The SynCage Evolution spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the SynCage Evolution spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Description

The Synthes SynCage Evolution spacer is a radiolucent device for use in interbody fusion. It is to be used in conjunction with supplemental fixation to provide structural stability in skeletaly mature individuals. The Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. Implantation is through an anterior or anterolateral approach. The Synthes SynCage Evolution spacer is provided sterile. The Synthes SynCage Evolution spacer is available in three footprints (Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit individual pathology and anatomical conditions. 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 a 510(k) summary for the Synthes SynCage Evolution Spacer, an intervertebral body fusion device. It details the device's description, intended use, and a comparison to predicate devices, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify explicit acceptance criteria in terms of numerical thresholds or performance targets for a device meeting clinical or diagnostic accuracy. Instead, it states that the device's performance was evaluated through non-clinical bench testing and compared to predicate devices for substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria Category	Specific Criteria (Inferred from document)	Reported Device Performance
Mechanical Performance	Static Axial Compression (ASTM F2077-11)	Substantially equivalent in performance to predicate devices.
	Dynamic Axial Compression (ASTM F2077-11)	Substantially equivalent in performance to predicate devices.
	Static Compression Shear (ASTM F2077-11)	Substantially equivalent in performance to predicate devices.
	Expulsion (ASTM F2267-04)	Substantially equivalent in performance to predicate devices.
	Subsidence (ASTM F2267-04)	Substantially equivalent in performance to predicate devices.
Material Biocompatibility	Fabricated from Invibio® PEEK-OPTIMA® LT-1 (ASTM F2026-10) with tantalum (ASTM F560-08) radiopaque markers.	Materials conform to specified ASTM standards.
Radiopacity	Markers allow intra-operative radiographic assessment of implant position.	Meets requirement for intra-operative radiographic assessment.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."
Therefore, there was no test set of clinical data used to evaluate the device's performance in humans. The evaluation was based solely on non-clinical bench testing.

Sample Size for Test Set: Not applicable (no clinical test set).
Data Provenance: Not applicable (no clinical data).

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

As no clinical data was used for evaluation, there was no ground truth established by experts for a test set. The evaluation relied on engineering principles and bench testing standards.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed.

Adjudication Method: Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study was conducted. The document states: "Clinical data and conclusions were not needed for this device."

MRMC Study: No.
Effect Size of Human Readers with vs. without AI: Not applicable.

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

This device is an intervertebral fusion spacer, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance was evaluated through bench testing.

Standalone Study: Not applicable (device is not an algorithm).

7. The Type of Ground Truth Used

For the non-clinical performance evaluation, the "ground truth" was established by standardized engineering testing protocols as defined by ASTM F2077-11 and ASTM F2267-04. The performance was then compared to that of legally marketed predicate devices, implying that their established performance under these tests served as a reference for "substantial equivalence."

Type of Ground Truth: Bench testing standards (ASTM F2077-11 and ASTM F2267-04) and performance of predicate devices.

8. The Sample Size for the Training Set

This document describes a physical medical device, not an AI or machine learning model. Therefore, the concept of a "training set" is not applicable.

Sample Size for Training Set: Not applicable.

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

As there is no training set mentioned or implied for this physical device, this question is not applicable.

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for SYNTHES Spine. The logo consists of the SYNTHES trademark symbol, the word "SYNTHES" in bold, and the word "Spine" in a smaller font size. There is a horizontal line below the word "Spine".

510(k) Summary : K122639 6

510(k) Summary -SynCage Evolution Spacer
Name of Firm:	DePuy Synthes Spine
	1302 Wrights Lane East
	West Chester, PA 19380
510(k) Contact:	Hemal Mehta
	Regulatory Affairs Specialist
	Telephone: 610-719-5424
	Facsimile: 610-719-5102
	Email: mehta.hemal@synthes.com
Date Prepared:	May 22, 2013
Trade Name(s):	Synthes SynCage Evolution Spacer
Classification:	21 CFR 888.3080 - Intervertebral Body Fusion Device
	Class II (special controls)
	Orthopaedic and Rehabilitation Devices Panel (87)
	Product Code MAX (Intervertebral Fusion Device with Bone Graft,
	Lumbar)
Predicates:	Synthes OPAL Spacer (K072791)
	LDR Spine ROI-A (K090507)
	Biomet Enclave (K081636)
	SeaSpine Redondo (K082310)
	DePuy Spine Cougar (K081917 & K113348)
	The Synthes SynCage Evolution spacer is a radiolucent device for use in
	interbody fusion. It is to be used in conjunction with supplemental
	fixation to provide structural stability in skeletaly mature individuals. The
	Synthes SynCage Evolution spacer is fabricated from Invibio® PEEK-
	OPTIMA® LT-1 (ASTM F2026-10) with four anterior and one posterior
	tantalum (ASTM F560-08) radiopaque markers. The markers allow intra-
	operative radiographic assessment of the position of the implant.
	Implantation is through an anterior or anterolateral approach. The
	Synthes SynCage Evolution spacer is provided sterile.
Device
Description(s):	The Synthes SynCage Evolution spacer is available in three footprints
	(Small: 32x25mm; Medium, 36x28mm; Large, 40x31mm), four lordotic
	angles (6°, 10°, 14°, 18°), and a range of heights (9-19mm) to suit
	individual pathology and anatomical conditions. 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).
Intended Use/	The SynCage Evolution spacer is indicated for use in patients with
Indications for	degenerative disc disease (DDD) at one or two contiguous levels from L2
510(k) Summary –SynCage Evolution Spacer
Use:	to S1 whose condition requires the use of interbody fusion combined withsupplemental fixation. The interior of the SynCage Evolution spacershould be packed with autogenous bone graft (i.e. autograft). DDD isdefined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. These patients should beskeletally mature and have had six months of non-operative treatment.
Comparison ofthe device topredicatedevice(s):	Synthes SynCage Evolution Spacer is substantially equivalent to thepredicates in design, 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 Guidances and in accordance with ASTM F2077-11 and ASTMF2267-04): Static Axial Compression; Dynamic Axial Compression;Static Compression Shear; Expulsion; and Subsidence.
	The conclusions drawn from testing and an engineering rationaledemonstrate that the Synthes SynCage Evolution Spacer is substantiallyequivalent in performance to predicate devices.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for this device.

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® SYNTHES® Spine

K122639

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized lines representing its wings and body.

Public Health Service

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

Letter dated: May 24, 2013

Synthes (USA) Products LLC % Mr. Hemal Mehta Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K122639

Trade/Device Name: Synthes SynCage Evolution Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 30, 2013 Received: May 1, 2013

Dear Mr. Mehta:

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 – Mr. Hemal Mehta

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 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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Image /page/4/Picture/0 description: The image shows the logo for Synthes Spine. The word "SYNTHES" is in bold, sans-serif font, with a registered trademark symbol next to it. Below the word "SYNTHES" is the word "Spine" in a smaller, sans-serif font. To the left of the word "SYNTHES" is a circular logo with a stylized image inside.

Indications for Use Statement 6

510(k) Number(s): K122639 (if known)

Device Name: Synthes SynCage Evolution Spacer

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.