SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

• K Number: K081132
• Device Name: SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer: SPINE SMITH PARTNERS L.P.
• Date Cleared: 2008-07-14 ( 84 days)
• Product Code: KWQ
• Regulation Number: 888.3060
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

• . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• . Spondylolisthesis
• Spinal Stenosis .
• Tumors .
• Trauma (i.e. fracture) .

Device Description

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

AI/ML Overview

The provided document is a 510(k) Summary for the SpineSmith Cequence Anterior Cervical Plate System. This document describes a medical device, specifically a spinal implant, and its mechanical testing for substantial equivalence to a predicate device.

Here's an analysis of the document regarding acceptance criteria and a study proving the device meets them, based on the provided questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device based on mechanical testing.	"Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device." (Page 2)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical test results" but does not specify the sample size used for these mechanical tests. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given it's a 510(k) for a spinal implant, the "data" would likely refer to physical testing of components and assemblies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing of a spinal implant is typically established by engineering standards and validated test methods, not by expert consensus in the medical field.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human assessment or a diagnostic device.

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 is a spinal implant, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a spinal implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device's performance is based on established mechanical engineering standards and validated test methodologies for spinal implants. The goal was to show "substantial equivalence" to a predicate device, meaning its mechanical properties and safety profile are comparable.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this type of device and study.

Summary

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K081132
Page 1 of 2

JUL 1 4 2008

SpineSmith Cequence Anterior Cervical Plate System 510(k) Summary of Safety and Effectiveness

SUBMITTED BY SpineSmith Partners, LP 8140 N. Mopac, Bldg II, Suite 120 Austin, TX 78759 ESTABLISHMENT 3006404071 REGISTRATION NUMBER Robert Jones CONTACT PERSON Vice President, Research and Development Phone: [phone] Fax: [phone] Email: [e-mail] SUBMISSION PREPARED BY Lisa Peterson Kaedon Consulting, LLC Phone: [phone] April 18, 2008 DATE PREPARED CLASSIFICATION KWQ 888.3060- Spinal Intervertebral Body Fixation Orthosis Spinal Fixation System COMMON NAME PROPRIETARY NAME SpineSmith Cequence Anterior Cervical Plate System SUBSTANTIAL The SpineSmith Cequence System was determined to be EQUIVALENCE substantially equivalent to the predicate device.

DEVICE DESCRIPTION

The Cequence anterior cervical plates are preassembled and are offered in both a constrained and semi-constrained configuration. Cequence consists of four (4) primary components: 1) anterior plate, 2) self-tapping bone screws, 3) locking screws and 4) locking plate.

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K081132
Page 2 of 2

INDICATIONS:

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

• . Degenerative disc disease [DDD] - defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• . Spondylolisthesis
• Spinal Stenosis .
• Tumors .
• Trauma (i.e. fracture) .

MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed Cequence System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three stripes forming the wings and a ribbon-like element below.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinc Smith Partners, L.P. % Mr. Robert Jones 8140 North Mopac Building II, Suite 120 Austin, TX 78759

JUL 1 4 2008

Rc: K081132

Trade/Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 27, 2008 Received: June 30, 2008

Dear Mr. Jones:

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. 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 such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Mr. Robert Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Miller

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: SpineSmith Partners, LP Cequence Anterior Cervical Plate System

Indications for Use:

The SpineSmith Cequence Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine at one level between C2-C7 for the following indications:

• Degenerative disc disease [DDD] defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis .
• Spinal Stenosis .
• Tumors .
• Trauma (i.e. fracture) .

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Barbare Buclind

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

510(k) Number_ (08 /132-

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.