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TYRX Neuro Non-Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body.
TYRX Neuro Non-Absorbable Antibacterial Envelope 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.
TYRX Neuro Non-Absorbable Antibacterial Envelope is intended for single-patient, one-time use only.

TYRX TM Neuro Non-Absorbable Antibacterial Envelope is a dual component (absorbable and non-absorbable) sterile device designed to hold a vagus nerve stimulator (VNS), a deep brain stimulator (DBS), a spinal cord neuromodulator (SCN) or a sacral nerve stimulator (SNS) securely to create a stable environment when implanted in the body. The device is available in 2 sizes, Medium (2.5" x 2.7" ) and Large (2.9" x 3.3"). The device is constructed of knitted filaments of polypropylene (mesh substrate) that are coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocvcline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable pulse generator. This device is to be used in a healthcare facility/hospital by personnel experienced in the implantation of VNS, DBS, SCN, or SNS.

This is a 510(k) premarket notification for a medical device called the "TYRX™ Neuro Non-Absorbable Antibacterial Envelope". The document establishes the device's substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria are primarily related to substantial equivalence to predicate devices, particularly regarding safety and effectiveness, antimicrobial activity, and biocompatibility.

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

• Antimicrobial Activity (In vitro/In vivo efficacy testing): The document references studies from predicate devices (K132699 and K150291). The specific sample sizes for these in vitro and in vivo tests are not provided in this document. The provenance is from previous studies submitted for the predicate devices.
• CNS Effects (Sheep Study): The sample size for the sheep study is not explicitly stated beyond "a study in sheep." The data provenance is a prospective animal study conducted to address specific safety concerns related to minocycline diffusion into the CNS.
• Biocompatibility: The document states that "Biocompatibility testing in accordance to the current ISO 10993 series was conducted." The specific sample size for these tests is not provided. Data provenance is from biocompatibility tests.
• Functionality (IPG Interference): The document states "An in vivo functionality study showed..." The specific sample size for this study is not provided. Data provenance from an in vivo functionality study.

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

This document describes pre-clinical testing and substantial equivalence claims, not clinical efficacy studies with human experts establishing ground truth for diagnostics. Therefore, this information is not applicable in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable as the document describes pre-clinical testing and substantial equivalence, not a clinical study requiring adjudication of expert readings.

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. This document is for a physical medical device (an antibacterial envelope), not an AI/software device, and thus no MRMC study involving human readers and AI assistance was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the device is a physical antibacterial envelope, not an algorithm.

7. The Type of Ground Truth Used:

• Antimicrobial Activity: The ground truth would be established by microbiological laboratory analyses (e.g., inhibition zones in in vitro studies, bacterial counts/infection rates in in vivo animal models) demonstrating effectiveness against specific bacterial strains.
• Biocompatibility: Ground truth is established by conformance to ISO 10993 standards for biological evaluation of medical devices, involving various in vitro and in vivo tests to assess cytotoxicity, sensitization, irritation, etc.
• Safety (CNS Effects): Ground truth was established by analytical chemistry methods (to detect minocycline/rifampin concentrations in plasma and CSF) and clinical observation (for adverse clinical signs) in the sheep model.
• Functionality (IPG Interference): Ground truth would be established by direct measurement of IPG function/parameters in the presence of the device in an in vivo model.

8. The Sample Size for the Training Set:

This information is not applicable. This submission concerns a physical medical device, not a machine learning or AI algorithm that requires a training set. The "studies" mentioned are pre-clinical tests, not training for an algorithm.

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

This information is not applicable as no training set for an algorithm was used.

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TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body.

TYRX Neuro Absorbable Antibacterial Envelope 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.

TYRX Neuro Absorbable Antiqacterial Envelope is intended for single patient, one-time use only.

TYRX 110 Neuro Absorbable Antibacterial Envelope is a fully absorbable, dual component sterile device designed to hold a vagus nerve stimulator (VNS), a deep brain stimulator (DBS), a spinal cord neuromodulator (SCN) or a sacral nerve stimulator (SNS) securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocvcline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device. This device is to be used in a healthcare facility/hospital by qualified personnel experienced in the procedure of VNS, DBS, SCN, or SNS implantation.

This document is a 510(k) summary for the TYRX Neuro Absorbable Antibacterial Envelope. It describes the device and its indications for use, and argues for its substantial equivalence to a predicate device (K142611).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, based on the specific questions:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes various studies and results to demonstrate safety and effectiveness for its expanded indications for use. The overall acceptance criterion is demonstrating substantial equivalence to the predicate device.

