The PRECICE® Plate 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.

Device Description

The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments. The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.

AI/ML Overview

The provided text is a 510(k) summary for the PRECICE Plating System, a medical device for orthopedic indications. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical performance data.

However, the document does not contain information regarding acceptance criteria for device performance in the context of clinical studies, sample sizes for test sets or training sets, ground truth establishment methods (expert consensus, pathology, etc.), details about human expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

The provided text details non-clinical performance verification, establishing substantial equivalence to existing predicate devices through mechanical testing and engineering analysis. It lacks the elements typically associated with proving device performance against specific acceptance criteria in a clinical setting, particularly for AI/machine learning devices where the requested information is highly relevant.

Therefore, many of the requested fields cannot be filled from the given document.

Here's a breakdown of what information can and cannot be extracted based on your request:

#	Information Requested	Details from the Document
1	A table of acceptance criteria and the reported device performance	Not available. The document details non-clinical testing for substantial equivalence against predicate devices rather than specific acceptance criteria thresholds for clinical performance. It states that the subject device performs substantially equivalent to the predicate devices under various loading conditions.
2	Sample sizes used for the test set and the data provenance	Not available. This document describes non-clinical performance verification (mechanical testing and engineering analysis). There are no test sets or training sets in the context of clinical data for algorithmic performance.
3	Number of experts used to establish the ground truth for the test set and the qualifications of those experts	Not applicable. No test set with ground truth established by experts is mentioned, as this is a mechanical device, not typically evaluated by human expert consensus on diagnostic images or other clinical data.
4	Adjudication method (e.g., 2+1, 3+1, none) for the test set	Not applicable. No test set requiring expert adjudication is mentioned.
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	Not applicable. This device is a mechanical orthopedic implant, not an AI/ML diagnostic or assistive tool for human readers. Therefore, MRMC studies comparing human performance with/without AI assistance are not relevant to this submission.
6	If a standalone (i.e., algorithm only without human-in-the-loop performance) was done	Not applicable. This device is a mechanical orthopedic implant. "Standalone" performance as an algorithm is not relevant. The document refers to the "PRECICE Plate" as containing an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing and being adjusted by an External Remote Controller (ERC), implying a physical device with a control mechanism, not a software algorithm.
7	The type of ground truth used (expert consensus, pathology, outcomes data, etc.)	Not applicable. For the non-clinical performance verification, the "ground truth" is defined by the standards of mechanical testing (e.g., ASTM F384, ASTM F543) and engineering analysis, comparing the device's physical properties and performance against those of predicate devices.
8	The sample size for the training set	Not available. No training sets are mentioned, as this is not an AI/ML device.
9	How the ground truth for the training set was established	Not applicable. No training sets are mentioned, as this is not an AI/ML device.

Summary of Device Performance (Based on "Performance Data" section):

The "Performance Data" section describes non-clinical testing performed to demonstrate substantial equivalence. The device's performance is reported in terms of its ability to perform "substantially equivalent" to predicate devices under various mechanical tests.

Table of Performance (Based on H. Performance Data section):

Testing Description	Comparison to Predicate Devices (Reported Performance)
Static Compression Bending Strength per ASTM F384	Bending load on construct of subject device performs substantially equivalent under the same loading conditions as predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086).
Dynamic Compression Bending strength per ASTM F384	(Continuation of above - "substantially equivalent" implied).
Engineering Analysis of Bending Construct	Characterization of an offset bending load of the subject device was demonstrated to perform substantially equivalent to the predicate device (Orthofix Modulsystem K955848).
Torque Resistance per ASTM F543	Characterization of torque resistance of subject device is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086).
Axial Pullout per ASTM F543	Characterization of screw pullout force is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086).
Torsion	Characterization of torsional strength of subject device is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and PRECICE STRYDE K180503).
Tensile and Collapse Strength	Subject device resists tensile loads substantially equivalent to the predicate devices (Inter-Os Limb Lengthener K031875 and Orthofix Modulsystem K955848).
Distraction Force	Distraction force is substantially equivalent to the predicate device (PRECICE STRYDE K180503) and clinical literature. (Note: "clinical literature" suggests external evidence rather than direct device testing within this submission for distraction force comparison).

