The Ellipse PRECICE System is composed of an implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and surgical implantation tools and accessories. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. Likewise, the locking screws are available in two different diameters and a variety of lengths from 20 mm to 75 mm increments. The distracting rod is a modular system that includes the PRECICE Actuator component and various configurations of PRECICE Extension Rods. The PRECICE Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

AI/ML Overview

The provided document, K131490, describes the Ellipse PRECICE® System, specifically focusing on the second-generation External Remote Controller (ERC 2P). This submission aims to demonstrate substantial equivalence to previously cleared devices (K101997 and K113219) rather than introducing a new clinical indication or demonstrating a novel clinical performance through a standalone study.

Therefore, the acceptance criteria and study details discussed below are primarily focused on the usability, safety, and performance of the ERC 2P in demonstrating equivalence to its predicate, not on the clinical effectiveness of the limb lengthening system itself.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Safety & Performance	Risk Management Report	EN ISO 14971 compliance	Risk analysis performed; results included in submission.
	Electrical Safety	IEC 60601-1 (3rd edition) compliance	Testing demonstrated compliance.
	Electromagnetic Compatibility and Interference	IEC 60601-1-2 compliance	Testing demonstrated compliance.
	Minimum Rated Voltage Testing	Device functions as intended at minimum rated voltage	Testing performed to establish equivalence.
	Shock and Vibration Testing	Device maintains integrity and function under specified conditions	Testing performed in accordance with IEC 60601-1-11; demonstrated equivalence.
	Ingress Protection	Device meets specified IP rating for home use environment	Testing performed in accordance with IEC 60601-1-11; demonstrated equivalence.
Usability	Usability Evaluation	Device is suitable for use by target population in home environment; user interfaces and ergonomic handling are improved/suitable compared to predicate.	Usability study undertaken on 15 participants showed suitability for use by proposed patient population in the home environment and in accordance with indications.
Labeling	Labeling Readability	Labeling is clear and understandable.	Evaluation performed; results included in submission.

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

Sample Size for Usability Study: 15 participants.
Data Provenance: The document does not explicitly state the country of origin for the usability study participants. Given the company (Ellipse Technologies, Incorporated) is based in Irvine, California, USA, and the submission is to the FDA, it is highly probable the study participants were from the USA or North America. The study was prospective for the usability evaluation, as it was specifically undertaken to evaluate the ERC 2P. Other tests (electrical safety, EMC, etc.) are laboratory-based and not patient-data dependent in this context.

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

For this type of submission (focused on a new controller for an existing system), "ground truth" isn't typically established by medical experts in the way it would be for a diagnostic AI algorithm.

Usability Study: The "ground truth" for the usability study was the observed performance and feedback from the 15 participants using the ERC 2P in a simulated home environment, evaluated against pre-defined usability tasks and criteria. The document states a "representative population" was used, which implies users matching the demographic and cognitive profile of the actual patient users.
Other Tests (Safety, Performance): The "ground truth" for these tests (e.g., electrical safety, EMC, shock/vibration) is defined by the standards themselves (e.g., IEC 60601-1). The "experts" involved would be qualified test engineers and technicians performing the tests and interpreting the results against established regulatory standards.

4. Adjudication Method for the Test Set

Not applicable in the typical sense for this submission.

For the usability study, the "adjudication" would involve human factors specialists or researchers observing participant interactions, collecting quantitative and qualitative data (e.g., task completion rates, errors, subjective feedback), and interpreting this data against usability goals. There isn't a "2+1" or "3+1" medical expert adjudication method described or typically used for usability studies of this nature.
For laboratory tests, compliance with standards is usually a pass/fail determination, sometimes with detailed reports and expert review of those reports by test house engineers or regulatory affairs professionals, but not "adjudication" in the multi-reader sense.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This submission is for a new version of an external controller for a mechanical medical device, not a diagnostic imaging AI algorithm. Therefore, improving human reader performance with or without AI assistance is not relevant to this device's function or the scope of this 510(k) submission.

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

Not applicable in the context of an "algorithm only" performance.

The device (ERC 2P) is an interactive electromechanical device. While it has embedded software and a camera to assist alignment, its primary function is to enable the patient to non-invasively lengthen the implantable rod under physician prescription. Its performance is inherently "human-in-the-loop" due to the user activating it and ensuring proper alignment. The usability study evaluated this human-in-the-loop performance.

7. The Type of Ground Truth Used

For safety and performance tests (electrical, EMC, shock/vibration, ingress protection): Compliance with recognized international standards (e.g., IEC 60601 series) served as the ground truth.
For the usability evaluation: The ground truth was based on observed user performance, task completion, error rates, and subjective user feedback against pre-defined usability goals and criteria.

