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The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach.

The use of the device in males and children under 18 years of age is not supported by clinical studies.

The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ -1011 is comprised of the same polypropylene knitted mesh as its Model 1010 and Model 1012 predicates, protected by the same disposable polypropylene sheath as its Model 1012 predicate with a disposable low density polypropylene universal sleeve at each end made of the same material and similar in design to the sleeve of its Model 1010 predicate, for attachment of the sling to GMD's reusable trocars (sold separately). Similar to both predicates, the Universal Urinary Incontinence Sling™ -- 1011 is used for inside-out / bottom-up and outside-in / top-down approaches. Similar to both predicates, the method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

The provided text describes a medical device, the GMD Universal Urinary Incontinence Sling™-1011, and its substantial equivalence to predicate devices based on non-clinical studies. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study that defines or proves the device meets specific performance metrics in the way the requested information (e.g., sample size for test/training sets, expert qualifications, MRMC study, standalone performance) would imply for a diagnostic or AI-driven device.

Therefore, I cannot fulfill the request as the provided text pertains to a regulatory submission for a surgical mesh device, focusing on its design modifications and substantial equivalence to existing predicate devices through bench and cadaver studies, rather than performance criteria of a device with measurable output like an AI algorithm or diagnostic tool. The document is a 510(k) summary for a physical medical implant, not a study evaluating performance of a diagnostic or decision-support system.

To answer your request, the input document would need to be a study report or regulatory submission for a device that has quantifiable performance metrics and a methodology for evaluating those metrics (e.g., an AI algorithm for image analysis).

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The GMD Universal Sling is indicated for use in women as a suburethral sling for the treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

The GMD Universal Sling System ™ – is a sterile, single use device for the treatment of female stress urinary incontinence. The Universal Sling is comprised of a polypropylene knitted mesh protected by a disposable polyurethane sheath with a disposable low density polypropylene universal sleeve at each end for attachment of the sling to GMD's single use or reusable trocars (sold separately). The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out / bottom-up approaches and a sleeve end trocar insertion point is for outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

The provided text describes a 510(k) premarket application for the "GMD Universal Sling™," a medical device for treating female stress urinary incontinence. The focus of the application is to demonstrate substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance acceptance criteria through a standalone study with defined metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for this 510(k) submission are implicitly defined by demonstrating substantial equivalence to predicate devices. This means the GMD Universal Sling™ needs to show that it is as safe and effective as the already-approved predicate devices for the specified indications. The "reported device performance" directly addresses this by stating that the new device has "the same intended use" and "similar technological characteristics," and that bench and animal studies demonstrate "similar mechanical and performance characteristics" to the predicates. Specific quantitative performance metrics or acceptance thresholds are not provided in this type of submission focused on substantial equivalence.

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, which typically relies on non-clinical (bench and animal) studies and comparison to existing predicate devices rather than a dedicated clinical "test set" to establish efficacy against specific performance criteria.
• Data Provenance: The document mentions "Bench and animal studies were performed." It does not specify the country of origin for these studies or whether they were retrospective or prospective.

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

• Number of Experts: Not applicable. This type of submission does not involve human expert adjudication of a "test set" in the way a clinical study for an AI/diagnostic device would. The "ground truth" for the non-clinical studies would be based on the outcomes of the bench and animal tests against established scientific or engineering principles, or comparison to results obtained from predicate devices in similar testing.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no mention of a human expert adjudication process for a "test set" in the document.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical (bench and animal) studies and comparison to predicate devices, not on human reader performance with or without AI assistance.

• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study involving AI was conducted.

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

• Standalone Performance: Not applicable. The GMD Universal Sling™ is a physical surgical mesh device, not an algorithm or AI-powered system, so the concept of "standalone (algorithm only)" performance does not apply.

7. The type of ground truth used

• Type of Ground Truth: For the "Bench and animal studies," the ground truth would be established by the physical and biological responses observed in these studies, evaluated against engineering specifications, biocompatibility standards, and in comparison to the known performance characteristics of the predicate devices. For example, in bench testing, "ground truth" might be tensile strength measurements or material degradation rates. In animal studies, it would be biological response, inflammation levels, tissue integration, etc.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical medical implant, not an AI or 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 training set for this type of device.

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The Universal Surgical Mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Universal Surgical Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (ETHICON, INC). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue in-growth. Universal Surgical Mesh in knitted by a process that interlinks each fiber junction and 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 adaptation to various stresses encountered in the body.

This document describes a 510(k) submission for the Universal Surgical Mesh. As such, it does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria.

This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through a detailed study.

Here's why the requested information is not available in the provided text:

• Acceptance Criteria and Reported Device Performance: This device is a surgical mesh. The submission asserts that it is "identical in composition" and has the "same intended use and same technological characteristics" as a predicate device (PROLENE Polypropylene Mesh). There are no specific performance metrics or acceptance criteria for things like sensitivity, specificity, or accuracy that would be relevant for an AI/software device.
• Clinical/Non-Clinical Studies: The document explicitly states: "The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as there is no change to the clinical intended use as compared to the two predicate devices." This means there was no study performed to evaluate the device's performance against any set criteria.
• Ground Truth, Training Sets, Adjudication, MRMC studies, Standalone performance: These concepts are relevant for studies evaluating the performance of diagnostic or AI-driven devices. They do not apply to the Universal Surgical Mesh, which is a physical implant with a demonstrated equivalence to a previously approved device.

In summary, the provided text is for a traditional medical device (surgical mesh) seeking 510(k) clearance based on substantial equivalence, not the type of device (e.g., AI/diagnostic software) that would involve the extensive performance study details you've asked for.

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The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.

The provided 510(k) summary for the GMD Universal Circumcision Clamp does not contain information about acceptance criteria or a study proving the device meets them.

Instead, the document states:

"The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use."

This indicates that the device's substantial equivalence was established based on its similarity to a legally marketed predicate device (GOMCO Circumcision Clamp - K894201) and the long history of clinical use of this type of technology, rather than through performance-based acceptance criteria and a specific study.

Therefore, the requested tables and details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as they are not present.

In summary, none of the specific information requested regarding acceptance criteria and performance studies is available in the provided text. The 510(k) submission relied on substantial equivalence to a predicate device and existing clinical history rather than new performance data.

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