The Rectangular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft.

Device Description

The Rectangular Corpectomy Cage consists of multiple components comprised of sterile, single-use implants fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Rectangular Corpectomy Cage is used to replace a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectorny procedures due to tumor or trauma. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Rectangular Corpectomy Cage is comprised of implants designed to treat the thoracolumbar spine. The implants are available in a range of sizes and shapes to accommodate anterior. anterolateral, lateral and posterolateral surgical approaches and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Rectangular Corpectomy Cage) and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device is not available in these documents.

However, I can extract the information related to the performance testing that was conducted to demonstrate substantial equivalence, which serves a similar purpose in the context of this device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with corresponding performance results for these non-clinical tests. Instead, it states that "Design verification demonstrated the Subject Device is substantially equivalent to the predicate device." This implies that the performance of the Rectangular Corpectomy Cage met the standards demonstrated by the predicate devices, though specific values are not presented.

Acceptance Criteria	Reported Device Performance	Comments
Static Compression (per ASTM F2077)	Performed, demonstrated substantial equivalence to predicate device.	Specific values not provided.
Dynamic Compression (per ASTM F2077)	Performed, demonstrated substantial equivalence to predicate device.	Specific values not provided.
Static Torsion (per ASTM F2077)	Performed, demonstrated substantial equivalence to predicate device.	Specific values not provided.
Dynamic Torsion (per ASTM F2077)	Performed, demonstrated substantial equivalence to predicate device.	Specific values not provided.
Expulsion Testing	Performed, demonstrated substantial equivalence to predicate device.	Specific values not provided.

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

Sample Size: The document mentions that testing was performed "on the worst case subject device." This implies that a limited number of physical devices were tested to represent the entire product line under the most challenging conditions. A specific numerical sample size is not provided, and for non-clinical mechanical testing, it's typically fewer units than for clinical trials.
Data Provenance: The testing is non-clinical, meaning it's laboratory-based mechanical testing, not human subject data. Therefore, concepts like country of origin for data or retrospective/prospective do not apply.

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. For mechanical testing of a physical medical device, "ground truth" is defined by established engineering and biomechanical principles and standards (e.g., ASTM F2077). The "experts" involved would be the engineers and technicians performing and analyzing these tests.

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

This information is not applicable. Adjudication methods are relevant for human interpretation or clinical outcomes, not for objective mechanical performance tests.

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. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices involving human readers. This document describes a physical implantable device.

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

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

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

The "ground truth" for this type of non-clinical mechanical testing is established by the specified industry standards (e.g., ASTM F2077) and the physical properties and performance characteristics defined by sound engineering principles for intervertebral body fixation orthoses.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

December 22, 2015

Amendia, Incorporated Ms. Chelsea Proffitt Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062

Re: K152460

Trade/Device Name: Rectangular Corpectomy Cage Regulation Number: 21 CFR 888.3060 Regulation Name: Spine intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 22, 2015 Received: September 23, 2015

Dear Ms. Proffitt:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Casey Hanley -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K152460

Device Name Rectangular Corpectomy Cage

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Rectangular Corpectomy Cage

Submitter:	Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062
Contact Person:	Chelsea ProffittRegulatory Affairs Specialist770-575-5181 (W), 877-420-1213 (F)cproffitt@amendia.com (e-mail)
Date Prepared:	December 11, 2015
Trade Name:	Rectangular Corpectomy Cage
Common Name:	Spinal intervertebral body fixation orthosis
Device Product Code andClassification:	MQP, 888.3060, Class II, Spinal Vertebral Body ReplacementDevice
Primary Predicate Device:	Samson Corpectomy Cage (K091426)
Additional Predicate Devices:	Synthes XRL System (K103320)Phenix™ VBR (K072029)

Purpose of Submission: This traditional 510(k) is seeking clearance for modifications to the Samson Corpectomy Cage, including modifications to the shape, to add Ti6Al4V ELI implant configurations in addition to two PEEK materials (Invibio Optima LT1 and Solvay Zeniva ZA-500) and an addition of dimensions.

Device Description:

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Indications and Intended use:

The Rectanqular Corpectomy Cage is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Rectangular Corpectomy Cage is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Summary of Technological Characteristics:

The subject Rectangular Corpectomy Cage is substantially equivalent to predicate devices cleared for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. Both the subject and predicate devices are vertebral body replacement devices designed to contain graft material and replace a collapsed, damaged or unstable vertebral body resected or excised during total and partial vertebrectomy procedures due to tumor or trauma in the thoracolumbar region of the spine.

Summary of Performance Testing:

The substantial equivalence of the Rectangular Corpectomy Cage to the predicate is shown by similarity in intended use, indications for use, materials and performance. Non-clinical mechanical testing for the Rectangular Corpectomy Cage system was performed on the worst case subject device. Performance testing included static and dynamic compression (per ASTM F2077), static and dynamic torsion (per ASTM F2077) and expulsion testing. Design verification demonstrated the Subject Device is substantially equivalent to the predicate device.

Conclusion:

Based on the comparison to predicate devices and performance testing. the Rectangular Corpectomy Cage has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.