Here's a summary of the performance claims based on the provided text, linked to the implicit acceptance criteria for establishing substantial equivalence:

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

• Animal Study (for expanded indications):

  • Sample Size: 8 sheep (2 sheep per treatment group across 4 treatment groups).
  • Data Provenance: Not explicitly stated, but animal studies are typically prospective. No country of origin is mentioned.

• In vitro and In vivo efficacy testing (referenced from predicate K142611):

  • Sample Size: Not specified in this document, as these studies belong to the predicate device.
  • Data Provenance: Not specified.

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 device is a physical medical device (an absorbable antibacterial envelope), not an AI/imaging device requiring expert interpretation for ground truth establishment in the traditional sense. The "ground truth" here relates to objective measures like drug concentrations (in the animal study), microbial inhibition (in vitro), and infection rates (in vivo), or material properties. Therefore, there are no explicitly mentioned "experts" establishing ground truth in the way described for diagnostic AI.

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

Not applicable. As this is not an AI/imaging device with human reader evaluations, there is no adjudication method for a test set of interpretations.

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 a diagnostic AI device, so no MRMC study involving human readers and AI assistance was conducted or described.

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

Not applicable. This is not an algorithm or software device. The product is a physical medical device.

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

• Animal Study: Ground truth was based on objective measurements:
  • Absence of adverse clinical signs (clinical observation).
  • Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid samples (laboratory analysis).
• In vitro studies (referenced from predicate K142611): Ground truth would be based on laboratory methods for demonstrating antimicrobial activity (e.g., zones of inhibition, minimum inhibitory concentrations).
• In vivo studies (referenced from predicate K142611): Ground truth would be based on outcomes data related to infection rates/reduction in animal models.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of AI development. The studies performed are for device safety and efficacy, not for training a model.

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

Not applicable, as there is no training set.

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TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body.

TYRX™ Neuro Absorbable Antibacterial Envelope 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the gluteal region.

TYRX™ Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.

TYRX ™ Neuro Absorbable Antibacterial Envelope is a fully absorbable , dual component sterile device designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device is to be used in a healthcare facility/hospital by personnel experienced in the procedure of vagus nerve or spinal cord neuromodulator implantation.

This document describes a 510(k) premarket notification for the TYRX™ Neuro Absorbable Antibacterial Envelope. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets new acceptance criteria through a dedicated study with specific performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted directly from this document. The document primarily details comparative information with predicate devices and safety testing.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria (e.g., a certain percentage reduction in infection rate, a specific tensile strength at a given time point) that the new device was tested against in its own clinical study. Instead, it relies on demonstrating equivalence to predicate devices, which were previously cleared.

However, it does mention results from in vitro and in vivo studies that support the predicate devices' antimicrobial activity, which is a key performance aspect.

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

• Test Set Sample Size: Not explicitly stated for any new clinical test set for the subject device. The document refers to "in vitro studies" and "in vivo efficacy testing" performed on the predicate devices. The sample sizes for these predicate studies are not provided in this document.
• Data Provenance: The "in vivo efficacy testing" was "previously submitted with the primary predicate, K132699" and "previously submitted with predicate K130943." This implies the data is likely retrospective relative to this 510(k) submission, as it comes from prior submissions. The country of origin is not specified, but given the FDA submission, it would adhere to US regulatory standards.

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

This information is not provided. The document highlights laboratory (in vitro), animal (in vivo), and bench testing, not studies requiring human expert adjudication of clinical outcomes in the same way a diagnostic imaging device might.

4. Adjudication Method for the Test Set

Not applicable for the types of tests described (in vitro, in vivo efficacy in animals, bench testing).

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 device is a medical implant (envelope for neuromodulators) containing antibiotics, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an algorithm. However, the in vitro and in vivo animal efficacy studies can be considered standalone performance assessments of the antimicrobial properties and safety profile.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For antimicrobial activity (in vitro): Direct observation of bacterial inhibition/killing.
• For in vivo efficacy (animal studies): Likely based on direct measurement of infection rates or bacterial counts at the surgical site in animal models, comparing treated groups to control groups. This would be considered "outcomes data" in an animal model.
• For biocompatibility: Standardized toxicological and immunological endpoints as per ISO 10993.
• For degradation and interaction: Bench testing and chemical analysis.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

Not applicable. This device does not involve machine learning or AI that requires a "training set."

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AIGISRx N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator securely in order to create a stable environment when implanted in the body. AIGISRx N 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the qluteal region.

AIGISRs N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator or spinal cord neuromodulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device.

