The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.

AI/ML Overview

The provided text focuses on the FDA's 510(k) clearance for the M6-C™ Single Use, Disposable Instrumentation. It details the device's intended use and design, emphasizing its equivalence to a predicate device. However, it does not contain information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details (effect size, human improvement).
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document describes a surgical instrumentation device, not an AI/ML diagnostic device. The performance testing mentioned (Impact Testing, Bend/Functional Testing, Sterilization and Biocompatibility Testing) are typical for physical surgical instruments, not for evaluating AI model performance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2024

Spinal Kinetics / Orthofix / SeaSpine Tony John Regulatory Affairs Program Manager 501 Mercury Drive Sunnyvale, California 94085

Re: K241117

Trade/Device Name: M6-C™ Single Use, Disposable Instrumentation 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: April 22, 2024 Received: April 23, 2024

Dear Tony John:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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

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Indications for Use

Submission Number (if known)

K241117

Device Name

M6-C™ Single Use, Disposable Instrumentation

Indications for Use (Describe)

The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

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

< 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 SpinalKinetics. The logo consists of a blue spine graphic on the left, followed by the word "Spinal" in blue and "Kinetics" in gray. The letters "TM" are in superscript to the right of the word Kinetics.

510(k) Summary

Device Trade Name:	M6-C™ Single Use, Disposable Instrumentation
Manufacturer:	Spinal Kinetics LLC501 Mercury DriveSunnyvale, CA 94085USA
Contact Person:	Tony JohnProgram Manager, Regulatory AffairsOrthofix/Spinal Kinetics/SeaSpine3451 Plano ParkwayLewisville, TX 75056Phone: (214) 937-2153tonyjohn@orthofix.com
Date Prepared:	April 22, 2024
Registration Number:	3004987282
Product Code:	QLQ
Classifications:	Class II - 21 CFR §888.4515
Classification Name:	Orthopedic manual surgical instrumentation for use with total discreplacement devices
Primary Predicate:	K220861 - M6-C Artificial Cervical Disc Instruments AS

Reason for the 510(k) Submission:

To introduce a single-use version of the existing re-usable M6-C Cervical Surgical Instrumentation cleared under K220861.

Device Description:

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Image /page/4/Picture/1 description: The image shows the logo for Spinal Kinetics. The word "Spinal" is in blue, and the word "Kinetics" is in gray. To the left of the word "Spinal" is a blue spine-like graphic. The letters "TM" are in superscript to the right of the word "Kinetics".

Indications for Use:

The M6-CTM Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-CTM Artificial Cervical Disc.

Performance Testing Summary:

M6-CTM Single Use, Disposable Instrumentation has been evaluated via the following performance testing:

Impact Testing
Bend/Functional Testing
. Sterilization and Biocompatibility Testing

The results demonstrated the performance of M6-CTM Single Use, Disposable Instrumentation is substantially equivalent to the reusable M6-C Artificial Cervical Disc Instrument predicate device.

Substantial Equivalence:

The subject device is substantially equivalent to the M6-C Artificial Cervical Disc Instrument predicate devices with respect to indication, design, materials, function, and performance.

Conclusion:

M6-C™ Single Use, Disposable Instrumentation has the same intended use, indications for use as the predicate M6-C Artificial Cervical Disc Instrument predicate. The minor difference in technological characteristics do not raise any new question of safety or effectiveness and the sterilization, biocompatibility, and performance testing demonstrates that the subject device is substantial equivalent to the predicate device.

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.