The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one 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 EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

Device Description

EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°. The FLXfit components are manufactured from titanium alloy (ASTM F136). It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape.

AI/ML Overview

The provided document is a 510(k) summary for the FLXfit Intervertebral Body Fusion Device, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It is not a study that evaluates the performance of a device using clinical or reader studies, especially for AI/ML devices. Therefore, a significant portion of the requested information, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance, is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the provided mechanical testing data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data based on mechanical testing standards, rather than clinical efficacy. The acceptance criterion for this type of submission is typically "substantial equivalence" to predicate devices, meaning the device performs at least as well as or better than the predicate devices under the specified tests. The reported performance is that the device met these criteria.

Acceptance Criteria	Reported Device Performance
Static Axial Compression (ASTM F2077)	The FLXfit's strength was found sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Static Compression-Shear (ASTM F2077)	The FLXfit's strength was found sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Dynamic Axial Compression (ASTM F2077)	The FLXfit's strength was found sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Dynamic Compression-Shear (ASTM F2077)	The FLXfit's strength was found sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Subsidence (ASTM F2267 and ASTM F2077)	No specific quantitative reported performance, but results show the strength is sufficient and substantially equivalent.
Usability cadaveric study (clinical application, expansion mechanism, intra-operative subsidence)	No specific quantitative reported performance, but the study was conducted to evaluate clinical application, and the overall conclusion is substantial equivalence.

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

Test Set Sample Size: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of patient cases for an AI/ML device. The document does not specify the number of devices tested for each mechanical test.
Data Provenance: The data comes from "non-clinical testing" and a "usability cadaveric study." No country of origin is specified, but it can be inferred to be from the manufacturer's testing facilities or contract labs. The nature is experimental, not retrospective or prospective clinical data.

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

Not applicable. For mechanical testing, "ground truth" is established by the specifications of the ASTM standards themselves, and the measurement of physical properties, not by expert consensus on clinical cases. The usability study involved cadavers, likely evaluated by surgical or biomechanical experts, but no details are provided on their number or qualifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among human readers for establishing ground truth from patient data. This document describes 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 medical device (intervertebral body fusion device), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used

For Mechanical Testing: The ground truth is defined by the requirements of the ASTM standards (e.g., F2077, F2267) which specify acceptable load-bearing capacities, fatigue life, and other mechanical properties for intervertebral body fusion devices. Substantial equivalence to predicate devices also serves as a comparative "ground truth" for performance.
For Usability Cadaveric Study: The ground truth would be the direct observation and evaluation of the device's clinical application, expansion mechanism, and intra-operative subsidence in a cadaveric model by qualified personnel (likely surgeons or biomechanical engineers).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing or regulatory submission for a physical medical device. This term applies to machine learning models.

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

Not applicable. There is no training set mentioned in this document.

Summary

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JUL 1 5 2014

5.510(K) SUMMARY

Submitter's Name:	Expanding Orthopedics, Inc.
Submitter's Address:	17 West Pontotoc Avenue Suite 200Memphis, TN 38103
Submitter's Telephone:	901-322-0332
Submitter's Fax:	901-322-0339
Authorized Contact Person:	Meredith L. May, MSEmpirical Testing Corp. - Empirical Consulting719.337.7579
Date Summary wasPrepared:	15-Jul-14
Trade or Proprietary Name:	FLXfit Intervertebral Body Fusion Device
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	CoAlign Innovation AccuLiF® TL-PEEK Cage andAccuLiF® TL and PL (K112095, K123281, andK123752)Synthes T-PAL Spacer (K100089)Custom Spine Pathway AVID (K090566)Kiscomedica L-Varlock (K080537)

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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with supplemental spinal fixation system and with autogenous bone graft. The indication for use for the Expanding Orthopedics FLXfit is similar to those of the predicate devices.

TECHNICAL CHARACTERISTICS

The FLXfit components are manufactured from titanium alloy (ASTM F136). The predicate devices are manufactured from the same or similar materials. It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape. The device also expands in height to provide lordosis angle correction of up to 10°.

PERFORMANCE DATA

The FLXfit has been tested in the following test modes:

Static Axial Compression (ASTM F2077) .
Static Compression-Shear (ASTM F2077) .
Dynamic Axial Compression (ASTM F2077) �
Dynamic Compression-Shear (ASTM F2077) .
. Subsidence (ASTM F2267 and ASTM F2077)
Usability cadaveric study conducted to evaluate clinical application of the device, . including the expansion mechanism. and intra-operative subsidence

The results of this non-clinical testing show that the strength of the FLXfit is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the FLXfit is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 15, 2014

Expanding Orthopedics, Incorporated % Meredith L. May, MS, RAC Empirical Consulting. LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K133813

Trade/Device Name: FLXfit Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 12, 2014 Received: June 13, 2014

Dear Ms. May:

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 complics 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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Page 2 - Meredith L. May, MS. RAC

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 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/Safetv/ReportalProblem/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,

Ronald P. Jean -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES		Form Approved: OMB No. 0910-0120
Food and Drug Administration		Expiration Date: January 31, 2017
Indications for Use		See PRA Statement on last page.
510(k) Number (if known)	K133813
Device Name	FLXfit Intervertebral body fusion device
Indications for Use (Describe)
The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patientswith degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD isdefined as back pain of discogenic origin with degeneration of the disc confirmed by historyand radiographic studies. These DDD patients may also have up to Grade I spondylolisthesisor retrolisthesis at the involved level(s). These patients should be skeletally mature and havecompleted six months of non-operative treatment. The EOI FLXfit device is intended to beused with supplemental spinal fixation system and with autogenous bone graft.
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)
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)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
FORM FDA 3881 (9/13)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

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This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB mumber. "

FORM FDA 3881 (9/13)

Page 2 of 2

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.