The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with autograft to facilitate fusion.

The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

Device Description

The VisuALIF Challenging Access System an extension to the VisuALIF System and both are part of the Cynch Spinal System. It is available in various sizes to accommodate individual patient anatomy. The VisuALIF Challenging Access implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. VisuALIF Challenging Access is intended to be used with the two (2) or more bone screws provided with the accompanying anterior cover plate assembly. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the typical sense of a diagnostic or AI-driven medical device.

This document describes the SpineSmith Cynch Spinal System – VisuALIF Interbody Fusion Implant System. The submission is for an extension to an already cleared device and demonstrates substantial equivalence to a predicate device (VisuALIF System, K102090). Substantial equivalence is the primary acceptance criterion for 510(k) clearances.

Here's an analysis based on the information provided, reinterpreting "acceptance criteria" in the context of a 510(k) submission for a spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance (or Evidence of Equivalence)
Intended Use (same as predicate)	The VisuALIF Challenging Access System is an extension to the VisuALIF System and has no changes with respect to indications or intended use as compared to the previously cleared VisuALIF Spinal System (K102090).
Material Composition (same as predicate)	- Implant material: PEEK Optima LT1 per ASTM F2026 with radiopaque tantalum marker bar per ASTM F-560-05. - Titanium alloy screws/cover plate assembly per ASTM F-136. These are the same as used in the predicate device.
Design Characteristics (similar to predicate)	- 'U' shaped implant design to allow for placement of autograft bone. - The primary change is the addition of additional screw holes and positions to the existing VisuALIF System to provide surgeons with additional surgical approach options, which is considered a minor difference.
Biocompatibility	Implied as the materials are the same as the predicate and commonly used in implants. (Not explicitly stated as a separate test in this summary, but assumed for existing materials.)
Mechanical Performance (equivalent to predicate)	- Static and dynamic compression testing (per ASTM F2077-03) conducted. - Static and dynamic compression-shear testing (per ASTM F2077-03) conducted. - Subsidence testing (per ASTM F2267-04) conducted. - Expulsion testing (per ASTM Draft Standard F-04.25.02.02) conducted. Conclusion: "The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the VisuALIF Challenging Access System is substantially equivalent to the predicate device."

2. Sample Size for Test Set and Data Provenance

Test Set (for mechanical testing): The document does not specify exact sample sizes (number of implants tested) for the non-clinical mechanical tests (static, dynamic, subsidence, expulsion). Instead, it states that testing was "conducted in accordance with" specific ASTM standards. These standards typically define the number of samples required for such tests.
Data Provenance: The data comes from non-clinical mechanical testing performed by the manufacturer, SpineSmith Partners, LP. It is not patient or human subject data.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for this spinal implant relates to its mechanical properties and equivalence to a predicate device, which is established through standardized engineering tests, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical spinal implant, not a diagnostic imaging device or AI-driven system that would involve human readers or image interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is an implant, not an algorithm. Its "standalone performance" refers to its mechanical integrity, which was evaluated through the non-clinical tests mentioned.

7. Type of Ground Truth Used

For the non-clinical mechanical testing, the "ground truth" is defined by the pass/fail criteria and methodologies outlined in the referenced ASTM standards (e.g., F2077-03, F2267-04, F-04.25.02.02 draft standard) for static and dynamic compression, compression-shear, subsidence, and expulsion. The results of the new device were compared against these standards and against the established performance of the predicate device to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.

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

Not applicable. See point 8.

Summary

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K122168

OCT 1 1 2012

SpineSmith Cynch Spinal System – VisuALIF Interbody Fusion Implant System

510(k) Summary of Safety and Effectiveness			OC
SUBMITTED BY	SpineSmith Partners, LP93 Red RiverAustin, TX 78701
ESTABLISHMENTREGISTRATION NUMBER	3006404071
CONTACT PERSON	Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068Fax: 512-637-2096Email: cnaivar@spinesmithusa.com
SUBMISSION PREPARED BY	Clifton (Chris) NaivarDirector - Quality and Regulatory AffairsPhone: 512-637-2068
DATE PREPARED	October 10, 2012
CLASSIFICATION	OVD 888.3080- Intervertebral Fusion Devicewith Bone Graft, Lumbar
COMMON NAME	Intervertebral Body Fusion Device
PROPRIETARY NAME	SpineSmith Cynch Spinal System - VisuALIFChallenging Access Interbody Fusion ImplantSystem

IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith VisuALIF Challenging Access System was determined to be substantially equivalent to the previously cleared VisuALIF System (K102090, SpineSmith; Cleared 09/09/2010).

DEVICE DESCRIPTION:

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Addition of additional screw holes and positions to the existing VisuALIF System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the VisuALIF Spinal System cleared previously via K102090.

INDICATIONS:

The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment.The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with autograft to facilitate fusion.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The purpose of this submission is to add the VisuALIF Challenging Access device, which may be implanted via an open anterior approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device. The subject device (VisuALIF Challenging Access - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K102090). Specifically, the following characteristics support this conclusion:

Intended for stand-alone use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
'U' shaped implant design to allow for placement of autograft bone -
Implant material: PEEK Optima LT1 per ASTM F2026 with radiopaque tantalum marker bar per ASTM F-560-05, and Titanium alloy screws/cover plate assembly per ASTM F-136
Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

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DISCUSSION OF NON-CLINICAL TESTING:

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with । ASTM F2077-03
Static and dynamic compression-shear testing, conducted in accordance . with ASTM F2077-03
Subsidence testing, conducted in accordance with ASTM F2267-04 -
Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02

CONCLUSIONS:

The subject and predicate device share the same intended use, primary implant design and material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the VisuALIF Challenging Access System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

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

OCT
11
2012

Spine Smith Partners, LLC % Mr. Clifton (Chris) Naviar Director, Quality and Regulatory Affairs 93 Red River Austin, Texas 78701

Re: K122168

Trade/Device Name: SpineSmith Cynch Spinal System - VisuALIF Challenging Access Plate Interbody Fusion Implant System

Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 12, 2012 Received: September 14, 2012

Dear Mr. Naviar:

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

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Page 2 - Mr. Clifton (Chris) Naviar

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eiriel Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K122168

Device Name:

SpineSmith Cynch Spinal System - VisuALIF Challenging Access Plate Interbody FisciAL Implant System

Indications for Use:

The VisuALIF System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolistics a DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with autografic studi
device system is designed for use with autografit to facilitate fusion.

The VisuALIF is a stand-alone device intended to be used with an anterior cover plate and a minimum of two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral both cephalad and physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl-R

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number. K122168

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.