The Biomet Microfixation PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for mandible reconstruction procedures. The plates include variations of straight, angle, curved, Y-shape, double Y-shape, and matrix, options with various lengths and thickness. Plates are offered flat or pre-bent. Pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K063052 (cleared 01/12/07), K113152 (cleared 06/29/12), and K081067 (cleared 05/09/08). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K063052.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Acceptance Criteria and Study for Biomet Microfixation PreBent Plates with Virtual Surgical Planning

Based on the provided 510(k) summary, the device submission does not include specific acceptance criteria or performance data for the "PreBent Plates with Virtual Surgical Planning" device itself. Instead, the submission relies on the substantial equivalence principle, arguing that the new device is essentially the same as previously cleared predicate devices, with an added option of using the VSP system for pre-bending.

The core argument is that the pre-bent plates are "100% verified to the Medical Modeling output, anatomical model, for every case," which implies that the accuracy of the bending process is continuously checked against a patient-specific anatomical model created by Medical Modeling.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria:
Plates conform to patient-specific anatomical model	"Because the plates are verified to a patient specific model they are 100% verified to the Medical Modeling output, anatomical model, for every case."
Material equivalence to predicate devices	"The subject PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design."
Design equivalence to predicate devices	"The subject PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design."
Indications for Use equivalence to predicate devices	"The subject PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design."

Explanation: The document states that "no additional testing was conducted on the subject plates" because they "are identical" to cleared predicate devices, with the only difference being the method of shaping (using the VSP system and patient-specific guides/instruments). The acceptance criteria are, therefore, implicitly tied to the established safety and effectiveness of the predicate devices and the verification of the custom bending process.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No dedicated test set, clinical, or non-clinical testing was performed for the current submission. The justification for safety and effectiveness is based on substantial equivalence to predicate devices and a process specification for bending and inspection.
Data Provenance: Not applicable, as no new testing data was generated for this submission. The "provenance" for the justification comes from the cleared status of the predicate devices and Biomet Microfixation's internal process specifications for plate bending and inspection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No specific expert review of a test set for this submission is mentioned. The "ground truth" for the pre-bent plates is the patient-specific anatomical model generated by Medical Modeling from CT scans provided by the surgeon.
Qualifications of Experts: The CT scans are provided by a "surgeon," and Medical Modeling creates the anatomical model. The document does not specify the qualifications of the surgeons or the personnel at Medical Modeling involved in creating the anatomical models.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was used. The verification process is described as "100% verified to the Medical Modeling output, anatomical model, for every case," implying a direct comparison rather than an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable. This device is a physical medical implant (bone plates) and a virtual surgical planning process for custom-bending these plates, not an AI diagnostic algorithm that assists human readers in interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? No. This device is not an algorithm for standalone performance evaluation in the typical sense (e.g., diagnostic image analysis). The "Virtual Surgical Planning" aspect refers to the use of software (the VSP System) to create patient-specific models and guides that aid in the manual pre-bending of plates, which is then verified.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the custom bending of the plates is the patient-specific anatomical model created by Medical Modeling from the patient's CT scans. This model dictates the precise contours to which the plates are bent.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device submission is for a physical implant (pre-bent plates) and a process, not a machine learning algorithm that requires a training set. The VSP system (K120956), which creates the anatomical model, would have had its own validation/verification at the time of its clearance, but details of its training set are not part of this submission.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device in the context of the current submission.

Summary

{0}------------------------------------------------

510(k) Summary

Date Prepared:	August 1, 2013
Manufacturer:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218-2480
Contact:	Elizabeth WheelerRegulatory Affairs Specialist904-741-4400 x 9558
Proprietary Name:	Biomet Microfixation PreBent Plates with Virtual SurgicalPlanning
Common or Usual Name:	Bone Plate
Device Classification:	Class II
Device Product Code:	76 JEY (21 CFR 872.4760)
Secondary DeviceProduct Code(s):	76 DZJ90 LLZ
Predicate Device:	K063052- Lorenz Titanium Fracture/ Reconstruction Devices andPre-Bent PlatesK120956- VSP System (Medical Modeling)K113512- Biomet Microfixation Mandibular Fracture/Reconstruction Devices and Pre-Bent Plates SystemK081067- Fracture/Reconstruction System (TraumaOne)
AUG 0 8 2013

Device Description:

{1}------------------------------------------------

is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K063052.