8. The Sample Size for the Training Set

Not applicable.

Because this is a submission for a hardware device (an external controller) with embedded software, not a machine learning or AI algorithm in the contemporary sense that would require a "training set" of data to learn from. The software in the ERC 2P is deterministic and programmed, not "trained."

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

Not applicable. (See answer to #8). There was no "training set" in the context of machine learning. The device was developed and tested against engineering specifications, risk analyses, and recognized standards.

Summary

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August 2013 Product Code: HSB

510(K) SUMMARY OR 510(K) STATEMENT

JAN 2 3 2014

Ellipse PRECICE® System 510(k) Summary - K131490 July 2013

Company:

Eilipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618 Phone: (949) 837-3600 Fax: (949) 837-3664

FDA Establishment Registration No: 3006179046

Contact: John McIntyre Vice President, RA/QA/CA

Proprietary Trade Name: Ellipse PRECICE® System

Common Name: Intramedullary Fixation Rod

Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)

Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)

Product Description:

The second generation External Remote Controller (ERC 2P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The

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August 2013 Product Code: HSB

ERC 2P is an electrically powered handheld unit. The ERC 2P contains two large rareearth magnets that are rotated using gears. After the rod has been implanted into the patient, the external device can be placed over the actuator portion of the implant and activated. When activated, the magnets within the ERC 2P rotate, which causes the magnet in the implantable device to rotate, lengthening or shortening the rod. Periodic lengthening (typically daily) of the rod is performed after the primary implantation surgery to lengthen the limb. The physician writes the patient prescription on an SD card which is placed in the ERC 2P. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis.

Indications:

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

Substantial Equivalence:

Documentation demonstrates substantial equivalence to the Ellipse System cleared under K101997 (cleared on July 12, 2011) and K113219 (cleared on October 19, 2012). The purpose of this premarket notification is to include a second generation External Remote Controller (ERC 2P) into the PRECICE® system. Data provided in this submission includes information relevant to the second generation ERC (ERC 2P). Substantial equivalence is based on similar indications for use, designs, in vitro testing, software validation, and Usability and labeling readability evaluations performed. The in vitro evaluations included specific tests performed on the ERC 2P to demonstrate the suitability of the device for its intended use, and electrical safety and electromagnetic compatibility tests. Usability evaluation of the ERC 2P in a representative population was performed to demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications.

The ERC 2P was designed to improve ergonomic handling and user interfaces, and has the same methods and principles of operation as the first generation ERC. The ERC 2P incorporates the controller and hand piece into one unit, to be more ergonomic and user friendly. The ERC 2P contains a camera and colored LCD-display screen to assist the

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patient in proper alignment with the implant location. The second generation ERC for the Ellipse PRECICE System was developed and evaluated in accordance with recognized standards and with in-house developed test methodologies. This testing includes risk assessment of the device, testing to applicable IEC standards, and a usability study undertaken on 15 participants to evaluate the usability of the ERC 2P in an equivalent patient population. Risk analysis, draft labeling, and test results are included in this premarket notification. The results of testing demonstrate that the ERC 2P for the Ellipse PRECICE System that is the subject of this premarket notification is substantially equivalent to the predicate External Remote Controller device.

The following documentation and testing have been included in order to establish equivalence to the predicate device. Testing includes a usability evaluation for the Home Use of the ERC 2P by the patient, minimum rated voltage testing, shock and vibration testing, and ingress protection testing performed in accordance with IEC 60601-1-11;2010. The following tests have been performed in order to establish equivalence to the predicate device:

Test/Document Description	Applicable test standard
Risk Management Report	EN ISO 14971
Electrical Safety	IEC 60601-1 (3rd edition)
Electromagnetic Compatibility and Interference	IEC 60601-1-2
Minimum rated voltage testing
Shock and Vibration Testing	IEC 60601-1-11
Ingress protection
Labeling Readability	n/a
Usability evaluation	n/a

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

January 23, 2014

Ellipse Technologies, Incorporated Mr. John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618

Re: K131490

Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 19, 2013 Received: December 20, 2013

Dear Mr. McIntyre:

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 - Mr. John Meintyre

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.

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" (21 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/ReportalProblem/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/Industrv/default.htm.

Sincerely vours.

Ronald##Jean -S for

Mark N. Melkerson Director Division of Orthopedie 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) K131490

Device Name

Ellipse PRECICE® System

Indications for Use (Describe)

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

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

父 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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

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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.