Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add Mesa Hooks to the system.

Materials: The proposed devices are manufactured from Titanium Alloy per ASTM F136 and ASTM F1472.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

Purpose of Submission: To add Mesa Hooks.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Range/Mesa/Denali Spinal System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving 'acceptance criteria' in the rigorous, quantitative sense of a new, novel AI-powered device or a drug.

For a medical device like a spinal fixation system, the "acceptance criteria" are primarily related to biocompatibility, mechanical performance, and substantial equivalence to existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to the pre-clinical mechanical testing and the comparison to predicate devices, rather than clinical trials or AI-specific performance metrics.

Therefore, many of the requested points are not applicable to this type of regulatory submission and device. I will address the relevant points based on the provided document and note where information is not present or not applicable.

Acceptance Criteria and Study Proving Device Meets Criteria

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device performance and ASTM standards)	Reported Device Performance
Material Biocompatibility	Manufactured from materials with established biocompatibility for implant use.	Manufactured from Titanium Alloy per ASTM F136 and ASTM F1472.
Mechanical Performance	- Static compression strength	Constructs representing worst-case components were tested in static compression and dynamic compression bending in accordance with ASTM F1717.
	- Dynamic compression bending endurance	Determined to be substantially equivalent to predicate devices.
Design & Function	- Similar design features and sizing to predicate devices.	The Range Spinal System was found to be substantially the same as predicate systems in design features and sizing.
Intended Use	- Indications for use consistent with predicate devices and established clinical practice.	Indications for use listed are consistent with those of the predicate devices.

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

Sample Size: The document states "Constructs representing the worst case components were tested." It does not specify the exact number of samples tested for static and dynamic compression bending.
Data Provenance: The testing was conducted in accordance with ASTM F1717, which are recognized standards for mechanical testing of spinal implant constructs. The location of the testing is not specified, but it would typically be a lab qualified to perform such tests on medical devices. The data is prospective, generated specifically for this submission.

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

This is not applicable to a submission for a mechanical spinal fixation system. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., ASTM F1717) and the performance of predicate devices. Expert consensus in the traditional sense of clinical interpretation (like image reading) is not part of this evaluation.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to mechanical testing results, which are objectively measured against defined standards, not subject to human interpretation requiring adjudication.

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 device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are related to clinical interpretation and AI assistance, which is irrelevant for this product.

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

Not applicable. This device is a mechanical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by:

Engineering Standards: Adherence to recognized ASTM standards (F136, F1472 for materials; F1717 for mechanical testing).
Performance of Legally Marketed Predicate Devices: The key "ground truth" for substantial equivalence is that the new device performs at least as well as, and has similar characteristics to, devices already cleared for market (K2M Range/Mesa/Denali Spinal System (K052398, K042635 K070229, K121630, K140529), Medtronic CD Horizon (K091445)).

8. The sample size for the training set

Not applicable. This device is a mechanical implant, not an AI model requiring a training set.

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

Not applicable. As above, there is no "training set" for this type of device.

Summary

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JUL 1 0 2014

510(k) Summary for the RangeMesa/Denali Spinal System: Mesa Hooks

This 510(k) summary for the Range/Mesa/Denali Spinal System is provided as required per 21 CFR 807.92

1. Submitter :

K2M, Inc. 751 Miller Drive SE, Leesburg, VA 20175 Contact Person : Nancy Giezen K2M. Inc. Telephone: 703-777-3155

Date Prepared: 07/09/2014

2. Tradename:	Range/Mesa/Denali Spinal System
Common Name:	Spinal Fixation System
Regulatory Class:	Class II, Class III (NKB)
Pedicle Screw Spinal System	(21 CFR 888.3070)	(NKB, OSH, MNH, MNI)
Spinal Intervertebral body fixation Orthosis	(21 CFR 888.3060)	(KWQ)
Spinal Interlaminal fixation Orthosis	(21 CFR 888.3050)	(KWP)

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

K2M Range/Mesa/Denali Spinal System (K052398. K042635 K070229, K121630, K140529) .
Medtronic CD Horizon (K091445) .

4. Description of the device:

Materials: The proposed devices are manufactured from Titanium Alloy per ASTM F136 and ASTM F1472.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

Purpose of Submission: To add Mesa Hooks.

5. Intended Use:

RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:

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spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

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

The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.

7. Comparison of the performance data of the device to predicate and legally marketed devices :

Constructs representing the worst case components were tested in static compression and dynamic compression bending in accordance with ASTM F1717 and were determined to be substantially equivalent to predicate devices.

8. Conclusion:

There are no significant differences between the proposed implants and other devices 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.

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

July 10, 2014

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

Re: K140765

Trade/Device Name: Range/Mesa/Denali Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH. KWP, KWQ Dated: June 9. 2014 Received: June 10, 2014

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 requirements for annual registration. Iisting 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 vou, however, that device labeling must be truthful and not misleading.

If your device is classified (sec 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 is 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

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Page 2 - Ms. Nancy Giezen

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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Biometries/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.

Ronald P. Jean -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140765

Device Name Range/Mesa/Denali Spinal System

Indications for Use (Describe)

RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical fixation as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondviolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Division of Orthopedic Devices

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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.