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K Number
K191911
Device Name
3Shape Splint Design
Manufacturer
3Shape A/S
Date Cleared
2019-11-27

(133 days)

Product Code
PNN
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
K161884
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

3Shape Splint Design for splints and mouthguards is intended for use as a medical front-end device providing tools for systematic inspection, detailed analysis, treatment simulation and virtual appliance design based of 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of Splint Design software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

The Splint design software for splints and mouthquards/nightquards is a software system used for the virtual planning of orthodontic treatments by simulating jaw movements, and design of orthodontic appliances based on 3D scanned orthodontic models.

The realization of the above-mentioned orthodontic appliances is done using splint workflow which supports

  • Direct production using 3D printer or milling machines with FDA cleared or . listed materials included in the splint workflow.
    The actual production of appliances is done by the user and it is under their control and responsibility.

3Shape Splint Design has no patient contact being a software only device.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) summary for a medical device (3Shape Splint Design) stating that it is substantially equivalent to a predicate device.

Specifically, the text does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details on sample size, data provenance, or the nature of any test set used.
  3. Information about experts used to establish ground truth or their qualifications.
  4. Adjudication methods.
  5. A multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size for human readers with and without AI assistance.
  6. Information about a standalone (algorithm only) performance study.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The document only states that "Software, hardware, and integration verification and validation testing was performed" and "All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the primary predicate device." It also explicitly states that "Clinical testing is not a requirement and has not been performed."

Therefore, I cannot provide the requested information based on the given input.

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.