The Ellipse Intramedullary Limb Lengthening System is composed of a modular implantable intramedullary rod ("Distracting Rod"), locking screws, an external remote controller (ERC), and 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 in 5 mm increments. The distracting rod is a modular system that includes the IMLL Actuator component and various configurations of IMLL Extension Rods. The IMLL Actuator includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The IMLL Actuator is supplied sterile by gamma sterilization while the IMLL Extension Rods, locking screws, and reusable accessories are supplied non-sterile and must be sterilized prior to use.

AI/ML Overview

The provided text does not contain detailed acceptance criteria with numerical thresholds, nor does it present specific performance metrics from a study that directly proves the device meets such criteria to the extent that would typically be seen in a clinical trial or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through various forms of in vitro testing and a comparison of technological characteristics. The "performance" in this context refers to the device successfully passing a series of mechanical, sterilization, biocompatibility, and electrical safety tests, rather than a clinical performance measured against specific clinical acceptance criteria.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document lists several tests performed to establish substantial equivalence. While it doesn't explicitly state "acceptance criteria" with numerical values used in the studies, the implicit acceptance criterion for each test is successful completion and compliance with the specified standard.

Test Description	Applicable Test Standard	Implied Acceptance Criteria	Reported Device Performance
VDmax25 Gamma Radiation Sterilization Validation	ANSI/AAMI/ISO 11137-2: 2007	Successfully achieve sterility assurance level (SAL) of 10^-6.	Document states "Testing included sterilization," implying successful validation.
6 month shelf life packaging validation	ISO 11607	Maintain packaging integrity and device functionality for a minimum of 6 months.	Document states "shelf life testing for the packaging and the device functionality," implying successful validation.
Biocompatibility testing	ISO 10993-1: 2003	Demonstrate no unacceptable biological risk when in contact with human tissue.	Document states "biocompatibility testing," implying successful compliance.
External remote controller software validation testing	IEC 60601-1-4	Software functions as intended and meets safety requirements.	Document states "software verification and validations," implying successful.
External remote controller electrical safety testing	IEC 60601-1	Meet general safety requirements for medical electrical equipment.	Document states "electrical safety testing," implying successful.
External remote controller electromagnetic interference and compatibility testing	IEC 60601-1-2	Operate without causing unacceptable electromagnetic interference and without being unduly affected by electromagnetic phenomena.	Document states "electromagnetic interference and compatibility testing," implying successful.
Locking screw Static and dynamic three-point bend testing (Implied for intramedullary rods as well based on standard use)	ASTM F1264-03	Withstand static and dynamic bending forces as specified by the standard without failure (e.g., fracture, permanent deformation beyond limits).	Document lists testing to ASTM F1264-03, implying successful completion to demonstrate equivalence.
Locking screw axial pullout testing	ASTM F543-07	Withstand specified axial pullout forces without failure.	Document lists testing to ASTM F543-07, implying successful completion to demonstrate equivalence.
Locking screw torque to failure	ASTM F543-07	Withstand specified torsional forces without failure.	Document lists testing to ASTM F543-07, implying successful completion to demonstrate equivalence.
Implantable rod static and dynamic 4-point bend testing	ASTM F1264-03	Withstand static and dynamic bending forces as specified by the standard without failure.	Document lists testing to ASTM F1264-03, implying successful completion to demonstrate equivalence.
Implantable rod torque to failure (Though F543-07 is for bone screws, the context with other rod tests and lack of other rod-specific torque standards suggests it might be referenced for comparative purposes or a related component like the mechanism)	ASTM F543-07	Withstand specified torsional forces without failure.	Document lists testing to ASTM F543-07, implying successful completion to demonstrate equivalence.
Implantable rod torsional stiffness	ASTM F1264-03	Exhibit torsional stiffness within acceptable ranges for intramedullary rods.	Document lists testing to ASTM F1264-03, implying successful completion to demonstrate equivalence.
Fixture and device compliance	ASTM F1264-03	Ensure that the testing setup and the device itself adhere to the requirements of the standard during mechanical testing.	Document lists testing to ASTM F1264-03, implying successful completion to demonstrate equivalence.
Safety of magnetic fields (from rare earth magnet and ERC)	(Not specified, but internal safety guidelines)	Induced magnetic fields are below established safety guidelines.	Document states "demonstrated that the induced magnetic fields are below established safety guidelines," implying successful.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes used for each of the mechanical or other in vitro tests. It refers to "testing" performed.
Data Provenance: The tests are in vitro tests performed on the device components, not on human or animal subjects. Therefore, there is no country of origin of data or distinction between retrospective/prospective in the clinical sense. These are laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to the type of testing described. The "ground truth" here is the pass/fail criteria defined by the applicable test standards (e.g., ISO, ASTM, IEC). Evaluation of test results against these standards is typically done by engineers or quality control personnel, not medical experts establishing a clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts independently evaluate cases and then resolve discrepancies. The tests mentioned are objective engineering and material science tests, not subjective interpretations requiring medical 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:
This is not applicable. The device is a mechanical intramedullary limb lengthening system, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical implant with an external remote controller, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed is the compliance with recognized international and national standards (e.g., ISO, ASTM, IEC) for mechanical properties, sterility, biocompatibility, electrical safety, and software validation. For the magnetic field safety, it refers to "established safety guidelines." There is no clinical ground truth (like pathology or outcomes data) derived from human subjects for these substantial equivalence tests.

