The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-LS) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.

For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the inplanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Device Description

The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo. The cages are available in a variety of footprints, with adjustable heights and lordoses to match the patient's anatomy.

Function: The system functions as a vertebral body replacement device to used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

AI/ML Overview

This document is a 510(k) summary for the CAPRI Corpectomy Cage System, a medical device. The information provided outlines the device's characteristics and its comparison to predicate devices, focusing on demonstrating substantial equivalence rather than presenting an exhaustive study proving that the device meets specific acceptance criteria via a clinical trial setup.

Therefore, many of the requested categories related to clinical study design (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of FDA submission.

Here's an analysis of the provided text based on your questions:

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

The document does not specify quantitative acceptance criteria in the form of specific thresholds (e.g., minimum tensile strength, maximum wear rate) that the device must meet for mechanical performance. Instead, it states that the device was compared to predicate devices and performed equally to or better than these systems.

Performance Metric	Acceptance Criteria (Not explicitly stated as numerical thresholds)	Reported Device Performance
Static Compression	Performance equal to or better than predicate devices	Performed equally to or better than predicate systems
Static Torsion	Performance equal to or better than predicate devices	Performed equally to or better than predicate systems
Dynamic Compression	Performance equal to or better than predicate devices	Performed equally to or better than predicate systems
Dynamic Torsion	Performance equal to or better than predicate devices	Performed equally to or better than predicate systems
Design, Function, Material, Intended Use	Substantially equivalent to predicate devices with no adverse affect	No significant differences that would adversely affect use; substantially equivalent.

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

This document describes non-clinical performance evaluation through mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "sample size for the test set" in a clinical sense, or data provenance (country of origin, retrospective/prospective clinical data), is not applicable here. Mechanical testing typically involves a specific number of device samples manufactured to specification. The document does not provide the exact number of devices tested for each mechanical evaluation.

Data provenance: Mechanical testing is typically conducted in a laboratory setting, likely in the US where the company is based, but this is not explicitly stated.

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)

Not applicable. This is a mechanical evaluation of a physical device, not a study requiring expert clinical review to establish ground truth. "Ground truth" in this context would refer to the true mechanical properties, which are measured directly by engineering tests.

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

Not applicable. This concept relates to disagreement resolution in expert reviews for clinical or imaging studies, which is not relevant to 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

Not applicable. This is a mechanical device evaluation, not an AI-assisted diagnostic or clinical assessment study.

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

Not applicable. This is a mechanical device evaluation.

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

The "ground truth" for the mechanical performance evaluation is the direct measurement of physical properties through standardized engineering tests (ASTM F2077) performed on the device samples. This is considered objective, empirical data.

8. The sample size for the training set

Not applicable. This document describes mechanical testing for a medical device's 510(k) submission, not a machine learning model's development.

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

Not applicable. This document does not describe the development or training of an algorithm or model.

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 border 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 to the right, stacked on top of each other, resembling a bird-like shape.

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

November 6, 2014

K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, VA 20175

Re: K142016

Trade/Device Name: CAPRI Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 8, 2014 Received: October 9, 2014

Dear Ms. Giezen:

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 (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/Resourcesfor You/Industry/default.htm. 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 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 vours.

Mark N. Melkerson -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) K142016

Device Name CAPRI Corpectomy Cage System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY CAPRI Corpectomy Cage System

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175

Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 07/23/2014

Classification

Trade Name:	CAPRI Corpectomy Cage System
Common Name:	Vertebral Body Replacement Device
Regulatory Class:	Class II

Classification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code MQP)

Predicate Device(s)

Primary Predicate:

K2M SANTORINI Corpectomy Cage System (K111294) .
Additional Predicates:
Ulrich Obelisc (K060416)
DePuy X-Mesh (080568) ●
DePuy Surgical Titanium Mesh (K003043) ●

Device Description

Function: The system functions as a vertebral body replacement device to used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

Intended Use

The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The Capri device may be used with allograft or autograft.

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For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Technological Comparison to Predicate(s)

The CAPRI Corpectomy Cage System was compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

The CAPRI Corpectomy Cage System was mechanically tested and compared to predicate devices. The CAPRI Corpectomy Cage System performed equally to or better than these systems in static compression, static torsion, dynamic compression and dynamic torsion, in accordance with ASTM F2077.

Conclusion

There are no significant differences between the CAPRI Corpectomy Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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.