The iBalance AKRxx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.

Device Description

The iBalance AKRFx Medial Opening Wedge Tibial System is comprised of an instrumentation set (AKRFX Medial Instrumentation), a PEEK wedge-like implant (the iFX® Medial PEEK Implant) and PEEK fixation (the iFX® Medial PEEK Cancellous and Cortical Anchors). The system enables surgeons to perform a high tibial opening wedge osteotomy with fixation. The iFX® Medial PEEK Implant is provided in three general sizes; Small (SM), Medium (MD), and Large (LG). Two configurations of implant and anchors exist. The implant and anchors work as a single construct to fixate and support the opening wedge at its corrective angle.

AI/ML Overview

The provided 510(k) summary for the iBalance Medical, Inc.'s AKRyx Medial Opening Wedge Tibial System does not contain detailed acceptance criteria or a comprehensive study report that would allow for a complete description of the device's performance against specific acceptance criteria. The document states that the system meets certain standards and that testing was performed, but it lacks the quantitative results and methodologies typically expected for such a report.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Biocompatibility	Meet ISO 10993-1 standard (for PEEK materials)	"Biomaterials... meet standard ISO 10993-1 standard for biocompatibility"
	Meet ASTM F 899 (for stainless steel)	"Biomaterials... meet... ASTM F 899 for stainless steel"
Physical Properties	Comparable to the Arthrex System predicate device (based on ASTM F 2077)	"Performance testing according to ASTM F 2077 compared physical properties of the iBalance AKREX System to the Arthex System predicate device."
Instrumentation Functionality	Enable proper placement of the iFX implant and anchors	"cadaver studies demonstrated the performance of the AKREx Instrumentation cnables the proper placement of the iFX implant and anchors."
Clinical Safety	Differences in design do not raise new safety issues; healing of osteotomy not adversely affected (compared to predicates)	"the company's clinical safety study shows that the differences in the iFX® Medial PEEK Implant System do not raise new safety issues and healing of the osteotomy is not adversely affected by differences in device design as compared to the predicates."
Overall Functionality	"functioned as intended"	"In all instances, the iBalance AKRFX Medial Opening Wedge Tibial System functioned as intended and testing results observed were as expected."

Important Note: The "Reported Device Performance" in the table above paraphrases the statements made in the 510(k) summary. The document does not provide specific data points (e.g., tensile strength values, specific biomechanical outcomes, success rates, complication rates) that would allow for a direct comparison against quantitative acceptance criteria. The statements are general affirmations of compliance or performance.

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

Test Set Sample Size: Not specified for any of the studies mentioned.
Data Provenance:
- Biomaterials: Implied to be laboratory testing against ISO and ASTM standards.
- Physical Properties: Laboratory testing (ASTM F 2077).
- Instrumentation Functionality: "cadaver studies" – suggests prospective, ex-vivo data.
- Clinical Safety: "clinical safety study" – suggests prospective human data. No country of origin is specified.

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

This information is not provided in the summary. For the cadaver studies, it's implied that surgeons or trained personnel evaluated placement, but no details on their number or qualifications are given. For the clinical safety study, it's not stated how "ground truth" (e.g., successful healing, lack of adverse events) was established or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study is not mentioned. The document describes studies on the device's physical properties, biocompatibility, and clinical safety, but not on human reader performance with or without the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical medical implant system, not an AI algorithm.

7. The Type of Ground Truth Used

Biocompatibility/Physical Properties: Ground truth is established by standardized material testing (ISO 10993-1, ASTM F 899, ASTM F 2077) and comparison to predicate device characteristics.
Instrumentation Functionality: "Proper placement" in cadaver studies would likely be determined by expert observation during and after the procedure using the instrumentation. This could be considered expert consensus/observation in a controlled cadaveric setting.
Clinical Safety: "No new safety issues" and "healing of the osteotomy is not adversely affected" would be determined through clinical assessments, follow-up imaging, and patient outcomes in a clinical study. The specific methods for establishing this "ground truth" (e.g., radiographic evidence of union, absence of infection, pain scores) are not detailed.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical implant, not an AI/machine learning model that requires a training set.

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

This question is not applicable for the same reason as above.

Summary

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510(k) Summary

iBalance Medical, Inc.'s AKRyx Medial Opening Wedge Tibial System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

iBalance Medical, Inc. 4900 Nautilus Court, Ste 100 Boulder, CO 80301 Phone: 303-381-6333 Facsimile: 303-530-0530

OCT 2 7 2009

Contact Person: Kelly Ammann

Date Prepared: August 4, 2009

Name of Device and Name: AKREx Medial Opening Wedge Tibial System

Common or Usual Name: Opening Wedge Osteotomy device

Classification Name: Bone fixation appliances and accessories

Predicate Devices

Arthrex, Inc.'s Titanium Opening Wedge Osteotomy System (K032187) Spine Wave, Inc.'s Wafer System (K033303) Synthes Spiked Washer (K011583) Cayenne AperFix Interference Screw (K073426) Cayenne AperFix Implant (K083607)

Intended Use / Indications for Use

The iBalance AKRFX Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.

Technological Characteristics

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K092381 2/2

510(k) Summary

The iFX® Medial PEEK Implant is provided in three general sizes; Small (SM), Medium (MD), and Large (LG). Two configurations of implant and anchors exist. The implant and anchors work as a single construct to fixate and support the opening wedge at its corrective angle.

Performance Data

Biomaterials in the AKREX Medial Opening Wedge Tibial System meet standard ISO 10993-1 standard for biocompatibility or ASTM F 899 for stainless steel. Performance testing according to ASTM F 2077 compared physical properties of the iBalance AKREX System to the Arthex System predicate device. In addition, cadaver studies demonstrated the performance of the AKREx Instrumentation cnables the proper placement of the iFX implant and anchors. Lastly, the company's clinical safety study shows that the differences in the iFX® Medial PEEK Implant System do not raise new safety issues and healing of the osteotomy is not adversely affected by differences in device design as compared to the predicates.

In all instances, the iBalance AKRFX Medial Opening Wedge Tibial System functioned as intended and testing results observed were as expected.

Substantial Equivalence

The iBalance AKREX Medial Opening Wedge Tibial System is as safe and effective as the identified predicate devices. The iBalance AKREX Medial Opening Wedge Tibial System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the iBalance AKREx Medial Opening Wedge Tibial System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the iBalance AKRpx Medial Opening Wedge Tibial System is as safe and effective as the identified predicate devices. Thus, the iBalance AKREx Medial Opening Wedge Tibial System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

iBalance Medical. Inc. % Hogan & Hartson LLP % Ms. Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103

OCT 2 7 2009

Re: K092381

Trade/Device Name: iBalance AKRFx Medial Opening Wedge Tibial System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 4, 2009 Received: August 5, 2009

Dear Ms. Hogan:

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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Page 2 - Ms. Janice M. Hogan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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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Indications for Use

510(k) Number (if known):

Device Name: iBalance® AKRFx Medial Opening Wedge Tibial System

Indications for Use:

"The iBalance AKRxx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies.

It is intended to be used with adequate post-operative immobilization."

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)

Omite for Mxm

(Division Sign-0 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092381

Page I of I

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.