The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

Device Description

Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.

AI/ML Overview

The provided document is a 510(k) summary for the Biomet Microfixation Sternal Closure System. It is focused on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than describing a clinical study with detailed acceptance criteria and performance metrics typically found in clinical trials for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is not applicable or not available in this type of regulatory submission.

The document primarily describes mechanical non-clinical testing to support the substantial equivalence claim.

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

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity) that a new AI device might have. Instead, the "performance" is demonstrated through mechanical non-clinical testing comparing the device to a predicate.

Characteristic	Acceptance Criteria (Implied by Substantial Equivalence and Bench Testing)	Reported Device Performance (Sternalock Blu Plating System vs. Suture Wire)
Fatigue Testing	Performance at least equivalent to or better than predicate surgical wire for sternal closure.	The Sternalock Blu Plating System demonstrably had better performance compared to stainless steel surgical wire.
Shear Force Testing	Performance at least equivalent to or better than predicate surgical wire for sternal closure.	The Sternalock Blu Plating System demonstrably had better performance compared to stainless steel surgical wire.
Lateral Pull Apart Testing	Performance at least equivalent to or better than predicate surgical wire for sternal closure.	The Sternalock Blu Plating System demonstrably had better performance compared to stainless steel surgical wire.

Study Proving Device Meets Acceptance Criteria:

A mechanical non-clinical testing study was performed.

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

Test Set Sample Size: Not specified in terms of number of samples, but the testing involved a "polyurethane foam substrate" to simulate bone.
Data Provenance: The mechanical testing was conducted using a "polyurethane foam substrate which simulates Osteoporotic bone." The article "Compressive properties of commercially available polyurethane foams as mechanical models for osteoporotic human cancellous bone" by Patel et al. is referenced as the basis for this simulation. This is a retrospective selection of a material model for testing, not real-world patient data.

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

Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of mechanical device testing. The "ground truth" here is the physical properties of the materials and the defined testing methodologies.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication is not relevant for mechanical device testing.

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

No. An MRMC study is relevant for comparing diagnostic performance with and without AI assistance using human readers. This document describes a mechanical device, not a diagnostic AI system.

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

Not Applicable. This is a hardware device, not an algorithm. The testing described is intrinsic to the device's physical properties.

7. Type of Ground Truth Used

Physical properties and standardized test methods. The "ground truth" for this testing is the quantifiable mechanical performance (fatigue, shear force, lateral pull apart) of the device and the predicate under controlled laboratory conditions using a simulated bone substrate.

8. Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI algorithm that requires a training set.

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

Not Applicable. No training set was used.

Summary

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NOV 2 9 2011

510(k) Summarv

September 27, 2011

Contact: Biomet Microfixation 1520 Tradeport Drive : Jacksonville, FL 32218-2480

Kim Reed, Regulatory Affairs Manager kim.reed@biomet.com 904-741-9443 fax 904-741-9425

Device Name: Biomet Microfixation Sternal Closure System Common Name: Plates and Screws

Classification Name: Single/multiple component metallic bone fixation appliances and accessories

Device Product Code: 87HRS (21 CFR 888.3030) Device Classification: Class II

Intended Use: The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

Description: Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

Material: Titanium

Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.

Possible risks:

Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or 1. infection can cause loosening, bending, cracking or fracture of the device.
Nonunion or delayed union, which may lead to breakage of the implant. 2.
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.
Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. 6.
Increased fibrous tissue response around the fracture site and/or the implant. 7.
1. Necrosis of bone.
Inadequate healing. g.
1. Selection of screws which are longer than the depth of the sternum may cause possible impingement on structures internal to the chest wall including vessels, pleura and other structures.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.

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Image /page/1/Picture/1 description: The image shows the logo for Biomet Microfixation. The logo consists of the word "BIOMET" in a stylized font, with the word "MICROFIXATION" underneath in a smaller, sans-serif font. The logo is black and white and appears to be a vector graphic.

Substantial Equivalence: Biomet Microfixation considers the Biomet Microfixation Sternal Closure System to be equivalent to the Lorenz Sternal Closure System with Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biomet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K110789), and Ethicon K931271 and K946173 Stainless Steel Suture Wire.

Characteristic	Device In this submission	Predicates:K011076,K033740,K063506,K110574	Predicates: Synthes K093772and K110789	Ethicon Stainless steel suturewire K931271 and K946173
Design	The Sternal Closure Systemincludes the same plate and screwconfigurations contained in the predicate510k's listed to the right.	Identical	K093772 Titanium plates andscrews plates and screwsK110789 (PEEK Optima LT-3)cable ties with detachable,stainless steel needle.	Stainless steel wire
Material	Plates: TitaniumScrews: Titanium	Plates: TitaniumScrews: Titanium	Plates: TitaniumScrews: TitaniumZipfix: PEEK LT-3	316L Stainless steel
Size Range	Plates: various configurationsScrews: 8mm to 20mm length	Plates: variousconfigurationsScrews:8mm to 20mm length	unknown	Unknown
Indication	The Biomet MicrofixationSternal Closure System isintended for use in thestabilization and fixation offractures of the anterior chestwall including sternal fixationfollowing sternotomy andsternal reconstructive surgicalprocedures, to promotefusion. The BiometMicrofixation Sternal ClosureSystem is intended for use inpatients with normal and poorbone quality.	The Biomet MicrofixationSternal Closure System isintended for use in thestabilization and fixation offractures of the anterior chestwall including sternal fixationfollowing sternotomy andsternal reconstructive surgicalprocedures.	Intended for use in theprimary or secondaryclosure/repair of the sternumfollowing sternotomy orfracture of the sternum tostabilize the sternum andpromote fusion.	Current standard of care forsternal closure applications – allbone typesA nonabsorbable, sterile surgicalsuture composed of 316Lstainless steel. Surgical stainlesssteel suture is available as amonofilament. Indicated for usein abdominal wound closure,hernia repair, sternal closure andorthopaedic procedures includingcerclage and tendon repair.
Non-Clinical Testing
Mechanical testing was performed to compare the Sternalock Blu Plating System to Stainless Steel surgical wire, for sternal closure. The testing wasconducted using a polyurethane foam substrate which simulates Osteoporotic bone (see Patel Article, "Compressive properties of commerciallyavailable polyurethane foams as mechanical models for osteoporotic human cancellous bone") The mechanical testing showed that the SternalockBlu Plating System had better performance compared to stainless steel surgical wire with respect to fatigue testing, shear force testing and lateral

: .

. .

pull apart testing.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white.

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

Biomet Microfixation % Ms. Kim Reed Regulatory Affairs Manager 1520 Tradeport Drive Jacksonville, Florida 32218

NOV 2 9 2011

Re: K111908

Trade/Device Name: Biomet Microfixation Sternal Closure System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: September 27, 2011 Received: October 3, 2011

Dear Ms. Reed:

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

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Page 2 - Ms. Kim Reed

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 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/ReportalProblem/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.

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

Sincerely yours,

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K111908

Device Name: Biomet Microfixation Sternal Closure System

Indications For Use:

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 GDRH, Office of Device Evaluation (ODE)

Mitchel Dues for MXM
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number 111508

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.