The CoAlign Innovations AccuLIF TL 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 TL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL Cage is to be used with autogenous bone graft.

Device Description

The AccuLIF TL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL Cage is manufactured from TI6A14V 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 an articulating delivery handle and expanded insitu 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 Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. Each size also comes in an 11mm x 34mm footprint and a 13mm x 34mm footprint. 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.

In addition, the AccuLIF TL Cage System includes distractor trials to aid in distracting the disc space and in selecting the appropriate size cage to use in the surgical procedure. The set also contains a variety of other instruments to aid in the implantation of the cages.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AccuLIF TL Cage. This submission is for an update to an existing device, specifically adding new instruments (distractor trials) to the system. Therefore, the "study" conducted is primarily focused on demonstrating that these new additions do not negatively impact the safety and effectiveness of the previously cleared device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
The addition of distractor trials does not raise any new issues of safety and effectiveness.	"The addition of distractor trials to the system does not raise any new issues of safety and effectiveness.""The non-clinical test results demonstrate that the addition of the distractor trial instruments to the system do not impact device safety and effectiveness or performance as compared to the predicates."
Performance of the subject device (with new instruments) is comparable to predicate devices.	"The subject and predicate devices share the same indications for use, design, function, and materials of manufacture.""The AccuLIF® TL Cages were shown to be substantially equivalent to the AccuLIF® TL Cage (K113465) and CRESCENT® Spinal System Titanium (K110543)."
The device (with new instruments) maintains its intended function as an intervertebral body fusion device.	"Validated through cadaver testing." (Implicitly demonstrates continued functionality and effectiveness in a surgical setting.)

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

Sample Size for the Test Set: Not explicitly stated as a number. The text mentions "cadaver testing." For cadaver tests in medical devices, sample sizes can vary, but details like the number of cadavers or test repetitions are not provided.
Data Provenance: The cadaver testing implies a prospective experimental setup. The country of origin for the cadaver data is not specified.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. For cadaver testing, it would typically involve surgeons or other medical professionals experienced in spinal procedures, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. In cadaver testing, the "adjudication" would typically involve direct observation and assessment by the testing team and/or the participating medical professionals. There's no mention of a formal consensus method like 2+1 or 3+1.

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

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission focuses on the safety and effectiveness of new instruments via cadaver testing, not on comparative effectiveness (e.g., human reader performance with/without AI assistance). The device itself is an implantable surgical device, not a diagnostic or AI-powered system that involves human interpretation of output.

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

Standalone Study: No, a standalone performance study was not done. This is not an AI algorithm or software-only device. The "device" in question is a physical surgical implant system.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the cadaver testing would be based on direct observation and surgical assessment of proper instrument function and implantation success within the cadaveric model. This would include evaluating ease of use, ability to distract the disc space, and proper selection of cage size, as intended by the new distractor trials.

8. The Sample Size for the Training Set

Sample Size for Training Set: This concept is not applicable here as there is no "training set" in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The device's design and mechanical properties are pre-determined.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

Summary

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K/21683

510(k) Summary

Submitted By: CoAlign Innovations 150 North Hill Drive, Suite 1 Brisbane, CA 94005 Establishment Registration Number: 10030843 Contact Person: (Submission Prepared by) Justin Eggleton Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 202.552.5800 Date Prepared: July 3, 2012 Device Trade Name: AccuLIF Cage Manufacturer: CoAlign Innovations, Inc. 150 North Hill Drive, Suite 1 Brisbane, CA 94005 Common Name: Intervertebral body fusion device Classification: 21 CFR §888.3080 Class: II Product Code: MAX

Device Description:

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5 2012 JUL

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K171683

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 Cage (K113465) -

CRESCENT® Spinal System Titanium (K110543)

Summary of Technological Characteristics

AccuLIF® TL Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136. There have been no changes to the implants and subject and predicate cages have identical technological characteristics. The addition of distractor trials to the system does not raise any new issues of safety and effectiveness.

Discussion of Testing:

The only change to the system was to add additional Class II instruments to the AccuLIF® Cage system, which was validated through.cadaver testing. No bench testing was required.

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 the addition of the distractor trial instruments to the system do not impact device safety and effectiveness or performance as compared to the predicates. The AccuLIF® TL Cages were shown to be substantially equivalent to the AccuLIF® TL Cage (K113465) and CRESCENT® Spinal System Titanium (K110543).

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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 & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Coalign Innovations, Incorporated % Musculoskeletal Clinical & Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street Northwest Washington, District of Columbia 20005

5 2012 JUL

Re: K121683

Trade/Device Name: AccuLIF TL Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: June 06, 2012 Received: June 07, 2012

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

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Page 2 - Mr. Justin Eggleton

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.

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 vours.

ely yours,
for

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

Enclosure

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CoAlign Innovations AccuLIF IBF Cage Special 510(k)

4. Indications for Use

510(k) Number (if known): _

Device Name: AccuLIF TL Cages

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)

Aathh

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

.510(k) Number K121683

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.