The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.

The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.

Device Description

The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.

AI/ML Overview

The provided text describes two medical devices, Synthes ACIS and Synthes Vertebral Spacer CR, and their 510(k) submissions to the FDA. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for artificial intelligence (AI) or an algorithm. Instead, it details the non-clinical performance (bench testing) of these intervertebral fusion devices.

Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided document:

Acceptance Criteria and Device Performance (based on non-clinical testing)

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	The devices underwent various bench tests according to ASTM F2077-03 and ASTM F2267-04 standards, including:
Static Axial Compression	Passed, demonstrated substantial equivalence to predicate devices.
Dynamic Axial Compression	Passed, demonstrated substantial equivalence to predicate devices.
Static Compression Shear	Passed, demonstrated substantial equivalence to predicate devices.
Dynamic Compression Shear	Passed, demonstrated substantial equivalence to predicate devices.
Static Torsion	Passed, demonstrated substantial equivalence to predicate devices.
Dynamic Torsion	Passed, demonstrated substantial equivalence to predicate devices.
Subsidence	Passed, demonstrated substantial equivalence to predicate devices.
Substantial Equivalence	The devices were found to be substantially equivalent in performance to predicate devices based on the conducted bench testing.

Information NOT Available from the provided text:

The document clearly states: "Clinical data and conclusions were not needed for this device." This implies that the device achieved substantial equivalence based solely on non-clinical testing against predicate devices. Therefore, the following AI-specific study details are not applicable or provided:

Sample size used for the test set and the data provenance: Not applicable as no clinical or AI-specific test sets were used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for image interpretation or diagnosis was established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes traditional medical device approval based on non-clinical bench testing and substantial equivalence to existing predicate devices, not an AI or algorithm-driven device with corresponding performance criteria and studies.

