The Pro-Link 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 non-operative treatment. This device is intended to be used with autogenous bone graft.

Device Description

The PRO-LINK Cervical Spacer System is intended to serve as a stand-alone intervertebral body fusion device. The system is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. The implant is hollow to permit packing with autogenous bone graft to help promote fusion. It includes two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) to provide internal fixation while a titanium lock plate (Ti 6Al-4V ELI) prevents screw back out.

AI/ML Overview

The provided document is a 510(k) summary for the Pro-Link Cervical Spacer System, a medical device for spinal fusion. It focuses on demonstrating substantial equivalence to previously cleared devices rather than direct clinical performance studies against specific acceptance criteria. Therefore, several of the requested sections are not applicable or cannot be extracted directly from this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it demonstrates "substantial equivalence" to predicate devices through technical characteristics and a specific type of performance testing related to the device's physical properties.

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated as AC)	Reported Device Performance
Mechanical Performance	Adherence to ASTM F2077 standards for static and dynamic torsion and compression.	"Static and dynamic torsion and compression testing in accordance with ASTM F2077 was presented." (Implies compliance/equivalence)
Material Composition	Use of implantable grade PEEK-Optima LT1 (ASTM F2026), Tantalum markers (ASTM F560), and implantable grade Titanium (Ti 6Al-4V ELI, ASTM F136).	The device is manufactured from these specified materials according to the respective ASTM standards.
Indications for Use	Same as predicate devices.	Stated as "substantially equivalent to the predicate systems in terms of ... indications for use."
Design and Function	Same as predicate devices.	Stated as "substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used."

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often done through performance testing (like the mechanical testing mentioned) that shows the new device meets established standards or performs comparably to the predicate, and by showing similar materials, design, and intended use. Specific quantitative clinical performance metrics with pre-defined thresholds (e.g., sensitivity/specificity for a diagnostic device) are typically not included in this type of submission for an intervertebral body fusion device unless a new indication or technology is being introduced that requires clinical trials.

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

Sample Size for Test Set: Not applicable / Not mentioned. The document describes mechanical testing of the device itself, not a clinical study with a "test set" of patients or data. The testing mentioned (ASTM F2077) would involve a sample of the manufactured devices. The specific number of devices tested is not provided.
Data Provenance: Not applicable. The "performance data" refers to in-vitro mechanical testing of the device. There is no mention of country of origin for clinical data, as no clinical data from patients is referenced. The testing type is in-vitro, not retrospective or prospective clinical data.

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

Not applicable. This device is an intervertebral body fusion system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance data" section focuses on mechanical testing, which would be evaluated by engineers and regulatory bodies based on compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is relevant to the mechanical testing described.

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, not an AI-assisted diagnostic or decision support tool that would involve human readers or MRMC studies.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For Mechanical Testing: The "ground truth" for the mechanical performance testing lies in the established ASTM standards (ASTM F2077, ASTM F2026, ASTM F560, ASTM F136). The device's performance is compared against these engineering standards and to the performance of predicate devices to establish substantial equivalence.
For Substantial Equivalence: The ultimate "ground truth" for a 510(k) is the legal determination by the FDA that the new device is as safe and effective as a predicate device already on the market. This is a regulatory "truth" based on the submitted evidence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

Not applicable. This device does not involve a training set.

Summary

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1121151

page 1 of 2

NOV 1 6 2012 Pro-Link Cervical Spacer System Submitted Bv: Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates. IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 Randy Lewis 510(k) Contact: RA/QA Manager Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 April 13th, 2012 Date Prepared: Trade Name: Pro-Link Cervical Spacer Classification: OVE, 21 CFR 888.3080, Class II, Intervertebral Body Fusion Device Predicate Device: The Small Plateau (Plateau-C) Spacer System (K111835) LDR Spine Cervical Interbody Fusion System (K113559) Globus Coalition (K083389) RSB Spine Interplate (K081194)

510(k) Summary

Device Description:

Intended Use of the Device:

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

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KISI 151

Technological Characteristics:

The Pro-Link Cervical Spacer System is substantially equivalent to the predicate systems in terms of design, materials, and indications for use.

Material:

The PRO-LINK Cervical Spacer System is manufactured from implantable grade PEEK-Optima LT1 per ASTM F2026, incorporates tantalum markers per ASTM F560, and implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136.

Performance Data:

Static and dynamic torsion and compression testing in accordance with ASTM F2077 was presented to demonstrate the substantial equivalency of the Pro-Link Cervical Spacer System.

Conclusion:

The Pro-Link Cervical Spacer System was shown to be substantially equivalent to the previously cleared devices in indications for use, design, function, and materials used.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 16, 2012

Life Spine, Incorporated % Mr. Randy Lewis Regulatory Affairs and Quality Assurance Manager 2401 West Hassell Road, Suite 1535 Hoffman Estates. Illinois 60169

Re: K121151

Trade/Device Name: Pro-Link Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: OVE Dated: October 11, 2012 Received: October 11, 2012

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Mr. Randy Lewis

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Laurence D. Coyne

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

K 12/15/

510(k) number (if known):

Device Name: Pro-Link Cervical Spacer System

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

Prescription Use x (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Carl-Roffi

(Division Sign-Off Division of Orthopenic Device 12-115 510(k) Number

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.