When used as an Intervertebral Body Fusion device, the Novel ALIF 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 ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

When used as a Vertebral Body Replacement device, the Novel ALIF 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 ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

Device Description

The Novel® ALIF 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Novel® ALIF Spinal Spacer System:

The provided documents (510(k) summary and FDA clearance letter K090782) are for a medical device implant (spinal spacer system), not an AI/software device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to this type of submission.

Medical device clearance for implants like the Novel ALIF Spinal Spacer System typically relies on demonstrating substantial equivalence to a predicate device through material science, mechanical testing, and sometimes biocompatibility testing. It does not involve AI performance metrics.

Here's the information extracted from the provided text, with explanations where categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for the Novel® ALIF Spinal Spacer System:
The fundamental acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device. This is demonstrated by showing equivalence in:

Indications for Use
Design
Material
Function
Mechanical Performance

Reported Device Performance:

Acceptance Criterion (implicitly by substantial equivalence)	Reported Device Performance
Indications for Use Equivalence	"Data was provided which demonstrated the Novel ALIF Spinal Spacer System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use..."
Design Equivalence	"...design..."
Material Equivalence	"...material..." (manufactured from PEEK and titanium alloy)
Function Equivalence	"...and function."
Mechanical Performance Equivalence	"The test results demonstrate that the mechanical performance of the Novel ALIF Spinal Spacer System is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This is a medical implant, not an AI/software device that uses "test sets" of data in the common sense for performance evaluation in the way AI models do. The "testing" refers to mechanical tests to compare its properties to a predicate device. The document does not specify sample sizes for these mechanical tests.
Data Provenance: Not applicable in the context of clinical data for AI; the "data" here would be mechanical test results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. Ground truth in the context of AI refers to labels or diagnoses provided by experts on a dataset. For a spinal implant, the "truth" is established through engineering and biomechanical principles, material specifications, and regulatory standards, not expert consensus on image interpretation or clinical outcomes of a dataset.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts who are labeling data for an AI model. This is not relevant to the clearance of a mechanical spinal implant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is used to assess the effectiveness of an AI system's influence on human reader performance. This device is a physical implant and does not involve human readers interpreting images or data with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. There is no "algorithm" in the sense of software or AI for this device. It is a physical implant.

7. The Type of Ground Truth Used

Engineering/Biomechanical Standards and Predicate Device Performance Data. The "ground truth" for this type of device is the established performance characteristics (e.g., strength, durability, material properties) of its predicate device, as well as adherence to relevant mechanical testing standards (e.g., ASTM standards for spinal implants). The device's performance is then compared against these established benchmarks.

8. The Sample Size for the Training Set

Not Applicable. This is a medical implant, not an AI/software device that uses "training sets."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no training set in the context of this device.

Summary

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K090782

510(k) SUMMARY

APR 2 2 2009

Novel® ALIF Spinal Spacer System 510(k) SUMMARY March 2009

Company:	Alphatec Spine, Inc.5818 El Camino RealCarlsbad, CA 92008 USADirect: (760) 494-6771Fax: (760) 431-0289
Contact Person:	Mary Stanners, Regulatory Affairs Specialist II
Trade/Proprietary Name:	Novel® ALIF Spinal Spacer System
Common Name:	Intervertebral Body Fusion DeviceVertebral Body Replacement Device
Classification Name:	Intervertebral Body Fusion DeviceSpinal Intervertebral Body Fixation Orthosis
Classification Number(s)/Product Code(s):	21 CFR 888.3080 (MAX)21 CFR 888.3060 (MQP)

Product Description:

Indications for Use:

Pg 1 of 2

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K090782

Substantial Equivalence:

Data was provided which demonstrated the Novel ALIF 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 ALIF Spinal Spacer System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The seal is simple and iconic, representing the department's role in promoting health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc % Ms. Mary Stanners Regulatory Affairs Specialist II 5818 EL Camino Road Carlsbad, California 92008

Re: K090782

Trade/Device Name: Novel® ALIF Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MOP Dated: March 20, 2009 Received: March 23, 2009

APR 2 2 2009

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.

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 (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.

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Page 2- Ms. Mary Stanners

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

erely yours,

k N. Melkerson

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): K090782

Device Name: Novel® ALIF Spinal Spacer System

Indications for Use:

Intervertebral Body Fusion

Vertebral Body Replacement

When used as a Vertebral Body Replacement device, the Novel ALIF 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 ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically-the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

Prescription Use X (Per 21 CFR 801.109)

OR ·

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)

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

510(k) Number K090782
Pg. 1 of 1

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.