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K Number
K960988
Device Name
LACTOSORB TRAUMA PLATING SYSTEM
Manufacturer
POLY-MEDICS,INC.
Date Cleared
1996-04-10

(34 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.

  • Comminuted fractures of the naso-ethmoidal and l. infraorbital areas.
    1. Comminuted fractures of the frontal sinus wall.
    1. Trauma of the midface or craniofacial skeleton.
  • 4 . Reconstructive procedures of the midface or craniofacial skeleton.
    This system is not designed for use in the mandible and/or full load bearing procedures.
Device Description

The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surqical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in for over 10 years in Poly humans Surqiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.

AI/ML Overview

This document is a "Summary of Safety and Effectiveness" for the LactoSorb® Trauma Plating System, dated April 8, 1996. It describes the device, its intended use, material composition, and general claims about its safety and effectiveness.

However, the provided text does not contain the specific information requested in the prompt's numbered points regarding acceptance criteria and a study that proves the device meets them.

The document states: "The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region. This system is as effective as similar metal micro fixation systems on the market."

While it mentions a "clinical study" and "mechanical testing," it does not provide:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details or effect size.
  6. Standalone (algorithm only) performance. (This is not applicable as it's a physical device, not an AI algorithm)
  7. Type of ground truth used.
  8. Training set sample size. (This is not applicable as it's a physical device, not an AI algorithm)
  9. How ground truth for the training set was established. (This is not applicable as it's a physical device, not an AI algorithm)

Therefore, based only on the provided text, I cannot fulfill the request for information beyond reiterating that a clinical study and mechanical testing were performed, and the system was found to provide adequate fixation. The specific details, metrics, and acceptance criteria are not present in this summary document.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.