The Precice® System (inclusive of Precice, Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions or bone transport of long bones.

The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.

The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

Device Description

The fourth generation External Remote Controller ERC 4P is a portable hand-held system used to non-invasively distract or retract the Precice System Family implants. The ERC 4P device has a touch screen interface, ergonomic design, a single magnet, and implant detection features that provide feedback to the user on the status of the coupling of the implant with the ERC 4P. It can be operated either cordlessly through a rechargeable battery or with a power cord. When the ERC 4P magnet begins to rotate, it induces a magnetic field which rotates an internal magnet attached to a lead screw in the implanted nail/plate, which then either distracts or retracts accordingly. The ERC 4P has a touch screen interface, as well as a hard button for the user's modes of interaction.

AI/ML Overview

The provided text is a 510(k) summary for the NuVasive Specialized Orthopedics, Inc. External Remote Controller ERC 4P device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study design, or performance metrics typically associated with studies proving a device meets specific performance criteria, especially in the context of AI-driven medical devices that involve image analysis or diagnostic support.

The document primarily focuses on regulatory approval, establishing substantial equivalence for an orthopedic device controller based on its engineering characteristics and safety standards (Electrical Safety, EMC, Magnet Safety, Usability, Labeling Readability). It details the type of device (a remote controller for limb lengthening/fixation implants), its function (non-invasively distract or retract implants), and general safety testing.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: This information is not present in the document. The document lists "Usability Study" as a test but provides no details on its methodology, acceptance criteria, or results.
Sample sizes used for the test set and data provenance: No such data is mentioned.
Number of experts used to establish ground truth and their qualifications: Not applicable, as this device does not involve image analysis or diagnostic ground truth establishment by medical experts in the way an AI diagnostic tool would.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study: Not applicable.
Stand-alone performance: Not relevant in the context of how this device's performance is assessed.
Type of ground truth used: Not applicable.
Sample size for training set and how ground truth was established: Not applicable, as this device is not a machine learning/AI model.

In summary, the provided document is a regulatory submission for a medical device that does not involve artificial intelligence, image analysis, or complex diagnostic performance evaluation as per your request's focus. The "performance data" referred to in the document pertains to electrical safety, electromagnetic compatibility, and magnet safety, rather than diagnostic accuracy or human-AI interaction in a diagnostic context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.

December 22, 2020

NuVasive Specialized Orthopedics, Inc. Miriam Cervantes Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656 USA

Re: K202348

Trade/Device Name: External Remote Controller ERC 4P Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, KTT, HWC, HRS Dated: August 17, 2020 Received: August 18, 2020

Dear Miriam Cervantes:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm = identifies = combination = product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202348

Device Name External Remote Controller ERC 4P

Indications for Use (Describe)

The Precice® System (inclusive of Precice, Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions or bone transport of long bones.

The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions and non-unions of long bones in pediatrics and small stature adult patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, block letters. Below "NUVASIVE" is the phrase "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple font.

510 (k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

A. Submitted by:

Miriam Cervantes Regulatory Affairs Specialist Nu Vasive Specialized Orthopedics Incorporated 101 Enterprise, Suite 100 Aliso Viejo, California, 92656 Telephone: (909) 229-7836

Date Prepared: August 17, 2020

B. Device name

Proprietary Name:	External Remote Controller ERC 4P
Common or Usual Name:	Intramedullary Fixation Rod, Smooth or threaded metallic bone fixation fastener
Classification Name:	Rod, Fixation, Intramedullary and Accessories
Regulation Number:	21 CFR § 888.3020, 21 CFR 888.3030, 21 CFR 888.3040
Classification:	Class II
Product Code (primary):	HSB
Product Code (subsequent):	KTT, HWC, HRS

C. Predicate Devices

The subject External Remote Controller ERC 4P is substantially equivalent to the primary predicate device, Precice System (K191336), and additional predicate devices Precice Intramedullary Limb Lengthening System (K113219) Precice Plating System (K192181) and Precice Ankle Salvage System (K200430).

D. Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC.". The logo features a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. Below "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple, sans-serif font. The logo is clean and modern, with a focus on the company name and specialization.

The purpose of this 510(k) Premarket Notification is to expand the indications for use of the ERC 4P to allow its use with the Precice Plating System and the Precice Ankle Salvage System.

E. Indications for Use

The Precice® System (inclusive of Precice, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport of long bones.

The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talocalcaneal fusion has been achieved.

F. Technological Characteristics

As was established in this submission, the subject External Remote Controller ERC 4P is substantially equivalent to the predicate device cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and functions.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject External Remote Controller ERC 4P is substantially equivalent to predicate devices. Following testing have been included in the submission to show substantial equivalence to the predicate device.

Test	Applicable standard
Electrical Safety	IEC 60601-1
Electromagnetic Compatibility andInterference	IEC 60601-1-2
Magnet Safety Analysis	N/A
Usability Study	N/A
Labeling Readability	N/A

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic on the left, followed by the company name in gray, sans-serif font. Below the company name, "SPECIALIZED ORTHOPEDICS, INC." is written in smaller, purple font.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate device, the subject External Remote Controller ERC 4P has been shown to be substantially equivalent to legally marketed 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.