The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the ULC 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Device Description

The ULC spinal pedicle screw system is one touch single unitary locking cap, posterior spinal fixation system which consists of pedicle screws (monoaxial screw & poly-axial screw), rod and locking cap.

The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.

The ULC system is fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the ULC Spinal pedicle screw systems.

AI/ML Overview

The provided text is a 510(k) Summary for the ULC spinal pedicle screw system. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way a clinical performance study would.

Instead, the document states: "Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

This refers to mechanical and material testing, not a clinical study involving human or even animal subjects to assess performance metrics like sensitivity, specificity, or reader agreement. Therefore, most of the requested information regarding acceptance criteria and studies (like sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in the provided text.

Based on the provided text, here's what can be answered:

A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. It refers generally to "bench testing as listed in Section 14 and Appendix D... conducted in accordance with ASTM F1717." ASTM F1717 is a standard for in vitro static and fatigue testing of spinal implant constructs in a corpectomy model. The "reported device performance" would be the results of these mechanical tests demonstrating the device's ability to withstand certain static and fatigue loads, but these specific results are not included in this summary.

Acceptance Criterion	Reported Device Performance
Not specified for clinical performance or accuracy. However, the device met the requirements of ASTM F1717 for mechanical performance.	Specific results not provided in this summary. It states: "demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document refers to "bench testing" (mechanical testing) not a clinical study with a test set of data/patients.
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):
Not applicable, as this was not a clinical or diagnostic study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this was not a clinical or diagnostic study.
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. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a spinal pedicle screw system, not an AI/imaging diagnostic device. The "standalone" performance would refer to the mechanical performance of the physical implant itself in bench testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing (ASTM F1717), the "ground truth" would be the engineering specifications and performance limits defined by the standard.
The sample size for the training set:
Not applicable. This is not a study involving machine learning or AI with a training set.
How the ground truth for the training set was established:
Not applicable. This is not a study involving machine learning or AI with a training set.

Summary

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ICOF 3077

Premarket Notification 510(k) 5. 510(k) Summary

5. 510(k) Summary

[As Required by 21 CFR 807.87(h) & 21 CFR 807.92]

OCT 2 6 2009

1. Submission information

Name of Company: OTIS Biotech Co., Ltd
FDA registration No. 3005140381
#514 Sihwa industrial complex 2Ba Block
Jeongwang-Dong, Siheung-si
Gyounggi-Do, Republic of Korea 429-450
Tel: 82-31-319-0406
Fax: 82-31-319-0414

Contact:	JiSuk Yoo
	Researcher
	E-mail: jsy1979@otisbiotech.com
	Tel: 82-31-414-4616
	Fax: 82-31-411-1076

30 Sep, 2008 Date Prepared:

2. Device Identification

Trade Name:	ULC spinal pedicle screw system
Common Name:	Pedicle Screw Spinal Fixation system
Classification:	Class II
	MNI 888.3070 - Orthosis, Spinal Pedicle Fixation.
	MNH 888.3070 - Orthosis, Spondyloisthesis Spinal Fixation.

3. Substantial Equivalence Predicate Legally Marketed Devices

BK Meditech Co., Ltd., MEGA spine system -- MNI MNH - K072436 Jemo Spine, LLC., DELTA™ spinal fusion system - MNI MNH KWQ -K071857

Stryker Spine, Xia 9 Spinal system - MNI MNH KWP KWQ - K053115

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U&I Corporation, OPTIMATM Spinal System - MNI MNH KWQ - K051971

The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.

4. Device Description

The ULC system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Components of the ULC system are supplied non-sterile and single use.

5. Indications for Use

The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicte fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

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ge 2 of 3

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Premarket Notification 510(k) 5. 510(k) Summary

6. Statement of Technological Comparison

Bench testing as listed in Section 14 and Appendix D. was conducted in accordance with ASTM F1717. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles.

5-3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Otis Biotech Co., LTD % Jisuk Yoo 514, 2-BA Block, Jungwang-Dong, Sihma Sihung City, Kyonggi-do Republic of Korea 429-450

OCT 2 $ 2009

Re: K083077

Trade/Device Name: ULC Spinal Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: October 21, 2009 Received: October 21, 2009

Dear Mr. Yoo:

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 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 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.

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Page 2 - Mr. Jisuk Yoo

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/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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4. Indications for Use

510(k) Number: [co&3077 Device Name: ULC spinal pedicle screws system Indications For Use:

The ULC spinal pedicle screw systems are intended for posterior and noncervical pedicle fixation for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the ULC 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Artificial Joint Research Center
OTIS Biotech co., Ltd.	(Division Sign-Off)
	Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K083027

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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.