8. The sample size for the training set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set.

Summary

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Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB Original 510(k) Application

JUL 1 2 2011

June 2010

14. 510(K) SUMMARY OR 510(K) STATEMENT

Ellipse Intramedullary Limb Lengthening System 510(k) Summary - K101997 June 2010

Ellipse Technologies, Incorporated 1. Company: 13844 Alton Parkway, Suite 130 Irvine, CA 92618
Contact: John McIntyre Vice President, RA/QA/CA
Proprietary Trade Name: Ellipse Intramedullary Limb Lengthening System 2.
Classification Name: 21 CFR 888.3020 -- Intramedullary fixation rod 3.
Product Code: HSB Rod, Fixation, Intramedullary and Accessories 4.
Product Description: 5.

, j

6. Indications

The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.

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K101997
June 2010
p213

Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB Original 510(k) Application

Substantial equivalence 7.

Documentation that includes mechanical test results and detailed comparison to the predicate device demonstrates that the Ellipse Intramedullary Limb Lengthening System is substantially equivalent to the Orthodyne/Orthofix ISKD device (K010322 and K031219).

Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performed.

The Ellipse IMLL System and the predicate device have similar technological characteristics. Specifically, the Ellipse IMLL System and the predicate devices are both designed to be implanted into the medullary canal of the femur or tibia. These devices are available in a variety of geometrical configurations and diameters/lengths to accommodate a variety of patient anatomies. Both devices are designed as a telescoping rod that can be lengthened non-invasively. The ISKD device is lengthened by manual mechanical rotation of the limb while the Ellipse IMLL system is lengthened by the interaction of the rare earth magnet which is contained within the actuator portion of the rod and the external remote controller. The Ellipse IMLL system has the advantage that the length of the rod can be shortened if the rod has been distracted too much. The ISKD device can only be adjusted in one direction (i.e., distraction).

Furthermore, the Ellipse IMLL and the ISKD device have a number of common design features, such as a telescoping Titanium alloy rod that is attached proximally and distally using locking screws. Both devices have telescoping features that are adjustable non-invasively. The Ellipse IMLL gives the user a better level of control of the distraction amount and direction, however.

The Ellipse IMLL device and the predicate device feature similar overall shapes. The various configurations and dimensions are available to accommodate the variety of patient anatomies encountered in limb lengthening procedures.

Testing included sterilization, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264-03 for intramedullary rods and F543-07 for metallic medical bone screws. Additional testing to demonstrate the safety of the magnetic fields from both the rare earth magnet included in the IMLL Actuator as well as the External Remote Controller demonstrated that the induced magnetic fields are below established

Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.

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K101997
June 2010 p313

Ellipse Technologies, Inc. Ellipse Intramedullary Limb Lengthening SystemProduct Code: HSB

Original 510(k) Application

ﺎ ﺃ

safety guidelines. Testing on the external remote controller also included software verification and validations, electrical safety testing, and electromagnetic interference and compatibility testing. The following specific tests have been performed in order to establish equivalence to the predicate device:

Test Description	Applicable test standard
VDmax25 Gamma Radiation Sterilization Validation	ANSI/AAMI/ISO 11137-2: 2007
6 month shelf life packaging validation	ISO 11607
Biocompatibility testing	ISO 10993-1: 2003
External remote controller software validation testing	IEC 60601-1-4
External remote controller electrical safety testing	IEC 60601-1
External remote controller electromagnetic interference and compatibilitytesting	IEC 60601-1-2
Locking screw Static and dynamic three point bend testing	ASTM F1264-03
Locking screw axial pullout testing	ASTM F543-07
Locking screw torque to failure	ASTM F543-07
Implantable rod static and dynamic 4-point bend testing	ASTM F1264-03
Implantable rod torque to failure	ASTM F543-07
Implantable rod torsional stiffness	ASTM F1264-03
Fixture and device compliance	ASTM F1264-03

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol 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 bird symbol.

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

JUL 1 2 2011

Ellipse Technologies, Inc. % Mr. John McIntyre Vice President. Regulatory. Quality and Clinical Affairs 13844 Alton Parkway, Suite 130 Irvine, California 92618

Re: K101997

Trade Name: Ellipse Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 25, 2011 Received: March 28, 2011

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

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Page 2 - Mr. John McIntyre

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 nûmber (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Euis Keith

Jo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number: ~~Unknown~~ K101997

Device Name: Ellipse Intramedullary Limb Lengthening System

Indications for Use: The Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

for m. Melkerm.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101997

Confidential - This document and the information contained herein may not be reproduced, used or disclosed without written permission from Ellipse Technologies, Inc.

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.