The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

Device Description

The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Biomet Microfixation Sternalock® 360 Sternal Closure System. It is a submission to the FDA for a medical device and not a study proving a device meets acceptance criteria. Rather, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System) rather than performing new studies against specific performance acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable in the context of this 510(k) submission.

Here's why and what information can be extracted:

No new performance studies were conducted or required to demonstrate substantial equivalence. The document explicitly states:
- "Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence."
- "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

This means there's no data available in this document to populate most of your requested fields directly, as the device's performance was not re-evaluated against new acceptance criteria. The FDA's substantial equivalence determination implies that the predicate device already met established safety and effectiveness criteria, and the new device is sufficiently similar.

However, to address your request based on the spirit of the question and the available information:

1. Table of acceptance criteria and the reported device performance:

Since no new performance studies were conducted, there are no specific new acceptance criteria and reported device performance from this submission. The acceptance criteria would conceptually align with the predicate device's demonstrated safety and effectiveness.

Acceptance Criteria Category	Reported Device Performance (N/A for new studies in this submission)
Indications for Use:	Met by substantial equivalence to predicate device
* Stabilization & fixation of sternal fractures	Intended for use in stabilization and fixation of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive procedures.
* Promote fusion	Intended to promote fusion.
* Use in normal/poor bone quality	Intended for use in patients with normal and/or poor bone quality.
Contraindications:	Met by substantial equivalence to predicate device
* Active infection	Identical to predicate device.
* Foreign body sensitivity	Identical to predicate device.
* Unwilling/incapable patients for post-op care	Identical to predicate device.
Device Design:	Met by substantial equivalence to predicate device
* Equivalent to predicate	"The design of the subject devices is equivalent to the predicate devices."
Material Composition:	Met by substantial equivalence to predicate device
* Equivalent to predicate	"The materials of the subject devices are equivalent to the predicate devices."
Sterilization Method:	Met by substantial equivalence to predicate device
* Equivalent to predicate	"The sterilization method (steam sterilization) of the subject devices is equivalent to the predicate devices."
Sterility & Endotoxin:	Met for provided sterile implants
* Bacterial endotoxin limit met	"Bacterial endotoxin testing was completed and met the defined endotoxin limit defined in FDA Guidance..."

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. No new test set was used as no new non-clinical or clinical studies were performed.

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. No new ground truth for a test set was established.

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

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

Not applicable. This device is a mechanical sternal closure system, not an AI or imaging device.

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

Not applicable. This device is a mechanical sternal closure system, not an algorithm.

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

Not applicable. The submission relies on the established safety and effectiveness of the predicate device as a "ground truth" for substantial equivalence rather than generating new ground truth data for this specific submission.

8. The sample size for the training set

Not applicable. No new training set was used.

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

Not applicable.

Summary of what the submission does state:

The changes proposed in this 510(k) were primarily to update the Package Insert to provide additional information to users. The claim for substantial equivalence rests on the following similarities to the predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System):

Identical indications for use and contraindications.
Equivalent device design.
Equivalent sterilization method (steam sterilization).
Equivalent materials.

The FDA concluded that "any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

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

November 23, 2016

Biomet Microfixation Lauren Jasper Senior Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K163007

Trade/Device Name: Biomet Microfixation Sternalock® 360 Sternal Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 25, 2016 Received: October 28, 2016

Dear Ms. Jasper:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K163007

Device Name: Biomet Microfixation SternaLock® 360 Sternal Closure System

Indications for Use: The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

Prescription Use xx (Part 21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1

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Image /page/3/Picture/1 description: The image shows the logo for Biomet Microfixation. The word "BIOMET" is in large, bold, black letters. Below that, in smaller gray letters, is the word "MICROFIXATION". There is a thin green line separating the two words.

One Surgeon. One Patient.

510(k) Summary

Prepared November 22, 2016

Submitter:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218
Contact:	Lauren Jasper, Senior Regulatory Affairs Specialistlauren.jasper@zimmerbiomet.comTelephone: (904) 741-9259Fax: (904) 741-9425

Device Name: Biomet Microfixation SternaLock® 360 Sternal Closure System

Common or Usual Name: Bone Plate

Classification Name: Plate, Fixation, Bone

Device Classification:

Product Code	ClassificationName	DeviceClassification	RegulationNumber	Regulation Description
HRS	Plate, Fixation,Bone	2	888.3030	Single/multiple componentmetallic bone fixationappliances and accessories

Contraindications: 1. Active infection. 2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation. 3. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.

Device Description: The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.

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Predicate Devices:

K151019, Biomet Microfixation SternaLock® 360 Sternal Closure System

The similarities of the subject devices to the predicate devices are as follows:

. The indications for use and contraindications are identical to that of the predicate device.
The design of the subject devices is equivalent to the predicate devices.
The sterilization method (steam sterilization) of the subject devices is equivalent to the predicate ● devices.
The materials of the subject devices are equivalent to the predicate devices.

The changes proposed by this Special 510K are to update various sections of the Package Insert to provide additional information to users.

Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence.

Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence.

Sterilization Information: The implants are provided sterile by the manufacturer; sterilization method is exposure to Ethylene Oxide gas. Implants are single use and cannot be re-sterilized by the user. The reusable instrumentation (identified by outer product label) is provided non-sterile to be sterilized by the end user.

Bacterial endotoxin testing was completed and met the defined endotoxin limit defined in FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile."

Substantial Equivalence: The proposed devices have indications for use as the predicate devices. The submission demonstrates that (1) any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates. It is concluded that the information included in this summary supports substantial equivalence.

Regulation Number and Section

§ 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.