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The Pinnacle LITE Pelvic Floor Repair Kit is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior vaginal vault prolapse.

The Uphold LITE Vaginal Support System is indicated for tissue reinforcement in women with pelvic organ prolapse, for the transvaginal repair of anterior and apical vaginal wall prolapse.

The proposed devices were submitted for a leg assembly modification to the previously cleared LITE Pelvic Floor Repair Kits: Pinnacle LITE Posterior and Uphold LITE Vaginal Support System. The modification to the leg assembly removes the mesh tack welds, separator weld and adds a second leader loop to maintain the mesh leg location within the sleeve to facilitate mesh leg placement. There are no changes to the mesh design, shape, size, material or indications for use.

The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one lightweight synthetic mesh assembly and a needle holder.

The mesh assembly consists of a macroporous 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 dart designed for use with the Capio™ Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

The provided text describes a 510(k) summary for the Boston Scientific Pinnacle LITE Pelvic Floor Repair Kit, Posterior, and Uphold LITE Vaginal Support System. The submission is for a modification to an already cleared device, specifically a change in the leg assembly.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample sizes used for each of the performance tests (Leg Assembly Flexibility, Mesh/Leg Tensile, Leader/Dilator/Sleeve Tensile, Sleeve Removal).

The data provenance is bench evaluation (laboratory testing) conducted by Boston Scientific. The text does not mention any human clinical data, retrospective or prospective studies, or country of origin for such data.

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

This information is not applicable as the provided study involves bench testing of device components, not a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided study involves bench testing, not an assessment requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study described is a bench evaluation of physical device characteristics.

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

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

7. The Type of Ground Truth Used:

The "ground truth" for the bench tests would be the pre-defined engineering specifications and performance characteristics of the predicate device. The goal was to prove "equivalence" to the predicate, meaning the modified device performs similarly within acceptable tolerances for these physical and mechanical properties.

8. The Sample Size for the Training Set:

This question is not applicable as the study did not involve machine learning or AI, and therefore no training set.

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

This question is not applicable for the same reason as above.

Summary of the Study:

The study described is a bench evaluation to demonstrate substantial equivalence of a modified surgical mesh device (Pinnacle LITE Pelvic Floor Repair Kit, Posterior and Uphold LITE Vaginal Support System) to its predicate device. The modification was solely to the "leg assembly" of the device, specifically removing mesh tack welds and a separator weld, and adding a second leader loop to facilitate mesh leg placement. No changes were made to the mesh design, shape, size, material, or indications for use.

The study involved four types of performance testing:

• Leg Assembly Flexibility
• Mesh/Leg Tensile Strength
• Leader/Dilator/Sleeve Tensile Strength
• Sleeve Removal Performance

The results of these tests indicated that the modified device performed equivalently to the predicate device in these aspects. This bench testing was deemed sufficient to support the claim that the modified device is as safe, as effective, and performs as well as the predicate devices, thereby establishing substantial equivalence for 510(k) clearance.

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Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.

Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.

Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).

The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.

The provided document, K121612, is a 510(k) summary for the Elevate® Anterior and Apical Prolapse Repair System, Elevate® Apical and Posterior Prolapse Repair System, and Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP. This document states that the devices are substantially equivalent to their predicate devices and focuses on non-clinical testing for a modified sheath component. It explicitly states that no clinical testing was required. Therefore, a study demonstrating device performance against acceptance criteria in a clinical setting, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

The document primarily addresses the substantial equivalence of the modified devices to their predicates based on manufacturing process and design verification of a component (sheath).

Here's a breakdown of the available information from the document related to testing, recognizing that it does not provide the clinical study details requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study demonstrating device performance against acceptance criteria is described, a direct table cannot be created as requested. The document focuses on performance of a modified sheath through non-clinical testing.

Note: The document only states that these tests were performed and that the modified devices are considered substantially equivalent, implying the tests met their internal acceptance criteria for design verification. No specific numerical results or thresholds are provided in this summary.

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

• Test Set Sample Size: Not applicable in the context of clinical performance. For the non-clinical design verification tests of the sheath, the sample sizes are not specified.
• Data Provenance: Not applicable for a clinical study. For design verification, the data would be laboratory-generated from American Medical Systems, Inc.

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

Not applicable. No ground truth was established by experts from a clinical study for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No clinical test set or human adjudication method is described.

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, nor is there any mention of AI assistance.

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 kit, not an algorithm or an AI-based system.

7. The type of ground truth used

Not applicable in the context of clinical performance. The "ground truth" for the non-clinical testing was defined by the specifications and parameters of the design verification tests for the components.

