The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, 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 supplemental fixation and with autograft to facilitate fusion.

The Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. 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 System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct.

Addition of an ALIF version to the existing Cynch 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 Cynch Spinal System cleared previously via K090376.

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 - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376).

AI/ML Overview

The provided text describes a medical device, the "SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System," and its clearance process. However, it does not contain information about acceptance criteria in the typical sense for evaluating device performance in a clinical study (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence to a predicate device.

The study presented is a non-clinical testing study conducted to demonstrate substantial equivalence, not a clinical trial evaluating human performance or AI effectiveness.

Here's an breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

Since this is a non-clinical substantial equivalence study, the "acceptance criteria" are implied by the comparison to the predicate device's performance in mechanical tests. The reported device performance is that the subject device's results were "substantially equivalent" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Performance equivalent to predicate in Static Compression (ASTM F2077-03)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Dynamic Compression (ASTM F2077-03)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Static Compression-Shear (ASTM F2077-03)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Dynamic Compression-Shear (ASTM F2077-03)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Subsidence (ASTM F2267-04)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Expulsion (ASTM Draft Standard F-04.25.02.02)	Results demonstrated substantial equivalence to predicate device.
Performance equivalent to predicate in Wear Debris Characterization (ASTM F1877)	Results demonstrated substantial equivalence to predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a number of devices or tests. The document refers to "testing" being conducted in accordance with ASTM standards. For mechanical testing of medical devices, samples are typically tested until statistical significance is achieved or to meet the requirements of the specific ASTM standard. The exact number of samples (e.g., number of implants tested per condition) is not provided.
Data Provenance: Not applicable in the context of geographical origin for mechanical testing. The testing was non-clinical (laboratory-based) as opposed to human or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. This was a non-clinical, mechanical testing study comparing a device to a predicate based on standardized ASTM test methods. No human experts were involved in establishing "ground truth" in the way they would for, say, image interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There was no "ground truth" established by human experts requiring adjudication in this type of mechanical testing study.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission concerns a physical medical implant (intervertebral fusion device) and involves non-clinical mechanical testing, not an AI-powered diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

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

7. The type of ground truth used

Type of Ground Truth: The "ground truth" in this context is the performance of the predicate device measured against established ASTM standards for mechanical properties. The goal was to show that the subject device's performance was "substantially equivalent" to that of the already cleared predicate device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a non-clinical study for a physical implant, not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there was no training set for an AI/machine learning model.

Summary

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K102090

SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System

510(k) Summary of Safety and Effectiveness
SUBMITTED BY	SpineSmith Partners, LP93 Red RiverAustin, TX 78701
ESTABLISHMENTREGISTRATION NUMBER	3006404071 SEP 30 2010
CONTACT PERSON	Laura LeBoeufVice President - Quality and Regulatory AffairsPhone: 512-637-2068Fax: 512-302-4920Email: lleboeuf@spinesmithusa.com
SUBMISSION PREPARED BY	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746
DATE PREPARED	July 10, 2010
CLASSIFICATION NAME	Intervertebral Fusion Device with Bone Graft, Lumbar(Product Code: MAX)
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080
COMMON NAME	Intervertebral Body Fusion Device
PROPRIETARY NAME	SpineSmith Cynch Spinal System - Visualif InterbodyFusion Implant System

IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith Visualif System was determined to be substantially equivalent to the previously cleared Cynch System (K090376, SpineSmith; Cleared 4/1/2009).

DEVICE DESCRIPTION:

g 1 of 2

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K102090

INDICATIONS:

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The purpose of this submission is to add the Visualif 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 - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376). Specifically, the following characteristics support this conclusion:

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.
'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)

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 -
Wear Debris Characterization, conducted in accordance to ASTM F1877. -

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 System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

SEP 1 2 2011

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

Spine Smith Partners, LP % Ms. Laura LeBoeuf Vice President - Quality and Regulatory Affairs 93 Red River Austin, Texas 78701

Re: K102090

Trade/Device Name: Cynch Spinal System - Visualif 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 1, 2010 Received: September 3, 2010

Dear Ms. LeBoeuf:

This letter corrects our substantially equivalent letter of September 30, 2010.

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 (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.

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

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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 (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,

Mark M. Milkersen

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):

102090

SEP 30 2010

SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System

Indications for Use:

Device Name:

The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

tion (SDL)

(Div/sion Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

KID 2010 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.