The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.

The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.

AI/ML Overview

This document is a 510(k) summary for the Simplify Disc Inserter FP. It details the device's intended use and design modifications, but it does not contain the kind of detailed information about acceptance criteria, study design, or AI performance that you are requesting.

The document states:

Performance Testing: "Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria."

However, it does not provide any specific acceptance criteria or detailed results from these tests. It also does not mention any AI component or related studies (like MRMC or standalone performance studies).

Therefore, based on the provided text, I cannot extract the information you requested regarding:

A table of acceptance criteria and the reported device performance: This information is not detailed.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth and their qualifications: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study, effect size: Not applicable, as no AI component is mentioned.
Standalone (algorithm only) performance: Not applicable, as no AI component is mentioned.
Type of ground truth used: Not applicable, as no AI component or clinical evaluation requiring such ground truth is detailed.
Sample size for the training set: Not applicable, as no AI component is mentioned.
How the ground truth for the training set was established: Not applicable, as no AI component is mentioned.

This document pertains to regulatory approval for a physical medical instrument (the Disc Inserter) and not an AI/software as a medical device (SaMD).

Summary

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August 20, 2021

NuVasive, Inc. % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K211757

Trade/Device Name: Simplify Disc Inserter FP Regulation Number: 21 CFR 888.4515 Regulation Name: Orthopedic Manual Surgical Instrumentation For Use With Total Disc Replacement Devices Regulatory Class: Class II Product Code: QLQ Dated: June 4, 2021 Received: June 7, 2021

Dear Mr. Eggleton:

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.

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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 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-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.

Brent Showalter -S

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal 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) K211757

Device Name Simplify Disc Inserter FP

Indications for Use (Describe)

The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

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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510(k) SUMMARY

Device Trade Name:	Simplify Disc Inserter FP
Manufacturer:	NuVasive, Inc.7475 Lusk Blvd.San Diego, CA 92121 USAPhone: (858) 909-1800
Contact:	Mark AlvisNuVasive, Inc.Phone: (831) 600-6859malvis@nuvasive.com
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: (202) 552-5800jeggleton@mcra.com
Date Prepared:	July 20, 2021
Classifications:	21 CFR §888.4515
Classification Name:	Orthopedic Manual Surgical Instrumentation For Use With TotalDisc Replacement Devices
Class:	II
Product Codes:	OLO

Indications for Use:

The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

Device Description:

The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.

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Primary Predicate Device:

The Simplify Disc Inserters were downclassified in response to an Accessory Classification Request under Classification Order Q200722. This 510(k) put forth a discussion to claim substantial equivalence to the Simplify Disc Inserters that were originally PMA Approved (P200022) prior to the downclassification.

Technological Characteristics:

The purpose of this Traditional 510(k) is to seek marketing clearance for modifications to the Simplify Disc Inserter to Simplify Disc Inserter FP utilized to insert the Simplify® Cervical Artificial Disc. The modifications include the following:

Ejector subfeature addition ●
Enlarged thumb nut ●
. Wider jaws

Performance Testing:

Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria.

Conclusion:

The indications for use and intended use are consistent with FDA classification per Q200722. Comparisons of technological characteristics and results of performance testing demonstrate the modifications to the design do not introduce any new questions of safety or effectiveness. Therefore, the Simplify Disc Inserter FP is substantially equivalent to the cited primary predicate.

Regulation Number and Section

§ 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.

(a)
Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.