Indications for Use:

For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Possible Risks:

1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can 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.
1. Metal sensitivity or allergic reaction to a foreign body.
1. 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.

Technological Characteristics:

The subject PreBent Plates with Virtual Surgical Planning devices are identical to the predicate devices in terms of indications, use, material, and design. The only difference between the subject device and the predicate device is that the subject device, is not only shaped based on an anatomical specific model, but also the provided patient specific guides and instruments of the VSP System (K 120956, cleared December 12, 2012), where the predicate pre-bent plates are shaped based on an anatomical specific model only, Biomet Microfixation has a process specification for bending plates and an inspection criteria to verify the plate matches the anatomical model. Because the plates are verified to a patient specific model they are 100% verified to the Medical Modeling output, anatomical model, for every case. Therefore, no additional testing was conducted on the subject plates.

Sterility Information:

The plates will be marketed as non-sterile, single-use devices.

Clinical Testing:

Clinical testing was not performed to support this submission.

Non-Clinical Testing:

Non-clinical testing was not performed, as the predicate plates have been previously cleared and the subject devices are identical. We have provided the process specification for bending the plates and inspection criteria for inspecting the output to ensure the proper alignment to the anatomical model.

{2}------------------------------------------------

Substantial Equivalence Conclusion:

When compared to the predicate devices, Lorenz Titanium Fracture/ Reconstruction Devices and Pre-Bent Plates (K063052, cleared 01/12/07), Fracture/Reconstruction System (TraumaOne) (K081067, cleared 05/09/08) and Biomet Microfixation Mandibular Fracture Reconstruction Devices and Pre-Bent Plates System (K113152, cleared 06/29/12), substantial equivalence is based on the same indications for use and technological characteristics. The subject devices are identical to the predicate devices, but an update to the labeling will be made to give the option of the prebent plates with Medical Modeling VSP System to include patient specific guides, instruments and anatomical model.

Based on the determination that no clinical or non-clinical testing was deemed necessary, it can be concluded that the subject devices, PreBent Plates with Virtual Surgical Planning, are safe and effective and perform as well as the predicate devices. Therefore, we conclude that the subject devices are substantially equivalent.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 8, 2013

Biomet Microfixation Ms. Elizabeth Wheeler Regulatory Affairs Specialist 1520 Tradeport Drive JACKSONVILLE FL 32218-2480

Re: K131674

Trade/Device Name: Biomet Microfixation PreBent Plates with Virtual Surgical Planning Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZJ, LLZ Dated: July 8, 2013 Received: July 11, 2013

Dear Ms. Wheeler:

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 for ase saled in the May 28, 1976, the enactment date of the Medical Device Amendments, or 10 conninered processified 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 I ou may merelor symbols of the Act include requirements for annual registration. Ilisting of general controls provide in of active, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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.

{4}------------------------------------------------

Page 2 - Ms. Wheeler

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Kwame O. Ulmer -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Biomet Microfixation Special 510(k)-PreBent Plates with Virtual Surgical Planning

Indications for Use

510(k) Number (if known): |૮٦ | ٢٠٦ | ١٦ |

Device Name: Biomet Microfixation PreBent Plates with Virtual Surgical Planning

Indications For Use: For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

Prescription Use xx AND/OR (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)

Andrew I. Steen -S 2013.08.06 09:33:55 -04'00'

Division Sign-Off) rivision of Anesthestology, General Hospital ifection Control, Dental Devices

Page 1 of 1

510(k) Number: الح الك اك اك

Regulation Number and Section

§ 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.