The Ellipse PRECICE System is composed of the PRECICE nail (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters, lengths 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 is a 510(k) premarket notification letter for the PRECICE® Intramedullary Limb Lengthening System and its associated 510(k) summary. It describes the device, its indications for use, and a demonstration of substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text with respect to your specific questions:

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

The document does not explicitly state acceptance criteria in a quantitative table format alongside performance results. Instead, it refers to general findings of "substantial equivalence" based on "in vitro testing" and "FEA Simulations."

Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance, as assessed by in vitro testing (tensile strength) and FEA simulations, is comparable to, and does not negatively impact, the safety and effectiveness demonstrated by the predicate devices. The phrase "meet the performance specifications" suggests that certain internal design specifications or established performance benchmarks were met, though these are not detailed.
Reported Device Performance:
- In Vitro Testing (Tensile Strength): The table lists "In Vitro Testing (Tensile Strength)" as a performed test. The conclusion section states "Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications." This indicates that the tensile strength of the modified nails was found to be acceptable and comparable to the predicate. No specific numerical performance values (e.g., specific tensile strength in MPa) are provided.
- FEA Simulations: The table lists "FEA Simulations" as a performed test. Similar to the in vitro testing, the conclusion states that these simulations supported substantial equivalence and met performance specifications. No specific numerical results of the simulations (e.g., stress distribution, deformation values) are provided.

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 does not provide a sample size for any test set. The tests mentioned are "In Vitro Testing (Tensile Strength)" and "FEA Simulations," which are likely conducted in a lab environment rather than using patient data. Therefore, questions of retrospective/prospective and country of origin are not applicable in this context.

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 question is not applicable to the information provided. The study mentioned involves in vitro testing and finite element analysis (FEA) simulations, which are engineering and mechanical assessments, not clinical studies requiring expert ground truth for diagnostic or prognostic purposes.

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

This question is not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth or interpret results. The study described here is focused on mechanical and engineering performance.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any indication that the device incorporates AI. This device is an intramedullary nail for limb lengthening, a mechanical implant.

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 (an intramedullary nail) and does not involve an algorithm working in a standalone capacity.

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

Since the "study" involves in vitro testing and FEA simulations, the "ground truth" would be established by the physical measurements from the in vitro tests (e.g., force-displacement curves for tensile strength) and the mathematical/computational results from the FEA simulations (e.g., stress and strain values calculated according to material properties and geometry). There is no "expert consensus," "pathology," or "outcomes data" ground truth in this type of engineering assessment.

8. The sample size for the training set

This question is not applicable. The device is a mechanical implant, and the assessment involves direct testing and simulation. There is no "training set" in the context of an algorithm or machine learning.

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

This question is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

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

April 23, 2015

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

Re: K150656

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: March 12, 2015 Received: March 13, 2015

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 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/Resourcesfor You/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 vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150656

Device Name

PRECICE Intramedullary Limb Lengthening 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)

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 logo for Ellipse. 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.

PRECICE® Intramedullary Limb Lengthening System 510(k) Summary - K150656 March 2015

1. Company: Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
- Contact: Rebecca Shelburne Regulatory Affairs Project Manager Phone: (949) 837-3600 x227 Fax: (949) 837-3664

Date Summary Prepared: March 12, 2015

1. Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System
1. Common Name: Intramedullary Nail
Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 4.
1. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
The Ellipse PRECICE System is composed of the PRECICE nail Product Description: 6. (supplied sterile), locking screws, surgical instruments and an external remote controller (ERC, ERC2P). The nail is available in tibia or femur models with various diameters, lengths 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.
1. Indications for Use: The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

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Substantial Equivalence: Documentation that includes a performance assessment and detailed 8. comparison to the predicate device demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device:
Trade Name: Ellipse PRECICE System Common Name: Intramedullary Nail 510(k) Clearance Number: K141023, K133289, K131677

Substantial equivalence is based on identical indications for use, technological characteristics, in vitro testing performed and Finite Element Analysis (FEA) Simulations. The Risk Management file was updated to include the design modifications and no new risks were identified.

The additional diameter PRECICE nails that are subject of this premarket notification and the predicate device have the same indications for use. Specifically, both the predicate PRECICE System and the PRECICE System that is subject of this Special 510(k) is indicated for limb lengthening of the tibia or femur. The additional diameter PRECICE nails are available in the same application, screwhole configurations, stroke lengths, and overall lengths. No changes are being made to the materials, technological characteristics or principles of operation as a result of this premarket notification. 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 or ERC2P). The differences between the subject device and the predicate device are as follows:

Additional diameters added to the product offerings.
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:

Test Description	Applicable Test Standard
In Vitro Testing (Tensile Strength)	N/A
FEA Simulations	N/A

There are no changes being made to the ERC, Locking Screws or PRECICE Instruments as a result of this submission.

Conclusions can be drawn from the tests that the modifications to the PRECICE System are substantially equivalent and meet the performance specifications.

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.