When intended to provide stabilization as an adjunct to fusion of the cervical junction (occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft for the following: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Spinal stenosis
Fracture/dislocation
Atlantoaxial fracture with instability
Occipitocervical dislocation
· Revision of previous cervical spine surgery
Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12) or lumbar spine.

Device Description

The tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length.

The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.

AI/ML Overview

This document is a 510(k) premarket notification for the DePuy Synthes Spine's Synapse System. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than conducting a de novo study with acceptance criteria and a specific performance study as one might see for novel AI/ML devices or completely new technologies.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert adjudication as they would apply to an AI/ML algorithm or a new diagnostic device are not present in this document.

Here's an analysis of what can be extracted and what information is missing based on the provided text:

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

Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating substantial equivalence to predicate devices. This means the "acceptance criteria" are generally that the device performs as well as the predicate device and has similar technological characteristics and intended use.
Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, failure rates, accuracy) are reported for the Synapse System in this document. The "performance" assessment is based on the lack of change from the predicate device and engineering rationale.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable/not provided. This document does not describe a clinical study with a "test set" in the context of evaluating a diagnostic or AI/ML algorithm.
Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/not provided. Ground truth establishment by experts for a test set is not described as this is not a study evaluating human reader or algorithm performance on a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/not provided. No test set adjudication method is described.

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 document pertains to a spinal fixation system, not an AI-assisted diagnostic tool.
Effect Size of AI: Not applicable, as no AI component or human reader study is described.

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

Standalone Performance: No, a standalone performance study as described (algorithm only without human-in-the-loop performance) was not done. This document is not about an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as it would apply to a diagnostic or AI algorithm study is not applicable here. The document relies on previous testing and validation of the predicate devices and engineering rationale.

8. The sample size for the training set

Not applicable/not provided. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable/not provided.

Summary of Device and Regulatory Basis:

This 510(k) submission for the Synapse System (incorporating tapered rods) is a request for clearance based on substantial equivalence to predicate devices (Synthes Synapse System, DePuy EXPEDIUM Spine System, and Synthes Matrix Spine System). The core argument for equivalence is:

Technological Characteristics: The design, material (titanium alloy), and established performance of the tapered rods and other Synapse System components remain unchanged from their previously cleared predicate versions.
Intended Use: The intended use of the devices also remains unchanged from their predicate versions (as an adjunct to fusion for various spinal conditions in skeletally mature patients, primarily C1-T3).
Performance Data: Instead of new performance testing, an engineering rationale is provided because the designs and technological characteristics are unchanged and have been "extensively tested in their predicate submissions." The specific modification being addressed is the ability of the Synapse System to link with the DePuy EXPEDIUM 5.5 Titanium Spine System using titanium tapered rods.

In essence, this document is a regulatory filing asserting that because the device is fundamentally the same as previously cleared devices, new comprehensive performance studies (as would be required for a novel device or AI/ML product) are not necessary.

Summary

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

October 1, 2014

DePuy Synthes Spine, a Johnson & Johnson Company Ms. Jaclyn Porsolt Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K142460

Trade/Device Name: Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: August 29, 2014 Received: September 2, 2014

Dear Ms. Porsolt:

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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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 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/ResourcesforYou/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.

Ronald刷Aean -S for

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) K142460

Device Name Synapse System

Indications for Use (Describe) These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

· Spondylolisthesis
· Spinal stenosis
Fracture/dislocation
Atlantoaxial fracture with instability
Occipitocervical dislocation
· Revision of previous cervical spine surgery
Tumor

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars The rods, clamps, screws, nuts, variable axis screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12) or lumbar spine.

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

즈 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter Information A.

DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767
Contact Person:	Jaclyn Porsolt
Address:	325 Paramount Drive
	Raynham, MA 02767
Telephone number:	(508) 828-3269
Fax number:	(508) 828-3797
Email:	jporsol1@its.jnj.com
B. Date Prepared	September 30, 2014
C. Device Name
Trade/Proprietary Name:	Synapse System
Common/Usual Name:	Spinal Interlaminal Fixation Orthosis
Classification and Regulation:Classification Product and	Class II per 21 CFR 888.3050
Panel Code:	KWP; Orthopedic
Subsequent Regulation:Subsequent Classification	21 CFR 888.3070
Product and Panel Code:	MNI; Orthopedic
	MNH: Orthopedic

Predicate Device Name D.

Trade names: Primary Predicate: Synthes Synapse System (most recently cleared K091689) Additional Predicate: DePuy EXPEDIUM Spine System (most recently cleared K111136) Additional Predicate: Synthes Matrix Spine System (K100634)

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E. Device Description

F. Intended Use (proposed changes highlighted in blue font)

Synthes Synapse System

These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis ●
Spinal stenosis
Fracture/dislocation
Atlantoaxial fracture with instability
Occipitocervical dislocation
Revision of previous cervical spine surgery
Tumor ●

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When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes Synapse System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

Summary of Similarities and Differences in Technological Characteristics, G. Performance and Intended Use

The technological characteristics of the tapered rods and Synapse System that are the subjects of this submission remain unchanged from their predicate versions in their design, material, and performance. The intended use of the subject devices also remains unchanged from their predicate versions.

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H. Materials

The tapered rods, which are the subject of this submission, previously cleared with the Matrix System, are available in titanium alloy conforming to ASTM F-1295 specifications.

The previously cleared System components are available in titanium alloy conforming to ASTM F-1295 specifications.

I. Performance Data

Since the subject devices have been extensively tested in their predicate submissions and their designs and technological characteristics remain unchanged, an engineering rationale is provided in lieu of performance testing for the proposed modification.

J. Conclusion

Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices because the intended use and technological characteristics remain unchanged. The engineering rationale further demonstrates that the subject tapered rods can be added to the Synapse System to expand the system's compatibility for use with the EXPEDIUM Spine System.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.