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K Number
K130682
Device Name
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
Manufacturer
HAGER & MEISINGER GMBH
Date Cleared
2013-08-13

(153 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
K092855,K973180
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Tacs and Pins are used for the fixation of membranes (resorbable membranes non-resorbable membranes) to the bone structure.

Tacs and Pins are intended for single use only.

Device Description

The Meisinger Tacs and Pins consist of titanium alloy Grade 5. The Meisinger Pins are a Tac- equivalent with an extra mini- thread.

Both articles are available with a head diameter of 2.51 mm, the Pin is available with overall length of 3.65mm (pin length 2.65mm) and the Tac with a length of 3.5mm (2.8mm)

Tacs and Pins are delivered non sterile.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance for the Meisinger Tacs and Pins.

This 510(k) submission (K130682) is for a medical device (Tacs and Pins) that is seeking clearance based on substantial equivalence to existing predicate devices. In such cases, the FDA often does not require new clinical studies if the device's technological characteristics and intended use are similar enough to already-cleared devices.

The key statement in the document that explains this is:

  • "Clinical Testing: Not applicable"
  • "Based on the information provided in the summary we conclude that the Meisinger Tacs and Pins are substantially equivalent to the legally marketed predicate devices described."

Therefore, I cannot provide the requested information as it is not present in the provided text.

To directly answer your numbered points based on the absence of this information:

  1. A table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data from a study is reported as clinical testing was deemed not applicable for this substantial equivalence submission.
  2. Sample size used for the test set and the data provenance: Not applicable. No test set was used as no clinical study was conducted.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for a test set as no clinical study requiring such a test set was conducted.
  4. Adjudication method for the test set: Not applicable. No test set requiring adjudication was used.
  5. 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: Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study was conducted.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, and no standalone performance study was conducted.
  7. The type of ground truth used: Not applicable. No ground truth was established as no clinical study was conducted.
  8. The sample size for the training set: Not applicable. This device is not an algorithm, and no training set was used.
  9. How the ground truth for the training set was established: Not applicable. No training set was used.

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.