The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters. Iengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific 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.

AI/ML Overview

This document describes the Ellipse PRECICE Intramedullary Limb Lengthening System and its substantial equivalence to a previously cleared device. The focus of the provided text is on demonstrating the device's safety and effectiveness through mechanical and functional testing, rather than clinical study results involving human readers or comparative effectiveness studies with AI.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance values for the modified device in a table format. Instead, it describes tests performed to establish equivalence to predicate devices, implying that the modified device met the performance of those predicates. The "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications" suggests that the device passed these tests according to predefined specifications, which are not detailed in the text.

Test Description	Applicable Test Standard	Implied Acceptance Criteria	Reported Device Performance
Static Four Point Bend	ASTM F1264-03	Performance equivalent to predicate device as per ASTM F1264-03	Met specifications
Dynamic Four Point Bend	ASTM F1264-03	Performance equivalent to predicate device as per ASTM F1264-03	Met specifications
Static Torque to Failure	ASTM F1264-03	Performance equivalent to predicate device as per ASTM F1264-03	Met specifications
Magnet Holding Torque	None	Functionality equivalent to predicate device	Met specifications
Device functionality and verification	None	Functionality equivalent to predicate device, safe and effective	Met specifications

Note: "Met specifications" in the "Reported Device Performance" column is inferred from the statement "Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications." The specific numerical results or detailed performance metrics are not provided in this submission summary.

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

The provided text details mechanical and functionality testing for a medical device (an intramedullary nail), not a medical imaging or diagnostic device that would typically use human test sets or patient data with a "sample size" in the context of clinical studies. Therefore, this question is not applicable to the type of safety and efficacy evidence presented. The "test set" here refers to the device prototypes or components undergoing mechanical stress tests. The data provenance is laboratory testing conducted by Ellipse Technologies, Inc. No information on country of origin of the data or retrospective/prospective nature is relevant for these in vitro tests.

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

This question is not applicable. The "ground truth" for mechanical and functional testing of a medical device like an intramedullary nail is established by engineering specifications, international standards (e.g., ASTM F1264-03), and comparison to predicate devices, not by medical experts interpreting results from a test set in a diagnostic context.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials or diagnostic studies to resolve discrepant expert opinions on patient data. The current document describes in vitro engineering tests.

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

This question is not applicable. The device described is a physical implant (intramedullary nail) for limb lengthening, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study involving AI assistance is mentioned or relevant to this type of device.

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

This question is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical and functional testing, the "ground truth" is based on:

Established engineering standards: ASTM F1264-03 for Static/Dynamic Four Point Bend and Static Torque to Failure.
Performance of predicate devices: The modified device's performance is compared to that of previously cleared Ellipse PRECICE Systems (K131677 and K133289) to demonstrate "substantial equivalence." This implies that the predicate devices' established safety and performance serve as the "ground truth" for the modified device.
Internal design specifications: For tests like "Magnet Holding Torque" and "Device functionality and verification" where no external standard is cited, the ground truth would be the device's own design specifications, validated through testing.

8. The Sample Size for the Training Set

This question is not applicable. The context is not machine learning or AI, so there is no "training set." The testing involved physical prototypes or samples of the device.

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

This question is not applicable, as there is no "training set" in this context.

Summary

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MAY 2 0 2014

Ellipse Technologies, Inc. PRECICE Intramedullary Limb Lengthening System Special 510(k) Application

April 2014 Product Code: HSB

PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K TBD April 2014

Company: Ellipse Technologies. Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618

Rebecca Shelburne Contact: Regulatory Affairs Specialist Phone: (949) 837-3600 x227 Fax: (949) 837-3664 Date Summary Prepared: April 17, 2014

Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System 2.

Common Name: Intramedullary Nail 3.

Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)

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

Product Description: The Ellipse PRECICE System is composed of the PRECICE nail 6. (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The nail is available in tibia or femur models with various diameters. Iengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE nail is supplied sterile by gamma radiation while the locking screws and PRECICE specific 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.

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

Substantial equivalence: Documentation that includes mechanical test results and 8. detailed comparison to the predicate devices demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device:

Ellipse PRECICE System (K131677 and K133289) .

Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed. The Risk Management file was updated to include the design modifications and no new risks were identified.

The modified Ellipse PRECICE System and the predicate device have the same intended use. Specifically, to lengthen the femur or tibia. The modified PRECICE nail and the predicate are available in the same application, screwhole configurations, stroke lengths, and overall lengths. The PRECICE Nail has the same patient contacting materials, technological characteristics and principles of operation as that of the predicate. Both devices are inserted into the intramedullary

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canal of the femur or tibia and secured with locking screws. Both devices are adjusted noninvasively by the Ellipse external remote controller (ERC). The differences between the modified PRECICE System and the predicate device are as follows:

The magnet stabilizer feature is being modified and re-located to the proximal end of the . housing tube for ease of manufacturing, and
The anti-rotation lug feature is being modified to be press-fit into the internal diameter of . the housing tube, eliminating the tack welding process.

Data relied upon to determine substantial equivalence of the PRECICE System with the device modifications described in this submission to the cleared PRECICE System include the following:

. Mechanical testing
Design functionality and verification testing .

Conclusions can be drawn from the tests that the modifications to the PRECICE System are safe and effective and meet the performance specifications. The following specific tests have been performed in order to establish equivalence to the predicate devices:

Test Description	Applicable Test Standard
Static Four Point Bend	ASTM F1264-03
Dynamic Four Point Bend	ASTM F1264-03
Static Torque to Failure	ASTM F1264-03
Magnet Holding Torque	None
Device functionality and verification	None

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

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

May 20, 2014

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

Re: K141023

Trade/Device Name: Ellipse PRECICE® System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 17, 2014 Received: April 21. 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 notc: 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) K141023

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)

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.

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Casey antev-Division of Orthopedle D vices

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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.