The Poseidon OCT Spinal Fixation 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 thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and 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 Poseidon OCT Spinal Fixation 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.

In order to achieve additional levels of fixation, the Poseidon OCT Spinal Fixation System may be connected to the Medyssey Zenius, Iliad or Kora Spinal Systems using parallel connectors and taper rods.

Device Description

The Poseidon OCT Spinal Fixation System is a posterior fixation system designed for occipito-cervicalthoracic use for single and/or multilevel rigid fixation to treat occipital and/or cervical conditions of the spine.

AI/ML Overview

Based on the provided text, the device in question is the Poseidon OCT Spinal Fixation System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving novel acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/ML performance, is not present in this document.

For clarity, I will address each point based on what is available in the document, and explicitly state when the requested information is absent.

Here's an analysis of the provided text:

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

The document does not provide a table of acceptance criteria or reported device performance in the manner typically associated with clinical studies or performance testing against specific numerical benchmarks for new or AI/ML-driven devices. Instead, it states:

Criterion Type	Details from Document
Performance Standards Utilized	Pre-clinical testing was conducted per ASTM F2706 and ASTM F1798. This implies that the device's mechanical performance was evaluated against the standards outlined in these ASTM specifications. The "acceptance criteria" would implicitly be the passing requirements of these standards.
Tests Conducted	- Static and dynamic axial compression, static torsion and static tension per ASTM F2706.- Static and dynamic interconnection mechanism and subassemblies per ASTM F1798.
Stated Outcome	"These comparisons demonstrate substantial equivalence to the predicate devices." This is the primary "reported device performance" in the context of a 510(k), meaning its performance is considered comparable to the legally marketed predicates.
Specific Performance Values	Not provided in this document.
Acceptance Criteria Values	Not explicitly stated but are inherent to the ASTM standards.

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

This information is not available in the provided document. The document describes pre-clinical mechanical testing, not a clinical study involving a test set of human data. Therefore, concepts like sample size for a test set, data provenance, or retrospective/prospective nature do not apply in the context of this 510(k) summary.

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)

This information is not applicable as the document describes pre-clinical mechanical testing, not a study requiring expert consensus or ground truth establishment from medical professionals.

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

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. The device is a spinal fixation system, a physical implant, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This information is not applicable. The device is a physical spinal fixation system, not an algorithm.

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

For the pre-clinical mechanical testing, the "ground truth" would be the expected mechanical behavior according to the ASTM standards (F2706 and F1798). This is determined by the specifications and measurement techniques defined within those engineering standards, rather than medical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a symbol and text arranged in a circular format. The symbol features a stylized representation of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.

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

January 5, 2017

Medyssey USA, Inc. % Rich Jansen, Pharm.D. Consultant Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K161637

Trade/Device Name: Poseidon OCT Spinal Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: December 2, 2016 Received: December 5, 2016

Dear Dr. Jansen:

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 devicerelated adverse events) (21 CFR 803); 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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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.

Lori A. Wiggins -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) K161637

Device Name Poseidon OCT Spinal Fixation System

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	January 4, 2016
Submitter:	Shawn Kim
	Medyssey USA, Inc.
	1550 E. Higgins Road
	Suite 123
	Skokie, IL 60077
	847-427-0200
	888-518-9070 (fax)
Regulatory Contact:	Rich Jansen, Pharm. D.
	Silver Pine Consulting, LLC
Product
Trade Names:	Poseidon OCT Spinal Fixation System
Product Class:	Unclassified
Classification:	Unclassified
Common Name:	Posterior, Cervical Pedicle Screw System
Product Codes:	NKG, KWP
Panel Code:	87

Device Description:

Indications for Use:

The Poseidon OCT Spinal Fixation 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 thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and 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.

Predicate Device(s):

Medyssey believes these devices are substantially equivalent to a predicate device previously cleared by FDA. The primary predicate device is the Synapse OCT System from DePuy/Synthes (K142838). One additional predicate device is the Vertex Reconstruction System from Medtronic (K143471).

Performance Standards:

The pre-clinical testing was conducted per ASTM F2706 and ASTM F1798. Testing included:

Static and dynamic axial compression, static torsion and static tension per ASTM F2706.
Static and dynamic interconnection mechanism and subassemblies per ASTM F1798.

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Technological Characteristics:

Medyssey has compared the Poseidon OCT Spinal Fixation System to the predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.

Conclusion:

Medyssey concludes that the Poseidon OCT Spinal Fixation System is substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.

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.