Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation.

Vertebral Body Replacement: When used as a vertebral body replacement, the CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The CoAlign Innovations AccuLIF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

Device Description

The AccuLIF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The AccuLIF Cage is manufactured from Ti6Al4V and stainless steel. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes.

AI/ML Overview

This is a spinal implant (AccuLIF Cage) and not an AI/ML device, therefore, the requested information about acceptance criteria for AI/ML performance, study design with test sets, ground truth establishment, expert reader qualifications, adjudication methods, MRMC studies, and training set details are not applicable.

The document describes the device, its indications for use, and a comparison to a predicate device (SEC IBF Cage - K093669) to establish substantial equivalence. The "study" referenced in this document are non-clinical bench tests focused on the mechanical properties of the implant.

Here's a breakdown of the provided information, framed to address the prompt's structure where applicable, and noting where it's not relevant for a non-AI/ML device:

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

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance comparable to predicate device	Non-clinical tests showed minor differences do not impact performance.
Meet ASTM F2077-03 standards for spinal implants	Tests conducted in accordance with ASTM F2077-03.
Maintain proper intervertebral/vertebral body spacing/angulation	Device acts as a spacer to maintain specified spacing and angulation.
Restore biomechanical integrity	Designed to restore biomechanical integrity of the spinal column.

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 (Test Set): Not applicable in the context of an AI/ML device. For the non-clinical mechanical tests, the "sample size" would refer to the number of physical devices tested. This specific number is not provided, but it's implied that sufficient samples were tested to meet ASTM standards.
Data Provenance: Not applicable. The "data" here refers to mechanical test results from laboratory (bench) testing of the physical implant.

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)

Number of Experts/Qualifications: Not applicable. For mechanical bench testing, ground truth is established by engineering specifications, material properties, and adherence to established ASTM standards, not by expert interpretation.

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

Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of medical images or data. For mechanical testing, results are objective measurements.

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

MRMC Study: No, not applicable. This is a spinal implant, not an AI diagnostic tool.

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

Standalone Performance: No, not applicable. This is a physical medical device, not an algorithm.

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

Type of Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established engineering specifications and material properties as defined by ASTM F136 (for material) and ASTM F2077-03 (for mechanical testing). The comparison to the predicate device also serves as a benchmark for performance.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

Training Set Ground Truth: Not applicable.

Summary

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KI10270

APR - 7 2011

510(k) Summary

Submitted By:	CoAlign Innovations150 North Hill Drive, Suite 1Brisbane, CA 94005
EstablishmentRegistration Number:	10030843
Contact Person:(Submission Prepared by)	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	January 27, 2011
Device Trade Name:	AccuLIF Cage
Manufacturer:	CoAlign Innovations, Inc.150 North Hill Drive, Suite 1Brisbane, CA 94005
Common Name:	Spinal intervertebral body fixation orthosis
Classification:	21 CFR §888.3080
Class:	II
Product Code:	MAX, MQP

Device Description:

Indications For Use:

Page 1 of 3

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spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation.

Identification of Predicates

SEC IBF Cage (K093669) -

Summary of Technological Characteristics

AccuLIF Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Indications for Use -
Materials of manufacture -
-Device footprint
Bone graft port -
Expansion mechanism -
Structural support geometry -

Discussion of Testing:

The following non-clinical tests were conducted:

Dynamic compression testing, conducted in accordance with ASTM F2077-03
Dynamic shear testing, conducted in accordance with -ASTM F2077-03
Dynamic torsion testing, conducted in accordance with -ASTM F2077-03
Static compression testing, conducted in accordance with ASTM F2077-03
-Static shear testing, conducted in accordance with ASTM F2077-03

Page 2 of 3

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Static torsion testing, conducted in accordance with ASTM F2077-03
Wear assessments following dynamic compression, dynamic shear, and dynamic torsion testing
. Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.

Conclusions:

The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF Cage was shown to be substantially equivalent to the SEC IBF Cage (K093669).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of the nation.

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

CoAlign Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisors, LLC Mr. Justin Eggleton 1331 H Street, Northwest, 12th Floor Washington, District of Columbia 20005

Re: K110270

APR - 7 2011

· Trade/Device Name: AccuLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MQP Dated: March 8, 2011 Received: March 10, 2011

Dear Mr. Eggleton:

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. Justin Eggleton

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A. B. R.A
fer

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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Indications for Use 4.

510(k) Number (if known): ≤110220_

Device Name: AccuLIF Cage

Vertebral Body Replacement: When used as a vertebral body replacement, CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T) to LS) to replace or restore height a collapsed, diseased, or unstable portion of a vertebral body. excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The CoAlign Innovations Accul.IF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

Prescription Use ਪ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-(1) Division of Sur ... . Orthopedic, and Restorative Devices

KII0270 : ! ^( ) Number___

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.