Intervertebral Body Fusion: The Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

Vertebral Body Replacement: The Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.

Device Description

The Novel® Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.

AI/ML Overview

The provided 510(k) summary for the Novel® Spinal Spacer System does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically described for AI/ML devices or diagnostic accuracy studies.

Instead, this document is a 510(k) premarket notification for a spinal implant device, a hardware medical device. For such devices, acceptance criteria and performance are typically evaluated through mechanical testing, biocompatibility testing, and a demonstration of substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

Here's an analysis based on the provided text, highlighting what is and is not available:

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

The document states:

Acceptance Criteria (Implied): The mechanical performance of the Novel® Spinal Spacer System should be "substantially equivalent to the predicate device."
Reported Device Performance: "The test results demonstrate that the mechanical performance of the Novel® Spinal Spacer System is substantially equivalent to the predicate device."

Table:

Acceptance Criteria	Reported Device Performance
Substantially equivalent mechanical performance to predicate device	Mechanical performance demonstrated to be substantially equivalent to the predicate device.

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

Sample size for test set: Not specified. Mechanical testing typically involves a set number of samples per test type (e.g., fatigue, static compression, expulsion), but the exact number is not detailed in this summary.
Data provenance: Not specified. As mechanical testing is performed in a lab setting, "country of origin of the data" in the context of patient data is not applicable here.

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 is not applicable to the evaluation of this device. Mechanical performance testing does not rely on expert interpretation of imaging or clinical data for ground truth. Instead, it relies on standardized test methods and engineering measurements.

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

This is not applicable to the evaluation of this device. Adjudication methods are typically used in clinical or diagnostic studies involving human interpretation.

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

This is not applicable to the evaluation of this device. An MRMC study is relevant for diagnostic devices or AI algorithms that assist human readers, not for mechanical spinal implants.

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

This is not applicable to the evaluation of this device. Standalone performance refers to the performance of an algorithm without human intervention, which is not relevant for a spinal implant.

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

For mechanical testing, the "ground truth" would be defined by the validated standards and test methods (e.g., ASTM or ISO standards for spinal implants) and the measured physical properties and behaviors of the device under specific loads. These are objective engineering measurements, not clinical or pathological ground truth as understood in diagnostic studies.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for a spinal implant device undergoing mechanical testing and substantial equivalence review.

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

This is not applicable, as there is no training set for this type of device submission.

In summary:

This 510(k) summary focuses entirely on demonstrating substantial equivalence for a physical medical device (spinal implant) through mechanical performance testing and material comparisons. It does not involve any AI/ML, diagnostic accuracy, or clinical reader studies. Therefore, most of the requested information (related to test sets, experts, adjudication, MRMC, standalone performance, training sets, and clinical ground truth) is not present because it is not relevant to the type of device and regulatory submission presented. The primary "study" proving acceptance criteria is the mechanical performance testing that demonstrated substantial equivalence to a predicate device.

Summary

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510(k) SUMMARY

MAY 2 1 2008

Novel® Spinal Spacer System 510(k) SUMMARY March 2008

Company:	Alphatec Spine, Inc.2051 Palomar Airport Road #100Carlsbad, CA 92011 USADirect: (760) 494-6771Fax: (760) 431-9132
Contact Person:	Mary Stanners, Regulatory Affairs Specialist
Trade/Proprietary Name:	Novel® Spinal Spacer System
Common Name:	Vertebral Body Replacement DeviceIntervertebral Body Fusion Device
Classification Name:	Spinal Intervertebral Body Fixation OrthosisIntervertebral Body Fusion Device
Classification Number(s)/Product Code(s):	21 CFR 888.3060 (MQP)21 CFR 888.3080 (MAX)

Product Description:

Indications for Use:

Intervertebral Body Fusion

The Novel® Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel® Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

Vertebral Body Replacement

The Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation

Page 1 of 2

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system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.

Substantial Equivalence:

Data was provided which demonstrated the Novel® Spinal Spacer System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material and function.

Performance Data:

The test results demonstrate that the mechanical performance of the Novel® Spinal Spacer 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2008

Alphatec Spine, Inc. % Ms. Mary Stanners Regulatory Affairs Specialist 2051 Palomar Airport Road, #100 Carlsbad, CA 92011

K080699 Re:

Trade/Device Name: Novel® Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: March 10, 2008 Received: March 12, 2008

Dear Ms. Stanners:

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 - Ms. Mary Stanners

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Willson

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): K080699

Device Name: Novel® Spinal Spacer System

Indications for Use:

Intervertebral Body Fusion

Vertebral Body Replacement

The Novel® Spinal Spacer System is intended for use in the thoracolumbar spine (T1-I.5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel® Spinal Spacer System is intended for use with supplemental spinal fixation system. Specifically the Novel® Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the Novel® Spinal Spacer System is intended for use with allograft.

Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogles for MKM

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

510(k) Number K080699

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.