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Advantage Ultra System and Advantage Fit Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures.

Lynx Ultra System

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Advantage Ultra System and Advantage Fit Ultra System

The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device.

The Advantage Ultra System and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size.

Lynx Ultra System

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device.

This document is a 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, surgical mesh devices for treating female stress urinary incontinence. The core of this submission is to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K211223). The primary change in these new submissions is related to procedural steps in the electronic Instructions for Use (eIFU), specifically regarding the release and removal of disposable components of the mesh assembly.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on ensuring that the changes (eIFU modifications) do not negatively impact safety or effectiveness, and that the device remains substantially equivalent to its predicate. There isn't a traditional performance study proving clinical efficacy against a disease endpoint, as this is a 510(k) submission for substantial equivalence.

Here's an interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance (in the context of a 510(k) for eIFU changes)

Since the document explicitly states "there are no changes to the intended use or indications for use, design, materials, sterilization, technological and performance characteristics, or principle of operation," the acceptance criteria are implicitly tied to demonstrating that the eIFU modifications do not introduce new safety or effectiveness concerns and allow the device to function as intended.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The studies performed are "Performance bench testing" in the form of "Design Validation" and a "Summative Usability Evaluation."

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

   • Test Set Sample Size: The document does not specify the exact number of participants (users) or instances for the "Design Validation" and "Summative Usability Evaluation." It refers generally to "performance bench testing."
   • Data Provenance: Not specified, but "bench testing" typically implies laboratory or simulated environments, not patient data.

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

   • Not applicable in the sense of clinical "ground truth" (e.g., pathology, outcomes). The "ground truth" here is the successful and safe use of the device according to the eIFU. The design validation and usability studies themselves aim to verify this by testing user interaction and performance. The document does not specify the number or qualifications of evaluators/experts involved in conducting or assessing these bench tests.

3. Adjudication method for the test set:

   • Not explicitly stated. For bench testing and usability studies, adjudication might involve expert review of test results, error analysis, and user feedback, but no specific method like "2+1" or "3+1" is mentioned.

4. 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/imaging device. The study type is bench testing and usability evaluation for a surgical mesh delivery system with modified instructions for use.

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

   • Not applicable. This is a medical device (surgical mesh and delivery system), not an algorithm.

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

   • The "ground truth" for this submission's studies is the successful and safe operation of the device according to the updated eIFUs. This is assessed via controlled testing environments (bench testing) and usability studies, rather than clinical endpoints, pathology, or outcomes data, as this 510(k) specifically addresses changes to the instructions for use, not the fundamental device design or clinical performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable (as above).

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The ArcSP Suprapubic Sling System is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcSP Suprapubic Sling System consists of the following:

• 1 ArcSP Sling with bio-resorbable Suture with plastic sheath
• 2 ArcSP Handle and Needle Delivery Assemblies.
  The Handle and Needle delivery assembly is a sterile, single-use system, consisting of a two curved, stainless-steel Needles with attached Handles. The conical tip of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted.
  The ArcSP Sling assembly is identical to the predicate. ArcTV Sling assembly and includes one knitted polypropylene mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ArcSP Suprapubic Sling System:

Device: ArcSP Suprapubic Sling System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that "The ArcSP meets all its physical and performance specifications." The performance data is presented as a list of tests performed. Without the specific quantitative requirements for each test, a precise comparison table cannot be created from the provided text.

Here's a table based on the types of performance specifications listed:

Note: The document states that for "Fatigue", "Tensile", "Packaging Testing", and "Biocompatibility", "No testing was repeated for this submission since the Sling implant assembly and packaging are identical to the predicate, ArcTV." This implies that the acceptance criteria for these aspects were met by the predicate device and are assumed to be met by the subject device due to identical components.

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

The document does not explicitly state the sample size used for the test set for the "Needle Functional Testing," "Usability Testing," or "Distribution Testing."

For the Sling implant assembly (including Fatigue, Tensile, Packaging, and Biocompatibility), the data provenance is by reference to the predicate device, ArcTV Transvaginal Sling System (K183134). The original sample sizes and provenance for these tests on the predicate device are not detailed in this document.

The studies mentioned are likely prospective studies, as they involve testing the device to ensure it meets specifications. However, the specific details of the study design (e.g., number of units tested per batch or simulation scenario) are not provided.

