(90 days)
The TVT device is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer and Rigid Catheter Guide accessories are intended to facilitate placement of the TVT device. The accessories, available separately, are provided nonsterile and are reusable.
The Tension Free Vaginal Tape (TVT) System is comprised of three components; the device (TVT device) and its accessories (TVT Introducer and TVT Rigid Catheter Guide). Each is available separately for use at the surgical site. The TVT device is composed of PROLENE polypropylene mesh (tape). The mesh is covered with a polyethylene sheath with a slit in the middle. Both the mesh and sheath are attached to two (2) stainless steel needles. The TVT Introducer (accessory) is made of stainless steel. It is composed of three (3) parts; handle, threaded staft and rubber O-ring. The introducer functions to facilitate passage of the TVT device from the vagina to the abdominal skin. The TVT Rigid Catheter Guide is made of stainless steel and used to add rigidity to the Foley Catheter during the surgical procedure.
The provided text describes the regulatory submission for the "Tension Free Vaginal Tape (TVT) System" and its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The "Performance Data" section merely states: "Results of clinical evaluations were used to show that the TVT System functioned as clinically intended. Sufficient data has been gathered from clinical testing to assess that the TVT System performs as clinically intended." This statement lacks any quantitative or qualitative acceptance criteria and does not provide details about the clinical study itself.
Therefore, many of the requested elements for the response cannot be extracted from the provided text.
Here is a summary of what can be inferred or directly stated, and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document only generally states, "TVT System functioned as clinically intended," and "Sufficient data has been gathered from clinical testing to assess that the TVT System performs as clinically intended." No specific performance metrics (e.g., success rates, complication rates, symptom improvement scores) are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (country, retrospective/prospective).
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 specified. The document only mentions "clinical evaluations."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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/specified. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/specified. This device is a surgical implant, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but "clinical evaluations" typically imply patient outcomes or assessments by clinicians. No specific "ground truth" definition is provided beyond "functioned as clinically intended."
8. The sample size for the training set
- Not applicable/specified. This device is a surgical implant, not an AI diagnostic tool that requires a 'training set.' Clinical data would be considered a 'test set' or 'validation set' for device performance, but no details are provided.
9. How the ground truth for the training set was established
- Not applicable/specified (see point 8).
§ 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.