The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scolosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.

Device Description

The Range Spinal System is a top-loading, multiple component, spinal fixation system which consists of pedicle screws, rods, hooks, connectors, staples and washers. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

AI/ML Overview

The provided document is a 510(k) summary for the Range Spinal System, Staples and Washers. This type of document is for a medical device seeking clearance from the FDA, and it focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through mechanical testing and comparison of design features and materials. It does not typically involve clinical studies with human participants or AI performance evaluation that would require the detailed acceptance criteria and study information you've requested.

Therefore, many of your requested points are not applicable to the content of this document. I will fill in what information is available and indicate where information is not present in the provided text.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the Range Spinal System primarily relies on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex algorithm performance evaluations. The key acceptance criteria are related to the mechanical performance and design characteristics of the device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static Torsion Strength - Dynamic Compression Strength	The Range Spinal System performed equal to or better than predicate systems and other currently marketed systems in static torsion and dynamic compression in accordance with ASTM F1717.
Design Features and Sizing: - Substantial similarity to predicate devices	The design features and sizing of the components were compared and the Range Spinal System was found to be substantially the same as predicate systems.
Material: - Use of appropriate, biocompatible materials consistent with predicate devices	The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards, which is the same material as other marketed systems.
Intended Use: - Consistent indications for use with predicate devices	The Range Spinal System is indicated for the same intended uses as predicate systems (e.g., as an adjunct to fusion for indications like trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion, and severe spondylolisthesis in L5-S1).
Overall Substantial Equivalence: - No significant differences adversely affecting product use	"There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." (Page 2 of 510(k) Summary)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of device samples (screws, rods, hooks, connectors, staples, washers) tested for static torsion and dynamic compression. However, mechanical testing typically involves a sufficient number of samples to generate statistically meaningful data according to the relevant ASTM standards.
- Data Provenance: The data is from mechanical testing, not human patient data. No country of origin for the testing itself is specified, but the submitter (K2M, Inc.) is based in Leesburg, VA, USA. The testing would be prospective in the sense that the device was specifically manufactured and tested for this submission.
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. This submission relies on mechanical testing against established ASTM standards, not a ground truth established by medical experts for diagnostic or clinical performance. The "ground truth" here is the performance required by the ASTM F1717 standard and comparison to predicate device performance benchmarks.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in clinical or image-based studies. Mechanical testing results are objective measurements.
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 traditional medical device (spinal fixation system) submission, not an AI software/device. No MRMC study was performed, and thus no effect size related to AI assistance is provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is defined by ASTM F1717 standards for static torsion and dynamic compression, and the established performance and design characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's mechanical properties and design are equivalent or superior within the context of these standards and predicate devices.
The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical medical device being evaluated through mechanical testing for substantial equivalence, not an AI or machine learning model.
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 to the provided document.

Summary

{0}------------------------------------------------

1</06851

510(k) Summary for the

Range Spinal System, Staples and Washers

This safety and effectiveness summary for the Range Spinal System is provided as required per Scetion 513(i)(3) of the Food, Drug and Cosmetic Act.

Submitter :

K2M, Inc. 751 Miller Drive SE, Suite F 1 Leesburg, VA 20175

Date Prepared: July 08, 2010

Contact Person : Nancy Giezen Manager Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155

2. Tradename: Range Spinal System Common Name: Spinal Fixation System Classification Name: Spinal Intervertebral Body Fixation Orthosis ( 21 CFR 888.3060 )

3. Predicate or legally marketed devices which are substantially equivalent :

. Range Spine System ( K2M, Inc. )
. Kaneda (DePuy Acromed)
Revere (Globus Medical )
Blackstone (Blackstone Medical) .

4. Description of the device :

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

5. Intended Use:

The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :

The Range Spinal System was mechanically tested and compared to the predicate systems and other currently marketed systems. The Range Spinal System performed equal to or better than these systems in static torsion and dynamic compression in accordance with ASTM F1717. The design features and sizing of the components were also compared and the Range Spinal System was found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.

Page 1 of 2

{1}------------------------------------------------

There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, finction, material and intended use.

、

100 - 100 -

Page 2 of 2

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Public Health Service

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

K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

AUG 02 2010

Re: K100851

Trade/Device Name: Range Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWQ Dated: July 08, 2010 Received: July 12, 2010

Dear Ms. Giezen:

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 reguirements 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

{3}------------------------------------------------

Page 2 - Ms. Nancy Giezen

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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark A. Milliken

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Range Spinal System

AUG 02 2010

Indications for Use:

The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARJ Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fosion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion.

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)

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

K100851 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.