The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

· Traumatic spinal fractures and/or traumatic dislocations;
Instability or deformity;
· Failed previous fusions (e.g. pseudarthrosis);
· Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

Device Description

The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as offset rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.

AI/ML Overview

The provided text is a 510(k) summary for the SYMPHONY™ OCT System, which is a posterior spinal fixation system. It does not describe a study that uses AI or machine learning, nor does it discuss acceptance criteria in the context of diagnostic accuracy or performance metrics commonly associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on the substantial equivalence of the device to existing predicate devices based on its intended use, technological characteristics, materials, and non-clinical performance data (mechanical testing and MR compatibility).

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because this document does not pertain to such a device. The "performance data" section refers to mechanical testing for spinal implants and MR compatibility, not to the diagnostic or analytical performance of an AI/ML algorithm.

Here's why each requested point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: The document discusses non-clinical mechanical testing (Static Torsion, Static Compression, Dynamic Compression) and MR compatibility. It states these tests were conducted "in alignment with the following standards" and that "Results demonstrated compatibility conditions." However, it does not provide specific numerical acceptance criteria (e.g., minimum torque resistance, maximum displacement force) or the specific numerical results obtained for the SYMPHONY™ OCT System components against these criteria.
Sample size used for the test set and the data provenance: This refers to data for an AI/ML algorithm. The document describes mechanical and MR compatibility testing of physical components, not a test set of medical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is relevant for AI/ML diagnostic or analytical studies. The document describes engineering tests, not expert-adjudicated ground truth for medical images or other data.
Adjudication method: Not applicable to the reported mechanical and MR compatibility testing.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance with and without AI assistance, which is not relevant to a spinal implant system.
Standalone performance study: Not applicable. The document describes the mechanical and MR properties of the device itself, not the performance of an algorithm.
Type of ground truth used: Not applicable. Ground truth typically refers to confirmed diagnoses or outcomes in clinical studies, not the results of engineering tests.
Sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

To summarize, the provided text describes a medical device clearance for a spinal fixation system, not an artificial intelligence medical device. Therefore, the specific questions regarding acceptance criteria and study design for AI/ML performance cannot be answered from this document.

Summary

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February 5, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medos International Sarl % Eric Zhu Sr. Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K203319

Trade/Device Name: SYMPHONY™ OCT System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: November 9, 2020 Received: November 12, 2020

Dear Eric Zhu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203319

Device Name SYMPHONY™ OCT System

Indications for Use (Describe)

· Traumatic spinal fractures and/or traumatic dislocations;
Instability or deformity;
· Failed previous fusions (e.g. pseudarthrosis);
· Tumors involving the cervical/thoracic spine;

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· Degenerative disease of the facets with instability.

The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

A.	Submitter Information
	Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
	Contact Person:	Eric Zhu325 Paramount DriveRaynham, MA 02767
	Telephone:	(508) 828-3730
	Fax:	(508) 828-3797
	Email:	Ezhu@its.jnj.com
B.	Date Prepared	November 9, 2020
C.	Device Name
	Trade/Proprietary Name:	SYMPHONY™ OCT System
	Common/Usual Name:	Posterior Cervical Screw System
	Regulatory Class:	II
	Review Panel:	Orthopedic
	Product Codes:	NKG – Class II – 21 CFR §888.3075Posterior Cervical Screw System
		KWP – Class II – 21 CFR §888.3050Appliance, Fixation, Spinal Interlaminal
D.	Predicate Device Names
	Primary Predicate:	SYMPHONY OCT System (K181949)
	Additional Predicates:	SYMPHONY OCT System (K190895, K192646)SYNAPSE OCT System (K142838)MOUNTAINEER OCT Spinal System (K151885)CONNECTOR System by Orthofix Inc. (K190751)

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E. Submission Purpose

Obtain clearance for additional offset rod components of the SYMPHONY OCT System and update in MR Conditional product labeling to include additional scanning parameters.

F. Device Description

G. Indications for Use

The SYMPHONY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):

· Traumatic spinal fractures and/or traumatic dislocations;
Instability or deformity;
· Failed previous fusions (e.g. pseudarthrosis);
· Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.

The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.

The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

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

The intended use, technological characteristics, and performance of the SYMPHONY OCT System subject devices are consistent with those of the predicate devices.

I. Materials

The additional SYMPHONY OCT System components in scope are comprised of Titanium alloy conforming to ASTM F136.

J. Performance Data

Offset Rods:

Non-clinical testing was conducted in alignment with the following standards:

. ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
The following tests were completed to support substantial equivalence:
Static Torsion
Static Compression ●
Dynamic Compression .

MR Compatibility:

Non-clinical testing was conducted in alignment with the following standards:

ASTM F2213 Standard Test Method for Measurement of Magnetically Induced . Torque on Medical Devices in the Magnetic Resonance Environment
ASTM F2052 Standard Test Method for Measurement of Magnetically Induced . Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from . Passive Implants

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ASTM F2182 Standard Test Method for Measurement of Radio Frequency . Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Results demonstrated compatibility conditions of the subject devices in the MR environment.

K. Conclusion

Evaluation of the subject device intended use, technological characteristics, and performance data demonstrates substantial equivalence with the predicate devices.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.