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Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.

• Excision of intrauterine myomas -
• Excision of intrauterine polyps -
• Lysis of intrauterine adhesions -
• Incision of uterine septa
• Endometrial ablation

The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed to secure the distal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

This document describes a 510(k) premarket notification for a modified medical device, the VERSAPOINT* Resectoscopic System. The modification involves changing the material of a component, the telescopic clip, from Polypropylene (PP) to Polybutyleneterephthalate (PBT).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only mentions "Biocompatibility and bench testing" were performed. There is no information on the number of units tested or the specific conditions of these tests.
• Data Provenance: Not specified. Given this is a 510(k) submission to the FDA, it is expected that the testing was conducted under controlled conditions, likely in a laboratory setting, in compliance with relevant standards. However, the country of origin of the data or whether it was retrospective or prospective is not mentioned.

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

• Number of Experts: Not applicable. The "ground truth" in this context refers to the device meeting its performance requirements, which is established through technical testing (biocompatibility and bench testing), not through expert consensus on observational data.
• Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The performance testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench and biocompatibility testing, the results are typically evaluated against pre-defined specifications and standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human reader performance, typically in imaging. This submission focuses on a material change to a surgical instrument, not an AI-based diagnostic tool.

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

• Standalone Performance Study: No, a standalone performance study was not done. This concept is also specific to AI algorithms. The device in question is a surgical instrument.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device modification is the established performance requirements for the predicate device and relevant industry standards concerning material properties, biocompatibility, and functional integrity for surgical instruments. The testing aims to demonstrate that the modified device, despite the material change, continues to meet these pre-defined engineering and safety standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission is for a physical device with a material change, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no machine learning model, there is no training set or associated ground truth to establish.

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GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

GYNEMESH PROLENE Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaption to various stresses encountered in the body.

The provided text is a K013718 510(k) Summary for GYNEMESH PROLENE Soft (Polypropylene) Mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states that nonclinical laboratory testing was not performed, and it relies on published clinical data on the predicate devices (PROLENE Mesh and MERSILENE mesh) to support the use of the new material.

Therefore, many of the requested sections regarding acceptance criteria and performance studies of the specific device (GYNEMESH PROLENE Soft Mesh) cannot be extracted from this document, as such studies were not conducted or reported for this device in this submission.

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

1. Table of acceptance criteria and the reported device performance

This information is not available within this document. The document states: "Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices." Instead, it refers to "Sufficient bench testing...in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.'" and "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh was submitted to support the used of these materials as reinforcing or bridging materials in fascial deficiencies of the pelvic wall." No specific performance data or acceptance criteria for GYNEMESH PROLENE Soft Mesh are reported.

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 available for GYNEMESH PROLENE Soft Mesh as no specific clinical test set was used for this device in this submission. The document refers to "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh," but does not provide details about these studies' sample sizes or provenance.

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 available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh is described.

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

This information is not available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh 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

This is not applicable. The device is a surgical mesh, not an AI or imaging device that would involve human readers.

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

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

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

This information is not available for GYNEMESH PROLENE Soft Mesh. The submission relies on the established clinical history of the predicate devices.

8. The sample size for the training set

This information is not applicable/available as no training set for an algorithm is relevant to this device submission.

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

This information is not applicable/available for the same reason mentioned above.

In summary, the K013718 submission for GYNEMESH PROLENE Soft Mesh relies on showing substantial equivalence to existing predicate devices (PROLENE Soft Mesh, PROLENE Mesh, and MERSILENE Mesh) based on similar materials, construction principles, and intended use, rather than presenting new clinical study data for the device itself.

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