The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.

Device Description

The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136. The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Spectrum Spine Expandable Titanium PLIF/TLIF System, an interbody fusion device. The focus of the provided text is on demonstrating the substantial equivalence of the new device to existing predicate devices, primarily through mechanical performance testing, rather than an AI/ML-based device requiring a study proving its performance against acceptance criteria for diagnostic or prognostic tasks.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these in the context of AI/ML performance (e.g., sensitivity, specificity, reader improvement, ground truth establishment) is not applicable to this submission.

The document primarily provides the following:

1. A table of acceptance criteria and the reported device performance:
This is described in terms of mechanical testing for intervertebral fusion devices, not diagnostic performance.

Acceptance Criteria (Testing Modes):
- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
Reported Device Performance:
"The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
(Specific numerical results are not provided in this summary, but the conclusion of substantial equivalence based on these tests is stated.)

The remaining points (2-9) are not relevant as this is not an AI/ML device that requires a diagnostic or prognostic performance study:

Sample size used for the test set and the data provenance: Not applicable to a mechanical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical device is based on engineering standards and performance in stress tests, not expert interpretation of medical images or data.
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 is a physical implant, not a diagnostic AI tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its ability to withstand mechanical forces according to established ASTM standards, indicating its structural integrity and safety for its intended use, as compared to predicate devices.
The sample size for the training set: Not applicable. No AI model involved.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a Class II medical device (surgical implant) based on substantial equivalence through mechanical testing, not an AI/ML device requiring clinical performance evaluation against specific diagnostic or prognostic metrics.

Summary

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April 29, 2021

Spectrum Spine, LLC % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K201024

Trade/Device Name: Expandable Titanium PLIF/TLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 17, 2021 Received: March 18, 2021

Dear Mr. Wright:

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 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 STATEMENT

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) K201024 Device Name Expandable Titanium PLIF/TLIF System

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)

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510(K) SUMMARY

Submitter's Name:	Spectrum Spine, LLC
Submitter's Address:	4020 Stovall Terrace NEAtlanta, GA 30342
Submitter's Telephone:	404-550-1335
Contact Person:	Nathan WrightEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	April 17, 2020
Trade or Proprietary Name:	Expandable Titanium PLIF/TLIF 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:	Division of Orthopedics

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.

The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

INDICATIONS FOR USE

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K201024 Page 2 of 2

addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.

TECHNOLOGICAL CHARACTERISTICS

The Expandable Titanium PLIF/TLIF System is made from medical grade titanium allov that conforms to ASTM F136. The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

. Indications for Use
Materials of manufacture ●
Structural support mechanism .
Surgical Approach .
. Sizes

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K172696	FORZA® XP ExpandableSpacer System	Orthofix Inc.	Primary
K080537	L-Varlock Lumbar Cage	Kiscomedica	Additional
K173518	Spectrum Spine ExpandableCages	Spectrum Spine, LLC	Additional
K140411	ALTERATM Spacer	Globus Medical, Inc.	Additional

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Expandable Titanium PLIF/TLIF System has been tested in the following test modes:

. Static axial compression per ASTM F2077
. Static compression shear per ASTM F2077
Dynamic axial compression per ASTM F2077 .
Dynamic compression shear per ASTM F2077 .
Subsidence per ASTM F2267 .

The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System 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 Expandable Titanium PLIF/TLIF 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.