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

Device Description

The AccuLIF TL-PEEK Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF TL-PEEK Cage is manufactured from Tl6Al4V 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 1mm increments as it expands. The AccuLIF 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. 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

This document is a 510(k) Summary for the AccuLIF® TL-PEEK Cage, a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on mechanical testing to demonstrate the substantial equivalence of the AccuLIF TL-PEEK Cage to its predicates. The acceptance criteria are implicitly that the subject device's performance is comparable to or better than previously cleared predicate devices per the cited ASTM standards, and that minor differences do not raise new issues of safety and effectiveness.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance: Comparable to predicate devices in:	Non-clinical tests conducted (standards used for comparison):
- Dynamic compression strength	Conducted in accordance with ASTM F2077-03. (The submission states "comparison to the predicates," implying the results met or exceeded the predicates' performance, but specific numerical results for acceptance are not detailed in this summary.)
- Dynamic shear strength	Conducted in accordance with ASTM F2077-03.
- Static compression strength	Conducted in accordance with ASTM F2077-03.
- Static shear strength	Conducted in accordance with ASTM F2077-03.
- Static Subsidence resistance	Conducted in accordance with ASTM F2267-04.
- Static Expulsion resistance	Conducted in accordance with ASTM Draft Standard F-04.25.02.02.
Surgical Technique Validation: Comparable to predicate surgical technique.	Conducted in the same manner as the predicate surgical technique validation. (Implicitly passed by demonstrating no impact of minor differences on device performance).
Material Equivalence: Materials conform to specified ASTM standards.	AccuLIF TL-PEEK Cages are made from Titanium-6AL-4V ELI alloy (ASTM F136) and PEEK (Invibio Optima LT1) (ASTM F2026-07), which are the same materials as the predicates.
Indications for Use: Same as predicate devices.	The Indications for Use are identical to the predicate devices.

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

Sample Size for Test Set: The document does not specify the exact sample size (number of devices tested) for each of the non-clinical mechanical tests. It only lists the types of tests performed.
Data Provenance: The data is from non-clinical (laboratory/mechanical) testing of the device, performed by the manufacturer, CoAlign Innovations. The provenance is internal testing, not patient-derived data, and therefore the concepts of country of origin or retrospective/prospective do not apply in this context.

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

This section is not applicable. The "ground truth" for mechanical testing is established by the defined test standards (e.g., ASTM F2077-03) and the measured physical properties of the device, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 refer to human clinical review processes (e.g., for radiology reads), which are irrelevant for non-clinical mechanical device testing.

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

This section is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI are not relevant.

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

This section is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the "test set" (i.e., the non-clinical tests) is based on defined engineering standards (ASTM standards) and the measured physical properties and performance characteristics of the device and its predicate devices. The goal is to demonstrate that the new device meets the performance expectations already established by these standards and by the performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This section is not applicable, as there is no "training set" for a physical medical device.

Summary

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JAN 2 3 2013

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:	October 19, 2012
Device Trade Name:	AccuLIF® TL-PEEK 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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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 (K112095) *
AccuLIF TL Cage (K1216835) -
-AccuLIF TL Cage (K113465)

Summary of Technological Characteristics

AccuLIF TL-PEEK 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
- 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

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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 TL-PEEK Cage was shown to be substantially equivalent to the AccuLIF-PEEK Cage (K112095) and the AccuLIF TL Cage (K1216835 and K113465).

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is simple, using a single color, and is designed to be easily recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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, DC 20005

Re: K123281

Trade/Device Name: AccuLIF TL-PEEK Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX -Dated: October 19, 2012 Received: November 13, 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 or any Federal statutes and regulations administered by other Federal agencies. You must or any recently 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

Letter dated: January 23, 2013

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Page 2 - Mr. Justin Eggleton

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 11 you ucsire specific ad rios 10. Jour For your Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to inter/for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and readions by reference to premarket notification" (21CFR Part Ilote the regulation entined. "Informansing 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 I ou may ootan other general meetings 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

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

Enclosure

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Indications for Use

510(k) Number (if known): _K123281

Device Name: AccuLIF TL-PEEK Cage

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL-PEEK Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with mercured for like. Forcertand 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)

Stephanie Begchtold -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123281

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.