Summary

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MAY 2 5 2012

6 510(k) Summary

510(k) Summary –Synthes ACIS
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Heather Guerin, Ph.D., P.E.Senior Regulatory Affairs SpecialistTelephone: 610-719-5432 Facsimile: 610-719-5102Email: guerin.heather@synthes.com
Date Prepared:	January 27, 2012
Trade Name(s):	Synthes ACIS
Classification:	21 CFR 888.3080 – Intervertebral fusion deviceClass II (special controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code ODP (Intervertebral Fusion Device with Bone Graft,Cervical)
Predicates:	Synthes Zero-P device (K072981)NuVasive CoRoent System (K081611)BAK Cervical Interbody Fusion System (P980048)Medtronic Cornerstone PSR (K100214)Medtronic Prevail (K073285)Globus PATRIOTTM Spacers (ColonialTM ACDF) (K072991)
DeviceDescription(s):	The Synthes ACIS is a radiolucent cervical intervertebral body fusiondevice. The Synthes ACIS is fabricated from Invibio® PEEK-Optima®LT-1 (ASTM F2026-10) with two anterior and one posterior titaniumalloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. Themarkers allow intra-operative radiographic assessment of the position ofthe implant.
Intended Use/Indications forUse:	The Synthes ACIS is an anterior cervical interbody fusion deviceindicated for use in skeletally mature patients with degenerative discdisease (DDD) with accompanying radicular symptoms at one level fromC2-T1. DDD is defined as discogenic pain with degeneration of the discconfirmed by history and radiographic studies. These patients shouldhave had six weeks of non-operative treatment. The interior of theSynthes ACIS should be packed with autogenous bone graft andimplanted via an anterior approach. The Synthes ACIS is intended to beused with supplemental fixation.
Comparison of	Synthes ACIS is substantially equivalent to the predicates in design,
the device topredicatedevice(s):	function, performance, material, and intended use.
PerformanceDate(Non-Clinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Synthes conducted the following bench testing (as recommended withinFDA Guidance and in accordance with ASTM F2077-03 and ASTMF2267-04): Static Axial Compression; Dynamic Axial Compression;Static Compression Shear; Dynamic Compression Shear; Static Torsion;Dynamic Torsion; and Subsidence.The conclusions drawn from testing demonstrate that the Synthes ACISdevice is substantially equivalent in performance to predicate devices.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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510(k) Summary –Synthes Vertebral Spacer CR
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Heather Guerin, Ph.D., P.E.Senior Regulatory Affairs SpecialistTelephone: 610-719-5432 Facsimile: 610-719-5102Email: guerin.heather@synthes.com
Date Prepared:	January 27, 2012
Trade Name(s):	Synthes Vertebral Spacer CR
Classification:	21 CFR 888.3080 – Intervertebral fusion deviceClass II (special controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code ODP (Intervertebral Fusion Device with Bone Graft, Cervical)
Predicates:	Synthes Zero-P device (K072981);NuVasive CoRoent System (K081611);BAK Cervical Interbody Fusion System (P980048);Medtronic Cornerstone PSR (K100214);Medtronic Prevail (K073285);Globus PATRIOTTM Spacers (ColonialTM ACDF) (K072991)
DeviceDescription(s):	The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebralbody fusion device. The Vertebral Spacer CR is fabricated from Invibio®PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and oneposterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographicassessment of the position of the implant.The Synthes Vertebral Spacer CR is available in a range of heights, and isavailable in three different sagittal profiles. Pyramidal teeth that assist instabilization of the construct are located on the inferior and superiorsurfaces of the spacers. The open architecture of the device allows it to bepacked with autogenous bone graft material, i.e., autograft.
Intended Use/Indications forUse:	The Synthes Vertebral Spacer CR is an anterior cervical interbody fusiondevice indicated for use in skeletally mature patients with degenerativedisc disease (DDD) with accompanying radicular symptoms at one levelfrom C2-T1. DDD is defined as discogenic pain with degeneration of thedisc confirmed by history and radiographic studies. These patients shouldhave had six weeks of non-operative treatment. The interior of theSynthes Vertebral Spacer CR should be packed with autogenous bonegraft and implanted via an anterior approach. The Synthes VertebralSpacer CR is intended to be used with supplemental fixation.
Comparison ofthe device topredicate	Synthes Vertebral Spacer CR is substantially equivalent to the predicatesin design, function, performance, material, and intended use.
510(k) Summary -Synthes Vertebral Spacer CR
device(s):
PerformanceDate(Non-Clinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Synthes conducted the following bench testing (as recommended withinFDA Guidance and in accordance with ASTM F2077-03 and ASTMF2267-04): Static Axial Compression; Dynamic Axial Compression;Static Compression Shear; Dynamic Compression Shear; Static Torsion;Dynamic Torsion; and Subsidence.The conclusions drawn from testing demonstrate that the SynthesVertebral Spacer CR device is substantially equivalent in performance topredicate devices.
	Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.

Public Health Service

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

Synthes Spine % Heather Guerin, Ph.D., P.E. Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

MAY 2 5 2012

Re: K120275

Trade/Device Name: ACIS Spacer and Vertebral Spacer CR Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 24, 2012 Received: April 26, 2012

Dear Dr. Guerin:

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

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Page 2 - Heather Guerin, Ph.D., P.E.

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 Mellerson

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 Statement 5

510(k) Number: (if known)

K 120275

Device Name:

Synthes ACIS

Indications for Use:

The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.

Prescription Use X (21 CFR 801 Subpart D) AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Vivision of Surgical, Orthopedic, and Restorative Devices

KI20275 510(k) Number_

Page 1/2

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510(k) Number: (if known)

K 120275

Device Name:

Synthes Vertebral Spacer CR

Indications for Use:

Prescription Use X (21 CFR 801 Subpart D) AND / OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Digision of Surgical, Orthopedic, and Restorative Devices

K120275 510(k) Number_

Page 2/2

ರ್ಥಿ

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.