When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft

When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Device Description

Spinal Elements' Mosaic device is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device body has projections (or flanges) that encompass screw holes and may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).

The Mosaic system is provided with bone screws that are manufactured from titanium alloy (Ti-6Al-4V), and are available in both fixed and variable angle designs.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Mosaic™ Intervertebral Body Fusion Device, along with an FDA clearance letter. It describes the device, its intended use, and states that it was found "substantially equivalent" to predicate devices. The document explicitly states "Mechanical testing indicates that the Mosaic device is capable of performing in accordance with its intended use."

However, this document does not contain information regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI-powered device. The device described is a physical intervertebral body fusion device and not an AI/ML medical device. Therefore, the requested information about test sets, ground truth, expert adjudication, MRMC studies, and standalone algorithm performance, which are relevant to AI/ML device evaluations, cannot be extracted from this submission.

The document only discusses mechanical testing, which is a different type of performance evaluation relevant to physical implants.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them based on the input text.

Summary

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Spinal Elements, Inc. Premarket Notification - MosuicTM

Page 1 of 2

510(k) Summary MosaicTM

510(k) Number L071833

OCT 2 3 2007

Manufacturer Identification
Submitted by:	Spinal Elements, Inc.
	2744 Loker Ave. W., Suite 100
	Carlsbad, CA 92010
	760-607-0121
Contact Information:
	Kerri DiMartino
	Regulatory Affairs Specialist
	Spinal Elements, Inc.
	2744 Loker Ave. W., Suite 100
	Carlsbad, CA 92010
	760-607-1816
	kdimartino@spinalelements.com
Date Prepared:	October 16, 2007
Device Indentification
Proprietary Name:	Mosaic™
Common Name:	Intervertebral Body Fusion Device
Device Classification:	21 CFR 888.3080 (orthosis, spinal intervertebral fusion)

Device Description

The Mosaic system is provided with bone screws that are manufactured from titanium alloy (Ti-6Al-4V), and are available in both fixed and variable angle designs.

Intended Use of the Device

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and

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rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft

Substantial Equivalence

The Mosaic device was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices.

Performance Data

Mechanical testing indicates that the Mosaic device is capable of performing in accordance with its intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

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

SEP 12 2011

Spinal Elements, Incorporated % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K071833

Trade/Device Name: Mosaic™ Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: September 14, 2007 Received: September 17, 2007

Dear Ms. DiMartino:

This letter corrects our substantially equivalent letter of October 23, 2007.

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 (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.

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

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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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K671833
Page 1 of 1

Indications for Use

1607 1833 510(k) Number (if known):

Mosaic™M Device Name:

Indications for Use:

When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Millikin

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K071833

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.