Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are 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 CoAlign Innovations AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cages are to be used with autogenous bone graft.

Device Description

The CoAlign Innovations Accul.IF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as per ASTM F136-08. Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.

The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm. and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape. Also the TL crescent shape comes in an 8 degree lordotic model as well as a 0 degree model for a total of 18 TL and PL models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

The purpose of the special 510(k) is to introduce several design modifications to increase the surface area of the Top Plate.

AI/ML Overview

The provided text is a 510(k) summary for the CoAlign Innovations AccuLIF TL and PL Cage, which is an intervertebral body fusion device.

Based on the provided text, the device does not involve any AI or software for medical image analysis or interpretation. Therefore, it is not applicable to describe acceptance criteria or a study that proves the device meets those criteria in the context of AI performance.

The document describes a medical device (an expandable interbody fusion cage) and its 510(k) submission for design modifications. The "Discussion of Testing" section explicitly states:

"The following non-clinical tests were conducted: Surgical technique validation. conducted in the same manner as the predicate surgical technique validation."

This indicates that the testing focused on the mechanical and surgical aspects of the physical device, not on diagnostic performance or AI accuracy. The 510(k) process here is about demonstrating "substantial equivalence" of a modified physical device to a predicate device, primarily through non-clinical (e.g., bench) testing and comparison of technological characteristics.

Therefore, the following information points from your request are not present or applicable in this submission:

A table of acceptance criteria and the reported device performance (in the context of AI).
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI.
The sample size for the training set (for AI).
How the ground truth for the training set was established (for AI).

Summary

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CoAlign Innovations AccuLIF TL Cage Special 510(k)

5. 510(k) Summary

Submitted By:	CoAlign Innovations2684 Middlefield Road, Suite ARedwood City, CA 94063
EstablishmentRegistration Number:	10030843	SEP 1 2 2013
Contact Person:(Submission Prepared by)	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers. LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	August 12, 2013
Device Trade Name:	AccuLIF® TL and PL Cage
Manufacturer:	CoAlign Innovations. Inc.2684 Middlefield Road, Suite ARedwood City, CA 94063
Common Name:	Spinal intervertebral body fixation orthosis
Classification:	21 CFR §888.3080
Class:	II
Product Code:	MAX

Device Description:

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CoAlign Innovations AccuLIF TL Cage Special 510(k)

footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape. Also the TL crescent shape comes in an 8 degree lordotic model as well as a 0 degree model for a total of 18 TL and PL models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.

The purpose of the special 510(k) is to introduce several design modifications to increase the surface area of the Top Plate.

Indications For Use:

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative 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 CoAlign Innovations AccuLIF TL and PL Cage are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations Accub. IF TL and PL Cage are to be used with autogenous bone graft.

Identification of Predicates

AccuLIF TL and PL Cage (K123752) i

Summary of Technological Characteristics

AccuLIF TL and PL 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 -
Expansion mechanism
Structural support mechanism ।

Discussion of Testing:

The following non-clinical tests were conducted:

Surgical technique validation. conducted in the same i 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

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differences do not impact device performance as compared to the predicates. The AccuLIF TL and PL Cages were shown to be substantially equivalent to the AccuLIF TL and Pl. Cage (K123752).

. •

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird with three stylized wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2013

CoAlign Innovations % Mr. Justin Eggleton Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street North West, 12th Floor Washington. District of Columbia 20005

Re: K132505

Trade/Device Name: AccuLIF TL and PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 12, 2013 Received: August 13, 2013

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 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

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Page 2 - Mr. Justin Eggleton

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 yours.

Erin |: Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CoAlign Innovations AccuLIF TL Cage Special 510(k)

Indications for Use 4.

510(k) Number (if known): K132505_

Device Name: AccuLIF TL and PL Cage

Prescription Use V (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.