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K Number
K121624
Device Name
BIOMET MICROFIXATION NEURO PLATING SYSTEM
Manufacturer
BIOMET MICROFIXATION
Date Cleared
2012-10-12

(133 days)

Product Code
GWO,GXR,HBW
Regulation Number
882.5320
Type
Traditional
Panel
NE
Reference & Predicate Devices
K854886,K922741,K953385
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These devices are implantable bone plates and bone screws for neuro procedures including:

    1. Fractures
    1. Osteotomies
    1. Reconstructive procedures
    1. Revision procedures where other treatments or devices have failed
Device Description

Biomet Microfixation manufactures and distributes a variety of internal fixation devices intended to aid in the alignment and stabilization of bone in the cranial skeletal system. Instrumentation has been designed specifically for use with each system of implants.

The Biomet Microfixation Cranio/Neuro Plaing System is comprised of a variety of titanium plates and screws with shapes and sizes intended to aid in the alignment and stabilization of bone in the cranial skeletal system.

The plates include variations of straight, angle, double angle, L-shape, Z-shape, X-shape, burr hole, triangle, square, matrix, mesh, and crescent options with various lengths and thickness. The screws range in diameters of 1.0mm to 2.3mm and lengths from 3.0mm to 6.0mm.

AI/ML Overview

The provided text details the 510(k) summary for the Biomet Microfixation Neuro Plating System, demonstrating its substantial equivalence to previously cleared predicate devices. However, it does not describe a study involving acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert ground truth adjudication, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

  • Device Description and Intended Use: The Neuro Plating System includes titanium plates and screws for cranial procedures such as fractures, osteotomies, reconstructive procedures, and revision procedures.
  • Substantial Equivalence: The submission argues that the Neuro Plating System modifications are equivalent to existing predicate devices (Walter Lorenz Surgical Wuerzburg Titanium Mini Bone Plates and Bone Screws K854886, Lorenz 1.0 MM System K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system K953385) in terms of material, indications, use, sterility, and design.
  • Nonclinical Testing: The only "testing" mentioned relates to cleaning and sterilization processes for the device components. This testing aimed to prove that the device can be cleaned and sterilized effectively to achieve a 10⁻⁶ Sterility Assurance Level (SAL), thus ensuring safety for use.

Therefore, since the document does not contain information about acceptance criteria for device performance (beyond sterility and cleaning), a study demonstrating clinical or diagnostic performance, or details regarding data sets, experts, or comparative effectiveness studies, I cannot fill out the requested table or provide answers to most of the specific questions.

Here's an overview of what can be gathered from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

  • Acceptance Criteria Mentioned: The only quantitative acceptance criteria stated relate to cleaning and sterilization.
    • Cleaning: Achieved "required cleaning results as outlined in the testing." (No specific metric provided)
    • Sterility: Achieved a "10⁻⁶ Sterility Assurance Level (SAL)."
  • Reported Device Performance:
    • Cleaning: "demonstrates that the device can be cleaned... within the required parameters."
    • Sterility: "demonstrated results to have been effectively sterilized per required parameters."
    • Beyond cleaning and sterility, there is no performance data related to the device's efficacy in treating fractures, osteotomies, etc., as this is a substantial equivalence submission based on predicate devices, not a de novo clinical performance study.

2. Sample size used for the test set and the data provenance

  • N/A. The document describes nonclinical testing for cleaning and sterilization, not a clinical "test set" for device performance on patients. The "worst case sample components" were used for sterility testing, but the number is not specified, nor is the "data provenance" in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

  • N/A. Not applicable as this is not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.

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

  • N/A. Not applicable.

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

  • N/A. This is a medical device (bone plates and screws), not an AI/diagnostic software. No MRMC study was performed.

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

  • N/A. This is a physical medical device.

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

  • N/A. The "ground truth" here is compliance with cleaning and sterilization standards, not clinical outcomes.

8. The sample size for the training set

  • N/A. Not applicable. No training set for an algorithm described.

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

  • N/A. Not applicable.

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).