Conclusion from document: The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.

Summary

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November 7, 2019

Image /page/0/Picture/1 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" stacked on top of the word "ADMINISTRATION".

NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

Re: K192181

Trade/Device Name: PRECICE Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, HRS, HWC Dated: August 7, 2019 Received: August 12, 2019

Dear Madison Heffron:

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 (OS) 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-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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: Shumaya Ali Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192181

Device Name

PRECICE® Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Depreciation Use (Part 21 CFR 601 Subpart D)	☐ Over-The-Counter Use (21 CFR 601 Subpart C)
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|X|Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf shape in purple and gray on the left. To the right of the leaf shape is the word "NUVASIVE" in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller purple font below.

PRECICE Plating System 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:

Madison Heffron Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (949) 532-7868

Date Prepared: November 6, 2019

B. Device Name

Trade or Proprietary Name:	PRECICE® Plating System
Common or Usual Name:	Appliance, Fixation, Nail/Blade/Plate Combination, MultipleComponent
Classification Name:	Single/multiple component metallic bone fixation appliancesand accessories
Device Class:	Class II
Classification:	21 CFR § 888.3030
Product Code:	KTT, HRS, HWC

C. Predicate Devices

The subject PRECICE Plate System is substantially equivalent to the following predicate devices;

For limb lengthening, the Precice Plate System is substantially equivalent to the predicate device Inter-Os Limb Lengthener (K031875),

For fracture fixation, including open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, the Precice Plate System is substantially equivalent to the predicate device Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086),

In addition, the following reference devices were used to establish substantial equivalence, PRECICE STRYDE (K180503) and Orthofix Modulsystem (K955848).

D. Device Description

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Image /page/4/Picture/1 description: The image contains the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf-like shape on the left, with the top half in purple and the bottom half in silver. To the right of the leaf shape is the word "NUVASIVE" in silver, with the words "SPECIALIZED ORTHOPEDICS, INC." in purple underneath.

The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.

The purpose of this premarket notification is to market the new device PRECICE Plating System.

E. Indications for Use

The PRECICE Plate 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.

F. Comparison of Indications for Use with the Predicate Device

The Precice Plate System is substantially equivalent to the Inter-Os Limb Lengthener (K031875) for limb lengthening. The subject device is intended for use with pediatric and small stature adults compared to the predicate indicated for adults. Safety and effectiveness for limb lengthening of intended patient population of subject device can be determined by the device's ability to provide stability to the osteotomy site and to provide adequate force for distraction osteogenesis. The subject device is intended for use in all long bones compared to the predicate device indicated for the femur only. Differences in long bone placement present similar risks for surrounding soft tissue interaction and mechanical performance. Safety and effectiveness of the device is acceptable when used in accordance with labeling detailed to address each long bone specific anatomy. The differences between the subject device and predicate device are not critical for limb lengthening of long bones in adults, small stature adults and pediatric patients.

Additionally, the PRECICE Plate System has the same intended use as Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086) for fracture fixation.

Therefore, the differences in indications for use between the predicate devices and subject device do not create a new intended use.

G. Comparison of Technological Characteristics with the Predicate Device

As was established in this submission, the subject PRECICE Plating System is substantially equivalent to the predicates, Inter-Os Limb Lengthener (K031875) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086), and reference predicates PRECICE STRYDE (K180503) and Orthofix Modulsystem (K955848), which were previously cleared by the FDA for commercial distribution in the United States. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicates through comparison in areas including design. labeling/intended use, material composition, and function.

The following table describes the summary comparison of technological characteristics of the subject device with the predicate devices:

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Image /page/5/Picture/1 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized, abstract shape on the left, which is split into two colors: purple on the top and silver on the bottom. To the right of the shape is the word "NUVASIVE" in silver, block letters. Below "NUVASIVE" is the phrase "SPECIALIZED ORTHOPEDICS, INC." in smaller, purple letters.

