The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity

· Spondylolisthesis
· Spondylolysis
· Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies
· Degeneration of the facets with instability
· Trauma including spinal fractures and/or dislocations

Device Description

The Proficient™ Facet Screw Spine System consists of a selection of non-sterile, single use screws manufactured from titanium alloy conforming to ASTM F136. The screws are provided in multiple diameters and various lengths to accommodate variations in patient anatomy.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Proficient™ Facet Screw Spine System". The document is a clearance letter from the FDA to Spine Wave, Incorporated, confirming that their device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, or algorithm-only performance. This device is a physical implant (facet screw system) and the "performance data" refers to mechanical testing of the implant itself, not a diagnostic or AI-driven system.

Therefore, I cannot populate the table or answer the specific questions about AI/diagnostic device performance because such information is not present in the provided FDA 510(k) clearance letter for a mechanical implant. The performance data mentioned (Static and dynamic three-point bending, Axial pullout, Torque to failure) are mechanical tests to demonstrate the structural integrity and functionality of the physical screws, not a clinical study to evaluate software performance or diagnostic accuracy.

Summary

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

January 16, 2015

Spine Wave, Incorporated Ms. Roaida Johnson Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K142980

Trade/Device Name: Proficient™ Facet Screw Spine System Regulatory Class: Unclassified Product Code: MRW Dated: December 30, 2014 Received: December 31, 2014

Dear Ms. Johnson:

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 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 - Ms. Roaida Johnson

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/Resourcesfor You/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)

K142980

Device Name Proficient™ Facet Screw Spine System

Indications for Use (Describe)

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity

· Spondylolisthesis
· Spondylolysis

· Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies

· Degeneration of the facets with instability
· Trauma including spinal fractures and/or dislocations

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

☑ Beneficial Use (Part 61 SER 001 Subpart D)	☐ On-Site Composting (61 SER 001 Subpart C)
---------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Proficient™ Facet Screw Spine System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Roaida R. Johnson
Date Prepared:	December 30, 2014

2. Device Information

Trade Name:	Proficient™ Facet Screw Spine System
Common Name:	Facet Screw Spinal System
Classification:	Unclassified
Product Code:	MRW

3. Purpose of Submission

The purpose of this submission is to gain clearance for a new facet screw system.

4. Predicate Device Information

The Proficient™ Facet Screw Spine System described in this submission is substantially equivalent to the following predicates:

Primary Predicate Device	Manufacturer	510(k) Number
TranS1® Facet Screws	Trans1®	K073515

Additional Predicate Devices	Manufacturer	510(k) Number
Venus Facet Screw System	Apollo Spine	K120340
CS Facet Compression Device	Triage Medical, Inc	K052043

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5. Device Description

6. Indications for Use

The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine System is indicated for treatment of any or all of the following:

. Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
. Spondylolisthesis
. Spondylolysis
Degenerative Disc Disease (DDD) as defined by neck and/or back pain of ● discogenic origin as confirmed by radiographic studies
Degeneration of the facets with instability ●
. Trauma including spinal fractures and/or dislocations

7. Comparison of Technological Characteristics

The substantial equivalence of the Proficient™ Facet Screw Spine System to the predicates is shown by similarity in intended use, indications for use, materials and performance.

8. Performance Data

The following tests were performed to demonstrate the substantial equivalence of the Proficient™ Facet Screw Spine System to its predicate:

Static and dynamic three-point bending (ASTM F1264) ●
Axial pullout (ASTM F543)
Torque to failure (ASTM F543) ●

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Proficient™ Facet Screw Spine System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.

Regulation Number and Section

N/A