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K Number
K043555
Device Name
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
Manufacturer
SYNTHES (USA)
Date Cleared
2005-04-12

(106 days)

Product Code
MQN
Regulation Number
872.4760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes Alveolar Distractor is intended for vertical bone lengthening of the alveolar ridge in the mandible and the maxilla where gradual bone distraction is required, including deficiency in bone height as a result of:

  • . Trauma
  • Resorption after dental extraction .
  • Periodontal disease .
  • Tumor resection ◆
  • Congenital deformity .
Device Description

The Synthes Alveolar Ridge Distractor is an extraosseous distraction device consisting of a distractor body, a transport plate, a base plate, and a vector control mechanism. It is intended to be placed submucosally, with the base plate fastened to the stationary segment of the mandible or maxilla and the transport plate fastened to the mobile bone segment. The plates are fixed to the bone using 1.5 mm cortex screws.

AI/ML Overview

The provided document is a 510(k) summary for the Synthes Alveolar Ridge Distractor, which is a premarket notification to the FDA for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously marketed device rather than providing the results of a primary clinical study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

  • No acceptance criteria or device performance table is present. The document states that "Documentation was provided which demonstrated the Synthes Alveolar Ridge Distractor to be substantially equivalent to other legally marketed devices." This implies a comparison to predicate devices, not specific performance metrics against pre-defined acceptance criteria.
  • No details about sample size for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set are provided. These are typically elements of a clinical trial or performance study, which is not the primary purpose of a 510(k) summary focused on substantial equivalence.
  • The type of ground truth used is not specified.
  • The sample size for the training set and how its ground truth was established are not mentioned.

The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through bench testing, material characterization, and comparisons of design and intended use, rather than extensive clinical efficacy trials. The document highlights the intended use and predicates but does not detail a study proving specific performance metrics against acceptance criteria.

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.