This document describes the AIGISRx N Antibacterial Envelope, a surgical mesh designed to secure nerve stimulators. The submission is a 510(k) for an expanded indication for use to include spinal cord neuromodulators (SCNM).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, focusing on the expanded indication:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The core physical, chemical, and mechanical properties (mesh knit characteristics, suture retention strength, burst strength) are stated to be identical to the predicate device (K131007), implying they meet prior acceptance criteria for those aspects, though specific values are not provided in this document.

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

• Expanded Indication Study for Minocycline/Rifampin Diffusion and CNS Effects:
  • Sample Size: 8 sheep (2 sheep per treatment group across 4 groups).
  • Data Provenance: Prospective, animal (sheep) model data. The country of origin is not specified but it's an in vivo model.

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

• For the expanded indication study (minocycline/rifampin diffusion and safety in SCNM model), the "ground truth" would be the direct measurement of drug concentrations in plasma and CSF, and observation of clinical signs. This does not typically involve human expert adjudication in the same way image analysis or diagnostic studies do.
• The assessment of "absence of adverse clinical signs" would likely be performed by veterinary professionals or study personnel trained in animal welfare and observation. Their specific qualifications are not detailed in the document.

4. Adjudication Method for the Test Set

• For the expanded indication study, an adjudication method (like 2+1, 3+1) is not applicable. The outcome measures (drug concentrations, clinical signs) are objective measurements or direct observations rather than subjective interpretations requiring multiple expert reviewers.

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 typical for diagnostic algorithms (e.g., in radiology) to assess whether AI assistance improves human reader performance. The AIGISRx N is a physical medical device (surgical mesh), not a diagnostic algorithm, so this type of study is not relevant to its evaluation.

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

• Not applicable. The AIGISRx N Antibacterial Envelope is a physical medical device, not an algorithm. Its performance is assessed directly through bench testing and in vivo studies, not as an algorithm's standalone performance.

7. The Type of Ground Truth Used

• For the expanded indication study, the ground truth was based on:
  • Direct Analytical Measurement: Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid (CSF) samples.
  • Direct Observation/Clinical Assessment: Absence of adverse clinical signs in the sheep model.

8. The Sample Size for the Training Set

• Not applicable. As the device is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The studies mentioned (biocompatibility, sterility, functionality, and the sheep model) are performance and safety validation studies.

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

• Not applicable, as there is no training set for this type of device.

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AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N 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 a pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.

AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline.

The provided text describes the AIGISRx® N, a surgical mesh device, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the specific details requested in your prompt related to AI/algorithm performance.

The document is a 510(k) summary for a medical device (surgical mesh), which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It discusses the device's physical, chemical, and mechanical properties, biocompatibility, sterility, and intended use.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance (Table): The document states that the new device has the "same" characteristics as the predicate device (mesh knit, suture retention, tear, burst strength) and that "bench testing shows that gamma sterilization has no detrimental effect." It also mentions "Standard ISO 10993 testing demonstrated the biocompatibility and safety of the device." However, specific numerical acceptance criteria (e.g., minimum burst strength, maximum allowed bacterial growth) and the exact performance results against those criteria are not provided.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for a study): The document refers to an "in vivo functionality study showed that AIGIS devices do not alter or interfere with an implantable pacemaker or defibrillator" and an "in vivo model of bacterial challenge" for the antimicrobial agents. However, these are mentioned broadly to support the device's characteristics or an active ingredient's effect, not as a detailed study report with the specific elements you're asking for (test set size, ground truth establishment, expert involvement, etc.). There is no mention of an algorithm or AI in this document, therefore, details related to AI performance studies are absent.
• Training Set Sample Size & Ground Truth: Since no AI/algorithm study is detailed, there's no information about a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (surgical mesh), not on evaluating the performance of an AI/algorithm. Therefore, the specific details you requested regarding acceptance criteria, study methodologies, and AI performance are not available in this document.

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AIGISRx® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models 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® R is intended for single patient, one-time use only.

AIGISRx® R (AIGIS R) is a fully resorbable, dual component sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED), such as a pacemaker or an implantable cardioverter- defibrillator (ICD), when the electronic device is implanted in the body. AlGIS R is constructed of knitted filaments of a commercially available resorbable polymer, Glycoprene II, comprised of glycolide, caprolactone, trimethylene carbonate polymer, and coated with a bioresorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline in concentrations of 102 ug/cm.2

The AIGISRx® R (AIGIS R) is a medical device designed to securely hold and stabilize cardiovascular electronic implantable devices (CIEDs) like pacemakers or implantable cardioverter-defibrillators (ICDs) when implanted in the body. It is a fully resorbable, dual-component sterile prosthesis containing the antimicrobial agents rifampin and minocycline.

