(138 days)
Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting.
Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.
The provided text describes a 510(k) premarket notification for a medical device called the Desara TV EZ and Desara Blue TV EZ Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.
As such, the document details bench testing and validation of the device's physical and performance characteristics, biocompatibility, shelf life, packaging, and sterilization, primarily to show that the new device performs equivalently to the predicate devices. It does not present a study proving the device meets specific acceptance criteria related to a human subject study, nor does it involve AI assistance or human reader performance evaluation.
Therefore, I cannot extract the information required for the requested table and study details. The document does not contain any data on:
- Device performance in a clinical setting (e.g., accuracy, sensitivity, specificity).
- Sample sizes for test sets in human studies.
- Data provenance (retrospective/prospective, country of origin) related to clinical outcomes.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance or human-in-the-loop studies.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The document primarily focuses on demonstrating equivalence through non-clinical testing.
Here's what can be extracted regarding acceptance criteria and performance, but it pertains to the device's material and mechanical properties, not clinical outcomes:
1. Table of Acceptance Criteria and Reported Device Performance (for non-clinical characteristics):
The document states that the testing "met all pre-defined acceptance criteria and regulatory requirements" but does not numerically list the specific acceptance criteria or the measured performance values for each characteristic. It only lists the types of tests conducted.
| Acceptance Criteria Category | Specific Characteristics Assessed (Not numerical criteria) | Reported Device Performance (Qualitative) |
|---|---|---|
| Material/Mesh | Mesh thickness | Met pre-defined acceptance criteria and regulatory requirements. Utilizes identical mesh material and knit as predicate. |
| Mesh knit characteristics | Met pre-defined acceptance criteria and regulatory requirements. Utilizes identical mesh material and knit as predicate. | |
| Pore size | Met pre-defined acceptance criteria and regulatory requirements. Utilizes identical mesh material and knit as predicate. | |
| Mesh density | Met pre-defined acceptance criteria and regulatory requirements. Utilizes identical mesh material and knit as predicate. | |
| Flexible rigidity | Met pre-defined acceptance criteria and regulatory requirements. | |
| Tensile strength | Met pre-defined acceptance criteria and regulatory requirements. | |
| Tear resistance | Met pre-defined acceptance criteria and regulatory requirements. | |
| Burst strength | Met pre-defined acceptance criteria and regulatory requirements. | |
| Suture pull-out | Met pre-defined acceptance criteria and regulatory requirements. | |
| Pyrogen levels | Met pre-defined acceptance criteria and regulatory requirements. | |
| Mechanical/Performance (Device Function) | Dimensional characteristics | Demonstrated equivalent implant device function based on intended use when compared to predicate. |
| Junction Strength | Demonstrated equivalent implant device function based on intended use when compared to predicate. | |
| Bend and Fatigue Retropubic | Demonstrated equivalent implant device function based on intended use when compared to predicate. | |
| Torque and Tensile Strength | Demonstrated equivalent implant device function based on intended use when compared to predicate. | |
| Biocompatibility | - (Overall biocompatibility) | Supported by passing testing results per FDA guidance for permanent implant and limited use introducer. |
| Shelf Life/Packaging | Labeling, transportation, packaging integrity | Met all pre-defined acceptance criteria and regulatory requirements. |
| Sterilization | Sterility Assurance Level (SAL 10⁻⁶) | Validated and met all pre-defined acceptance criteria and regulatory requirements. |
The study described here is purely for regulatory clearance based on substantial equivalence to predicate devices, focusing on engineering and material performance, not clinical efficacy or AI performance.
§ 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.