Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Device Description

Synthes Medium External Fixation System is a system of components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.

AI/ML Overview

The provided 510(k) summary for the Synthes (USA) Medium External Fixation System (K011034) does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for AI/ML-based medical devices or diagnostic tools.

This K011034 submission is for a traditional medical device (an external fixation system for bone fractures), not an AI/ML device. Therefore, the traditional regulatory pathway focuses on substantial equivalence to a predicate device based on material composition, design, intended use, and mechanical/performance testing as opposed to clinical performance metrics like sensitivity, specificity, or AUC which are common for AI/ML diagnostic tools.

Here's why the requested information isn't present in the provided document and what this type of submission typically entails:

Acceptance Criteria and Reported Device Performance (Table): This type of table with performance metrics (e.g., accuracy, sensitivity, specificity) is not applicable to a mechanical device like an external fixator. For such devices, acceptance criteria would typically revolve around mechanical strength, fatigue life, biocompatibility, and sterilization effectiveness (if applicable). These are usually demonstrated through bench testing (e.g., ASTM standards for implants), not clinical performance studies with specific metrics.
Sample Size for Test Set and Data Provenance: Not applicable. There isn't a "test set" of clinical data in the context of AI/ML evaluation. Performance is related to the physical device itself.
Number of Experts and Qualifications: Not applicable. Ground truth for a mechanical device is established through engineering and material science, not expert interpretation of outputs.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable. This type of study compares human reader performance, with and without AI assistance, which is irrelevant for a mechanical fixation device.
Standalone Performance: Not applicable. There is no algorithm performance to assess independently.
Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth for an external fixator would involve validated engineering standards, material specifications, and potentially cadaveric biomechanical testing.
Sample Size for Training Set: Not applicable. There is no "training set" for an AI model.
How Ground Truth for Training Set was Established: Not applicable.

What K011034 does provide and how it demonstrates "performance":

The K011034 submission demonstrates the device's suitability for its intended use through:

Substantial Equivalence: The core of this 510(k) submission is the claim of substantial equivalence to a predicate device (Howmedica Hoffmann® II External Fixation System and Synthes Dynamization Clip). This means demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness than the legally marketed predicate device.
Device Description: Detailed description of components, materials (Stainless steel, titanium alloy, carbon fiber reinforced epoxy), and sizes.
Intended Use: Clearly defined intended use in the treatment of pediatric and adult fractures.

To demonstrate substantial equivalence for a device like an external fixator, the manufacturer would typically submit information regarding:

Mechanical Testing: Data showing that the device components meet or exceed relevant ISO, ASTM, or internal company standards for strength, fatigue, torque, and stiffness under physiological loading conditions. This would demonstrate that the device can withstand the forces it will encounter in the body and maintain fixation.
Biocompatibility Testing: According to ISO 10993, to ensure the materials are safe for patient contact.
Sterilization Validation: If provided sterile, validation of the sterilization process.
Design Specifications: Engineering drawings and specifications.

In summary, the provided document itself does not contain the detailed study results or acceptance criteria in the format requested because it pertains to a mechanical medical device, not an AI/ML-driven solution. The "study" proving its acceptance would be a series of engineering and material tests compared against established safety and performance benchmarks for similar devices, as implied by the substantial equivalence claims. This information would typically be in supporting documents referenced in a full 510(k) submission but not fully detailed in the K011034 summary provided.

Summary

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K011034

JUN 2 7 2001

3.0 510(k) Summary

Sponsor:

Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700

Contact: Bonnie Smith

Synthes Medium External Fixation System Device Name:

Classification: The classification of the Synthes Medium External Fixation System is Class II, as per Title 21 of the Code of Federal Regulations, Sections 888.3030: "Single/multiple component bone fixation appliances and accessories" and 888.3040: "Smooth or threaded metallic bone fixation fastener". The instruments used with this system are considered Class I Exempt, as per 21 CFR 888.4540: "Orthopedic manual surgical instruments".

Predicate Device: The predicate device for the Synthes Medium External Fixation System is the Howmedica Hoffmann® II External Fixation System. Synthes Medium Dynamization Clip, a component accessory to the system, is similar to the currently marketed Synthes Dynamization Clip.

Synthes Medium External Fixation System is a system of Device Description: components that form a construct intended to treat stable and unstable fractures. Frame components designed for this system are the Medium Multi-Pin Clamp and the Medium Combination Clamp. Also included in the system are the Medium Dynamization Clip and Medium Rod Attachment, which are accessories to the clamps that allow dynamization during bone healing and double stacking of the frame, respectively. The system is used with Synthes 8.0 mm carbon fiber rods ranging in lengths from 100 - 500 mm. System pin clamps accept Schanz screws in diameters of 4.0, 4.5 and 5.0 mm.

The Synthes (USA) Medium External Fixation System is intended for Intended Use: use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.

Materials: Clamps -Stainless steel and titanium alloy Dynamization Clip -- Stainless steel Rod Attachment - Stainless steel and titanium alloy Rods - Carbon fiber reinforced epoxy (CFRE)
Premarket Notification 510(k): Synthes (USA) Medium External Fixation System CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

JUN 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K011034

Trade Name: Synthes (USA) Medium External Fixation System Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: April 4 , 2001 Received: April 5, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Bonnie J. Smith

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mhichalairn fr

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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2.0 Indications for Use Statement

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510(k) Number (if known):

K011034

Device Name:

Synthes (USA) Medium External Fixation System

INDICATIONS:

Synthes Medium External Fixation System is intended for the construction of an external fixator frame for the treatment of pediatric and adult fractures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

510(k) Numb

Over-the-Counter Use _

BMitchell/RAduu
(Division Sign-Off)

Division of General, Restorative Premarket Notification 510(k): Synthes (USA) Medium External Fixation System and Neurological Devices CONFIDENTIAL

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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.