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 document. For a medical device like a surgical sling, "ground truth" establishment in terms of expert consensus would typically relate to clinical efficacy or surgical usability. The listed tests are primarily engineering and mechanical performance tests, for which "ground truth" is typically defined by engineering standards and specifications rather than expert consensus in the traditional sense of clinical imaging or diagnostic AI. Usability testing, however, would typically involve healthcare professionals, but their number and qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document. The tests described (dimensional, functional, fatigue, tensile, packaging, distribution, biocompatibility, usability) are typically evaluated against predefined specifications. Adjudication methods like "2+1" or "3+1" are usually applied to subjective assessments, such as those in clinical trials or image interpretation, where multiple reviewers' opinions need to be reconciled. For the engineering tests mentioned, the results are typically quantitative and objective, meaning an adjudication method is less applicable. For usability testing, if subjective feedback was collected, the adjudication method is not specified.

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 comparative effectiveness study was done or is applicable here. This type of study is specifically relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The ArcSP Suprapubic Sling System is a surgical implantable device, not a diagnostic imaging or AI-driven diagnostic tool.

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

No standalone algorithm performance study was done or is applicable here. As above, this device is a physical surgical implant, not an AI algorithm.

7. The type of ground truth used

For most of the performance tests (Dimensional, Needle Functional, Sling Functional, Fatigue, Tensile, Packaging, Distribution):

• The "ground truth" is established by predefined engineering specifications and standards. These are objective, measurable criteria that the device must meet.

For "Biocompatibility":

• The "ground truth" is established by ISO 10993-1:2009, Biological evaluation of medical devices requirements. This refers to international standards for assessing the biological compatibility of medical devices with the human body.

For "Usability Testing":

• While not explicitly stated, the "ground truth" for usability testing would typically be based on observational data, user feedback, and adherence to established usability engineering principles and task completion rates/error rates.

8. The sample size for the training set

This information is not applicable as the ArcSP Suprapubic Sling System is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as the ArcSP Suprapubic Sling System does not involve a "training set" for an AI model.

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The polypropylene sling is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTO Transobturator Sling System consists of the following:

• 1 ArcTO Sling with bio-resorbable Suture and plastic sheath .
• 2 ArcTO Handle and Needle Delivery Assemblies .
  The Handle and Needle delivery assembly is a sterile, single-use system, consisting of two helical, stainless-steel Needles with attached Handles. The tip portion of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted.
  The ArcTO Sling assembly is identical to the predicate, ArcTV Sling assembly and includes one knitted polypropylene mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

The provided text describes a medical device, the "ArcTO Transobturator Sling System," and its submission for FDA clearance. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on physical and performance specifications of the device components, rather than clinical efficacy studies with human subjects that would typically involve acceptance criteria for a diagnostic or AI-assisted device.

Here's a breakdown of the specific points you requested, based on the provided text:

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

This information is not provided in the document. The document lists "performance data" as:

• Dimensional
• Needle Functional Testing
• Sling Functional Testing
• Fatigue
• Tensile
• Packaging Testing
• Usability Testing
• Distribution Testing
• Biocompatibility

It states, "The ArcTO meets all its physical and performance specifications." However, it does not specify what those specifications (acceptance criteria) are or provide numerical results of the testing. For example, it doesn't state "Tensile strength must be >X Newtons; device achieved Y Newtons."

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 provided as there is no clinical study described in the document. The "testing" mentioned refers to engineering and material characterization, not patient data sets.

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 provided as there is no clinical study described that would require expert-established ground truth.

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

This information is not provided as there is no clinical study described that would involve adjudication.

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 provided. This device is a surgical mesh, not a diagnostic or AI-assisted device, so an MRMC study is not applicable.

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

This information is not provided. This device is a surgical mesh; it does not have an algorithm component.

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

This information is not provided as there is no clinical study described that would require ground truth. The "ground truth" for the engineering performance tests would be the established engineering standards and specifications for the materials and components, but these specific standards are not detailed.

8. The sample size for the training set

This information is not provided. There is no training set mentioned as this is not an AI/ML device.

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

This information is not provided. There is no training set mentioned.

In summary, the provided document focuses on the mechanical and material properties of the device components and its substantial equivalence to a predicate device for FDA clearance. It does not contain information related to clinical performance, diagnostic accuracy, or AI model validation, which are typically associated with the type of acceptance criteria and study details you've requested.

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Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting.

Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.

The provided text describes a 510(k) premarket notification for a medical device called the Desara TV EZ and Desara Blue TV EZ Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

As such, the document details bench testing and validation of the device's physical and performance characteristics, biocompatibility, shelf life, packaging, and sterilization, primarily to show that the new device performs equivalently to the predicate devices. It does not present a study proving the device meets specific acceptance criteria related to a human subject study, nor does it involve AI assistance or human reader performance evaluation.

