The Pro-Link® Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of nonoperative treatment. This device is intended to be used with autogenous bone graft.

Device Description

The Pro-Link® Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either Titanium (Ti 6Al-4V ELI) or Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers and titanium pins (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6Al-4V ELI) to prevent screw back out.

AI/ML Overview

The provided text describes a medical device, the Pro-Link® Stand-Alone Cervical Spacer System, and its substantial equivalence to predicate devices, focusing on its design, materials, and intended use. However, it does not contain the detailed acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive FDA submission.

The "Performance Data" section briefly mentions "Mechanical testing" and "engineering rationale" conducted according to FDA guidance, but it does not provide specific acceptance criteria values, reported device performance metrics, or the actual study results. It only states that the testing was performed to demonstrate that no 'worst-case condition' was introduced.

Therefore, I cannot fulfill your request for the specific table and study details as they are not present in the provided text.

Here's what I can extract based on the information given, and where the requested information is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Study Details:

Sample size used for the test set and the data provenance:
- Test set sample size: Not specified.
- Data provenance: Mechanical testing and engineering rationale were performed according to FDA guidance and specific ISO standards (though the full standard name is garbled in the text). This implies laboratory testing rather than human subject data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the reported "Performance Data" refers to mechanical testing, not clinical data requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical testing.
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 intervertebral body fusion device, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" would be established engineering principles and performance standards (e.g., ISO for intervertebral fusion devices).
The sample size for the training set:
- Not applicable, as this is a physical device undergoing mechanical testing, not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary of what the document does say about performance:

The document states:
"Mechanical testing and engineering rationale to compare compressive and static torsion conducted in accordance with '510(k) Guidance Document for Intervertebral Body Fusion Devices,' June 14, 2007, was presented to demonstrate that no 'worst-case condition' was introduced to the Pro-Link® Stand-Alone Cervical Spacer System."

This indicates that the "study" demonstrating performance was a series of mechanical tests (compressive and static torsion) and engineering analysis, rather than a clinical trial with human subjects. The purpose was to show that the new device did not introduce any "worst-case condition" compared to its predicate devices, thereby supporting the claim of substantial equivalence.

Summary

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.

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

September 2, 2016

Life Spine, Incorporated Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K160066

Trade/Device Name: Pro-link® Stand-Alone Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: August 5, 2016 Received: August 8, 2016

Dear Mr. Lewis:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

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" (21CFR 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,

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) K160066

Device Name

Pro-Link® Stand-Alone Cervical Spacer System

Indications for Use (Describe)

The Pro-Link® Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Pro-Link® Stand-Alone Cervical Spacer System

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Randy LewisLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	August 15th, 2016
Trade Name:	Pro-Link® Stand-Alone Cervical Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	OVE, 21 CFR 888.3080, Class II
Primary Predicate :	Pro-Link Cervical Spacer System (K121151)
Additional Predicate:	Endoskeleton® TCS Interbody Fusion Device (K151596)

Device Description:

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Intended Use of the Device<

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Technological Characteristics:

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Performance Data:

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Conclusion:

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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.