Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL 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 CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

Device Description

The AccuLIF XL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The Accul.JF XL Cage is manufactured from TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LT1) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating 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 Imm increments as it expands. The AccuLIF XL Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. In addition each size comes in 8 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 50mm length x 18mm width, 4) 50mm length x 22mm width. 5) 55mm length x 18mm width, 6) 55mm length x 22mm width 7) 60mm length x 18mm width, and 8) 60mm length x 22mm width. 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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CoAlign Innovations AccuLIF XL Cage, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study that establishes acceptance criteria and then proves the device meets those criteria through new performance data.

Therefore, many of the requested categories related to clinical study design, sample sizes, expert involvement, and ground truth establishment cannot be answered directly from the provided text. The approach taken here is a comparative one based on existing data from predicate devices.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	The device is demonstrated to be substantially equivalent to legally marketed predicate devices. This implies that its safety and effectiveness are considered comparable to those predicates previously cleared by the FDA. The submission argues that "minor differences do not raise any new issues of safety and effectiveness."
Technological Characteristics	The AccuLIF XL Cage has "nearly identical technological characteristics" to the predicate devices, including:Indications for UseMaterials of manufacture (Titanium-6AL-4V ELI alloy, PEEK)Expansion mechanismStructural support mechanism
Non-Clinical Testing	Surgical technique validation was conducted "in the same manner as the predicate surgical technique validation." This implies that the device performs acceptably within the established surgical technique.
Material Compliance	Manufactured from:TI6A14V ELI (as per ASTM F136-08)Stainless Steel (316 LVM) (as per ASTM F138-08)PEEK (Invibio Optima LT1) (as per ASTM F2026-07)Silicone Rubber (MED-4870)These conform to specified ASTM standards.

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

Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a distinct test set of patient data. The "testing" mentioned is non-clinical (surgical technique validation), not human patient data.

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

Not applicable. No external experts were reported as used to establish ground truth for a test set of patient data. The FDA reviews the submission and determines substantial equivalence based on the provided technical and comparative data.

4. Adjudication method for the test set

Not applicable. No test set of patient data requiring adjudication is mentioned.

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

Not applicable. This document describes a medical implant device, not an AI-assisted diagnostic tool.

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

Not applicable. This document describes a medical implant device, not an algorithm or AI system.

7. The type of ground truth used

Implied ground truth for substantial equivalence: For the purpose of this 510(k), the "ground truth" is that the predicate devices (AccuLIF XL Cage K130194 and AccuLIF TL-PEEK Cage K123281) have already been deemed safe and effective by the FDA. The current device's ground truth is its conformance to the performance, design, and material characteristics that made the predicates safe and effective.

8. The sample size for the training set

Not applicable. This device is an implant, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

K131443 Page 1 of 2

5. 510(k) Summary

JUN 1 9 2013

Submitted By:	CoAlign Innovations2684 Middlefield Road, Suite ARedwood City, CA 94063
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:	May 14, 2013
Device Trade Name:	AccuLIF® XL 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 XL Cage Special 510(k)

length x 22mm width. 5) 55mm length x 18mm width, 6) 55mm length x 22mm width 7) 60mm length x 18mm width, and 8) 60mm length x 22mm width. 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

Indications For Use:

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL 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 SI. 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.

Identification of Predicates

AccuLIF XL Cage (K130194) -

-AccuLIF TL-PEEK Cage (K123281)

Summary of Technological Characteristics

AccuLIF XL Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136 and PEEK (Invibio Optima LT1) that conforms to ASTM F2026-07. 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 ı 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 predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates. The Accul.IF XL Cage was shown to be substantially equivalent to the AccuLIF XL (K130194), the AccuLIF TL-PEEK Cage (K123281).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the graphic.

Public Health Service

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

June 19, 2013

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

Re: K131443

Trade/Device Name: AccuLIF XL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 14, 2013 Received: May 20, 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-Gosmetic-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. Iisting 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

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Page 2 - Mr. Justin Eggleton

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 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/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,

Erin Neith

For

Mark Melkerson Director Division_of_Orthopedic_Devices_ Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

4. Indications for Use

510(k) Number (if known): K131443

Device Name: AccuLIF XL Cage

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL 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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Prescription Use V (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)

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.