The STALIF X™ is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels: DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach.

The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

Device Description

The STALIF XTM is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used with supplemental fixation. The device is manufactured from PEEK Optima LT-1 or Zeniva ZA PEEK per ASTM F2026 and titanium alloy (Ti6Al4V) per ASTM F136.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called STALIF XTM. This submission focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and does not involve a study to evaluate AI algorithm performance or establish acceptance criteria related to such algorithms.

Therefore, most of the requested information regarding acceptance criteria for a device's performance (especially AI/software performance), sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from the given text.

The document is a regulatory submission for a physical intervertebral body fusion device and outlines its indications for use, device description, and mechanical performance testing against predicate devices.

Here's what can be extracted based on the provided text:

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

Acceptance Criteria Category	Specific Criteria (from predicate device standards)	Reported Device Performance (STALIF X™)
Mechanical Soundness	Static Compression (per ASTM F2077)	As mechanically sound as predicate devices (K073109, K101301, K112986, K121733, K103729)
	Static Compression-Shear (per ASTM F2077)	As mechanically sound as predicate devices
	Dynamic Compression (per ASTM F2077)	As mechanically sound as predicate devices
	Dynamic Torsion (per ASTM F2077)	As mechanically sound as predicate devices
	Dynamic Compression-Shear (per ASTM F2077)	As mechanically sound as predicate devices
	Expulsion (per ASTM F2267)	As mechanically sound as predicate devices
	Subsidence (per ASTM F-04.25.02.02)	As mechanically sound as predicate devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The text refers to "testing performed" but does not specify sample sizes for mechanical tests or data provenance.

3. 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)

This information is not applicable and not available. This is a submission for a physical medical device, not an AI or software device that requires expert ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not available.

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

This information is not applicable and not available. This is not an AI-assisted device.

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

This information is not applicable and not available. This is not an AI algorithm.

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

The "ground truth" for this device's performance demonstration is based on established mechanical testing standards (ASTM F2077, F2267, and F-04.25.02.02) and comparison to the performance of legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable and not available. This is not an AI/machine learning device that uses a training set.

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

This information is not applicable and not available.

Summary

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510(k) Summary

Contact:	Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Date Prepared:	August 23, 2013	AUG 2 8 2013
Device Trade Name:	STALIF XTM
Manufacturer:	Centinel Spine, Inc900 Airport Road, Suite 3BWest Chester, PA 19380
Classification:	21 CFR §888.3080, Intervertebral body fusion device
Class:	. II
Product Code:	. OVD

Indications For Use:

The STALIF X™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

Device Description:

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K130461

Predicate Device(s):

STALIF X™ was shown to be substantially equivalent to the previously cleared STALIF devices (K073109, K101301), Integra Vu aPOD-L (K112986), and Pinnacle Infill (K121733, K103729). The subject device has similar indications for use, design, function, and materials used.

Performance Standards:

. .

Testing performed indicate that the STALIF X™ is as mechanically sound as predicate devices. Testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077, F2267, and F-04.25.02.02.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a snake winding around it, representing health and medicine. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

August 28, 2013

Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K130461

Trade/Device Name: STALIF X TM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 30, 2013 Received: July 31, 2013

Dear Mr. Eggleton:

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

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Page 2 - Mr. Justin Eggleton

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportalProblem/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 yours,

Erin I. Keith

For

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): K130461

Device Name: STALIF XTM

The STALIF XTM is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to LS. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach.

The STALIF XTM is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.

The STALIF X™ system should be used with bone grafting material (autograft only).

Prescription Use > Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.