8. The sample size for the training set

Not applicable. This document describes a surgical device, not a machine learning model requiring a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (and why no clinical study is presented):

The document K121612 outlines that the device (Elevate® Prolapse Repair Systems) underwent a 510(k) submission for a modification to an existing, legally marketed device. The modification was specifically to the "Apical Needle Passer Sheath" component.

The core of the submission relies on demonstrating substantial equivalence to the predicate devices (K082677, K082730, and an unnamed system). The rationale is that:

• There were "no changes to the implant graft design, shape, size, and material."
• There were "no modifications made to the packaging or sterilization."
• There was "no change to the intended use or the implant procedure."

Therefore, the only testing required was non-clinical design verification and biocompatibility testing for the modified sheath. These tests included:

• Sheath compression strength and depth stop strength.
• Trigger/sheath locking interface push strength.
• Sheath cutout shear off strength and trigger/sheath locking interface pull strength.
• Sheath engagement force into lock.
• Cytotoxicity & physiochemical testing for biocompatibility.

The document explicitly states: "no clinical testing was required to support the sheath modification" because "the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices." The acceptance criteria for these non-clinical tests would have been internal design specifications to ensure the modified sheath performed as intended and did not negatively impact the safety or effectiveness of the overall device compared to the predicate. The document concludes that based on these non-clinical tests and the unchanged nature of the implant and procedure, the modified devices are "substantially equivalent to the predicate devices."

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AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite: The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite: The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor. The devices are identical to the predicate device AMS Elevate PC Prolapse Repair System with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.

The provided text describes a 510(k) premarket notification for a medical device, the "AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite" and "AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite". This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for performance.

Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, expert involvement, and ground truth establishment are not applicable or not found in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission is for a modification to a previously cleared device. The focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to the predicate device, rather than meeting new, specific quantitative performance acceptance criteria.

The submission states:

• "The test results for design verification, biocompatibility, sterilization, and packaging are virtually equivalent to the predicate device." (Section 2)
• "The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged." (Section 2)

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

Not applicable. No specific 'test set' in the context of an efficacy study is described. The document refers to "test results for design verification, biocompatibility, sterilization, and packaging" (Section 2), implying engineering and materials testing, but does not provide details on sample sizes or data provenance for these tests.

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

Not applicable. No ground truth establishment for a test set in the context of device performance or efficacy is described.

4. Adjudication method for the test set

Not applicable. No adjudication method is described.

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 surgical mesh system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical mesh system, not an algorithm.

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

Not applicable. Ground truth, in the context of an efficacy study, is not described as this is a substantial equivalence submission for a surgical device modification.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No ground truth for a training set is described.

Summary of Device and Rationale for Substantial Equivalence (as provided in the document):

The submission details a change to the AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite and the AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite.

The modification is solely to the Apical Needle Passer Sheath (a non-implantable surgical aid). There are no changes to the mesh design, shape, size, material, or Indications for Use.

The rationale for substantial equivalence is based on the following points:

• The devices are identical to the predicate device with the single exception of the Apical Needle Passer Sheath modification.
• There are no changes to the existing indications for use.
• The modifications are deemed equivalent, with no changes to the device indications for use/intended use and/or device functional scientific technology.
• The subject devices use the same surgical approach and mesh placement procedures as the predicate devices.
• Components underwent design verification, biocompatibility, sterilization, and packaging tests, with results "virtually equivalent" to the predicate device.
• The proposed devices have identical indications for use/intended use, identical implant materials, identical sterilization methods, and similar delivery tool materials/characteristics as the predicate.
• The proposed device performance and fundamental scientific technology remain unchanged.
• The differences between the proposed device and the predicate device do not have any negative effect on the safety and effectiveness of the device.

Therefore, the submission asserts that the modified devices are substantially equivalent to their predicate devices, implying that their safety and effectiveness are maintained despite the minor modification. No new clinical or performance studies demonstrating effectiveness against specific acceptance criteria are presented because the modification is considered minor and does not alter the fundamental performance or intended use of the device.

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The proposed LITE Pelvic Floor Repair Kits are 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 devices were submitted to introduce lightweight versions of previously cleared pelvic floor repair kits: Pinnacle Anterior/Apical, Pinnacle Posterior, Pinnacle Duet and Uphold Vaginal Support System. The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one or two light-weight synthetic mesh assemblies and a needle holder.

The mesh assemblies consist of a macroporous 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 The Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

The provided text from K103426 describes the LITE Pelvic Floor Repair Kits and their substantial equivalence to predicate devices, rather than a study with acceptance criteria for device performance in detecting or diagnosing conditions, or comparing AI assistance with human performance. The "performance testing" mentioned refers to bench testing of the physical characteristics of the mesh, not clinical performance or diagnostic accuracy.

