(46 days)
The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
The TriAngle Sling is a knitted patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.
This document does not include information about acceptance criteria or a study proving that a device meets such criteria.
The provided text is a 510(k) summary for the TriAngle Sling, which is a medical device for treating urinary stress incontinence. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria in the manner you've requested.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria & Reported Device Performance: The document states, "Performance testing and information in the application demonstrated that TriAngle sling is biocompatible and provides equivalent performance to the In-Sling." It does not list specific quantitative acceptance criteria (e.g., tensile strength, pore size, elasticity ranges) nor does it provide the measured performance values for the TriAngle Sling against those criteria. It relies on a general statement of equivalence to the predicate.
- Study Design Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): None of these details are present because a 510(k) summary for a Class II device like this typically does not require a comprehensive clinical trial or an in-depth performance study with human readers/experts. The demonstration of substantial equivalence often relies on material characterization, mechanical testing, biocompatibility testing, and comparison of technological characteristics to a legally marketed predicate device.
- Training Set Information: Similarly, there is no mention of a training set, as the evaluation type described doesn't involve machine learning algorithms that require training data.
In summary, the provided K980482 document for the TriAngle Sling is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study with the specific performance criteria and study methodology you've inquired about.
§ 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.