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

Device Description

The CoAlign AccuLIF TL-PEEK Cage is expandable in-situ via a hydraulic system comprising two piston and cylinder arrangements. The device is expanded to the desired height by injecting saline into the cylinders. The device locks in 1mm increments as it expands. The device is provided non-sterile and must be sterilized prior to use.

The CoAlign AccuLIF TL-PEEK Cage device comes in two sizes, a 6mm height which expands up to 9mm and an 8mm height which expands up to 12 mm. Both sizes have a 12mm wide by 25mm long 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. 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. The device is expanded by using a disposable tubing set and pressure syringe. The device may be implanted through a standard anterior, posterior or transforaminal approach.

AI/ML Overview

The provided text describes a medical device, the AccuLIF® TL-PEEK Cage, and its regulatory submission (K112095) to the FDA. The document outlines the device's indications for use, description, technological characteristics, and importantly, the testing performed to demonstrate substantial equivalence to predicate devices.

However, the information required to fully answer the user's request, specifically regarding a study that proves the device meets acceptance criteria in the context of typical AI/software medical device evaluations (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance), is not present in this document.

This document details non-clinical (mechanical) testing, not clinical studies or AI/software performance evaluations. The device is a physical implant, not a software algorithm. Therefore, many of the requested categories are not applicable.

Here's an attempt to answer based on the provided text, highlighting what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Specific Value/Standard)	Reported Device Performance (Value/Outcome)
Dynamic Compression	Adherence to ASTM F2077-03	Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates.
Dynamic Shear	Adherence to ASTM F2077-03	Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates.
Static Compression	Adherence to ASTM F2077-03	Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates.
Static Shear	Adherence to ASTM F2077-03	Device performance evaluated in accordance with ASTM F2077-03; deemed acceptable for substantial equivalence to predicates.
Static Subsidence	Adherence to ASTM F2267-04	Device performance evaluated in accordance with ASTM F2267-04; deemed acceptable for substantial equivalence to predicates.
Static Expulsion	Adherence to ASTM Draft Standard F-04.25.02.02	Device performance evaluated in accordance with ASTM Draft Standard F-04.25.02.02; deemed acceptable for substantial equivalence to predicates.
Surgical Technique Validation	Same manner as predicate surgical technique validation	Validated in the same manner as the predicate surgical technique validation; deemed acceptable for substantial equivalence to predicates.

Note: The document states the tests were "conducted in accordance with" specific ASTM standards and that "any minor differences do not impact device performance as compared to the predicates." This implies the device met the performance characteristics demonstrated by the predicate devices, which are implicitly acceptable as per the standards. Specific numerical acceptance values are not provided in this summary, but rather the adherence to the testing methodologies.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable and not present in the document. The testing described is non-clinical, mechanical testing of physical device specimens, not a clinical study involving patients or data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not present in the document. Ground truth in the context of clinical data or image interpretation is not relevant for the described mechanical device testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not present in the document. Adjudication methods are typically used in clinical studies or expert reviews of data, not for mechanical 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 information is not applicable and not present in the document. An MRMC study is relevant for AI-powered diagnostic/interpretive devices, not for a physical spinal implant.

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

This information is not applicable and not present in the document. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" or reference performance is adherence to the specified ASTM standards and comparison to the performance of the legally marketed predicate devices. The document concludes that "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates."

8. The sample size for the training set

This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical device undergoing mechanical testing.

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

This information is not applicable and not present in the document. This concept applies to AI/machine learning models, not to a physical medical device.

Summary

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

K112095 Poor h

DEC - 1 2011

Attachment L - 510(k) Summary

Contact:	Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	October 13, 2011
Device Trade Name:	AccuLIF® TL-PEEK Cage
Manufacturer:	CoAlign Innovation, 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

Indications For Use:

Device Description:

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

a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid. The device is expanded by using a disposable tubing set and pressure syringe. The device may be implanted through a standard anterior, posterior or transforaminal approach.

Identification of Predicates

AccuLIF IBF Cage (K110270) -
Caliber IBF Cage (K102293) -
SEC IBF and VBR (K093669) -

Summary of Technological Characteristics

AccuLIF TL-PEEK Cage is an expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136, polyetheretherketone (PEEK Optima LT1) that conforms to ASTM F2016, 316LVM Stainless Steel that conforms to ASTM138-08, and Silicon Rubber (MED-4870). 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
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 IBF Cage (K110270). the Caliber IBF Cage (K102293), and the SEC IBF and VBR (K093669).

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, 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, indicating the department's name and national affiliation. The seal is presented in black and white.

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

DEC - 1. 2011

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

Re: K112095

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: November 23, 2011 Received: November 28, 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.

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

Page 2 - Mr. Justin Eggleton

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 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 yours,

Mark N. Melkerson

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

Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: AccuLIF TL-PEEK Cage

Intervertebral Body Fusion Device: The CoAlign Innovations AcculLIF® 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 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-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.

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, Orthopedic, 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.