The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of 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 Spine 360 anterior cervical plates are provided preassembled and are offered with fixed angle bone screws. The system consists of four (4) primary components: 1) anterior plate, 2) self-tapping fixed angle bone screws, 3) locking shield screws and 4) locking shield.

AI/ML Overview

The provided text describes a medical device, the Spine 360 Anterior Cervical Plate System, and its substantial equivalence to a predicate device. It explicitly states that "Mechanical test results demonstrate that the Spine 360 ACP System is substantially equivalent to the predicate device." However, the document does not contain the specific "acceptance criteria" (e.g., specific thresholds for mechanical properties like pull-out strength, fatigue life, etc.) or detailed results of a study that would demonstrate meeting those criteria. It only makes a general statement about substantial equivalence based on mechanical test data.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for testing, ground truth establishment, or clinical study designs (MRMC, standalone algorithm performance) cannot be extracted from this document.

Here's what can be inferred and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of specific numerical thresholds (e.g., minimum tensile strength, fatigue cycles, etc.). Implied acceptance criteria are that the device's mechanical performance should be equal to or better than the predicate device.	"Mechanical test results demonstrate that the Spine 360 ACP System is substantially equivalent to the predicate device." (No specific numerical performance metrics are provided in this document.)

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided document. The "mechanical test data" typically refers to in-vitro biomechanical testing of the device itself, not necessarily patient data.
Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the study described is a mechanical test for substantial equivalence, not a clinical study requiring expert diagnosis or ground truth establishment based on patient cases.

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

Not applicable as this was a mechanical test, not a clinical study involving human readers or interpretation of results that would require adjudication.

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

No. This was a mechanical test comparing a new device to a predicate device for substantial equivalence, not an MRMC study or a study involving AI assistance.

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

No. This device is a physical medical implant, not an algorithm or AI system.

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

For mechanical testing, the "ground truth" would be the established engineering standards and physical properties of the predicate device. The performance of the Spine 360 device was compared against these.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.

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

Not applicable.

Summary

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K092531

Spine 360 Anterior Cervical Plate System

510(k) Summary of Safety and Effectiveness

SUBMITTED BY

Spine 360 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746 Phone: 512-772-4442 Fax: 800-640-6045

ESTABLISHMENT REGISTRATION NUMBER

CONTACT PERSON

Tim Hildebrand Project Manager Phone: 512-772-3774 Fax: 800-640-6045

3005841736

SUBMISSION PREPARED BY

Lisa Peterson Kaedon Consulting, LLC Phone: 512-507-0746

August 11, 2009 DATE PREPARED
CLASSIFICATION

Spinal Fixation System COMMON NAME

Spine 360 Anterior Cervical Plate System PROPRIETARY NAME

Orthosis

SUBSTANTIAL EQUIVALENCE

The Spine 360 ACP System was determined to be substantially equivalent to the Synthes CSLP predicate device.

KWQ 888.3060- Spinal Intervertebral Body Fixation

DEVICE DESCRIPTION

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K092531 page 2 of 2

INDICATIONS:

The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of 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 Spine 360 ACP System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

FEB - 4 2010

Spine 360 % Mr. Tim Hildebrand Project Manager 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

Re: K092531

Trade/Device Name: Spine 360 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 02, 2010 Received: February 03, 2010

Dear Mr. Hildebrand:

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. 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Tim Hildebrand

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 vours.

Qarbaro Buehn

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

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K(19253)

Device Name:

Spine360 Anterior Cervical Plate System

Indications for Use:

The Spine360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

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

Prescription Use × (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)

Division Sign-Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KO92531 510(k) Number__

5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

Spine360

Phone: 512-772-4442 Fax: 800-640-6045

Regulation Number and Section

N/A