The SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (at angles > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

Device Description

The subject of this 510(k) submission is the Sahara Stabilization System. The implants function as an expandable intervertebral body fusion devices to provide support and stabilization to the lumbar segments of the spine. The implants are manufactured from Titanium (ASTM F1472, F67) and Cobalt Chrome (ASTM F1537).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the SAHARA Stabilization System. It primarily outlines the device's substantial equivalence to previously cleared predicate devices. The information provided is typical for regulatory submissions and does not detail a clinical study of the type that would typically generate acceptance criteria and performance data for an AI/ML powered device.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This document does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) nor does it report such performance data. It focuses on mechanical testing.
Sample size used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is described.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML powered diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implanted medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

What can be extracted/inferred from the document:

Device Name: SAHARA Stabilization System
Device Type: Intervertebral body fusion device
Regulatory Class: Class II
Predicate Devices: K2M Chesapeake (K092211, K120031, 142487), K2M Santorini (K111294), Globus Rise (K113447), Wenzel Spine Vari-Lift-L (K100820). The primary predicate is K2M Chesapeake (K092211).
Non-clinical Performance Evaluation: Mechanical testing (static compression, static torsion, static compression shear, dynamic compression, expulsion, and subsidence) and a cadaver implantation study were performed. The conclusion was that the proposed implants were substantially equivalent to predicate devices in design, function, intended use, materials, and size based on these tests. These tests would have acceptance criteria related to biomechanical properties, but they are not detailed in this summary.
Ground Truth for Mechanical Testing: The "ground truth" for mechanical testing would be the engineering specifications and performance expectations established for spinal implants, often based on industry standards (e.g., ASTM standards for titanium and cobalt chrome) and comparisons to the predicate devices.
Training Set for Mechanical Testing: Not explicitly stated as a "training set," but the design and materials used would be based on established engineering principles and data from previous successful spinal implants (including the predicate devices).

In summary, this document is for a traditional medical device (spinal implant) and does not contain the type of AI/ML-specific performance evaluation and acceptance criteria requested in the prompt.

Summary

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

December 21, 2015

K2M, Incorporated Ms. Nancv Giezen Manager Regulatory Affairs 751 Miller Drive, Southeast Leesburg, Virginia 20175

Re: K151481

Trade/Device Name: SAHARA Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 16, 2015 Received: November 17, 2015

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, 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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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,

Mark N. Melkerson -S

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

510(k) Number (if known) K151481

Device Name Sahara Stabilization System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Sahara Stabilization System K2M, Inc.

Submitter

K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 12/16/2015

Classification

Trade Name:	Sahara Stabilization System
Common Name:	Spinal Fixation System
Regulatory Class:	Class II

Classification Name(s): Intervertebral Body Fusion Device with Integrated Fusion (21 CFR 888.3080, Product Code OVD)

Predicate Device(s)

Primary Predicate: K2M Chesapeake (K092211) Additional Predicates: K2M Chesapeake (K120031, 142487) K2M Santorini (K111294) Globus Rise (K113447) Wenzel Spine Vari-Lift-L (K100820)

Device Description

Indications for Use

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Technological Comparison to Predicate(s)

The Sahara Stabilization System was compared to predicate systems and were found to be substantially the same as these systems.

Non-clinical Performance Evaluation

Mechanical testing (including static compression, static torsion, static compression shear, dynamic compression, dynamic compression, expulsion, and subsidence) and a cadaver implantation study was performed in support of this submission and the proposed implants were determined to be substantially equivalent to predicate devices in design, function, intended use, materials, and size.

Conclusion

It is substantially equivalent to these other devices in design, function, material and intended use.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.