The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Device Description

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Titanium Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

AI/ML Overview

The provided text is a 510(k) premarket notification decision letter from the FDA for the Altus Spine Titanium Interbody Fusion System. It states that the device is substantially equivalent to legally marketed predicate devices.

The document discusses the mechanical properties and design equivalency, but it does not describe any clinical study or provide acceptance criteria related to device performance in a clinical setting (such as accuracy, sensitivity, specificity, etc.) for an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving device performance in the context of an AI/ML device, as this document pertains to a medical device for spinal fusion that does not appear to involve AI/ML.

Here's why some of the requested points are not applicable to the provided document:

A table of acceptance criteria and the reported device performance: This document focuses on demonstrating substantial equivalence based on material and design, not clinical performance metrics for an AI/ML system.
Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document states that "Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates." This refers to mechanical integrity and design equivalence, not AI/ML performance.

Summary

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Public Health Service

March 10, 2017

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

Altus Partners, LLC Claudia Hill, MSME, RAC RAOA Lead 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K170512

Trade/Device Name: Altus Spine Titanium Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 1, 2017 Received: March 2, 2017

Dear Ms. Hill:

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 Part 801); medical device reporting (reporting of medical device-

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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 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/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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170512 Page 1 of 1

Device Name

Altus Spine Titanium Interbody Fusion System

Indications for Use (Describe)

The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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8. 510(k) Summary

SUBMITTER:	Altus Partners1340 Enterprise DriveWest Chester, PA 19380Phone: 610-355-4156Fax: 610-300-3049
CONTACT PERSON:	Claudia Hill, MSME, RACRA&QAchill@altus-spine.com
DATE PREPARED:	February 17, 2017
COMMON NAME:	Interbody Fusion Device
PROPRIETARY NAME:	Altus Spine Titanium Interbody Fusion System
PRIMARY PREDICATE DEVICES:	Altus Spine Interbody Fusion System (K160976)
ADDITIONAL PREDICATE DEVICES:	Life Spine Plateau Spacer System Titanium (K130630)
CLASSIFICATION NAME:	21 CFR §888.3080 Intervertebral Body Fusion Device
PRODUCT CODES:	MAX
DEVICE CLASS:	Class II
MATERIAL:	Titanium Alloy that conforms to ASTM F136

DEVICE DESCRIPTION:

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

INDICATIONS FOR USE:

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The Altus Spine Titanium Interbody Fusion System and the predicate (K160976) share the same indications for use and same implant design. The purpose of this Special 510(k) submission is to include titanium alloy intervertebral body fusion device into the Altus Spine Interbody Fusion System family, which is currently offered in polyetheretherketone (PEEK). The design is essentially the same fundamental technology with minor dimensional changes.

SUMMARY OF NON-CLINAL TESTS SUBMITTED:

Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Titanium Interbody Fusion System is the predicate (K160976) in regards to indications for use and surgical technique.

Altus Spine has determined that the modification of the Altus Spine Titanium Interbody Fusion System do not alter the system function, strength and stability. Therefore, the Altus Spine Titanium Interbody Fusion System is substantially equivalent to the predicate devices, and raises no new questions of safety or effectiveness.

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.