Intended Use	Limb Lengthening of Long Bones	Fracture fixation of Long Bones
PrimaryPredicate	Inter-Os Limb Lengthener(K031875)	Orthopediatrics Fracture andOsteotomy Bone Plate System(K111086)
ReferenceDevice	PRECICE STRYDE (K180503) andOrthofix Modulsystem (K955848)	PRECICE STRYDE (K180503)
Summary of thetechnologysimilarities tothe predicatedevice	Principle of Operation:Distraction osteogenesis. Material Composition:Stainless steel Similar compatible screw sizes Similar distracting platemechanism Intended to be removed afterbone consolidation	Principle of Operation: Fixationand osteotomy lengthening. Material Composition: Stainlesssteel Similar compatible screw sizes Similar implant shape and design Non-weight bearing
Summary of thetechnologydifferences tothe predicatedevice	The maximum stroke length forthe PRECICE Plate is less thanthe predicate. The PRECICEPlate contains less screw holesthan the predicate. Use of ERC with PRECICEPlate provides distraction ofplate non-invasively comparedto predicate device which usesa percutaneous handle.	The PRECICE Plate has a greaterprofile than the predicate device. Use of ERC with PRECICE Plateprovides compression non-invasively after index procedurecompared to predicate which canonly provide compressionthrough compression slotsintraoperatively.

H. Performance Data

Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicate devices.

The PRECICE Plate System is substantially equivalent to perform limb lengthening demonstrated by preclinical testing. Safety and effectiveness was also demonstrated by engineering analysis to support substantial equivalence of the subject device to the Inter-Os Limb Lengthener (K031875), Orthofix Modulsystem (K955848) and clinical literature.

The PRECICE Plate System is substantially equivalent to perform fracture fixation demonstrated by predicate device testing of Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086) to ASTM F384 and ASTM F543.

The following table describes summary testing performed and incorporated by reference from predicate devices to establish substantial equivalence:

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Testing Description	Predicate Device	Explanation of SubstantialEquivalence
Static CompressionBending Strength perASTM F384	Orthofix Modulsystem(K955848) andOrthopediatrics Fracture andOsteotomy Bone Plate System(K111086)	Bending load on construct of subjectdevice performs substantiallyequivalent under the same loadingconditions as predicate devices.
Dynamic CompressionBending strength perASTM F384	Orthofix Modulsystem(K955848) andOrthopediatrics Fracture andOsteotomy Bone Plate System(K111086)
Engineering Analysisof Bending Construct	Orthofix Modulsystem(K955848)	Characterization of an offsetbending load of the subject devicewas demonstrated to performsubstantially equivalent to thepredicate device.
Torque Resistance perASTM F543	Orthofix Modulsystem(K955848) andOrthopediatrics Fracture andOsteotomy Bone Plate System(K111086)	Characterization of torque resistanceof subject device is substantiallyequivalent to the predicate devices.
Axial Pullout perASTM F543	Orthofix Modulsystem(K955848) andOrthopediatrics Fracture andOsteotomy Bone Plate System(K111086)	Characterization of screw pulloutforce is substantially equivalent tothe predicate devices.
Torsion	Orthofix Modulsystem(K955848) and PRECICESTRYDE (K180503)	Characterization of torsionalstrength of subject device issubstantially equivalent to thepredicate devices.
Tensile and CollapseStrength	Inter-Os Limb Lengthener(K031875) and OrthofixModulsystem (K955848)	Subject device resists tensile loadssubstantially equivalent to thepredicate devices.
Distraction Force	PRECICE STRYDE (K180503)and clinical literature	Distraction force is substantiallyequivalent to the predicate device.

The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.

I. Conclusions

The subject device, the PRECICE Plating System, has been shown to be substantially equivalent to the legally marketed predicate devices for its intended use.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.