(99 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. | The GMD Universal Sling™ has the same intended use as the predicate devices Gynecare TVTTM Obturator System (K033568), Boston Scientific Lynx™ System (K081275), and Caldera Desara™ (K072456). |
| Technological Characteristics: Similar design and materials to predicate devices. | The GMD Universal Sling™ has similar technological characteristics to the predicate devices. Biocompatibility testing demonstrated the appropriateness of the device materials. |
| Mechanical & Performance Characteristics: Demonstrate similar mechanical and performance characteristics to predicate devices. | Bench and animal testing demonstrate that the GMD Universal Sling™ has similar mechanical and performance characteristics as the predicate devices. |
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
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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.
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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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.