Therefore, many of the requested fields cannot be populated based on the provided document.

Here's a breakdown of what can be extracted and what cannot:

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

The document describes several mechanical performance tests and biocompatibility tests. It does not provide specific acceptance criteria or quantitative reported values in the format of a table. It states that "The results of the performance testing demonstrate equivalence of the LITE Pelvic Floor Repair kits to the predicate devices." This implies that the LITE kits met the performance characteristics consistent with the predicate devices but doesn't quantify those.

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

Not applicable. The document describes bench testing of materials and device components, not a clinical study on a patient test set.

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

Not applicable. This was bench testing, not an expert-based evaluation of clinical images or data.

4. Adjudication method for the test set

Not applicable.

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. This document does not mention any MRMC studies or AI assistance.

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

No. This document does not describe an algorithm or AI.

7. The type of ground truth used

For the mechanical and biocompatibility testing, the "ground truth" was established by standardized test methods and validated measurements for the physical and biological properties of the mesh and its components, with predicate device characteristics serving as the benchmark for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The Coloplast Exair Anterior and Posterior Prolapse 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 Exair Anterior and Posterior Prolapse Repair System is composed of NovaSilk mesh precut into shape with an enlarged or elongated body with four appendages extending out from the main body. The mesh arms for both Exair Anterior and Posterior Prolapse Repair Systems are sleeved in 2-mil thick polypropylene to facilitate arm implantation and positioning: sleeves are removed after proper placement of the implant is achieved. The system instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms in place the tissues for positioning and fixating the mesh body. The system provided sterile and for single use only.

This is a 510(k) summary for a surgical mesh device (K112386). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document states that the proposed changes described in the submission do not affect the materials, design, components, or technological features of the device, implying that no new performance studies were conducted for this specific submission to demonstrate compliance with new acceptance criteria. The submission is focused on demonstrating substantial equivalence to a predicate device (K083499) based on existing characteristics.

Therefore, I cannot provide the requested information from the provided text.

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The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.

The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens.

The mesh has six fixation points (two posterior fixation points and four arms):

• Two posterior fixation points that are fixed to the sacrospinose ligaments.
• Two middle arms that are passed through the arcus tendineus.
• Two anterior arms that are passed through the anterior part of the obturator foramen.

When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.

Here's a breakdown of the acceptance criteria and study information for the Surelift Prolapse System, based on the provided 510(k) amendment:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than proving specific clinical safety and effectiveness through a dedicated clinical performance study with detailed acceptance criteria measured against clinical outcomes. The "performance tests" listed are primarily related to material properties, sterilization, and biocompatibility, ensuring the device meets established standards for medical devices of its type.

Study that Proves Device Meets Acceptance Criteria:

The document describes a series of "Performance tests" that were conducted to demonstrate the device meets established performance requirements and standards.

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

The document does not specify sample sizes for any of the individual performance tests (e.g., number of meshes tested for tensile strength, number of anchors for pullout strength). It also doesn't mention data provenance regarding country of origin or whether the data was retrospective or prospective. These types of tests are typically conducted in a laboratory setting using manufactured samples.

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

This information is not applicable in this context. The "performance tests" relate to physical, chemical, and biological properties, not clinical diagnostic accuracy or interpretation requiring expert consensus on a test set. The ground truth for these tests is based on objective measurements and adherence to recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a surgical implant (Surelift Prolapse System), not an AI-assisted diagnostic tool. Therefore, there is no mention of human readers or AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

No, a standalone performance study in the context of an algorithm's performance was not done. This device is a surgical mesh kit, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests described is based on:

• Objective measurements: For physical properties like dimensions, tensile strength, pore size, etc.
• Established standards and regulations: For sterilization (e.g., SAL), biocompatibility (e.g., ISO standards for cytotoxicity, irritation), and other performance requirements.

8. Sample Size for the Training Set:

This information is not applicable. The device is a surgical mesh kit, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a permanentlyimplanted synthetic mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor.

The devices is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.

The document provided describes a Special 510(k) Device Modification for the AMS Elevate® PC Prolapse Repair System with IntePro® Lite, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that modifications do not raise new questions of safety or effectiveness and primarily relies on non-clinical testing to prove equivalence, rather than extensive clinical studies with human participants.

