The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

Device Description

The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.

AI/ML Overview

This document is a 510(k) premarket notification for the ALTA Cervical Interbody Spacer. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and efficacy through clinical trials. Therefore, the information typically requested about acceptance criteria and detailed study designs for AI/medical imaging devices is not present here.

Specifically for your questions:

A table of acceptance criteria and the reported device performance
- This document does not contain quantitative acceptance criteria and reported performance metrics in the way one would see for an AI/imaging device. The device's "performance" is demonstrated through non-clinical mechanical testing, showing equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical "test set" data in the context of an AI/imaging device is provided. The non-clinical tests (static/dynamic compression, torsion, subsidence, expulsion) involve mechanical samples of the device itself.
- The document explicitly states: "No clinical studies were performed."
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. There is no clinical test set requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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 medical implant, not an AI/imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical implant, not an AI/imaging diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is based on established ASTM standards for mechanical properties (e.g., F2077 for compression and torsion, F2267 for subsidence). The device's performance is compared against these standards or against the performance of predicate devices as per those standards.
The sample size for the training set
- Not applicable. There is no AI model or "training set."
How the ground truth for the training set was established
- Not applicable. There is no AI model or "training set."

Summary of Device Performance (from the provided text, related to non-clinical testing):

Non-clinical Test Performed	Reported Device Performance
Static and dynamic compression per ASTM F2077	Results indicate equivalence to predicate devices.
Static and dynamic torsion per ASTM F2077	Results indicate equivalence to predicate devices.
Subsidence per ASTM F2267	Results indicate equivalence to predicate devices.
Expulsion testing per ASTM F04.25.02.02	Results indicate equivalence to predicate devices.

Conclusion: The provided document describes a 510(k) submission for a cervical interbody spacer. The device received clearance based on demonstrating "substantial equivalence" to existing predicate devices, primarily through non-clinical mechanical testing and comparison of design, materials, and intended use. No clinical studies were performed, and thus, no data regarding acceptance criteria, test set, training set, expert consensus, or AI performance metrics are included.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.

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

May 13, 2016

Astura Medical % Mr. J.D. Webb President The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K160154

Trade/Device Name: ALTA Cervical Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 25, 2016 Received: March 29, 2016

Dear Mr. Webb:

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160154

Device Name

ALTA Cervical Interbody Spacer

Indications for Use (Describe)

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

X | 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)

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510(k) Summary: ALTA Cervical Interbody Spacer

Date Prepared	March 25, 2016
Submitted By	Astura Medical, LLC5670 El Camino Real, Suite BCarlsbad, CA 92008760-814-8047 Tele
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-mail: jdwebb@orthomedix.net
Trade Name	ALTA Cervical Interbody Spacer
Common Name	intervertebral body fusion device
Classification Name	Intervertebral body fusion device - cervical
Class	II
Product Code	ODP
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary PredicateDevice	Spinal Elements, Crystal Cervical Cage (K073351)
Additional PredicateDevices	Titan, Endoskeleton® TC (K100889)Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)LDR Spine Cervical Interbody Fusion System (K091088)Titan Spine Endoskeleton TC (K100889)
Device Description	The ALTA Cervical Interbody Spacer was developed as implants for thestabilization of the cervical column. The devices have trapezoidal footprints andmultiple sizes to accommodate patient anatomy. This device is offered in twomaterial choices: PEEK and titanium.The PEEK implants have unidirectional teeth on both of their inferior and superiorsurfaces to prevent migration/expulsion, and graft windows which help facilitatebony integration. X-ray markers are integrated for visualization of the implants during and after surgery.The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.
Materials	Vestakeep® i4R PEEK conforming to ASTM F2026Unalloyed tantalum conforming to ASTM F560Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136
SubstantialEquivalence Claimedto Predicate Devices	The ALTA Cervical Interbody Spacer is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances.
Indications for Use	The ALTA Cervical Interbody Spacer is indicated for intervertebral bodyfusion procedures in skeletally mature patients with degenerative discdisease (DDD) of the cervical spine at disc levels (C2-T1). Cervicaldegenerative disc disease is defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies.This device is intended for use with supplemental internal fixation systemsand autogenous bone graft implanted via an open, anterior approach.Patients should have at least six weeks of non-operative treatment priorto treatment with intervertebral cages.
Non-clinical TestSummary	The following analyses were conducted:Static and dynamic compression per ASTM F2077Static and dynamic torsion per ASTM F2077Subsidence per ASTM F2267Expulsion testing per ASTM F04.25.02.02The results of these evaluations indicate that the ALTA Cervical Interbody Spaceris equivalent to predicate devices.
Clinical Test Summary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Astura Medical, LLC considers the ALTA Cervical Interbody Spacer to beequivalent to the predicate devices listed above. This conclusion is basedupon the devices' similarities in principles of operation, technology,materials, and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.