(90 days)
Synthes Quick Lock TM IMF System is indicated for use in intermaxillary and maxillo-mandibular fixation.
The Synthes Quick Lock ™ IMF System consists of brackets, arch bars and instrumentation which are used to facilitate temporary jaw immobilization. The Synthes Quick Lock ™ Bracket is a dental bracket that provides an attachment point for MMF wires and elastics. It incorporates a high tensile strength fiber that circumdentially attaches the bracket to the dentition. The Quick Lock ™ Arch Bar and Arch Bar Bracket provide additional support to the dental arch.
This document is a 510(k) summary for the Synthes Quick Lock™ IMF System, a device used for temporary jaw immobilization. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a detailed study for acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document does not describe specific acceptance criteria (e.g., performance metrics, thresholds) or present a study with performance data against such criteria.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth establishment process is mentioned.
- Adjudication method for the test set: No test set or adjudication method is mentioned.
- 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 an AI device, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device, and no such study is mentioned.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): No ground truth is mentioned.
- The sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.
Summary of the Document's Information:
The document is a "Summary of Safety and Effectiveness Information [510(k) Summary]" for the Synthes Quick Lock™ IMF System. This system consists of brackets, arch bars, and instrumentation for temporary jaw immobilization.
Key conclusions from the document:
- Device Classification: Class II, 21 CFR 872.4700 (Lock, Wire, and Ligature, Intraoral).
- Predicate Devices: Dimac Medical, Inc. Dimac Wires (K910090), W. Lorenz Traditional Wire and Arch Bars, Unisplint (K820944), Wall-Omnisplint Maxillofacial Fracture Kit (K number unknown).
- Intended Use: Indicated for use in intermaxillary and maxillo-mandibular fixation.
- Materials: 316L Stainless Steel, Ti-6Al-7NB, Vectran fiber, and Nylon.
- Regulatory Decision: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This allows the company to market the device subject to general controls provisions of the Act.
The document does not detail specific acceptance criteria or performance studies in the way one might expect for a novel device proving its effectiveness. Instead, the "acceptance criteria" here is met by demonstrating substantial equivalence to already approved predicate devices, implying that the safety and effectiveness are comparable.
§ 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.