XYPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The XYPAN Lumbar Expandable Cage System's implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

-XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
-XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
XYPAN-XL Expandable Cage is to be implanted via lateral approach. -

AI/ML Overview

The provided text is a 510(k) summary for the XYPAN Expandable Lumbar Cage System, a medical device for intervertebral body fusion. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The 510(k) summary explicitly states: "Engineering rationales and comparisons between the subject and predicate devices were used to leverage previously conducted performance testing." This means that no new performance study was conducted for the XYPAN Expandable Lumbar Cage System itself to prove it meets acceptance criteria. Instead, its performance is considered substantially equivalent to a previously cleared device (the predicate device) based on similar design, materials, and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them directly from this document.

However, I can extract information related to the device and the basis for its clearance:

Device Information:

Device Name: XYPAN Expandable Lumbar Cage System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Indicated Use: Intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without up to Grade 1 spondylolisthesis or retrolisthesis. To be used with autogenous and/or allogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment.
Material: Titanium 6AL-4V Alloy (ASTM F136)
Predicate Device: AccelFix Lumbar Interbody Fusion Cage System (K190708) from L&K Biomed Co., Ltd.

Basis for Substantial Equivalence (as per the document):

Identical Indications for Use
Identical Materials of manufacture
Identical Structural support mechanism

Because the document relies on substantial equivalence and engineering rationales to a predicate device rather than a new performance study with specific acceptance criteria, most of your requested points cannot be answered directly from the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: Not provided, as no new performance study was described.
Sample size used for the test set and the data provenance: Not applicable, as no new test set study was described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 29, 2021

Aegis Spine, Inc. Meredith Lee May, MS, RAC Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K203531

Trade/Device Name: XYPAN Expandable Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 24, 2020 Received: December 2, 2020

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. 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.

Brent L. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K203531 Device Name XYPAN Expandable Lumbar Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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510(K) SUMMARY

Submitter's Name:	Aegis Spine, Inc.
Submitter's Address:	9781 S. Meridian Blvd, Ste 300Englewood, CO 80112
Submitter's Telephone:	+1.303.741.4123
Contact Person:	Meredith Lee May MS, RACEmpirical Testing Corp.719.337.7579MMay@EmpiricalTech.com
Date Summary was Prepared:	24Nov2020
Trade or Proprietary Name:	XYPAN Expandable Lumbar Cage System
Common or Usual Name:	intervertebral fusion device with bone graft, lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedics

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

-XYPAN-XT Expandable Cage is to be implanted via transforaminal and posterior approach.
-XYPAN-XTP Expandable Cage is to be implanted via Anterior to Psoas approach.
XYPAN-XL Expandable Cage is to be implanted via lateral approach. -

INDICATIONS FOR USE

X YPAN Expandable Lumbar Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. XYPAN Expandable Lumbar Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

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TECHNOLOGICAL CHARACTERISTICS

X YPAN Expandable Lumbar Cage System is made from Titanium 6AL-4V alloy that conforms to ASTM F136. The subject and predicate device have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use
Materials of manufacture
Structural support mechanism

Table 5-1 Predicate device

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K190708	AccelFix Lumbar Interbody FusionCage System	L&K Biomed Co.,Ltd.	Primary

PERFORMANCE DATA

Engineering rationales and comparisons between the subject and predicate devices were used to leverage previously conducted performance testing.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the XYPAN Expandable Lumbar Cage System is substantially equivalent to the predicate device.

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.