Synthes Synapse System is indicated for the following: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated 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 pervious 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, 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 CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 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. 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 Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 – T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System and/or the Synthes Axon System. The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.

AI/ML Overview

The provided 510(k) summary for the Synthes Synapse System focuses on demonstrating substantial equivalence to predicate devices through design modifications, material commonality, and intended use. The performance data section explicitly states that "Non-Clinical Performance and Conclusions: Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, the information required to populate most of the acceptance criteria and study design details (especially those related to clinical studies, ground truth, expert review, training data, etc.) is not available in the provided document. The submission relies solely on non-clinical bench testing to demonstrate substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, indicating where information is absent:

Acceptance Criteria and Device Performance Study for the Synthes Synapse System (K070573)

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical data was not required and no specific objective acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, or mechanical properties) are detailed as "acceptance criteria" in a quantitative sense, this table will reflect the qualitative overarching acceptance criterion of "substantial equivalence" as demonstrated by bench testing.

Acceptance Criterion	Reported Device Performance
Overall Equivalence	"Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device."
Design Equivalence	Demonstrated through design modifications of the predicate.
Function Equivalence	Demonstrated through bench testing.
Material Equivalence	Implants manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, "the same as the predicate device."
Intended Use Equivalence	Identified as substantially equivalent to the predicate in intended use.

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

Test Set Sample Size: Not specified in terms of number of devices, materials, or specific test configurations. The document only references "bench testing results."
Data Provenance: Not applicable in the context of clinical data. It refers to non-clinical laboratory bench testing. The country of origin for the testing itself is not stated.
Retrospective/Prospective: Not applicable, as this refers to a non-clinical bench study, not a human subjects study.

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

Not applicable. No ground truth in the context of expert review or clinical diagnosis was established as this was a non-clinical bench study.

4. Adjudication method for the test set

Not applicable. No human experts or clinical cases were adjudicated.

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

No. An MRMC study was not conducted. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

Not applicable. For a non-clinical bench test, the "ground truth" would be established by validated scientific methodologies, engineering specifications, and measurement standards for mechanical properties (e.g., fatigue strength, torsional rigidity, pull-out strength). The document does not specify these individual "ground truths" but concludes overall substantial equivalence.

8. The sample size for the training set

Not applicable. This involved non-clinical bench testing of a medical device, not a machine learning algorithm requiring a training set.

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

Not applicable. See point 8.

Summary

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K070573

510(k) Summary

Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: lewandowski.susan@synthes.com
Date Prepared:	May 2007
Trade Name:	Synthes Synapse System
Common Name:	Posterior Cervical System
Classification:	21 CFR 888.3050 - Spinal Interlaminal Fixation OrthosisClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code KWP21 CFR 888.3070 - Pedicle Screw Spinal SystemClass IIOrthopaedic and Rehabilitation Devices PanelProduct Codes MNH, MNI
Predicate Device:	Synthes CerviFix System - Axon Components - K023675, hereinreferred to as the Axon SystemSynthes CerviFix System - K030377
Device Description:	The Synthes Synapse System consists of cancellous and cortexpolyaxial screws, hooks, rods, transverse bars, parallelconnectors, transconnectors, and locking screws. These implantsare designed for fixation of the cervical, and/or upper thoracicspine (C1 – T3). A complete occipital-cervical-thoracic constructcan be created by using components that have been previouslycleared within the Synthes CerviFix System and/or the SynthesAxon System.
Device Description:	The implants are manufactured from Titanium AluminumNiobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as thepredicate device.
Intended Use /	Synthes Synapse System is indicated for the following:
Indications for Use:
	Hooks, Plate/Rods, Rods and ScrewsWhen intended to promote fusion of the cervical spine and
	occipitocervical junction (occiput-T3), the plate/rod, rod, hook
	and screw (3.2 mm cortex) components of the Synthes Cervifix,
	Axon, and Synapse Systems are indicated for the following:
	• Degenerative Disc Disease (DDD) (defined as neck painof discogenic origin with degeneration of the disc asconfirmed by patient history and radiographic studies)
	• Spondylolisthesis
	• Spinal Stenosis
	• Fracture/dislocation
	• Atlantoaxial fracture with instability
	• Occipitocervical dislocation
	• Revision of pervious cervical spine surgery
	• TumorWhen used to treat these cervical and occipitocervical conditions,
	screws are limited to occipital fixation only.
	Hooks and RodsThe rod and hook components are also intended to providestabilization to promote fusion following reduction offracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
	Rods, Clamps, Screws, Nuts, Variable Axis Screws, LockingScrews, and Transverse Bars
	The rods, clamps, screws, nuts, variable axis screws, locking
	screws, and transverse bars are intended to promote fusionfollowing reduction of fracture/dislocation or trauma in the upperthoracic 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-T3in treating thoracic conditions only. They are not intended to beplaced in or treat conditions involving the cervical spine.
	The Synthes CerviFix, Axon, and Synapse Systems can also belinked to the Synthes Universal Spinal System using the 3.5mm/6.0 mm parallel connectors from that system and via theCerviFix tapered rods using lamina hooks, transverse processhooks, pedicle hooks, 4.2 mm screws and the 5.0 mm/6.0 mmparallel connector.
	Warning: This device is not intended for screw attachment orfixation to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine.
Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device:	The Synthes Synapse System is a result of design modificationsto the predicate device. It is substantially equivalent to thepredicate in design, function, material and intended use.
Performance Data(Nonclinical and/orClinical)	Non-Clinical Performance and Conclusions:Bench testing results demonstrate that the Synthes SynapseSystem is substantially equivalent to the predicate device.Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for this device.

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and the comments of the country

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and the comments of the comments of the comments of

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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 features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2007

Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, PA 19380

Re: K070573

Trade/Device Name: Synthes Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNI Dated: May 9, 2007 Received: May 10, 2007

Dear Ms. Lewandowski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 – Ms. Susan Lewandowski

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,
Mark A. Wilkerson

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

Enclosure

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2 Indications for Use Statement

Special 510(k) Device Modification

Indications for Use Statement

510(k) Number:

Device Name: Synthes Synapse System (modification to Synthes Axon System) Synthes Synapse System is indicated for the following: Indications: Hooks, Plate/Rods, Rods and Screws When intended to promote fusion of the cervical spine and occrpitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix, Axon, and Synapse Systems are indicated 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 pervious 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, 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

Synthes Synapse System CONFIDENTIAL

Special 510(k) Page 3 of 29 p. 1 of 2

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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 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.

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.

X Prescription Use (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)

Mark M. Melkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K070573

Special 510(k) Page 4 of 29 2 of 2

Synthes Synapse System CONFIDENTIAL

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.