Therefore, I cannot extract the information required for the requested table and study details. The document does not contain any data on:

• Device performance in a clinical setting (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test sets in human studies.
• Data provenance (retrospective/prospective, country of origin) related to clinical outcomes.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance or human-in-the-loop studies.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document primarily focuses on demonstrating equivalence through non-clinical testing.

Here's what can be extracted regarding acceptance criteria and performance, but it pertains to the device's material and mechanical properties, not clinical outcomes:

1. Table of Acceptance Criteria and Reported Device Performance (for non-clinical characteristics):

The document states that the testing "met all pre-defined acceptance criteria and regulatory requirements" but does not numerically list the specific acceptance criteria or the measured performance values for each characteristic. It only lists the types of tests conducted.

The study described here is purely for regulatory clearance based on substantial equivalence to predicate devices, focusing on engineering and material performance, not clinical efficacy or AI performance.

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The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Advantage Fit Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement.

The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

The provided text describes the 510(k) summary for the Advantage™ Ultra System, Advantage Fit™ Ultra System, and Lynx™ Ultra System, which are surgical meshes for treating female stress urinary incontinence. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the information required for "a table of acceptance criteria and the reported device performance" and the details of a study proving those criteria are not explicitly present in the provided text in the way one might expect for a typical performance validation study with specific metrics like sensitivity, specificity, or accuracy for an AI/CADe device.

However, based on the provided text, the closest interpretations for acceptance criteria and the "study" demonstrating their fulfillment are related to performance testing to ensure the device functions as intended and meets specifications compared to its predicates.

Here's an analysis based on the available information:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum tensile strength value) explicitly alongside reported performance results. Instead, it broadly states that performance testing was conducted, and the results "demonstrate that the proposed products function as intended and meet specification requirements."

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 for the performance tests (dimensional, tensile, functional, user evaluations, packaging, sterility, biocompatibility). It also does not mention the data provenance in terms of country of origin or whether a retrospective or prospective study was conducted for establishing clinical performance (as this submission is focused on substantial equivalence based on materials and design, not clinical outcomes from a trial). The "samples" referred to are likely physical devices or components of the device itself (non-aged and accelerated aged for shelf life testing).

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 applicable and not provided in the document. The performance tests described (dimensional, tensile, functional, biocompatibility, sterility) are technical evaluations of the device's physical properties and safety, not assessments requiring expert "ground truth" in a clinical diagnostic sense. "User evaluations" are mentioned, which would involve experts (e.g., surgeons or medical professionals) interacting with the device, but the number and qualifications are not detailed.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to establish ground truth or handle discrepancies, neither of which is described as part of the performance testing for this surgical mesh.

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 as the device is a surgical mesh, not an AI/CADe system for diagnostic imaging interpretation. Therefore, no MRMC study or AI-related effectiveness details are provided.

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

This is not applicable as the device is a surgical mesh, not an algorithm.

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

For the performance testing, the "ground truth" would be the established engineering specifications, material standards (e.g., ISO 10993-1:2018 for biocompatibility), and regulatory requirements for sterility and packaging integrity. These are objective measures and standards rather than clinical "ground truth" derived from patient data or expert consensus on a diagnosis.

8. The sample size for the training set

This is not applicable as the device is a physical surgical mesh, not an AI model requiring 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, not an AI model.

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The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Athena Surgical RMUS System consists of a sterile, single-use Retropubic Mid-Urethral Sling (RMUS) Implant Assembly and a non-sterile, reusable RMUS Handle Assembly. Each RMUS Implant Assembly contains one blue polypropylene mesh sling implant (1.1cm x 46cm), covered by a non-implantable clear plastic sheath and attached on each end to nonimplantable stainless steel needles. The mesh implant is constructed of knitted filaments of extruded polypropylene strands and is approximately 0.63mm thick. The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.

This FDA 510(k) summary is for a medical device called the Athena Surgical RMUS System, a pubourethral sling for treating female stress urinary incontinence.

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

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving individual clinical effectiveness based on a completely novel set of performance criteria. Therefore, many of the typical "acceptance criteria" for clinical efficacy studies (like sensitivity, specificity, accuracy) are not explicitly defined or measured in this type of submission. Instead, the "acceptance criteria" are primarily related to comparison with the predicate device and the results of non-clinical (bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, for a 510(k) submission, explicit "acceptance criteria" of the type one would see in a clinical trial for a new drug or novel device (e.g., "sensitivity must be >90%") are not typically provided. Instead, the criteria relate to demonstrating similarity to a predicate device and meeting relevant safety and performance standards through non-clinical testing.

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

• Sample Size: Not applicable in the context of this 510(k) summary. No clinical test set (i.e., patient data) was used for evaluation. The safety and effectiveness were demonstrated through non-clinical (bench) testing and comparison to a predicate device.
• Data Provenance: Not applicable. The "study" for this submission was primarily non-clinical bench testing.

