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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Biomet Microfixation. The logo is in black and white and features the word "BIOMET" in large, bold letters on top. Below that, the word "MICROFIXATION" is written in smaller, thinner letters. The logo appears to be for a medical or surgical company.

510(k) Summary

510(k) Number: Date Prepared: Submitter:

K121624 October 2, 2012 Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218-2480

Contact:

Sheryl Malmberg, Global Regulatory Affairs Specialist 904-741-4400 fax 904-741-9425

Common or Usual Name:	Neuro Plating System				Biomet MicrofixationNeuro Plating System	Walter LorenzSurgical K854886	Walter LorenzSurgical K922741	Walter LorenzSurgical K953385
Classification Name:	Preformed AlterableCranioplasty Plate	Burr Hole Cover	Cranioplasty PlateFastener	Material	Titanium	Titanium	Titanium	Titanium
Device Classification:	II (882.5320)	II (882.5250)	HBW (882.5360)	Indicationsfor Use	These devices areimplantable bone platesand bone screws forcranial proceduresincluding:1. Fractures2. Osteotomies3. Reconstructiveprocedures4. Revision procedureswhere other treatmentsor devices have failed.	These devices areimplantable boneplates and bonescrews for oral,cranio-maxillofacialprocedures including:1. Fractures, 2.Osteotomies,includingorthognathicprocedures, 3.Reconstructiveprocedures, and 4.Revision procedureswhere othertreatments or deviceshave failed.	These devices areimplantable boneplates and bonescrews for oral,cranio-maxillofacialprocedures including:1. Fractures, 2.Osteotomies,includingorthognathicprocedures, 3.Reconstructiveprocedures, and 4.Revision procedureswhere othertreatments or deviceshave failed.	These devices areimplantable boneplates and bonescrews for oral,cranio-maxillofacialprocedures including:1. Fractures, 2.Osteotomies,includingorthognathicprocedures, 3..Reconstructiveprocedures, and 4.Revision procedureswhere othertreatments or deviceshave failed.
Device Product Code:	GWO	GXR	HBW	Use	Single	Single	Single	Single
Sterility	Provided non-sterile;steam sterilizationvalidation on file	Provided non-sterile;steam sterilizationvalidation on file	Provided non-sterile;steam sterilizationvalidation on file	Provided non-sterile;steam sterilizationvalidation on file
Shape ofPlates	New shape includes pre-contoured mesh.Additional systemplates include variationsof straight, curved,angle, double angle, L-,T-, double T-, Z-, X-,Y-, double Y-shape,burr hole, triangle,rectangle, square,matrix, and meshoptions with variouslengths and thicknesses.	Variations of straight,curved, L-, T-, Y-shape, matrix, plateoptions.	Variations of straight,square, rectangular,and mesh plateoptions	Variations of straight,angle, curved, L-, T-,double T-, Z-, X-, Y-,double Y-, H-shape,triangle, square,rectangle, matrix,mesh, orbital floor,and LeFort plateoptions.
Screw Sizes	No new screws in thissubmission. Additionalsystem screws range indiameters of 1.0mm to2.3 and lengths from2.0mm to 7.0mm. Headgeometry includescross-drive and centerdrive, with HT (hightorque) and SD (self-drilling) options.	Screws range indiameters of 1.0mmto 2.3mm and lengthsfrom 2.0mm to29.0mmHead geometryincludes cross-driveand center drive, withHT (high torque) andSD (self-drilling)options	Not Applicable	Not Applicable

Device Name: Biomet Microfixation Neuro Plating System

Intended Use:

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

Fractures l .
1. Osteotomies
1. Reconstructive procedures
Revision procedures where other treatments or devices have failed 4.

Contraindications:

Active infection 1.
1. Foreign body sensitivity. Where material sensitivity is to be completed prior to implantation.
1. Patients with limited blood supply, insufficient quantity of bone, or latent infection.
1. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

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.

Sterility Information: The plates and screws will be marketed as non-sterile, single use devices.

Possible risks:

Poor bone formation, Osteolysis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can 1. cause loosening, bending, cracking or fracture of the device.
1. Nonunion or delayed union, which may lead to breakage of the implant.
1. Migration, bending, fracture or loosening of the implant.
Metal sensitivity, or allergic reaction to a foreign body. 4.
న్. Decrease in bone density due to stress shielding.
1. Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
1. Increased fibrous tissue response around the fracture site and/or the implant.
1. Necrosis of bone.
1. Inadequate healing.

OCT 1 2 2012

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1421624

Substantial Equivalence Biomet Microfixation considers the Neuro Plating System modifications equivalent to the Biomet Microfixation (formally Walter Lorenz Surgical) Wuerzburg Titanium Mini Bone Plates and Bone Screws cleared under K854886, Lorenz 1.0 MM System cleared under K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system cleared under K953385. Subject pre-contoured mesh are similar to the predicate devices in terms of material, indications, use, sterility, and design.

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Nonclinical testing: Referenced testing demonstrates that the device can be cleaned and sterilized within the required parameters, demonstrating equivalence to the predicate devices. A worst case scenario of instrumentation was compromised and underwent testing resulting in achieving the required cleaning results as outlined in the testing. The cleaning testing was performed per an FDA approved protocol. Sterility testing, (Reference AAMI TIR 12 and ANSI/AAMI/ISO 17665-1:2006) provided worst case testing by inoculating worst case sample components that then demonstrated results to have been effectively sterilized per required parameters.

Conclusion: This testing data supports the determination of substantial equivalence by demonstrating worst case scenarios for both cleaning and sterilization that fall within acceptable parameters providing a 10 * Sterility Assurance Level (SAL). No new safety and efficacy issues were raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 12 2012

Biomet Microfixation % Ms. Sheryl Malmberg Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, FL 32218

Re: K121624

Trade/Device Name: Biomet Microfixation Neuro Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: September 11, 2012 Received: September 12, 2012

Dear Ms. Malmberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Sheryl Malmberg

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Kesia Alexander

Image /page/4/Picture/6 description: The image shows a handwritten word, "for", in cursive script. The "f" is elongated with a large loop extending below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the overall style is elegant and fluid.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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Indications for Use

K121624 510(k) Number (if known):

Device Name: Biomet Microfixation Neuro Plating System

Indications For 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

AND/OR Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121624

Regulation Number and Section

§ 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).