The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

Device Description

The Expanding Innovations X-Pac Expandable Lumbar Cage System is a lumbar interbody fusion system comprised of a cage implant and surgical instruments. The implants are used to provide structural stability in skeletally mature individuals following discectomy and are placed via the transforaminal approach. The device is available in various sizes and footprints to accommodate varying anatomy, and is designed to allow for intraoperative adjustment in both the parallel and lordotic configurations. The implants are designed for use with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each implant grip the endplates of the adjacent vertebrae to resist expulsion. The implants are manufactured from medical grade titanium alloy per ASTM F136, and ASTM F1472. The Expanding Innovations X-Pac Expandable Lumbar Cage System implants are single-use, provided non-sterile, and are intended to be cleaned and steam sterilized before use. The surqical instruments are re-usable, provided nonsterile, and are intended to be cleaned and steam sterilized before each use. Additional cage sizes are the subject of this Special 510(k).

AI/ML Overview

This document describes the X-Pac Expandable Lumbar Cage System, an intervertebral body fusion device. The focus of the provided text is on demonstrating substantial equivalence to previously cleared devices rather than a de novo clinical study with specific acceptance criteria for performance.

Therefore, the information regarding acceptance criteria and performance is primarily concerned with mechanical testing to show the continued safety and effectiveness of new cage sizes, rather than a clinical study evaluating diagnostic accuracy or efficacy against specific clinical endpoints.

Here's a breakdown based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms.	New cage sizes successfully underwent performance testing. Test results demonstrate substantial equivalence to the predicate device.

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

Sample size: Not explicitly stated; however, "new cage sizes" implies a set of different configurations were tested.
Data provenance: Not explicitly stated, but the testing was conducted in-house by Expanding Innovations, Inc. (or a contracted lab) as part of their risk assessment. This is not patient data but rather engineering test data.

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

Not applicable. The "ground truth" here is based on engineering standards (ASTM F2077) and the performance of a predicate device, not on expert clinical interpretation of patient data.

4. Adjudication method for the test set:

Not applicable. This was mechanical testing against a standard, not a clinical trial requiring adjudication of patient outcomes or expert consensus.

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 device is a surgical implant (lumbar cage), 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. This is a medical device (implant), not an algorithm.

7. The type of ground truth used:

The "ground truth" for the mechanical testing was defined by the performance requirements of ASTM F2077 and comparison to a legally marketed predicate device (K152539, K160856, K201145, and K203802). The goal was to show that the new sizes of the device performed equivalently to the predicate and met the established mechanical standards.

8. The sample size for the training set:

Not applicable. This refers to mechanical testing of physical device variations, not a machine learning model with a training set.

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

Not applicable. As above, this is mechanical testing, not a machine learning study.

Summary from the document:

The core of this 510(k) submission is to demonstrate substantial equivalence of new cage sizes for the X-Pac Expandable Lumbar Cage System to previously cleared versions (predicates). The primary evidence provided is a risk assessment, including mechanical testing, which confirmed that the new cage sizes do not introduce new issues of safety or effectiveness. This testing was performed in accordance with ASTM F2077 for compression and compressive shear. The results indicated that the new device sizes performed equivalently to the predicate devices. There is no mention of a human-in-the-loop study, a multi-reader multi-case study, or an AI algorithm’s performance.

Summary

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March 24, 2022

Expanding Innovations, Inc % Carolyn Guthrie Director of QA/RA Kapstone Medical, LLC 510 Elliot Street Charlotte, North Carolina 28202

Re: K220655

Trade/Device Name: X-Pac Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 4, 2022 Received: March 7, 2022

Dear Ms. Guthrie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220655

Device Name

X-Pac Expandable Lumbar Cage System

Indications for Use (Describe)

The Expanding Innovations X-Pac Expandable Lumbar Cage System is indicated for use as an intervertebral body fusion device in skeletally mature patients. The system is designed for use with autogenous bone graft material to facilitate spinal fusion. The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Expanding Innovations. The logo features the words "Expanding Innovations" in blue text. The word "Expanding" is larger and bolder than the word "Innovations", which is located below it. To the left of the word "Expanding" is a curved line of red dots.

Special 510(k) Notification X-Pac Expandable Lumbar Cage System

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name, Address, Phone, and Fax Number of Applicant

Expanding Innovations, Inc. 110 Pioneer Way, Suite 1 Mountain View, CA 94041 Phone: (925)-819-2257

B. Contact Person

Katelyn Jessup Regulatory Affairs Consultant Kapstone Medical, LLC

C. Date Prepared

March 1, 2022

Device Name and Classification D.

Trade Name:	X-Pac Expandable Lumbar Cage System
Common Name:	Intervertebral Body Fusion Device
CFR Classification:	21 CFR§888.3080
Classification Name:	Intervertebral Body Fusion Device
Product Code:	MAX

E. Predicate Device

The Expanding Innovations X-Pac Expandable Lumbar Cage System is substantially equivalent to the previously cleared Expanding Innovations X-Pac Expandable Lumbar Cage System, K152539, K160856, K201145 and K203802.

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Image /page/4/Picture/1 description: The image contains the logo for Expanding Innovations. The logo has the word "Expanding" in blue, with a red dotted line extending from the left side of the "E" to the bottom of the "g". Below "Expanding" is the word "Innovations" in a smaller font, also in blue.

F. Device Description

Indications for Use / Intended Use G.

The system is intended for use in patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have at least 6 months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via transforaminal approach using autogenous bone graft material. The system is intended for use with supplemental fixation systems cleared for use by the FDA for use in the thoracolumbar spine.

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Image /page/5/Picture/1 description: The image shows the logo for Expanding Innovations. The logo features the word "Expanding" in a bold, blue font, with a series of red dots arching over the word. Below "Expanding" is the word "Innovations" in a smaller, gray font.

H. Technological Comparison

The technological characteristics of the Expanding Innovations X-Pac Expandable Lumbar Cage System implants are substantially equivalent to the predicate in terms of intended use, indications for use, overall design, function, technology, materials, and performance.

l. Performance Data

A risk assessment, including mechanical testing, was conducted to confirm that the new cage sizes do not introduce new issues of safety or effectiveness. The new cage sizes successfully underwent performance testing including mechanical testing in accordance with ASTM F2077 for compression and compressive shear paradigms. The mechanical performance tests were based on well-recognized test methods for interbody fusion devices, including those outlined in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Test results demonstrate substantial equivalence to the predicate device.

J. Basis for Substantial Equivalence

The modified X-Pac Expandable Lumbar Cage System is identical to the predicate with respect to intended use, indications for use, overall design, function, technology, materials, and performance as well as procedural steps, surgical instrumentation, and product labeling. The information provided supports the substantial equivalence of the modified X-Pac Expandable Lumbar Cage System to the legally marketed predicate devices.

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.