(38 days)
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.
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.
ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.
The provided text is a 510(k) summary for a medical device (Mentor ObTape Trans-obturator Tape and Introducers). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance evaluation in the way an AI/software device would.
Therefore, many of the requested categories for a study proving device acceptance against specific criteria are not applicable or cannot be extracted from this document, as it describes a physical surgical mesh and its introducers.
Here's an attempt to answer the questions based on the available information:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Properties | Adherence to established EDANA standards for Tear Strength | Complies with established EDANA standards for Tear Strength |
| Adherence to established EDANA standards for Tensile Strength | Complies with established EDANA standards for Tensile Strength | |
| Adherence to established EDANA standards for Elongation | Complies with established EDANA standards for Elongation | |
| Biocompatibility | Compliance with USP, ISO 10993, or EN standards for Cytotoxicity | Complies with established USP, ISO 10993 or EN standards for Cytotoxicity |
| Compliance with USP, ISO 10993, or EN standards for Genotoxicity | Complies with established USP, ISO 10993 or EN standards for Genotoxicity | |
| Compliance with USP, ISO 10993, or EN standards for Hemolysis | Complies with established USP, ISO 10993 or EN standards for Hemolysis | |
| Compliance with USP, ISO 10993, or EN standards for Implantation | Complies with established USP, ISO 10993 or EN standards for Implantation | |
| Compliance with USP, ISO 10993, or EN standards for Pyrogenicity | Complies with established USP, ISO 10993 or EN standards for Pyrogenicity | |
| Compliance with USP, ISO 10993, or EN standards for Intracutaneous Reactivity | Complies with established USP, ISO 10993 or EN standards for Intracutaneous Reactivity | |
| Compliance with USP, ISO 10993, or EN standards for Sensitization | Complies with established USP, ISO 10993 or EN standards for Sensitization | |
| Compliance with USP, ISO 10993, or EN standards for Systemic Toxicity | Complies with established USP, ISO 10993 or EN standards for Systemic Toxicity |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes tests against established standards for materials and biocompatibility, but it does not detail the specific sample sizes used for these tests, nor the data provenance in terms of country of origin or whether the tests were retrospective/prospective. This type of detail is typically part of the underlying test reports, not the summary.
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)
This is not applicable to the type of device and testing described. The "ground truth" for this device is determined by physical and biological testing against recognized industry standards (EDANA, USP, ISO, EN), not by expert interpretation of clinical data in the same way an AI device would require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of testing described. Adjudication methods are typically used when interpreting subjective data (like medical images), which is not the case for mechanical properties or biocompatibility testing. The compliance is determined by objective measurements against predefined thresholds within the standards.
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
This is not applicable. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI technologies. This submission is for a surgical implant (mesh), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is based on established industry and regulatory standards for material properties and biocompatibility.
- For mechanical testing: The ground truth for compliance is whether the measured Tear Strength, Tensile Strength, and Elongation meet the specified values within the EDANA standards.
- For biocompatibility: The ground truth for compliance is whether the results of tests for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous Reactivity, Sensitization, and Systemic Toxicity adhere to the requirements of USP, ISO 10993, or EN standards.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for a physical device, this question is irrelevant.
§ 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.