The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical 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 : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.

In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.

Device Description

The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.

AI/ML Overview

This is a 510(k) premarket notification for the "ORION" Spinal System. This document does not describe the acceptance criteria and study for an AI/ML device. It's for a traditional medical device (a pedicle screw system). Therefore, the requested information regarding AI/ML device testing criteria, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and not present in this document.

The document discusses the substantial equivalence of the "ORION" Spinal System to a predicate device based on its indications for use, technological characteristics, and performance data from engineering tests.

Here's what information is provided:

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

This document does not provide a table comparing acceptance criteria and reported device performance in the way typically expected for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the types of engineering tests performed on the "ORION" Spinal System:

Test Mode	Standard
Axial Grip	ASTM F1798
Torsional Grip	ASTM F1798
Static Compression Bending	ASTM F1717
Static Torsion	ASTM F1717
Dynamic Compression Bending	ASTM F1717

The document states that the "subect device is substantially equivalent to the predicate device," implying that the performance in these tests met the established criteria for substantial equivalence to the predicate device and relevant ASTM standards. However, the specific numerical results or acceptance thresholds from these tests are not detailed in this summary.

2. Sample sized used for the test set and the data provenance: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm evaluated on a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an engineering test of a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is an engineering test of a physical device.

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: Not applicable. This is an engineering test of a physical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an engineering test of a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For this device, the "ground truth" implicitly refers to the device's ability to withstand mechanical forces and maintain structural integrity as per relevant ASTM standards, demonstrating substantial equivalence to the predicate device.

8. The sample size for the training set: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.

Summary

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August 18, 2020

Orion Biotech Inc. Tun-Ling Li Chen Official Correspondent 5F-1, No.88, Sec.2, Chong-qing N. Rd., Datong Dist. Taipei, 103 Taiwan

Re: K190600

Trade/Device Name: "ORION" Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 20, 2020 Received: July 20, 2020

Dear Tun-Ling Li Chen:

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 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

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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-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 Advice (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. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190600

Device Name "ORION" Spinal 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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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. §807.92.

Preparation Date:	July 20, 2020
Applicant/Sponsor:	Orion Biotech Inc.5F-1, No.88, Sec.2, Chong-qing N. Rd., Datong DistTaipei 103, Taiwan
Contact Person:	Tung-Ling Li ChenTEL: +886 2 2550 3366 ext. 101Fax : +886 2 2559 3366Email: tunglingli@orionspine.com
Proprietary Name:	"ORION" Spinal System
Common Name:	Pedicle Screw System
Classification Name:	21 CFR 888.3070Thoracolumbosacral Pedicle Screw System

Classification Identification: Class II

NKB Product Codes:

Predicate Device: Facilis Spinal System K161231

Device Description:

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Indications for Use:

· The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical 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 : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.
· In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the implants is intended to be removed after solid fusion is achieved.

Technological Characteristics

The subject and predicate devices have similar technological characteristics and the minor differences do not raise any different issues of safety and effectiveness. The following characteristics are the same between the subject and predicates: Indications for use, Principles of operation, Materials of manufacture, Implant sizes, and Surgical technique.

Performance Data

The "ORION" Spinal System has been testing in the following test modes:

Axial Grip per ASTM F1798
Torsional Grip per ASTM F1798
Static Compression Bending per ASTM F1717
Static Torsion per ASTM F1717
Dynamic Compression Bending per ASTM F1717

Conclusion

The information provided in this submission demonstrate that the subject device is substantially equivalent to the predicate device.

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.