The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.

AI/ML Overview

This document describes the PRECICE Trauma Nail System, which is an intramedullary nail for fixing long bone fractures, pseudoarthrosis, mal-unions, and non-unions. The submission is a Special 510(k) focusing on modifications to an already cleared predicate device (PRECICE Trauma Nail System, K113695).

Based on the provided text, the device itself is a mechanical intramedullary nail system and thus the studies performed are not human-in-the-loop AI studies, nor does the device rely on AI/ML, algorithms, or data for ground truth establishment. Instead, the studies are focused on demonstrating the mechanical and functional equivalence of the modified device to its predicate.

Here's an analysis based on the provided text, with clarifications where the requested information is not applicable to this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device through engineering and performance testing, rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, etc.). The "performance" here refers to the physical and functional attributes of the modified nail.

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (Summary)
Design Equivalence	Same intended use	Identical intended use
	Same principles of operation	Same principles of operation
	Similar materials	Same materials as modified PRECICE Nail in PRECICE Intramedullary Limb Lengthening System
	Similar technological characteristics	Same technological characteristics as modified PRECICE Nail in PRECICE Intramedullary Limb Lengthening System
Physical/Functional Equivalence	Mechanical Testing (e.g., strength, fatigue)	Performed on referenced PRECICE Intramedullary Limb Lengthening System
	Design Verification Testing	Performed on referenced PRECICE Intramedullary Limb Lengthening System
	Magnetic Field Safety Testing	Performed on referenced PRECICE Intramedullary Limb Lengthening System
	Packaging and Shelf-life Validation	Performed on referenced PRECICE Intramedullary Limb Lengthening System
	Sterilization Validation	Performed on referenced PRECICE Intramedullary Limb Lengthening System
	Biocompatibility Testing	Performed on referenced PRECICE Intramedullary Limb Lengthening System
Specific Modifications	Incorporation of design changes from PRECICE Intramedullary Limb Lengthening System	Achieved
	Addition of 8.5mm diameter nail	Included in product offerings
	Supplied pre-distracted by 10mm	Confirmed for compression fracture reduction techniques

Study Details:

The study described is not a clinical trial or an AI/ML performance study. It's a benchtop and engineering study demonstrating that the modifications to the PRECICE Trauma Nail System (specifically, adopting design changes from the PRECICE Intramedullary Limb Lengthening System and adding an 8.5mm diameter) do not alter the substantial equivalence to the previously cleared predicate PRECICE Trauma Nail System. The core studies (mechanical, design verification, magnetic field safety, packaging/shelf-life, sterilization, biocompatibility) were performed on the referenced PRECICE Intramedullary Limb Lengthening System, and these results were deemed applicable because the modified PRECICE Trauma Nail is identical in design to the PRECICE Nail in that system, with the only difference being the pre-distraction feature.

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

Sample Size: Not applicable in the context of "test set" for data-driven AI/ML models. The "test set" here refers to the actual physical devices (or components) subjected to various engineering and performance tests. The document doesn't specify the exact number of nails or components tested, but it implies standard engineering testing practices where a sufficient number of samples are used to ensure statistical confidence in results (though specific numbers aren't provided in this summary).
Data Provenance: Not applicable in the context of country of origin of data or retrospective/prospective clinical data for AI/ML. The "data" comes from laboratory and benchtop testing of the specific medical device components.

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

Not applicable. "Ground truth" in this context is established by engineering specifications, validated test methods, and regulatory standards for mechanical and material performance, not by expert consensus on clinical findings. The evaluation is done by engineers and scientists, not clinical experts for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes. The "adjudication" in an engineering context would refer to internal validation and review processes by qualified engineers to ensure test protocols were followed and results were interpreted correctly, but this is not typically detailed in 510(k) summaries in the same way as clinical adjudication.

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

Not applicable. This is not an AI/ML device and does not involve human readers or image interpretation.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering specifications, material properties, and performance standards for intramedullary fixation rods. For example, the ground truth for mechanical testing would be the breaking point, fatigue life, or magnetic field compatibility as defined by relevant ISO or ASTM standards, and comparative performance to the predicate device's established performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth.

