The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments 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 Ellipse RLL System is a non-weight bearing device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ellipse Residual Limb Lengthening System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific clinical acceptance criteria in terms of performance. The information provided heavily relies on non-clinical testing.

Therefore, many of the requested categories cannot be directly addressed from the given text, as they pertain to clinical performance studies.

Here's an analysis based on the information available:

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

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., success rate of limb lengthening, complication rates within a defined threshold). Instead, it focuses on demonstrating equivalence through mechanical and functional tests.

Acceptance Criteria Category (Implied)	Reported Device Performance (from non-clinical testing)
Mechanical Strength (Static Four Point Bend)	Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate.
Mechanical Strength (Dynamic Four Point Bend)	Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate.
Mechanical Strength (Static Torque to Failure)	Met: Tested according to ASTM F1264-03, demonstrating equivalence to predicate.
Sterilization Assurance Level (SAL)	Met: Gamma radiation sterilization cycle validated in accordance with ISO 11137-2, achieving SAL of 10-6.
Device Functionality	Met: Design verification and validation performed.
Biocompatibility	Met: Applicable testing from predicate (ISO 10993-1) applies due to similar materials/design.
Shelf Life (Packaging)	Met: Applicable testing from predicate applies due to similar packaging.
O-ring Seal Performance	Met: Applicable testing from predicate applies.
External Remote Controller (ERC) Functionality	Met: No changes to ERC, therefore predicate's testing applies to RLL System.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to non-clinical mechanical and functional testing. For these tests, sample sizes are typically determined by the specific ISO/ASTM standards referenced, but are not explicitly stated in this summary. There is no mention of a clinical test set, country of origin, or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as no clinical test set requiring expert ground truth or assessment is described in this 510(k) summary. The testing described is non-clinical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as no clinical test set requiring adjudication is described.

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 an intramedullary limb lengthening system, not an AI or imaging diagnostic device.

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

This is not applicable. The device is a surgical implant system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements of the referenced ASTM/ISO standards and the device's design specifications. For example, the "ground truth" for sterilization is achieving an SAL of 10-6 as per ISO 11137-2. For mechanical tests, it's meeting the load and torque requirements defined by ASTM F1264-03.

8. The sample size for the training set

This is not applicable as the device is a mechanical implant system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary based on available information:

The provided text focuses on demonstrating the substantial equivalence of the Ellipse Residual Limb Lengthening System to a legally marketed predicate device (Ellipse PRECICE® Intramedullary Limb Lengthening System K141023) through a series of non-clinical tests. These tests cover mechanical properties, sterilization, functionality, and biocompatibility, aligning with relevant ASTM and ISO standards. The "acceptance criteria" are implicitly set by these standards and the equivalence to the predicate device. The document does not contain information about clinical performance studies, expert assessment, or AI-related evaluations.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined snakes and a staff.

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

Ellipse Technologies, Incorporated Ms. Rebecca Shelburne Regulatory Affairs Specialist 13900 Alton Parkway, Suite 123 Irvine, California 92618-0000

October 7, 2014

Re: K141739

Trade/Device Name: Residual Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 9, 2014 Received: July 10, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (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/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,

Mark N. Melkerson -S

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

510(k) Number (if known) K141739

Device Name Residual Limb Lengthening System

Indications for Use (Describe)

The Ellipse Residual Limb Lengthening System is indicated for lengthening of the residual limb of the femur.

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)

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Image /page/4/Picture/0 description: The image shows the Ellipse logo. The logo consists of three overlapping circles on the left and the word "ELLIPSE" in a bold, sans-serif font on the right. The circles are in shades of blue and green, while the word "ELLIPSE" is in a dark blue color.

13900 Alton Parkway. Suite 123 Irvine, California 92618 USA Office: 949-837-3600 949-837-3664 Fax: www.ellipse-tech.com

Ellipse Residual Limb Lengthening System 510(k) Summary - K141739 June 2014

1. 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 of Submission: June 26, 2014

1. Proprietary Trade Name: Ellipse Residual Limb Lengthening System
Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3.
1. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)

Product Description: The Ellipse Residual Limb Lengthening (RLL) System is composed of the intramedullary RLL Nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC). The RLL Nail has a 14 mm diameter with a telescoping distal end. The telescoping end has a 100 mm stroke length, making the RLL Nail capable of a maximum distracted length of 230 mm. The RLL Nail utilizes one distal and one proximal locking screw to secure the implant to the bone. The RLL Nail is supplied sterile by gamma radiation while the locking screws and instruments 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 Ellipse RLL System is a non-weight bearing device.

Indications: The Ellipse Residual Limb Lengthening System is indicated for lengthening of 6. residual limb of the femur.

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

● Ellipse PRECICE® Intramedullary Limb Lengthening System (K141023)

Substantial equivalence is based on similar indications for use, technological characteristics, principles of operation, designs, and on in vitro testing performed.

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Image /page/5/Picture/0 description: The image shows the logo for Ellipse. The logo consists of a circular design on the left and the word "ELLIPSE" on the right. The circular design is made up of three overlapping circles in different shades of blue and green. The word "ELLIPSE" is written in a bold, sans-serif font in a dark blue color.

3900 Alton Parkwav. Suite 123 vine California 92618 ffice: 949-837-3600 949-837-3664 www.ellipse-tech.com

The Ellipse RLL System and the predicate device have the same intended use. Specifically, the RLL System and the predicate PRECICE System are both designed for limb lengthening. The RLL System is indicated for lengthening of the residual limb of the femur, specifically.

The Ellipse RLL Nail has similar technological characteristics and the same principles of operation as that of the predicate. Both the RLL Nail and the predicate PRECICE Nail are titanium intramedullary nails with a telescoping portion that can adjust the length of the limb using principles of distraction osteogenesis. Both devices are inserted into the intramedullary canal of the femur or tibia and secured with locking screws. Both devices are adjusted non-invasively by the Ellipse External Remote Controller (ERC).

Non-clinical testing on the RLL System included mechanical testing according to the methods outlined in the standard ASTM F1264-03, validation of the gamma radiation sterilization cycle in accordance with the VDmax 3 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 10-6, and design verification and validation.

The following specific performance tests were completed on the RLL System in order to establish equivalence to the predicate device:

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
Sterilization of healthcare products - Radiation -Part 2: Establishing the sterilization dose	ANSI/AAMI/ISO 11137-2
Device functionality and verification	N/A

Tests that were performed on the predicate PRECICE System which are applicable to the RLL System include shelf life testing for the packaging after accelerated aging, O-ring seal performance testing and biocompatibility in accordance with ISO 10993-1 for the intended use of the device.

There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE System for the ERC are applicable to the RLL System.

Conclusions can be drawn from these tests that the RLL System is substantially equivalent to the predicate device.

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.