The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Device Description

The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 4 diameter sizes of 2.0mm, 2.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.

The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.

The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

AI/ML Overview

The provided text describes the regulatory clearance for the "OSTEOMED ExtremiFuse System" and does not contain information about an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence, which is a different type of evaluation from an AI/ML model.

Here's the information based on the document:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (K130412, K111536)	"The device was evaluated to be safe and effective in performing as well or better when compared to the predicate devices for the intended use."
Meets required mechanical strength criteria	"The ExtremiFuse implants underwent verification to ensure that the design features met the required mechanical strength criteria for their intended use."
Similar indications for use, function, design, technology, operational principles	"Substantial equivalence was shown through the pullout test, and bending test to the predicate devices. The indications, design, technology and operational principles are similar between the subject and predicate..."
Similar material, function, performance, and operating principles	"...and similarities in material, function, performance, and operating principles to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614)."
Does not raise new safety or effectiveness issues	"...OsteoMed believes that the addition of the 2.0mm implant to the scope of OSTEOMED ExtremiFuse System does not raise any new safety or effectiveness issues."

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

The document does not specify a "sample size" for a traditional clinical "test set" in the context of an AI/ML device. Instead, it refers to mechanical testing.

Sample Size for Mechanical Testing: Not explicitly stated. The document mentions "The ExtremiFuse implants underwent verification..." and references "pullout test, and bending test." It does not provide the number of implants tested.
Data Provenance: Not applicable in the context of clinical data. This refers to mechanical performance testing of the device itself.

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. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images or diagnoses) was not established for this type of device submission. The "ground truth" here is adherence to mechanical performance standards and achieving substantial equivalence to predicate devices.

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

Not applicable. There was no clinical assessment requiring adjudication by multiple experts. The evaluation was based on mechanical testing and comparison to predicate devices.

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

No. An MRMC comparative effectiveness study is designed for AI/ML devices involving human readers. This submission is for a physical orthopedic implant and does not involve AI/ML or human readers in that capacity.

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

Not applicable. This device is not an algorithm or AI system. It is a physical implant.

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

The "ground truth" for this device's evaluation was based on:

Mechanical performance standards: The device's physical properties (e.g., strength, durability in pullout and bending tests) were verified against established criteria for its intended use.
Comparison to predicate devices: The device's design, materials, function, and performance were compared to already legally marketed predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. No AI/ML model was trained.

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

Not applicable. No AI/ML model was trained.

Summary

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Image /page/0/Picture/1 description: The image shows the word "OSTEOMED" in bold, black letters. The word is slightly slanted to the right. There is a black oval shape surrounding the word, which gives the impression of a logo or brand name. The background is white.

FEB 2 8 2014

Special 510(k) Summary

Submitter Information:

OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601

Contact Person:

Blesson Abraham

Date Prepared:

January 31, 2014

Device Information:

Proprietary/Trade Name: Common Name:

OSTEOMED ExtremiFuseTM System Hammer Toe Implant

Classification Name:

· Regulation Number: 21 CFR 888.3040
· Regulation Name: Smooth or threaded metallic bone fixation fastener
· Product Code: o HWC

Device Class: II

Predicate Devices:

OsteoMed ExtremiFuse System, K130412

Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)

Device Class: II

Metasurg DigiFuse System, K111536

Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)

Device Class: II

OsteoMed Foot Plate and Screw Rigid Fixation System, K091614

Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)

Device Class: II

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OsteoMed Extended 2.0/2.4 Cannulated Screw System, K062863

Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)

888.3046

Device Class: II

Device Description:

The system instruments include guide wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.

Intended Use:

The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Technological Characteristics:

The 2.0mm OSTEOMED ExtremiFuse implant is recommended for arthrodesis of the proximal interphalangeal (PIP) joints of the Lesser Digits. The threaded portion of the implant is screwed into the proximal phalance to engage the bone and create a solid base. Following pilot drilling. the barbed side is pressed into the remaining distal phalange to create bone to bone contact during fixation.

ExtremiFuse devices are manufactured from titanium alloy (Ti6Al4V). This material is biocompatible.

Performance / Clinical Data:

The 2.0mm OSTEOMED ExtremiFuse System implants were compared to the Metasurg DigiFuse Implant, the OSTEOMED Cannulated Screw System, and the OSTEOMED Foot Plating System, K-Wires. The ExtremiFuse implants underwent verification to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OSTEOMED 2.0mm ExtremiFuse implant is the same as the OsteoMed ExtremiFuse System (K130412) and Metasurg DigiFuse Implant System (K101165).

Clinical Testing is not required to support substantial equivalence.

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In conclusion, the device was evaluated to be safe and effective in performing as well or better when compared to the predicate devices for the intended use.

Substantial Equivalence:

A design and dimensional comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary. The basis of substantial equivalence for this device is based on similarities in intended use, function, performance, design, technology and operational principles to the OsteoMed ExtremiFuse System (K130412), Metasurg DigiFuse System (K111536), and similarities in material, function, performance, and operating principles to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614).

Substantial equivalence was shown through the pullout test, and bending test to the predicate devices. The indications, design, technology and operational principles are similar between the subject and predicate, OsteoMed ExtremiFuse System, Metasurg DigiFuse System, and therefore OsteoMed believes that the addition of the 2.0mm implant to the scope of OSTEOMED ExtremiFuse System does not raise any new safety or effectiveness issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 28, 2014

OsteoMed Blesson Abraham Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001

Re: K140283

Trade/Device Name: OsteoMed ExtremiFuse™ System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 31, 2014 Received: February 4, 2014

Dear Mr. Blesson Abraham:

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

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Page 2 - Mr. Blesson Abraham

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" (2).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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Vincent J. Devlin -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140283

Device Name OsteoMed ExtremiFuse System

Indications for Use (Describe)

The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE FERE FOR FOR FOR FOR FOR FOR FOR FOR THE FOR THE FOR THE FORM 4 1575 - 3 ੱਡ ਅੰਤ ਦੇ ਸ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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.