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AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The PFR Sling System is a sterile, single use procedure kit that consists of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text describes a 510(k) summary for the "PFR Sling System, Part of the AMS Pelvic Floor Repair System," which is a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a device output.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.

The document states:

• "The components of the PFR Sling System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." (Page 1, under "Summary of Testing")

This indicates that a comparison was made against existing, legally marketed devices. However, the details of what "performance requirements" were and how "substantial equivalence" was demonstrated in terms of specific metrics, acceptance criteria, or a detailed study are not included in this summary.

In summary, the provided document does not contain the information necessary to fulfill the request as it describes a regulatory submission based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and device performance metrics.

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The proposed Pelvic Floor Repair System is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.

The provided text pertains to a 510(k) summary for a medical device called the "Pelvic Floor Repair System" (Tradename: TBD, later identified as Pinnacle Pelvic Repair Kit). A 510(k) submission is a premarket notification demonstrating that a medical device is at least as safe and effective as a legally marketed device (predicate device). This type of submission relies on demonstrating substantial equivalence, not necessarily on new clinical trials or detailed performance study reports with specific acceptance criteria that one would find for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This is because the 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than fulfilling specific performance metrics from a new, independent study with pre-defined acceptance criteria.

The document indicates that substantial equivalence was demonstrated by comparing key characteristics of the proposed device to predicate devices (K071957 and K081048, both also "Pinnacle Pelvic Floor Repair Kit"). It states: "A direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested. The proposed device is as safe, as effective, and performs as well as the predicate device."

Without a new performance study being conducted for this specific 510(k) submission, the requested information (acceptance criteria, sample size, ground truth, MRMC study details, etc.) cannot be extracted from this document. The "performance characteristics tested" mentioned likely refer to bench testing or material characterization to ensure similarity to the predicate, rather than a clinical study with human subjects.

Therefore, I cannot populate the table or answer the specific questions because the detailed information about a study proving the device meets acceptance criteria is not present in this 510(k) summary. The summary focuses on showing equivalence to existing devices.

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AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text is a 510(k) summary statement and related FDA correspondence for a surgical mesh device. The document states that the device components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." However, it does not provide specific quantitative acceptance criteria or a detailed study description that proves the device meets those criteria.

Therefore, the requested information, which typically involves detailed performance metrics, sample sizes, expert involvement, and ground truth establishment, is not present in the provided text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document states "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." It does not provide a table with specific criteria (e.g., tensile strength, pore size, elasticity) or the numerical results from these tests.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing described is for biocompatibility and performance, not involving human interpretation of medical data where experts would establish ground truth.
4. Adjudication method for the test set: Not applicable for the type of testing described (biocompatibility and performance).
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 document is about a surgical mesh, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
7. The type of ground truth used: Not applicable in the context of the described physical device testing. The "ground truth" for material properties would be the established standards or values of the predicate device.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

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The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement.

The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement.

The provided text is a 510(k) summary for the GYNECARE PROLIFT and GYNECARE PROLIFT+M Pelvic Floor Repair Systems. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the typical sense of a novel algorithm or diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be fully extracted from this document in the way it would for a machine learning or diagnostic device.

Here's an attempt to answer based on the available information:

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

The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) with associated thresholds as might be seen for a diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, focusing on material properties and functional testing, aligning with the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

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 mentions "bench and cadaver testing" and "preclinical modelling" for functional performance. It does not provide specific sample sizes for these tests, nor does it detail data provenance (e.g., number of cadavers, specifics of bench tests). This is typical for a 510(k) submission focused on mechanical and material properties rather than clinical performance data from patient populations.

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 hence not provided. The "ground truth" here relates to the material and functional properties meeting engineering specifications and biocompatibility standards, not to interpretations by medical experts as in a diagnostic study.

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

Not applicable. This is not a study requiring expert adjudication of cases.

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 such study was conducted or mentioned, as this is not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

The "ground truth" relates to:

• Biocompatibility: Conformance to ISO 10993-1 standards, which involves various biological tests (e.g., cytotoxicity, sensitization, irritation).
• Functional Performance: Meeting established engineering and functional requirements for surgical mesh, likely based on validated test methods and established in FDA guidance.
• Material Composition: Verification of the chemical and physical properties of the polymers to ensure they are identical or equivalent to those in the predicate devices.

