard surgical mesh devices. |
| Proper handling (stiffness facilitation) | Resorbable coating provides additional stiffness to the mesh to facilitate intraoperative handling during placement. |
| Resorption properties | Polymer resorbs in approximately 90 days. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions "animal testing" and "non-clinical laboratory testing." It does not specify the sample size (number of animals or test replicates) for either of these.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the company is based in Monmouth Junction, NJ, USA, but this doesn't confirm where the testing took place. The testing was "non-clinical laboratory testing" and "animal testing," which are typically considered prospective in nature for evaluating a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "histopathology" for evaluating tissue ingrowth. This implies expert assessment. However, the number of experts and their specific qualifications (e.g., "veterinary pathologist with 10 years of experience") are not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test results.
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
- MRMC Study Done? No. This device is a surgical mesh, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as described (human readers with/without AI assistance) is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance? No. This device is a physical surgical mesh, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal testing evaluating tissue ingrowth, the ground truth was established through histopathology, which typically involves examination and interpretation by a pathologist.
8. The sample size for the training set
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
Ask a specific question about this device
Page 1 of 1