(101 days)
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.
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 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°. The system instruments include 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.
The provided text describes a 510(k) submission for the OsteoMed ExtremiFuse System, a medical device for foot surgery. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding a study proving acceptance criteria is not present in the provided text.
However, I can extract the available information and highlight what is missing.
Here's a breakdown based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format that the device was tested against. Instead, it states that the device "underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." The performance is reported in terms of "substantial equivalence" to predicate devices based on specific mechanical tests.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Mechanical strength criteria for intended use (not quantified) | Demonstrated substantial equivalence in "pullout test, torque test, and bending test" compared to predicate devices. The device "perform[s] as well or better when compared to the predicate devices for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the text. The document refers to "verification evaluation" and "pullout test, torque test, and bending test," but does not specify the sample sizes (number of implants tested) for these mechanical tests. There is no mention of human subject data, and therefore no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. As this was a mechanical device rather than, for example, an AI diagnostic tool, "ground truth" as typically understood in AI/medical imaging studies (e.g., expert consensus on pathology) is not applicable here. The "truth" in this context would be engineering specifications and mechanical test results, which do not involve expert interpretation in the same way.
4. Adjudication Method for the Test Set
This information is not provided in the text. Adjudication methods (like 2+1 or 3+1) are typically used for clinical endpoints or expert interpretation, which are not detailed in this mechanical equivalence submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems where human readers interpret medical images or data. The OsteoMed ExtremiFuse System is a physical surgical implant, not an AI or diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
A standalone performance study, as typically understood for algorithms without human-in-the-loop, was not done. The "performance" assessment was based on physical mechanical testing of the implant itself, and its comparison to predicate devices, not on an algorithm's output.
7. The Type of Ground Truth Used
For this mechanical device, the "ground truth" used for performance assessment would inherently be the results of established engineering and biocompatibility tests (e.g., precise measurements of pullout strength, torque resistance, bending deflection as per industry standards like ASTM F136 for material or specific test methods for mechanical properties). The text refers to "mechanical strength criteria" and confirms the material (Ti6Al4V) is "biocompatible."
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The OsteoMed ExtremiFuse System is a physical surgical implant, not a data-driven model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of medical device.
Summary of Device Performance and Study:
The OsteoMed ExtremiFuse System's performance was assessed through mechanical testing (pullout, torque, and bending tests) to demonstrate substantial equivalence to legally marketed predicate devices (Pro-Toe VO HammerToe Implant System, OsteoMed Cannulated Screw System, OsteoMed Foot Plating System, K-Wires). The submission states that the device "meets the required mechanical strength criteria for their intended use" and "performs as well or better" than the predicate devices. Clinical testing was explicitly stated as "not required to support substantial equivalence." This means that the assessment relies entirely on engineering principles and comparative mechanical data, rather than clinical efficacy studies or deep statistical analysis of AI model performance.
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Image /page/0/Picture/0 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "Osteomed" in a bold, sans-serif font. The word is enclosed in an oval shape. The oval shape is slightly distorted, with the top and bottom edges being slightly curved.
Submitter Information:
510(k) Summary
MAY 3 1 2013
OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Piedad Peña
Date Prepared:
February 18, 2013
Device Information:
Proprietary/Trade Name: Common Name:
OSTEOMED ExtremiFuse™ System Hammer Toe Implant
Classification Name:
- · Regulation Number: 21 CFR 888.3040
- Regulation Name: Smooth or threaded metallic bone . fixation fastener.
- Product Code: . HWC o
Device Class: II
Predicate Devices:
Pro-Toe VO HammerToe Implant System, K101165
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: Il
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)
Device Class: II
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
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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 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.
The system instruments include 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.
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 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 phalange 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 (Ti6AI4V), the OSTEOMED Cannulated Screw System predicate. This material is biocompatible.
Performance / Clinical Data:
The OSTEOMED ExtremiFuse System was compared to the Pro-Toe VO Hammertoe Implant, the OSTEOMED Cannulated Screw System, and the OSTEOMED Foot Plating System, K-Wires. The ExtremiFuse implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsTEOMED ExtremiFuse implant is the same as the Pro-Toe VO Hammertoe Implant System predicate device (K101165).
Clinical Testing is not required to support substantial equivalence:
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.
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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 Pro-Toe VO Hammertoe Implant System (K101165), and similarities in material, function, and performance to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614).
Substantial equivalence was shown through the pullout test, torque test, and bending test to the predicate devices. The indications, design, technology and operational principles are similar between the subject and predicate, Pro-Toe VO Hammertoe Implant, and therefore OsteoMed believes that the OSTEOMED ExtremiFuse System does not raise any new safety or effectiveness issues.
EFS Page 74 of 302
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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
Letter dated: May 31, 2013
OsteoMed % Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K130412
Trade/Device Name: Osteomed ExtremiFuse System Regulation Number: 21 CFR 888.3040 Regulatory Class: Class II Regulation Name: Smooth or threaded metallic bone fixation fastener Product Code: HWC Dated: March 18, 2013 Received: March 19, 2013
Dear Ms. Peña:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Piedad Peña
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" (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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark Newlelkerson -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): K130412 ......
Device Name: OsteoMed ExtremiFuse System
Indications for 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.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethi @Frank -S
Division of Orthopedic Devices
§ 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.