In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures. Specific indications:

Metacarpus, proximal and middle phalangeal bones
Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Device Description

Deviet Desertifically cleared under K081588, consists of plates and fixation devices used:

General indications:

Metacarpus, proximal and middle phalangeal bones
Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

The purpose of this Special 510k is to expand the plate sizing and geometry options, and to add a marketing claim. The addition of the plate sizes and geometries are intended to give the user more options to better accommodate varying patient anatomy and varying surgical situations. There are 51 additional plates of varying lengths, widths, thicknesses and contours. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. The added marketing claim is designed to highlight the products use in reconstructive procedures of the thorax which is already covered by the specific indications for use of the predicate device.

AI/ML Overview

The provided text describes a Special 510(k) submission for the BioBridge® Plating System, which is a metallic bone fixation device. The purpose of this submission is to expand the plate sizing and geometry options and add a marketing claim. The underlying technology and intended use remain unchanged from the predicate device (K081588).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Defined in Design Control Activities Summary)	Reported Device Performance
Bending strength	Met acceptance criteria (through worst-case analysis, 4-point bend testing, and simulated use testing)
4-point bend testing	Met acceptance criteria
Simulated use testing	Met acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes mechanical testing of the device modifications. It does not refer to clinical test sets involving patients or patient data. Therefore, questions regarding "sample size for the test set" and "data provenance" in a clinical context are not applicable to this submission. The "test set" in this context refers to the physical samples of the modified plates subjected to mechanical tests. The specific number of samples for each mechanical test (bending, 4-point bend, simulated use) is not specified in the provided text.

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)

This question is not applicable as the submission focuses on mechanical performance testing of a physical device, not on the interpretation of medical data by experts. The "ground truth" here is the physical measurement of mechanical properties.

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

This question is not applicable as there is no human interpretation of data requiring adjudication. The assessment is based on objective mechanical test results.

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

This question is not applicable. The device is a metallic bone fixation system, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable. The device is a physical medical implant, not an algorithm.

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

For the mechanical testing conducted, the "ground truth" would be the physical measurements and engineering specifications for the bending strength, 4-point bend, and simulated use performance of the plates. These are objective, quantifiable metrics.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical medical device.

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

This question is not applicable as there is no training set.

Summary

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K120163(Yz)

FEB 1 7 2012

6. 510(k) Summary

BioBridge® Manufacturer:	ACUTE Innovations21421 NW Jacobson Road, Suite 700Hillsboro, OR 97124
Contact:	Mrs. Mariah KnightRegulatory and Quality ManagerPhone: (503) 686-7200 ext 3300
Date Prepared:	January 12, 2012
	DEVICE INFORMATION
Trade/Proprietary Name	BioBridge® Plating System
Common Name:	Plate, fixation system
Classification:	21 CFR 888.3030, Single/multiple component metallicbone fixation appliances and accessories
Class:	II
Product Code:	HRS
Predicate:	K081588 Re-Zorb Plating System (Acute Innovations)(now called BioBridge® Plating System)

Indications For Use:

General Indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses or manilaning the anginivance of relative position of weak bony tissue (e.g., bone grafts, bone grafts, and mannents from comminuted fractures), in trauma and reconstructive procedures.

Specific indications:

· 1. Metacarpus, proximal and middle phalangeal bones

Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Device Description:

Deviet Desertifically cleared under K081588, consists of plates and fixation devices used:

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General indications:

Metacarpus, proximal and middle phalangeal bones
Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

Comparison to Predicate Device:

The BioBridge® Plating System with these line extensions is substantially equivalent to the predicate previously cleared in K081588 with respect to indications, function, and type of materials and processing. The added marketing claim is substantially equivalent to the predicate system as it is covered by the previously cleared indications for use. None of the changes raise any new issues of safety or efficacy.

Design Controls/Mechanical Performance:

Disten Court conducted on the device modifications as part of the Design Control activities. A worst case analysis of the bending strength, 4-point bend testing, and simulated use testing of the plate additions was conducted. The results demonstrated that the acceptance criteria defined in the Design Control Activities Summary were met.

Conclusion:

Conclusion. BioBridge® Plating System with its line extensions and added marketing claim is substantially equivalent to its predicate device, BioBridge® Plating System, cleared Substantially "Squrrations for use and technological characteristics.

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Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

FEB 1 7 2012

Acute Innovations, LLC. % Ms. Mariah Knight Regulatory and Quality Manager 21421 NW Jacobson Road, Suite 700 Hillsboro, Oregon 97124

Re: K120163

Trade/Device Name: BioBridge® Plating 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: January 12, 2012 Received: January 19, 2012

Dear Ms. Knight:

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 ass black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered 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). and Oosmetic (110) the elevice, 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 r lease of advisou that I Dr. o'laboun that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 oderal statutes and equirements, 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

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Page 2 - Ms. Mariah Knight

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 11 You don't specific aar/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.lua.gom.cn/ Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the 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 r ou may obtain other general ers, 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,

Eric Keith

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

Enclosure

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5. Indications for Use

510(k) Number (if known): K120163

Device Name: BioBridge® Plating System

General Indications:

In the presence of appropriate additional immobilization or fixation, indicated for maintaining the alignment and fixation of bone fractures, osteotomies, arthrodeses mainting the anginish ance of relative position of weak bony tissue (e.g., or bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

Specific indications:

Metacarpus, proximal and middle phalangeal bones
Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax

V Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Signature Of)

(Division S (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Onthopedic, Division of Surges and Restorative Devices

510(k) Number K120163

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.