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

• Not applicable. There was no clinical test set requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The focus was on non-clinical testing and comparison to a predicate device.

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

• Not applicable. This device is a physical surgical implant and its associated delivery system, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" was established by engineering and biological standards and specifications. For instance, the ground truth for mechanical properties would be defined by established ASTM or ISO test methods and acceptance limits (e.g., "ultimate tensile strength must be X MPa"), and for biocompatibility, it would be the absence of toxic reactions as determined by ISO 10993 standards.
• For the overall submission, the "ground truth" for "acceptability" is the demonstration of substantial equivalence to a legally marketed predicate device (Ethicon GYNECARE TVT EXACT™), meaning it shares the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. No training set was used.

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The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.

The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).

The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.

The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.

The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument.

GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector.

GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle).

GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

The provided document is a 510(k) summary for the GYNECARE TVT™ System and related devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and efficacy through new clinical studies against specific acceptance criteria.

Therefore, the document does not contain information about:

• Clearly defined acceptance criteria for device performance.
• A standalone study proving the device meets specific acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for test and training sets.

Instead, the document states:

• Substantial Equivalence: The primary assertion is that "the subject devices are substantially equivalent to their respective predicate devices."
• Technological Characteristics: "The subject devices and their respective predicate devices are identical and therefore have the same technological characteristics."
• Differences from Predicates: The only stated differences are in "labeling (Instructions for Use)" which have been "revised to meet the new European Union (EU) Medical Device Regulation (MDR) requirements" and include additional information such as warnings, adverse events, safety information, and information for patients. Minor clarifications to "Indications and Contraindications statements" were also made.
• Performance Data: "No performance data are needed to evaluate these labeling changes." This explicitly states that no new performance studies were conducted or required for this particular submission.

In summary, there is no study described in this document that proves acceptance criteria because the submission's purpose is to demonstrate substantial equivalence based on identical technological characteristics and updated labeling, not new performance data.

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The ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a midurethral sling for the treatment of adult female stress urinary inconting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two delivery Needles and a Sling assembly. The tip portion of each delivery Needle is configured to allow for passage through tissue. The opposite end of the Needle is configured to connect with the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric Mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling. The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

The provided document is a 510(k) summary for the ArcTV Transvaginal Sling System. This document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT contain detailed information about acceptance criteria for a "device" in the context of an AI/ML algorithm or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this document is for a physical medical device (a surgical mesh system) and not an AI/ML powered device.

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Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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The provided text is a 510(k) premarket notification letter from the FDA regarding surgical mesh products (Desara TV and Desara Blue TV). It discusses regulatory aspects, general controls, and indications for use.

However, the document DOES NOT contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory approval letter and does not delve into the technical validation of the device's performance.

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Desara® Blue OV and Desara® Blue SS devices are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Desara® Blue OV and Desara® Blue SS devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device. Desara® Blue OV and Desara® Blue SS are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.

Desara® Blue OV incorporates an overlapping sleeve design as an alternative to the centerline sleeve gap utilized in the predicate devices, Desara® and Desara® Blue, K132069. Desara® Blue SS incorporates a shorter suture length than that of the predicate devices. Desara® and Desara Blue, K132069.

The provided text is a 510(k) summary for medical devices, specifically surgical mesh for stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical efficacy studies involving AI. As such, the information required for a detailed AI device study (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies) is not present.

However, I can extract the acceptance criteria and performance data for the mechanical and bench tests that were conducted to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not specify exact sample sizes for the "test set" in terms of number of devices or data points for each characteristic. The testing was described as "mechanical bench and validation testing," implying laboratory-based data, not patient data. The provenance is internal to Caldera Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The "ground truth" for these engineering and material characteristic tests would be the measured values themselves, compared against the predicate device's established values or industry standards. There were no human experts establishing a subjective ground truth for diagnostic accuracy.

4. Adjudication Method:

Not applicable. This type of testing does not involve adjudication of expert opinions.

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

No. This document describes a traditional 510(k) submission for a physical medical device, not an AI or imaging-based diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone (Algorithm Only) Performance:

No. This is not an AI algorithm. The performance evaluation is for a physical medical device.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation of the Desara® Blue OV and Desara® Blue SS devices was based on measured material and mechanical properties compared against those of the legally marketed predicate device, Desara® Blue (#K132069), and reference devices (Ascend® Blue, #K101462, and Desara® Mesh, #K112609). This falls under direct physical measurement and comparison to established product specifications.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI device, there is no "training set."

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

Not applicable. There is no training set for an AI model.

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