8. The sample size for the training set

Not applicable. There is no machine learning "training set" for this type of device.

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

Not applicable. There is no machine learning "training set" for this type of device.

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The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.

The provided document is a 510(k) premarket notification for the GYNECARE PROSIMA Pelvic Floor Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics for a novel technology like AI/ML.

Therefore, many of the requested categories are not applicable to this kind of regulatory submission. The document explicitly states that the approval is "Based on the similarities to the predicate devices identified in this submission," rather than a study against a pre-defined performance criterion for the new device.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Study Analysis for GYNECARE PROSIMA Pelvic Floor Repair Systems

This 510(k) submission for the GYNECARE PROSIMA Pelvic Floor Repair Systems establishes substantial equivalence to predicate devices, rather than demonstrating performance against pre-defined acceptance criteria for a novel device through a clinical study. The "performance data" section focuses on material biocompatibility and functional bench/cadaver testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Mesh Implant: Made from GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh, identical polymers to current Ethicon product.
• Vaginal Support Device-Balloon Assembly: Provides support to vaginal canal to reduce contracture, stenosis, adhesions; balloon inflated with air (like predicate); made of silicon (like predicate); remains in vaginal canal for up to four weeks (predicate up to twelve weeks).
• Intended Use: For tissue reinforcement and stabilization of fascial structures of the pelvic floor, and maintenance of vaginal canal during healing. |

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

This document does not describe a clinical "test set" with human subjects in the context of an AI/ML algorithm evaluation. The testing mentioned is "bench and cadaver testing." No specific sample sizes for these tests are provided, nor is data provenance in terms of country of origin or retrospective/prospective status for clinical data, as it's not a clinical study.

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

Not applicable. There is no mention of "experts" establishing ground truth for a test set in the context of this 510(k) summary. The evaluation focuses on material properties and functional tests, not diagnostics or interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned as there is no diagnostic test set requiring human consensus for ground truth.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

For the biological reactivity, the "ground truth" (or standard of acceptability) was established by ISO Standard 10993-1. For functional performance, the "ground truth" was whether the device "meets or exceeds all functional requirements," which would be defined by internal engineering specifications or industry standards for mechanical performance. No pathology, outcomes data, or expert consensus serving as ground truth for clinical performance is described.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

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The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

The provided text is a 510(k) summary for the AMS Pelvic Floor Repair System. Unfortunately, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

The "Summary of Testing" section is very brief, stating only: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices."

This highlights a common characteristic of 510(k) summaries, which often focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo performance studies against specific acceptance criteria. For devices cleared through the 510(k) process, the primary "acceptance criterion" is usually a finding of substantial equivalence to a legally marketed predicate.

Therefore, many of your questions cannot be answered from the provided document. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information (Based on the Provided Text)

Reported Device Performance: The document states: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility results) are provided or compared against acceptance criteria. |
| 2. Sample Size for Test Set & Data Provenance | Not provided. The summary just generally mentions "testing" without detailing the nature of the tests (e.g., clinical, bench, animal) or the sample sizes involved. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable/provided. This device is a surgical mesh; the "ground truth" would typically refer to clinical outcomes, mechanical properties, or biocompatibility, not expert interpretation of diagnostic images. |
| 4. Adjudication Method | Not applicable/provided. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No. This device is a surgical mesh, not an AI-assisted diagnostic tool. |
| 6. Standalone Performance Study (Algorithm Only) | No. This device is a surgical mesh, not an algorithm. Performance would relate to its physical and biological properties. |
| 7. Type of Ground Truth Used | Not explicitly stated. For a surgical mesh, "ground truth" would likely involve:

• Bench testing results: Mechanical strength, pore size, material composition, etc.
• Biocompatibility testing: In vitro and/or in vivo studies.
• Animal studies: To assess in-vivo performance and host response.
• Clinical outcomes: From studies on the predicate devices or potentially early clinical use if available (though not detailed here). |
  | 8. Sample Size for Training Set | Not applicable/provided. This is not a machine learning device. |
  | 9. How Ground Truth for Training Set Was Established | Not applicable/provided. |

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