Summary

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JUN 3 0 2014

May 2014 Product Code: HSB

PRECICE® Trauma Nail System 510(k) Summary - K TBD May 2014

1.	Company:	Ellipse Technologies, Incorporated13900 Alton Parkway, Suite 123Irvine, CA 92618
	Contact:	Rebecca ShelburneRegulatory Affairs SpecialistPhone: (949) 837-3600 x227Fax: (949) 837-3664
	Date Summary Prepared:	May 29, 2014
2.	Proprietary Trade Name:	PRECICE Trauma Nail System
3.	Common Name:	Intramedullary Nail
4.	Classification Name:	Intramedullary Fixation Rod (21 CFR 888.3020)
5.	Product Code:	HSB (Rod, Fixation, Intramedullary and Accessories)

Product Description: The Ellipse PRECICE Trauma Nail System is composed of the modified PRECICE Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The modified PRECICE Nail is supplied sterile by gamma radiation while the locking screws and accessories are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques.

Indications: The Ellipse PRECICE Trauma Nail System is indicated for closed fracture 7. fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.

Substantial equivalence: A detailed comparison to the predicate device demonstrates 8. that the Ellipse PRECICE Trauma Nail System is substantially equivalent to the following 510(k) cleared device:

Trade Name:	PRECICE® Trauma Nail System
Common Name:	Intramedullary Fixation Rod
510(k) Clearance Number:	K113695

Substantial equivalence is based on identical indications for use, designs, and on in virro testing performed.

The modified PRECICE Trauma Nail System and the predicate PRECICE Trauma Nail System have the same intended use. Specifically, the device is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones. In addition to the indication, the

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Ellipse Technologies, Inc.	May 2014
PRECICE Trauma Nail System	Product Code: HSE
Special 510(k) Application

principles of operation for the modified PRECICE Trauma Nail System are the same as that of the predicate PRECICE Trauma Nail System. The devices are inserted into the intramedullary canal of the bone and secured with locking screws. These devices contain an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. They both can be adjusted non-invasively by the Ellipse external remote controller (ERC).

The differences between the modified PRECICE Trauma Nail System and the predicate PRECICE Trauma Nail System are as follows:

The design of the Nail has been modified to incorporate the design changes made to the � PRECICE Intramedullary Limb Lengthening System.
The addition of an 8.5 mm diameter nail in the PRECICE Trauma Nail System product . offerings.

The design of the modified PRECICE Trauma Nail is identical to the PRECICE Nail in the PRECICE Intramedullary Limb Lengthening System, with the only difference being that the PRECICE Trauma Nail is supplied pre-distracted by 10 mm to allow for compression fracture reduction techniques. The modified PRECICE Trauma Nail has the same materials, technological characteristics and principles of operation as that of the modified PRECICE Nail in the referenced PRECICE Intramedullary Limb Lengthening System. Because the design of these two systems are identical, the following tests that were performed on the referenced PRECICE Intramedullary Limb Lengthening System also applies to the PRECICE Trauma Nail System that is subject of this premarket notification:

Mechanical Testing .
. Design Verification Testing
Magnetic Field Safety Testing .
. Packaging and Shelf-life Validation
Sterilization Validation .
. Biocompatibility Testing

Conclusions can be drawn that the modifications to the PRECICE Trauma Nail in the PRECICE Trauma Nail System is substantially equivalent to the predicate device.

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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 stylized eagle with three stripes forming its body and wing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2014

Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Specialist 13900 Alton Parkway, Suite 123 Irvine, California 92618

Re: K141447

Trade/Device Name: PRECICE® Trauma Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 29, 2014 Received: June 2, 2014

Dear Ms. Shelburne:

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. Rebecca Shelburne

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Lori A. Wiggins

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

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

510(k) Number (if known) K141447

Device Name

PRECICE® Trauma Nail System

Indications for Use (Describe)

The Ellipse PRECICE Truma Nail System is indicated for closed fracture fixution, pseudoarthrosis, or mal-unions of long bones.

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

X 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.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabet标检验Frank -S

Division of Orthopedic Devices

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FORM FDA 3881 (1/14)

キリシイで #1 ម្រ

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.