(25 days)
The Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or sphincter deficiency.
The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles.
The Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The tape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, allows tissue colonization and facilitates positioning during surgery.
A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.
The provided text describes a 510(k) submission for the Mentor ObTape™ Trans-obturator Surgical Kit. This is a medical device clearance process, not a study evaluating an AI algorithm, and therefore many of the requested elements (like sample size for test sets, number of experts, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of regulatory submission.
The "study" in this context refers to the pre-clinical and mechanical testing performed to demonstrate that the device is substantially equivalent to a previously cleared predicate device.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mentor ObTape Trans-obturator Tape: | |
| Substantial equivalence in material, function, performance, and design to the predicate Mentor ObTape Trans-obturator Tape cleared under 510(k) K031767. | "The tape included in the Mentor ObTape Trans-obturator Surgical Kit is identical to the Mentor ObTape which was cleared under 510(k) K031767." |
| Introducer Needles: | |
| Meet established criteria for mechanical performance. | "Mechanical testing of the sterile introducers showed that the introducers met all established criteria for mechanical performance." (Specific criteria are not detailed in this summary, but would have been part of the full submission). |
| Be non-toxic and non-irritant (biocompatibility). | "Biocompatibility testing on the sterile, disposable introducers demonstrated that the introducers are non-toxic and a non-irritant." (Specific tests like cytotoxicity, sensitization, irritation would have been performed, but are not detailed in this summary). |
| Overall Kit: | |
| Substantial equivalence to the predicate Mentor ObTape Trans-obturator Tape and Introducers cleared under 510(k) K031767. | "The Mentor ObTape Trans-obturator Surgical Kit is substantially equivalent in material, function, performance and design to the Mentor ObTape Trans-obturator Tape and Introducers which were cleared under 510(k) K031767." This is the overarching claim for the entire kit, based on the individual components meeting their respective criteria and remaining identical/equivalent to the predicate. |
Additional Information (Not applicable for AI algorithms)
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission focuses on the substantial equivalence of a physical medical device (surgical tape and introducers), not an AI algorithm. The testing involved mechanical and biocompatibility assessments of the physical components, not a "test set" of data in the AI sense. The text does not provide sample sizes for these tests. Data provenance in this context would refer to the origin of the materials and manufacturing standards, which are not detailed in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment in the AI sense for this device. The tape component's equivalence is based on it being identical to a previously cleared device. The introducers' performance is based on mechanical and biocompatibility testing against predefined standards, likely conducted by qualified engineers and toxicologists/biologists, but not "experts" establishing a "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is relevant as there is no "test set" or human interpretation of data in the AI context.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the tape, the "ground truth" is that it is identical to a predicate device already deemed safe and effective. For the introducers, the "ground truth" is adherence to established mechanical performance specifications and demonstrated biocompatibility as per relevant standards. These are not "ground truths" in the diagnostic AI sense.
8. The sample size for the training set:
- Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI 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.