The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors.

The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Device Description

The Spinal Elements Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks, and transverse connectors. Screws are intended for attachment to the thoracic (T1-T3) spine only. All components of the system are manufactured from titanium alloy (Ti-6A1-4V conforming to ASTM F 136 or ISO 5832-3). The system achieves fixation by the mechanical joining of the rods, screws, hooks, and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Spinal Elements Posterior Cervical/Thoracic Spinal System:

The provided text describes a medical device, its intended use, and the performance testing conducted. However, it does not contain information about a study proving the device meets acceptance criteria in the context of human performance (e.g., accuracy of a diagnostic AI product) or clinical outcomes. Instead, the document focuses on mechanical performance testing for a spinal implant system to demonstrate its substantial equivalence to predicate devices.

Therefore, many of the requested categories (e.g., AI performance, expert ground truth, sample sizes for training/test sets, MRMC studies) are not applicable to the information provided.

Let's break down what is available in the input:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicit)	Reported Device Performance	Comments
Mechanical Performance	Ability to withstand static compression forces without failure.	All test results indicate the system will perform as intended.	Testing was performed according to ASTM F1717.
	Ability to withstand dynamic compression forces without failure.	All test results indicate the system will perform as intended.	Testing was performed according to ASTM F1717.
	Ability to withstand torsion forces without failure.	All test results indicate the system will perform as intended.	Testing was performed according to ASTM F1717.
Biocompatibility	Compatibility with biological tissue. (Implicit by use of ASTM F136 or ISO 5832-3 Ti-6Al-4V)	Device components are manufactured from titanium alloy (Ti-6A1-4V conforming to ASTM F 136 or ISO 5832-3).	The use of this specific titanium alloy is a standard for biocompatibility in implantable devices.

Important Note: The document states "All test results indicate the system will perform as intended." This is a general statement. Specific numerical thresholds for "acceptance" (e.g., "withstanding X N of force") and the actual measured results are not provided in this summary. The "acceptance criteria" here are implied by the nature of the mechanical tests (i.e., the device should not fail under the tested conditions as defined by ASTM F1717).

The following sections are largely not applicable or cannot be fully answered based on the provided text, as the study described is a mechanical bench test, not a clinical or AI performance study.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the mechanical tests. ASTM F1717 would define the number of samples required for each test type (static, dynamic, torsion).
Data Provenance: The tests are "non-clinical, mechanical testing," implying benchtop lab testing rather than human or animal data. The location of the testing is not specified, but it's presumed to be in a controlled laboratory environment. It is not retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Mechanical testing does not involve human experts establishing "ground truth" in the way a diagnostic AI study would. The "ground truth" is defined by the physical properties and performance requirements of the materials and design, tested against established standards (ASTM F1717).

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

Not Applicable. Adjudication methods are relevant for subjective assessments, typically in clinical or image-based studies where different human readers might interpret data differently. Mechanical tests have objective outcomes (e.g., fracture, deformation, yield strength).

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 a mechanical device, not an AI diagnostic tool.

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

Not Applicable. This is a mechanical device, not an AI algorithm.

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

The "ground truth" for this device's performance is its ability to meet the mechanical performance standards defined by ASTM F1717 for spinal implant constructs. This is a physical/engineering standard, not a biological or clinical one (like pathology or outcomes data).

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device; there is no training set.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Conclusion:

The K120467 document details the mechanical safety and performance of a spinal implant system through conformity to established ASTM standards. It does not involve AI, human reader studies, or complex ground truth establishment by medical experts for diagnostic accuracy. The "study" referenced is a series of in-vitro mechanical tests, and its "acceptance criteria" are implied by the successful performance of the device under these standardized conditions, demonstrating substantial equivalence to predicate devices.

Summary

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K120467 Page 1 of 2

Spinal Elements, Inc. Premarket Notification - Spinal Elements Posterior Cervical / Thoracic Spinal System

510(k) Summary Spinal Elements Posterior Cervical / Thoracic Spinal System

JUL 30 2012

510(k) Number: K120467

Manufacturer Identification Submitted by:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121 761-607-0125 (fax)

Contact Information:

Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA ·92010 760-607-1816 Bkimball@spinalelements.com

Date Prepared:

July 26, 2012

Device Indentification Proprietary Name

Spinal Elements Posterior Cervical / Thoracic Spinal System

Spinal Interlaminal Fixation and Spinal Intervetebral

Common Name

Device Classification

Classification Name

Fixation Orthosis and/or Pedicle Screw System 21 CFR 888.3050 and / or 21 CFR 888.3070

Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis. Pedicle screw spinal system

Class III Proposed Regulatory Class

Device Product Code:

MNI, KWP, NKB

Purpose of this 510(k)

This 510(k) seeks clearance for a new system.

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Device Description

Intended Use of the Device

The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Performance Data

Non-clinical, mechanical testing was performed in accordance with ASTM F1717 to determine the performance profile of the device. Testing included:

Static compression testing
Dynamic compression testing
Torsion testing

All test results indicate the system will perform as intended.

Substantial Equivalence

Spinal Elements Posterior Cervical/Thoracic Spinal System is substantially equivalent to Alphatec's Solanas Posterior Stabilization System (K052201 and K071380), Depuy Spine's Summit® Ocipito-Cervico-Thoracic (OCT) Spinal System (K002733 and K010681), and SeaSpine's Sierra System (K062934) in indications, general design features, performance, function, and materials.

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

JUL 30 2012

Spinal Elements, Incorporated % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K120467

Trade/Device Name: Spinal Elements Posterior Cervical/Thoracic Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: July 18, 2012 Received: July 19, 2012

Dear Mr. Kimball:

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.

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Page 2 - Mr. Benjamin A. Kimball

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.

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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· Indications for Use

510(k) K:120467

Spinal Elements Posterior Cervical / Thoracic Spinal System Device Name:

Indications for Use:

The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis: spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors

The use of polyaxial pedicle screws is limited to placement in T1-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

signature

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of 1

K120467 510(k) Number_

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.