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.

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 AccuLIF XL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LTI) 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 1mm 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 4 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 60mm length x 18mm width, and 4) 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 Special 510(k) submission for the CoAlign Innovations AccuLIF XL Cage, a medical device for intervertebral body fusion. This document focuses on the mechanical and material performance of the device rather than the performance of a diagnostic or AI-driven system. Therefore, many of the requested points related to AI studies, ground truth establishment, expert review, and sample sizes for training/test sets are not applicable to this type of device submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
Dynamic Compression	ASTM F2077-03	Conducted in accordance with ASTM F2077-03
Dynamic Shear	ASTM F2077-03	Conducted in accordance with ASTM F2077-03
Static Compression	ASTM F2077-03	Conducted in accordance with ASTM F2077-03
Static Shear	ASTM F2077-03	Conducted in accordance with ASTM F2077-03
Static Subsidence	ASTM F2267-04	Conducted in accordance with ASTM F2267-04
Static Expulsion	ASTM Draft Standard F-04.25.02.02	Conducted in accordance with ASTM Draft Standard F-04.25.02.02
Surgical Technique Validation	Predicate surgical technique validation	Conducted in the same manner as the predicate surgical technique validation.

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

Not Applicable. This submission is for a physical medical device (intervertebral cage) undergoing mechanical and material testing, not a digital device or AI algorithm with test data. The tests are laboratory-based mechanical evaluations as per ASTM standards, not clinical studies with patient data. The "test set" in this context refers to the physical devices tested, but specific numbers are not provided in the summary. The provenance is the testing laboratory.

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

Not Applicable. As this is a mechanical device, "ground truth" is established by adherence to engineering performance standards (ASTM) and comparison to predicate devices, not by expert interpretation of data.

4. Adjudication method for the test set

Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for this type of mechanical testing. Compliance is determined by whether the device meets the specified criteria in the ASTM standards.

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 is not an AI-driven device, nor is it a diagnostic imaging device typically associated with MRMC studies.

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

Not Applicable. This is a physical intervertebral cage, not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device submission is adherence to established ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices, and demonstration of substantial equivalence to predicate devices in terms of design, function, materials, and intended use. The physical and mechanical properties outlined in these standards serve as the "truth" against which the device's performance is measured.

8. The sample size for the training set

Not Applicable. There is no "training set" for a physical medical device in this context. The manufacturing process and design principles are based on engineering knowledge, material science, and regulatory requirements, not machine learning training.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study involved a series of non-clinical biomechanical tests conducted on the AccuLIF XL Cage. These tests were performed in accordance with recognized ASTM (American Society for Testing and Materials) standards, specifically:

Dynamic Compression testing (ASTM F2077-03)
Dynamic Shear testing (ASTM F2077-03)
Static Compression testing (ASTM F2077-03)
Static Shear testing (ASTM F2077-03)
Static Subsidence testing (ASTM F2267-04)
Static Expulsion testing (ASTM Draft Standard F-04.25.02.02)
Surgical technique validation, which was conducted in the same manner as the predicate device's validation.

The conclusion of these tests was that the AccuLIF XL Cage was substantially equivalent to its predicate devices (AccuLIF-PEEK Cage K123281, AccuLIF TL Cage K1216835 and K113465, and the SEC Interbody Fusion Cage K093669). This substantial equivalence was based on shared indications for use, design, function, and materials of manufacture. The submission explicitly states that "the predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates." This implies that the new device's performance met or exceeded the established safety and effectiveness profile of the already-approved predicate devices under the specified testing conditions.

Summary

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

510(k) Summary

3 2013 APR

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 25, 2013
Device Trade Name:	AccuLIF® XL 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

Device Description:

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

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:

Identification of Predicates

AccuLIF TL-PEEK Cage (K123281) -
-AccuLIF TL Cage (K1216835)
AccuLIF TL Cage (K113465) -
SEC Interbody Fusion Cage (K093669) -

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:

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

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-Static Subsidence testing, conducted in accordance with ASTM F2267-04
Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
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 predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates. The AccuLIF XL Cage was shown to be substantially equivalent to the AccuLIF-PEEK Cage (K123281), the AccuLIF TL Cage (K1216835 and K113465), and the SEC Interbody Fusion 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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Letter dated: April 3, 2013

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

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

Re: K130194

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: March 7, 2013 Received: March 8, 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N!Melkerson -S

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

Enclosure

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K130194-Page 1 of 1

CoAlign Innovations AccuLIF XL Cage Special 510(k)

Indications for Use

510(k) Number (if known): K130194

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 or retrolisthesis 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.