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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.

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