Therefore, many of the requested categories related to clinical study design, human reader performance, and ground truth establishment from patient data are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "N/A" for Acceptance Criteria: The document states that the components were "subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements." It does not provide specific quantitative acceptance criteria for each of these tests, but rather states that the results conclude substantial equivalence. In a 510(k) submission, the "acceptance criteria" for these non-clinical tests would typically be defined internally by the manufacturer (e.g., specific tensile strength thresholds, cytotoxicity limits) and compared against the predicate's performance or established standards. The summary statement provides the overall conclusion of meeting these criteria.

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (design verification, biocompatibility, sterilization, packaging, product performance), not a clinical test set from patients.
• Data Provenance: Not applicable. The data is generated from laboratory and bench testing of the device components.

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

• Not applicable. Ground truth as typically defined in diagnostic AI/clinical studies (e.g., patient outcomes, pathology) is not relevant for this non-clinical submission. The "ground truth" for the non-clinical tests is established by industry standards, engineering specifications, and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" of patient data requiring adjudication in this context.

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 a medical device modification notification focused on non-clinical equivalence, not an AI-enabled device or a comparative effectiveness study involving human readers.

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

• Not applicable. This is not an algorithm-only or AI device.

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

• For the non-clinical tests, the "ground truth" is established by engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, biocompatibility would be assessed against ISO standards, and mechanical performance against the predicate's known capabilities.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this traditional medical device submission.

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

• Not applicable. There is no "training set" for which ground truth would be established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a summary of non-clinical testing. This testing included:

• Design Verification: To ensure the modified anterior needle passer and connection interface for tissue fixation elements function as intended and meet design specifications.
• Biocompatibility: To demonstrate that the device materials are safe for implantation.
• Sterilization: To validate the sterilization process ensures the device is sterile.
• Packaging: To confirm the packaging protects the device and maintains sterility during shelf life.
• Product Performance Requirements: To show the device performs mechanically and functionally equivalently to the predicate.

The conclusion of these non-clinical tests "substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite" serves as the proof that the device meets the acceptance criteria for a 510(k) modification. The key modifications were the addition of a release mechanism to the anterior needle passer handle and slight changes to the geometry of the internal diameter and base of the tissue fixation elements to accommodate the new needle tip shape. The study demonstrated that these changes did not negatively impact the safety or effectiveness, thus proving substantial equivalence to the legally marketed predicate device.

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RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.

Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.

It maintains excellent isotropic properties arising from its knitted construction.

Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body.

The device is supplied sterile.

The Mpathy Medical Devices, Ltd. Restorelle polypropylene mesh is a surgical mesh device. The provided text, a 510(k) summary, does not describe a study involving an algorithm or AI to meet acceptance criteria. Therefore, most of the requested information regarding AI-specific criteria and studies cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and mechanical testing for the physical mesh product itself, not a digital diagnostic or AI device.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance
(See table above for the general areas of performance comparison). The document states the device has "the necessary strength, flexibility, durability and surgical adaptability" but does not provide specific quantitative metrics or acceptance criteria for these characteristics. The primary performance claim is "substantial equivalence" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is for a physical medical device (surgical mesh), not a diagnostic algorithm or AI. The testing performed was biocompatibility and mechanical testing of the mesh material itself. The document does not specify sample sizes for these tests, nor the country of origin of testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is not a diagnostic device or AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device or AI.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a MRMC study was not done. This device is a surgical mesh, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI device. For the physical mesh, the "ground truth" for its properties would be established through standard material and biocompatibility testing per ISO standards or similar, comparing it to the known properties of the predicate devices.

8. The sample size for the training set
Not applicable, as this is not an AI or algorithm.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI or algorithm.

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The Coloplast Exair Anterior and Posterior prolapse 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 Exair Anterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an enlarged body and four appendages extending out from the main body. The Exair Posterior Prolapse Repair System is made of NovaSilk mesh precut into a shape with an elongated body and two appendages extending out from the main body. The mesh arms for both Exair Anterior and Exair Posterior Prolapse Repair Systems are sleeved in 2-mil thick polyethylene to facilitate device arm implantation and positioning; sleeves are removed after proper placement of implant is achieved. The System instrumentation includes a hollow introducer used to create a passage through the tissues and facilitate placement of the mesh arms, and four (4) anterior or two (2) posterior retrievers used to guide the mesh arms into place through the (1) and for positioning and fixating the mesh body. The System is provided sterile and for single use only.

The provided text is for a 510(k) summary for a medical device called Exair Anterior and Posterior Prolapse Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The summary states that "Substantial equivalence is supported by bench testing comparing Exair to the predicate devices and biocompatibility testing performed on the Exair device and instrumentation." This indicates non-clinical testing was performed, but no details about specific performance metrics or acceptance criteria for that testing are provided in this document.

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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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