The 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, or ERC 3P). 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.

The third generation External Remote Controller (ERC 3P) which is the subject of this premarket notification, is a non-invasive adjustment component of the system. The ERC 3P is an electrically powered handheld unit. The ERC 3P contains two large rare-earth magnets that are rotated using gears. After the PRECICE Nail has been implanted into the patient, the external device can be placed over the actuator portion of the nail and activated, the magnets within the ERC 3P rotate, which causes the magnet in the actuator portion of the PRECICE Nail to rotate, lengthening or shortening the nail. Periodic lengthening (typically daily) of the nail is performed after the implantation surgery to lengthen the limb. The ERC 3P also encompasses on-unit prescription programming. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis. The principles of operation of the ERC 3P are the same as those of the ERC and ERC2P previously cleared.

AI/ML Overview

This FDA_510k document describes the PRECICE Intramedullary Limb Lengthening System, specifically focusing on the new External Remote Controller (ERC 3P). The document primarily focuses on establishing substantial equivalence to previously cleared devices through design, in vitro testing, software validation, and usability/labeling readability evaluations. Therefore, the information provided does not fully align with the typical structure of a study proving a device meets specific acceptance criteria in terms of accuracy or efficacy, but rather demonstrating safety and performance equivalence.

Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria for performance metrics related to limb lengthening accuracy, speed, or similar clinical outcomes as would be found in a study demonstrating efficacy. Instead, it lists various engineering and usability tests and standards used to demonstrate equivalence and safety of the ERC 3P.

Test/Document Description	Applicable Test Standard	Purpose (Implied Acceptance)	Reported Performance / Outcome
Risk Management Report	EN ISO 14971: 2012	Comprehensive risk assessment and mitigation	(Implied: Risks adequately identified and mitigated)
Electrical Safety	IEC 60601-1 (3rd edition): 2005	Device electrical safety	(Implied: Meets electrical safety requirements)
Electromagnetic Compatibility and Interference	IEC 60601-1-2: 2014	Device EMC/EMI compliance	(Implied: Meets EMC/EMI requirements)
Minimum rated voltage testing	N/A (Internal method)	Device functionality at minimum voltage	(Implied: Operates as intended at minimum voltage)
Shock and Vibration Testing	IEC 60601-1-11: 2015	Device durability under shock/vibration (home use)	(Implied: Withstands specified shock/vibration for home use)
Ingress protection	N/A (Internal method; likely related to IEC 60601-1-11)	Protection against ingress of solids/liquids	(Implied: Meets ingress protection requirements for home use)
Usability evaluation	N/A (Internal method)	Ease of use and effectiveness for target users (patients)	"demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications."
Labeling Readability	N/A (Internal method)	Clarity and comprehension of device labeling	(Implied: Labeling is clear and understandable)
Software Validation	(Implied: Internal methods based on regulatory guidance)	Software functions as intended and is safe	(Implied: Software is validated)

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

Test Set (Usability Study): 17 participants
Data Provenance: The document does not explicitly state the country of origin for the usability study participants. It describes the study as being performed on a "representative population" and an "equivalent patient population," suggesting a prospective design within a clinical or simulated environment. It doesn't specify if it's retrospective or prospective, but usability studies are typically prospective.
Other Testing: For the engineering tests (electrical safety, EMC, shock/vibration, etc.), the "sample size" is generally the device itself or a limited number of test units, which is standard for such evaluations. The data provenance would be from laboratory testing.

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

This information is not provided in the document. For the usability study, there isn't a "ground truth" established by experts in the context of diagnostic accuracy. Instead, the "truth" is the user experience and ability to perform tasks. Usability studies typically involve observers and evaluators, but they are not usually referred to as "experts" establishing a ground truth in the same way a radiologist establishes a diagnosis.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant to the nature of the usability study described. Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers independently interpret data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth.

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

No, an MRMC comparative effectiveness study was not reported. The document focuses on demonstrating the substantial equivalence of the new ERC 3P to existing predicate devices (ERC and ERC2P) and confirming its safety and usability, not on comparing the efficacy of human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a medical hardware system (an intramedullary nail) with an external controller. It is not an AI algorithm or software-only device designed to standalone or diagnose. Therefore, a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and was not performed. The ERC 3P is a component that interacts directly with the patient and is operated by the patient.

7. The Type of Ground Truth Used

For the engineering tests, the "ground truth" is compliance with the specified standards (e.g., IEC 60601-1 for electrical safety). For the usability study, the "ground truth" is the successful and safe interaction of the participants with the device, and their ability to complete assigned tasks according to the device's intended use and design, as observed by the study team. It is not based on expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ERC 3P is a hardware device with software, not a machine learning model that requires a distinct "training set." Any internal software development or validation would involve standard software engineering practices, not a machine learning training set.

