(260 days)
The MINNE TIES™ MMF Suture System is an adjustable flexible plastic band that wraps between and around a tooth to create an anchorage point for maxilla-mandibular fixation and immobilization. MINNE TIES™ MMF Suture System is suitable for:
- Pre-operative fixation
- Per-operative fixation
- Short-term (up to 3 weeks) fixation for minimally displaced fractures
- Splintage post jaw dislocation
The MINNE TIES™ MMF Suture System contains:
- Four (4) 1.0mm sized sutures
- Seven (7) 0.7mm sized sutures
- One (1) 0.5mm Sized suture
and are used to establish maxilla-mandibular fixation (MMF) and immobilization by applying independently balanced series of sutures bilaterally between and/or around the teeth in the interdental space (i.e. triangular apical embrasure). The sutures provide a stabilizing occlusive force allowing for short term (up to 3 weeks) fixation for minimally displaced fractures for pre-operative and per-operative fixation and splintage post jaw dislocation. An Introducer is used to advance sutures between and/or around the teeth. A cheek retractor is included with the system to organize the ties during the procedure.
The MINNE TIES™ MMF Sutures are made of polypropylene, polyester and stainless steel. The cheek retractor is made of polypropylene.
The provided text describes a 510(k) premarket notification for the "MINNE TIES™ MMF Suture System". This document indicates the device's substantial equivalence to a legally marketed predicate device rather than a ground-up study proving its performance against acceptance criteria for a novel AI/ML device.
Therefore, the information required to answer the prompt for an AI/ML device (e.g., acceptance criteria for AI performance, sample sizes for AI training/test sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.
The document focuses on:
- Device Description: The components and general use of the MINNE TIES™ MMF Suture System.
- Intended Use/Indications for Use: What the device is intended for (maxilla-mandibular fixation).
- Predicate Device Comparison: A detailed comparison to a previously cleared device (Rapid IMF™ - K030605) to demonstrate substantial equivalence.
- Non-Clinical Testing: Physical and material tests (tensile strength, fatigue, biocompatibility, sterilization, packaging, shelf life, corrosion resistance, system handling/cadaver test) to show that the new device performs similarly and safely to the predicate.
- Clinical Testing: Explicitly states that clinical data was not required for this device, which further indicates the absence of human-in-the-loop performance studies or deep learning-based performance evaluations.
In summary, this document is for a medical device that does not involve artificial intelligence or machine learning, and thus the specific metrics and study methodologies requested in the prompt related to AI/ML device acceptance criteria are not applicable or provided.
§ 872.4600 Intraoral ligature and wire lock.
(a)
Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together.(b)
Classification. Class II.