LogoFDA 510(k) Search
K Number
K981070
Device Name
20-HOLE ADAPTATION PLATE
Manufacturer
BIOMET, INC.
Date Cleared
1998-05-20

(57 days)

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

The 20-Hole Adaptation Plate is intended for use in the following indications:

  1. comminuted fractures of the naso-ethmoidal infraorbital areas
  2. comminuted fractures of the frontal sinus wall
  3. orbital floor fractures
Device Description

The 20-Hole Adaptation Plate is made of LactoSorb®. LactoSorb®, resorbable copolymer, is a synthetic polyester" derived from lactic and glycolic acids. Polylactic/ polycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft tissue and bone.

AI/ML Overview

The provided text describes a 510(k) submission for the "20-Hole Adaptation Plate" and includes a summary of safety and effectiveness, but it does not contain information about acceptance criteria or a specific study proving the device meets them in the way a modern AI/software device submission would.

The context is a 1998 submission for a medical device (physical product made of LactoSorb®) and not a software/AI product. Therefore, the questions related to AI/software performance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to this document.

Based on the provided document, here's what can be extracted and what cannot be:

1. A table of acceptance criteria and the reported device performance

  • Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the traditional sense for an AI/software device. For a physical device like this plate, the implied acceptance criteria revolve around biocompatibility and biomechanical strength relative to predicate devices.
  • Reported Device Performance:
    • Biocompatibility: "The LactoSorb® material has been found to be biocompatible in both soft tissue and bone."
    • Biomechanical Strength: "The 20-Hole Adaptation Plate was found to have similar biomechanical strength as predicate devices used in similar indications."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not applicable. This information is for AI/software model validation, not a physical implant. The document does not describe a "test set" in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not applicable. This information is for AI/software model validation. The ground truth for a physical device's characteristics (biocompatibility, strength) would typically be established through laboratory testing and materials science evaluations, not expert consensus on data interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable. This is for AI/software model validation.

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 is for AI/software comparative effectiveness.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

  • Not applicable. This refers to AI/software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

  • For biocompatibility: Likely in vitro and in vivo biological testing results.
  • For biomechanical strength: Likely in vitro mechanical testing results.

8. The sample size for the training set

  • Not applicable. This is for AI/software model training.

9. How the ground truth for the training set was established

  • Not applicable. This is for AI/software model training.

In summary, the provided document is a regulatory submission for a physical medical implant from 1998. It addresses safety and effectiveness through statements about biocompatibility and biomechanical equivalency to predicate devices, rather than through the detailed data-driven validation studies typically required for modern AI/software as a medical device (SaMD).

§ 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.