The device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a predicate device, the AIGISRx® (AIGIS) antibacterial envelope (K063091), rather than setting specific performance metrics for sensitivity, specificity, or similar outcome measures typically seen in AI/diagnostic device submissions. The core of the study is to prove that the new device, AIGIS R, performs similarly to the predicate device, despite a change in the surgical mesh substrate from non-resorbable polypropylene to bioresorbable Glycoprene II.

Here's a breakdown of the information based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (a medical device rather than an AI/diagnostic software), the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity. Instead, they focus on equivalence to a predicate device regarding safety and efficacy aspects.

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

The summary does not explicitly state a "test set" in the context of clinical trials with human participant numbers for assessing diagnostic performance. The studies mentioned are primarily in vitro (bench testing) and in vivo (animal models, general biocompatibility, and AME).

• Sample Size: Not specified in terms of human subjects or a defined "test set" for a diagnostic/AI device. The in vivo studies likely refer to animal models, but specific numbers are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal in vivo) conducted by the sponsor (TYRX, Inc., Monmouth Junction, NJ, USA). The studies are retrospective/prospective in the sense that they were conducted to support the 510(k) submission for this new device.

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

This section is not applicable for this type of medical device submission. Ground truth, in the context of diagnostic or AI devices, typically refers to expert interpretation of data or pathological findings. The assessment here is based on physical, chemical, and biological performance characteristics, verified by standard laboratory and in vivo animal testing, rather than human expert interpretation of a "test set" of images or patient data.

4. Adjudication Method for the Test Set

This is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations within diagnostic studies, which is not relevant here.

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

This is not applicable for this type of medical device submission. MRMC studies are used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a physical implantable medical device, not an AI or diagnostic software.

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

This is not applicable for this type of medical device submission. "Standalone performance" refers to the performance of an AI algorithm on its own. The AIGIS R is a physical implantable device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Bench Testing Results: Demonstrating material degradation, chemical structure integrity post-sterilization, and absence of interactions between components.
• ISO Standard Compliance: Adherence to ISO 10993 for biocompatibility and ISO 11137 for sterility.
• In vivo Model Results: Demonstrating antimicrobial effectiveness (AME) in an animal model of bacterial challenge and demonstrating that the device does not interfere with CIED function.

8. The Sample Size for the Training Set

This is not applicable. The AIGIS R is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the computational sense. The "training" or development of the device would involve materials science, engineering, and preclinical testing, not machine learning.

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

This is not applicable as there is no "training set" for an AI algorithm. For the development and testing of the physical device, the "ground truth" (i.e., the desired properties and performance) was established through:

• Regulatory Standards: Compliance with ISO standards for biocompatibility and sterility.
• Predicate Device Performance: Benchmarks set by the established safety and efficacy profile of the AIGISRx® (K063091) predicate device.
• Scientific and Engineering Principles: Underlying principles for material science, chemical stability, and antimicrobial efficacy testing.

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PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. 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.

PIVIT A/BTM ST is intended for single patient one-time use only.

PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference.

PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents, rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.

The provided text describes a 510(k) summary for a medical device called PIVIT A/B ST, which is a polymeric surgical mesh. The document focuses on establishing substantial equivalence to previously cleared predicate devices rather than detailing a specific performance study with acceptance criteria and results.

Therefore, many of the requested sections about acceptance criteria, performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be extracted. The document states "Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656." It does not provide specific acceptance criteria or performance results for PIVIT A/B ST in this document. The basis for clearance is substantial equivalence to predicates, not specific performance metrics.

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

• Cannot be extracted. No new performance study or test set is described for PIVIT A/B ST. The clearance is based on equivalence to predicate devices.

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):

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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:

• Cannot be extracted. This device is a surgical mesh, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable.

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

• Cannot be extracted. This device is a physical surgical mesh, not an algorithm, so this question is not applicable.

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

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

8. The sample size for the training set:

• Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm requiring a training set.

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

• Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm.

Summary of what is known:

• Device Name: PIVIT A/B ST (Polymeric Surgical Mesh)
• Intended Use: As a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue, including hernias and/or body wall defects. The resorbable polymer coating also contains antimicrobial agents (rifampin and minocycline) to help protect from microbial colonization.
• Basis for Clearance: Substantial equivalence to predicate devices (PIVIT A/B (K053656), Strattice (K070560), HydroCoat Mesh (K090271)).
• Performance Data: Provided by reference to the previously cleared PIVIT A/B device (K053656). This summary introduces a line extension for PIVIT A/B ST, stating it is "identical to the PIVIT A/B device cleared via K053656."

In conclusion, this 510(k) summary does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that you are requesting. Its purpose is to demonstrate substantial equivalence to existing devices for a medical device that is a physical implant, not a diagnostic or AI-driven system.

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