When used as a pedicle screw fixation system in the non-cervical posterior spine (TI-SI) in skeletally mature patients, the VICEROY Spine System is 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis, (7) turnor, (8) failed previous fusion (i.e. pseudarthrosis).

Device Description

The VICEROY Spine System consists of four or more pedicle screws and two VICEROY solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The VICEROY rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The VICEROY Spine System is fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the VICEROY Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone algorithm evaluation. The "performance summary" section refers to mechanical testing of the device, not a study of its clinical or diagnostic accuracy.

Therefore, many of the requested fields regarding acceptance criteria related to diagnostic performance or clinical outcomes, and the type of study that proves it, are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance (Mechanical Testing)

The document states: "Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.' The following testing was performed in accordance with ASTM F1717: static compression bending, static torsion, and dynamic compression bending."

This indicates that the acceptance criteria are adherence to ASTM F1717 standards for the specified mechanical tests, and the device performs in a manner equivalent to predicate devices under these tests. However, specific numerical acceptance values or detailed performance results (e.g., specific bending moment values, torsion limits) are not provided in this summary. The document only states that the testing supports equivalence.

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Quantified in Document)	Reported Device Performance (Implied by Substantial Equivalence Claim)
Static Compression Bending	Adherence to ASTM F1717 standards for pedicle screw spinal systems.	Performance equivalent to predicate devices.
Static Torsion	Adherence to ASTM F1717 standards for pedicle screw spinal systems.	Performance equivalent to predicate devices.
Dynamic Compression Bending	Adherence to ASTM F1717 standards for pedicle screw spinal systems.	Performance equivalent to predicate devices.

Study Details (Mechanical Testing)

Sample size used for the test set and the data provenance: Not specified in the document. Mechanical testing typically uses a certain number of device samples, but this information is not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical testing of a physical device, not related to expert interpretation or ground truth establishment for diagnostic purposes.
Adjudication method for the test set: Not applicable.
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 device is a pedicle screw spinal system, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics defined by ASTM F1717, to which the device's measured performance is compared.
The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical testing.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does convey:

The VICEROY Spinal System is a medical device intended for spinal stabilization.
The manufacturer is seeking substantial equivalence to existing predicate devices (ACME Spinal System, Moss Miami, and Expedium Spinal System).
Substantial equivalence is claimed based on materials, design, indications for use, operational principles, and mechanical testing.
Mechanical testing was performed according to ASTM F1717 standards for static compression bending, static torsion, and dynamic compression bending.
The document implies the device met the requirements of these standards and demonstrated performance equivalent to the predicate devices.

Summary

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K122229
Page 1 of 2

NOV 2 0 2012

SECTION 5 510(k) Summary

Submitter's Name:	Torrey Spine
Submitted on behalf of:	FAIRWAY MEDICAL Co., Ltd.
	54-4 NONHYUN-DONG, ILSIM BLDG #308
	GANGNAM-GU
	SEOUL
	Republic of Korea
Submitter's Address:	12707 High Bluff Dr.
	Suite 200
	San Diego, CA 92130
Submitter's Telephone:	Phone 858-779-1370
	Fax 858-408-3326
Contact Name:	Jason Yim
Date Summary was Prepared:	05/10/2012
Trade or Proprietary Name:	VICEROY Spinal System
Common or Usual Name:	Pedicle Screw Spinal System
Classification:	Class III per 21 CFR §888.3070
Product Codes:	MNI, 21 CFR 888.3070, Pedicle screw spinal system
	MNH, 21 CFR 888.3070, Pedicle screw spinal system
	NKB, 21 CFR 888.3070, Pedicle screw spinal system
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Device Names:
	ACME Spinal System, 510(K) Number: K071824
	Moss Miami and Expedium Spinal System, 510(K) Number:
	K103490 & K955348

SUBSTANTIAL EQUIVILENCE

The VICEROY Spine System is substantially equivalent to the ACME Spinal System (K071824), DePuy Moss Miami and Expedium Spinal System (K103490 & K955348). The VICEROY Spine system is equivalent to the predicate systems with respect to materials, design, indications for use, and operational principles. There are no substantial differences between the subject device and the predicate devices and thus no differences which could affect safety or efficacy. Based on a comparison of testing between the subject and predicate devices, FAIRWAY Medical Co., LTD believes the VICEROY Spine System is substantially equivalent to the predicate devices.

PERFORMANCE SUMMARY

Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Spinal System 510(k)s." The following testing was performed in accordance with ASTM F1717: static compression bending, static torsion, and dynamic compression bending.

VICEROY Spine System

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K122229
Page 2 of 2

DESCRIPTION OF THE DEVICE

INDICATIONS FOR USE

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a flame, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Letter Dated: November 20, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Torrev Spine % Empirical Testing Corporation Ms. Meredith May Validation, Certification and Technical Specialist 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K12229

Trade/Device Name: VICEROY Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: October 31, 2012 Received: November 1, 2012

Dear Ms. May:

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

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Page 2 -- Ms. Meredith May

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 Indication for Use

510(k) Number (if known): Device Name: VICEROY Spine System

When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the VICEROY Spine System is 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis). (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

El Keith

(Division Sign-Off)
Division of Orthopedic Devices
510(k) Number22229

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.