The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters. lengths and screw hole 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 surgical instruments are supplied non-sterile and must be sterilized prior to use.

AI/ML Overview

This document is a 510(k) summary for the Ellipse PRECICE Intramedullary Limb Lengthening System (K160325). It is a letter from the FDA determining substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, focusing on the acceptance criteria and supporting studies. Please note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence to a predicate device rather than comprehensive performance studies with specific acceptance criteria and detailed statistical analysis typical of clinical trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or targets. Instead, it relies on demonstrating equivalence to a predicate device through various tests. The reported performance refers to the successful completion or comparability of these tests.

Test Description	Acceptance Criteria (Implicit)	Reported Device Performance
Static Torque to Failure	Comparable to predicate device and meet standard ASTM F1264 requirements.	Testing performed; conclusions of substantial equivalence drawn.
Device Functionality and Verification	Demonstrate proper operation and intended function.	Testing performed; conclusions of substantial equivalence drawn.
Sterilization Validation	Validated to achieve sterility.	Applicable from predicate device testing.
Shelf Life Testing	Maintain packaging integrity and device functionality over time.	Applicable from predicate device testing.
Biocompatibility Testing	Biocompatible for intended use.	Applicable from predicate device testing.
ASTM F1264 (Intramedullary Rods)	Conform to standard requirements for intramedullary rods, comparable to predicate devices.	Applicable from predicate device testing. Additional static torque testing performed.

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

The document does not specify sample sizes for the mechanical tests (Static Torque to Failure, Device Functionality). For sterilization, shelf-life, and biocompatibility, it states these were "applicable" from the predicate device testing (K151131). The data provenance is implied to be from laboratory testing rather than human clinical data, and the type is retrospective as it relies on past predicate device testing and new tests specifically for the line extension. There is no mention of country of origin for the data, but it's presumed to be from Ellipse Technologies, an American company.

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

This information is not applicable as the document describes bench and mechanical testing, not a clinical study involving expert assessment of outputs for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench and mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (intramedullary rod) and not an AI or imaging diagnostic device where such studies are typical. The focus is on mechanical and functional equivalence to a predicate device, not on diagnostic accuracy improvements or human reader performance.

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

Not applicable. This device is a physical medical implant and does not involve an algorithm or AI component in the typical sense of standalone performance evaluation.

7. The Type of Ground Truth Used

For the mechanical tests (Static Torque to Failure, Device Functionality, ASTM F1264), the ground truth is based on engineering standards and design specifications, ensuring the device performs as intended and withstands specified forces. For biocompatibility, sterilization, and shelf-life, the ground truth is established by validated laboratory methods and relevant industry standards/regulations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" would be used for algorithm development. The testing described focuses on validating the physical device's characteristics.

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

Not applicable for the reasons stated above.

Summary

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

April 4, 2016

Ellipse Technologies, Incorporated Ms. Cora Sim Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

Re: K160325

Trade/Device Name: PRECICE Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 4, 2016 Received: February 5, 2016

Dear Ms. Sim:

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 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.

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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.

Lori A. Wiggins -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K160325

Device Name

PRECICE Intramedullary Limb Lengthening System

Indications for Use (Describe)

The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and 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)

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101 Enterprise. Suite 100 Aliso Viejo, CA 92656-2604 949-837-3600 Office: 949-837-3664 Fax: www.ellipse-tech.com

510(k) Summary Ellipse PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K160325 February 4, 2016

1. Ellipse Technologies, Incorporated Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
  Contact: Cora Sim Regulatory Affairs Specialist Phone: (949) 837-3600 x221 Fax: (949) 837-3664

Date of Submission: February 4, 2016

1. Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System
1. Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
1. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
1. Product Description: The Ellipse PRECICE Intramedullary Limb Lengthening System is composed of the PRECICE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters. lengths and screw hole 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 surgical instruments are supplied non-sterile and must be sterilized prior to use.
1. Indications: The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
1. Substantial equivalence: Documentation that includes a performance assessment, mechanical test results and detailed comparison to the predicate device demonstrates that the PRECICE Intramedullary Limb Lengthening System is substantially equivalent to the following 510(k) cleared device:
- Ellipse PRECICE Intramedullary Limb Lengthening System (K151131)

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www.ellipse-tech.com

In addition, the PRECICE Intramedullary Limb Lengthening System designates the following 510(k) cleared reference device:

. Pega Medical, Incorporated Simple Locking IntraMedullary (SLIM) System (K143355)
Substantial equivalence is based on identical indications for use, technological characteristics, and on in vitro testing performed.

The PRECICE Intramedullary Limb Lengthening System and the predicate device have the same indications for use, similar technological characteristics, and the same principles of operation. Specifically, the subject PRECICE Intramedullary Limb Lengthening System and the predicate are both designed to lengthen the femur or tibia. This submission is for a line extension to the Ellipse PRECICE Intramedullary Nail to include additional shorter models with different locking screw hole patterns to the product line. An additional contraindication has also been added to the labeling for these models.

There are no changes to the design of the ERC or ERC2P being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Intramedullary Limb Lengthening System with regard to the ERC and ERC 2P are applicable.

Testing performed on the predicate Ellipse PRECICE Intramedullary Limb Lengthening System included sterilization validation, shelf life testing for the packaging and the device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. These results are also applicable to the subject PRECICE Intramedullary Limb Lengthening System.

The following additional tests have been performed on the subject PRECICE Intramedullary Limb Lengthening System in order to establish equivalence to the predicate device:

Test Description	Applicable Test Standard
Static Torque to Failure	ASTM F1264
Device functionality and verification	none

Conclusions can be drawn from the testing performed that the PRECICE Intramedullary Limb Lengthening 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.