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

This information is not applicable as there is no "training set" in the context of machine learning. For software validation, the "ground truth" would be established by the software requirements and design specifications, verified through testing.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Nuvasive Specialized Orthopedics, Inc. Cora Sim Associate Manager, Regulatory Affairs 101 Enterprise. Suite 100 Aliso Viejo, California 92656

June 9, 2017

Re: K170169

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: May 23, 2017 Received: May 24, 2017

Dear Cora 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 device

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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 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,

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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Indications for Use

510(k) Number (if known) K170169

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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PRECICE® Intramedullarv Limb Lengthening System 510(k) Summary - K170169 Mav 23, 2017

1. Company: NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Phone: (949) 837-3600 Fax: (949) 837-3664
- Cora Sim Contact: Associate Manager, Regulatory Affairs Phone: (949) 544-6478 Fax: (949) 837-3664

Date of Submission: May 23, 2017

1. Proprietary Trade Name: PRECICE® Intramedullary Limb Lengthening System
1. Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
Product Code: HSB (Rod, Fixation, Intramedullary and Accessories) 4.
ട്. Product Description: The 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, or ERC 3P). 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.

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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic on the left, followed by the word "Nuvasive" in silver lettering. Below "Nuvasive" is the phrase "Specialized Orthopedics, Inc." in purple lettering. The logo is clean and modern, with a focus on the company's name and specialization.

lengthening or shortening the nail. Periodic lengthening (typically daily) of the nail is performed after the implantation surgery to lengthen the limb. The ERC 3P also encompasses on-unit prescription programming. The distraction is confirmed in office using standard, routine x-ray of the limb. These office visits usually occur on a weekly basis. The principles of operation of the ERC 3P are the same as those of the ERC and ERC2P previously cleared.

Indications: The PRECICE Intramedullary Limb Lengthening System is indicated for limb 6. lengthening of the tibia and femur.
Substantial Equivalence: Documentation demonstrates substantial equivalence to the PRECICE 7. Intramedullary Limb Lengthening System cleared under K101997 (cleared on July 12, 2011), K 1 13219 (cleared on October 19, 2012), K 13 1490 (cleared on January 23, 2014), K 133289 (cleared on December 9, 2013), K141023 (cleared on May 20, 2014), K150656 (cleared on April 23, 2015), K151131 (cleared on June 19, 2015), and most recently K160325 (cleared on April 4, 2016) . The purpose of this premarket notification is to include a third generation External Remote Controller (ERC 3P) into the PRECICE® Intramedullary Limb Lengthening System. Data provided in this submission includes information relevant to the third generation ERC (ERC 3P). Substantial equivalence is based on similar indications for use, designs, in vitro testing, software validation, and Usability and labeling readability evaluations performed. The in vitro evaluations included specific tests performed on the ERC 3P to demonstrate the suitability of the device for its intended use, and electrical safety and electromagnetic compatibility tests. Usability evaluation of the ERC 3P in a representative population was performed to demonstrate its suitability for use by the proposed patient population in the home environment and in accordance with the indications.

The ERC 3P was designed to improve ergonomic handling and user interfaces, and has the same methods and principles of operation as the first and second generation ERCs. The ERC 3P incorporates an updated user interface and combines the controller and hand piece into one unit, to be more ergonomic and user friendly. The ERC 3P incorporates an updated user interface that utilizes an LCD touchscreen, camera, external magnet line to assist the patient in proper alignment with the implant location, as well as features to detect the pairing status of the ERC 3P with the implanted PRECICE Nail during lengthening sessions. The third generation ERC for the PRECICE Intramedullary Limb Lengthening System was developed and evaluated in accordance with recognized standards and with in-house developed test methodologies. This testing includes risk assessment of the device, testing to applicable IEC standards, and a usability study undertaken on 17 participants to evaluate the usability of the ERC 3P in an equivalent patient population. Risk analysis, draft labeling, and test results are included in this premarket notification. The results of

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testing demonstrate that the ERC 3P for the PRECICE Intramedullary Limb Lengthening System that is the subject of this premarket notification is substantially equivalent to the predicate External Remote Controller (ERC 2P) device.

The following documentation and testing have been included in order to establish equivalence to the predicate device. Testing includes a usability evaluation for the Home Use of the ERC 3P by the patient, minimum rated voltage testing, shock and vibration testing, and ingress protection testing performed in accordance with IEC 60601-1-11;2015. The following tests have been performed in order to establish equivalence to the predicate device:

Test/Document Description	Applicable test standard
Risk Management Report	EN ISO 14971: 2012
Electrical Safety	IEC 60601-1 (3rd edition): 2005
Electromagnetic Compatibility and Interference	IEC 60601-1-2: 2014
Minimum rated voltage testing
Shock and Vibration Testing	IEC 60601-1-11: 2015
Ingress protection
Usability evaluation	N/A
Labeling Readability	N/A

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.