The OP Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/flium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Device Description

The OP Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of -sizes to accommodate differing anatomic requirements.

AI/ML Overview

The provided text describes a medical device submission (K120291) for the OrthoPediatrics (OP) Spine System. However, it does not include information about acceptance criteria, device performance metrics, or study details in the format requested.

The document is a 510(k) summary and subsequent FDA determination letter, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria as would be found for a novel device requiring such proof for market clearance.

Here's a breakdown based on the provided text, highlighting what's missing in relation to your request:

Information not available in the provided text:

Acceptance Criteria Table and Reported Device Performance: This document does not specify quantitative acceptance criteria or report device performance against them. It states that "Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices," but no specific metrics or thresholds are provided.
Sample size and data provenance for test set: Not applicable as no specific test set (for performance evaluation against acceptance criteria) is described.
Number of experts and qualifications for ground truth: Not applicable.
Adjudication method for test set: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for training set was established: Not applicable.

Information that is available (though not directly answering your questions in the requested format):

The document indicates "PERFORMANCE DATA: Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices. Published clinical results for similar devices supported the safety and effectiveness of the device."

This suggests that the "acceptance criteria" were implied by meeting or exceeding the performance of the predicate devices in these specific mechanical tests, as per the ASTM F1717 standard. The "study" that proves this involves these mechanical tests. However, no specific numerical results are given.

The "ground truth" equivalent in this context for mechanical testing is adherence to the ASTM F1717 standard and comparison with known performance characteristics of predicate devices.

In summary, the provided document is a 510(k) submission for substantial equivalence based on materials, design, and mechanical testing against predicate devices, not a clinical trial report with specific acceptance criteria and detailed performance metrics.

Summary

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KI20291 Page 10f 2

APR 1 6 2012

	510(k) Summary
NAME OF FIRM:	OrthoPediatrics, Corp.2850 Frontier Drive.Warsaw, IN 46582
DATE PREPARED:	January 24, 2012
510(K) CONTACT:	Mark FoxVice President, Regulatory AffairsTel: (574) 268-6379
PROPOSED TRADE NAME:	OP Spine System
DEVICE CLASSIFICATION:	Class II; 21 CFR 888.3070 and 21 CFR 888.3050
CLASSIFICATION NAME:	Pedicle screw spinal system (bone screws, rods, and hooks);adolescent idiopathic scoliosis orthosis; spinal interlaminal fixationorthosis
PRODUCT CODE:	OSH; KWP
DEVICE DESCRIPTION:	The OP Spine System consists of longitudinal members (rods),anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of -sizes to accommodate differing anatomic requirements.
INDICATIONS FOR USE:	The OP Spine System is intended for posterior, non-cervicalfixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-- L5) in pediatric patients is indicated as an adjunct to fusion to treatadolescent idiopathic scoliosis. The device is intended to be usedwith autograft and/or allograft.
MATERIALS:	Medical grade titanium alloyMedical grade cobalt-chromium-molybdenum
PREDICATE DEVICES:	Medtronic CD Horizon (K091445)Synthes USS Spinal System (K994121, K082572)Biomet Synergy VLS (K011437, K081952)DePuy Spine Isola (K980485, K022285)U&I Optima (K051971, K031585, K024096)DePuy Spine Moss Miami (K030383, K022623, K011182, K982511)

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K120291. page 2 of 2

TECHNOLOGIC CHARACTERISTICS:

principles The fundamental scientific and technological characteristics, including the intended use, material, and general design, and sizes of the device are the same as, or similar to, the predicate devices.

PERFORMANCE DATA:

Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated that the device performs as well as or better than the predicate devices. Published clinical results for similar devices supported the safety and effectiveness of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of four stylized human figures facing to the right, with the figures overlapping each other.

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

June 27, 2013

OrthoPediatrics, Corp. % Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K120291

Trade/Device Name: OrthoPediatrics (OP) Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, KWP Dated: January 25, 2012 Received: January 31, 2012

Dear Mr. Fox:

This letter corrects our substantially equivalent letter of April 16, 2012.

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 - Mr. Mark Fox

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 yours,

Image /page/3/Picture/7 description: The image shows the name "Erin Keith" in a bold, sans-serif font. The letters "FLDK" in the middle of the name have a distressed, textured appearance, making them stand out from the rest of the text. The overall impression is a slightly stylized or artistic rendering of the name.

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 Statement

510(k) Number (if known): K120291

Device Name: OrthoPediatrics' (OP) Spine System

Indications for Use:

× Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use . Or

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K120291 510(k) Number.

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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.