The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Device Description

The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion.

The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances.

A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.

AI/ML Overview

Here's the information regarding the acceptance criteria and study for the Xsert™ Lumbar Expandable Interbody System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K160959 510(k) Summary) does not explicitly list specific numerical acceptance criteria (e.g., minimum compression strength in Newtons) and corresponding numerical performance results for the device. Instead, it refers to industry standards that implicitly contain performance requirements for such devices. Therefore, the table below reflects what is stated:

Acceptance Criterion (Referenced Standard/Guidance)	Reported Device Performance
Mechanical Testing:
Static and Dynamic Compression and Compression Shear (per ASTM F2077)	Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems."
Subsidence (per ASTM F2267)	Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems."
Expulsion (per FDA Guidance: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device)	Testing performed; device "found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems."
Simulated Use:
Design validation with surgeons in a cadaveric laboratory evaluation	Performed, including supplementary evaluations of packing expandable implants with bone graft.

Explanation of "Acceptance Criteria" in this context: For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are often implicitly met by demonstrating compliance with recognized consensus standards (like ASTM standards) and FDA guidance documents. The submission argues that by meeting these standards and guidance, the device's performance is "substantially equivalent" to legally marketed predicate devices, implying it meets the necessary safety and effectiveness thresholds defined by those standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Mechanical Testing: The document does not specify the exact number of devices tested for each mechanical test (Static/Dynamic Compression, Subsidence, Expulsion). It only states that "Mechanical testing was performed."
Sample Size for Simulated Use: The document mentions "surgeons in a cadaveric laboratory evaluation" but does not specify the number of cadavers or the number of device placements performed during this simulated use.
Data Provenance: The data appears to be prospective as it involves laboratory testing and cadaveric evaluations of the specific Xsert™ Lumbar Expandable Interbody System. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer's testing facilities (X-spine Systems, Inc.) in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Mechanical Testing: Not applicable in the sense of human experts establishing ground truth for mechanical test results. The "ground truth" for mechanical testing is based on the objective measurements against the specified ASTM standards and FDA guidance.
Simulated Use: The document mentions "surgeons" performing a cadaveric laboratory evaluation. It does not specify the number of surgeons involved or their specific qualifications (e.g., years of experience, subspecialty). These surgeons acted as "experts" for the human factors/usability aspect during simulated use, assessing device handling and surgical technique.

4. Adjudication Method for the Test Set

Mechanical Testing: Not applicable. Performance is measured objectively according to standard protocols.
Simulated Use: The document does not describe a formal adjudication method. It states that "Design validation... was performed with surgeons," implying their assessment of the device's usability and performance during the simulation serves as the validation. There's no mention of multiple reviewers or a consensus process for the simulated use results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/imaging diagnostics where human readers interpret medical images. The Xsert™ Lumbar Expandable Interbody System is a physical implant, and its evaluation consists of mechanical testing and simulated surgical use, not image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the Xsert™ Lumbar Expandable Interbody System. This device is a physical implant, not an algorithm or software. Its performance is inherent to its mechanical properties and design, not an algorithm that can operate standalone.

7. The Type of Ground Truth Used

Mechanical Testing: The ground truth is defined by the objective pass/fail criteria and performance thresholds established within the referenced ASTM standards (ASTM F2077, ASTM F2267) and FDA Guidance for Intervertebral Body Fusion Devices.
Simulated Use: The ground truth for the simulated use in a cadaveric laboratory evaluation is the effectiveness and ease of use in a simulated surgical environment, as assessed by the participating surgeons. This is functionally a form of "expert assessment" or subjective feedback regarding the device's practical application.

8. The Sample Size for the Training Set

Not applicable. This device is a physical interbody fusion system, not an artificial intelligence or machine learning model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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

November 17, 2016

X-spine Systems, Inc. % Kriss Anderson Director, Regulatory Affairs 452 Alexandersville Rd. Miamisburg, Ohio 45342

Re: K160959

Trade/Device Name: Xsert™ Lumbar Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 19, 2016 Received: September 21, 2016

Dear Mr. Anderson:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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/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 yours,

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

510(k) Number (if known)

K160959

Device Name

Xsert™ Lumbar Expandable Interbody System

Indications for Use (Describe)

The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

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 (21 CFR 807.92)

Xsert™ Lumbar Expandable Interbody System March 31, 2016

l. SUBMITTER/MANUFACTURER:

X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342

Telephone (937) 847-8400 FAX (937) 847-8410

Establishment Registration Number: 3005031160

Official Contact: Mr. Kriss Anderson Director, Requlatory Affairs Email: kanderson@X-spine.com Telephone (937) 847-8400, ext. 2137

II. OWNER/OPERATOR:

Xtant Medical Inc. 604 Cruiser Lane Belgrade, MT 59714

Xtant Medical, Inc.

Owner/Operator Number: 10028385

Official Correspondent:

lll. DEVICE

Trade/Proprietary Name:

Device Common Name: Requlation Number: Product Code:

Xsert™ Lumbar Expandable Interbody System

Regulatory Assurance/ Quality Assurance

Stephen Smith, Vice President

Telephone (406) 388-0480

Intervertebral Body Fusion Device 21 CFR §888.3080 MAX (888.3080) Intervertebral body fusion device

Review Panel:

Orthopedic

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IV. PREDICATE DEVICES

●

Primary: Globus Medical Caliber Spacers (K102293) . This predicate has not been subject to a design related recall. O
Additional: X-spine Calix Lumbar Spinal Implant System (K131350) .
- o This predicate has not been subject to a design related recall.
- Additional: Stryker AccuLIF® TL and PL Cage (K152651) o This predicate has not been subject to a design related recall.
Additional: Interventional Spine Opticage Interbody Fusion Device (K113527) ●
- This predicate has not been subject to a design related recall. o

V. REFERENCE DEVICE

X-spine Pedicle Screw System (K152132) – grit blasting technology

o This predicate has not been subject to a design related recall.

INDICATIONS FOR USE VI.

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VII. DEVICE DESCRIPTION

A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.

VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological principle for both the subject and predicate devices is posterior, fixation at one or two contiguous levels (L2 - S1 inclusive) for skeletally mature patients with degenerative disc disease of the lumbosacral spine.

At a high level, the subject device, and one or more of the predicate devices identified above are based on the following same or equivalent technological elements:

FDA Product Code: MAX -- Intervertebral Body Fusion Device O
Indications for Use. O
lmplants use the same material: Titanium alloy O
Multiple sizes to account for variations in patient anatomy. O
Anatomical region. O
Surgical approach. O
Mechanical performance. O
Sterility of package Sterile, single use implants o

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IX. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Mechanical Testing

Mechanical testing was performed as follows:

. Static and Dynamic Compression and Compression Shear per ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
Subsidence per ASTM F2267 Standard Test Method for Measuring Load . Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
Expulsion per FDA Guidance Class II Special Controls Guidance Document: . Intervertebral Body Fusion Device

Simulated Use

Design validation of the Xsert™ Lumbar System components and Surgical Technique Guide was performed with surgeons in a cadaveric laboratory evaluation. The surgeons also performed supplementary evaluations of packing the expandable implants with bone graft.

X. CONCLUSION

Based on a review of the information provided, X-spine finds that the Xsert™ Lumbar Expandable Interbody System is substantially equivalent to the referenced predicate device systems. The Xsert™ Lumbar Expandable Interbody System was found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems.

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.