Intervertebral Body Fusion Device: 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 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 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 Accul.IF 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

AI/ML Overview

The provided text describes the regulatory submission for a medical device called the AccuLIF® TL Cage, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.

However, based on the discussion of testing section, we can infer the types of acceptance criteria being addressed by the non-clinical tests. The "reported device performance" would be the successful completion of these tests in accordance with the specified ASTM standards and the conclusion of substantial equivalence.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and performance values are not explicitly provided in the document for the device itself, but rather compliance with standards is indicated:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Acceptance Criteria (Inferred from tests)	Reported Device Performance (Summary)
Mechanical Performance:
Dynamic compression strength	Met requirements of ASTM F2077-03
Dynamic shear strength	Met requirements of ASTM F2077-03
Static compression strength	Met requirements of ASTM F2077-03
Static shear strength	Met requirements of ASTM F2077-03
Static Subsidence resistance	Met requirements of ASTM F2267-04
Static Expulsion resistance	Met requirements of ASTM Draft Standard F-04.25.02.02
Surgical Technique Performance:
Surgical technique validation	Validation conducted and shown to be similar to predicate

Note: The document does not provide specific numerical acceptance thresholds or the raw data for device performance. Instead, it states that tests were "conducted in accordance with" specific ASTM standards, implying successful completion to meet the standards' criteria. The overall conclusion is that these tests demonstrate "any minor differences do not impact device performance as compared to the predicates."

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

Sample Size: Not specified. The document only mentions that non-clinical tests were conducted. Typically, such tests involve a certain number of samples for each test type, but these numbers are not disclosed.
Data Provenance: Not applicable in the context of clinical data. These are non-clinical (mechanical and surgical technique) tests conducted in a laboratory setting.

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

This question is not applicable. The study involves non-clinical engineering and mechanical testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense (e.g., radiologists interpreting images). The "surgical technique validation" would involve skilled personnel, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical spinal implant, not an AI-powered diagnostic or assistive tool.

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

Not applicable. The device is a physical spinal implant, not an algorithm. The non-clinical tests performed are inherently "standalone" in the sense that they assess the device's physical properties.

7. The type of ground truth used

The "ground truth" for the non-clinical tests is based on established engineering principles and the requirements of the specified ASTM international standards (e.g., F2077-03, F2267-04, ASTM Draft Standard F-04.25.02.02). For the surgical technique validation, the "ground truth" would be the successful and safe deployment and function of the device as intended, in a similar manner to the predicate.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI study.

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

Not applicable. This is not a machine learning or AI study.

Summary Explanation:

The provided document is a 510(k) summary for a medical device (AccuLIF® TL Cage), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices. The "study" described consists of a series of non-clinical, biomechanical tests and surgical technique validation. The acceptance criteria for these tests are implicitly defined by compliance with the referenced ASTM standards. The reported device performance is that these tests were conducted "in accordance with" these standards and that the device's performance is comparable to the predicates, without explicitly listing raw data or specific numerical thresholds. The submission's goal is to show that the device meets safety and effectiveness requirements by being functionally equivalent to already approved devices, rather than through a novel clinical trial with quantitative performance metrics against a "ground truth" in a human study.

Summary

{0}------------------------------------------------

K113465 DEC 1 2 2011 Page 1 of 3

5. 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 27, 2011
Device Trade Name:	AccuLIF® TL 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:

{1}------------------------------------------------

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 Cage (K110270) -
SEC IBF Cage (K093669) "
Globus Medical Caliber Spacer (K102293) i

Summary of Technological Characteristics

AccuLIF TL 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:

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

{2}------------------------------------------------

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 Cage was shown to be substantially equivalent to the AccuLIF IBF Cage (K110270), SEC IBF Cage (K093669), and Globus Medical Caliber Spacer (K102293).

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

DEC 1 2 2011

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

Re: K113465

Trade/Device Name: AccuLIF TL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 18, 2011 Received: November 22, 2011

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

{4}------------------------------------------------

Page 2 - Mr. Justin Eggleton

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 (OS) 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.

For D. Th. mait

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

Enclosure

{5}------------------------------------------------

Indications for Use 4.

510(k) Number (if known): K113465

Device Name: AccuLIF TL Cage

V Prescription Use (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)

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.