The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 anterior approach.

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Device Description

STALIF TTTTT, MIDLINE™/ MIDLINE II-Ti™ are radiolucent intervertebral body fusion cages with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF devices are similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. The STALIF devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The MIDLINE II-Ti™ is identical to this design with a titanium plasma spray coating on the device endplates.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided documents (FDA 510(k) letter and 510(k) Summary) describe a medical device, the Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ intervertebral body fusion devices. Crucially, these documents are for a 510(k) submission, which means the device is being cleared based on substantial equivalence to a predicate device, not on meeting specific, pre-defined acceptance criteria through a de novo clinical trial demonstrating performance metrics.

Therefore, direct "acceptance criteria" in the sense of specific sensitivity, specificity, or similar performance thresholds, and a "study that proves the device meets the acceptance criteria" in that context, are not applicable to this type of FDA submission.

Instead, the "acceptance criteria" here are regulatory requirements for substantial equivalence, and the "study" is the comparison to predicate devices and supporting evidence to demonstrate that equivalence.

Here's a breakdown of the information that is available in the provided text, structured to address your questions as much as possible within the context of a 510(k):

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

As explained above, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) defined in the provided documents for this 510(k) submission. The "acceptance criteria" are the regulatory requirements for showing substantial equivalence.

Acceptance Criteria (Regulatory)	Reported Device Performance (Demonstration of Substantial Equivalence)
Equivalence in Indications for Use	The devices (STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™) have expanded indications to include use with allograft (allogenic bone graft). The core indications (DDD at L2-S1, up to Grade I Spondylolisthesis, 6 months non-operative treatment, etc.) are similar to predicate devices. The submission asserts that the expanded indication for allograft does not introduce additional risks and is supported by literature review and reimbursement data.
Equivalence in Design and Function	The subject devices are described as having similar design and function to the predicate devices. They are radiolucent intervertebral body fusion cages with unicortical cancellous bone screws, a central cavity for bone graft, and are intended for stand-alone use without supplementary fixation. The MIDLINE II-Ti™ is a variation with a titanium plasma spray coating. No design changes were made to the device itself for this submission, only an expanded indication for bone graft type.
Equivalence in Materials	The subject devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and Tantalum marker wires, which is stated to be similar to the predicate devices. The MIDLINE II-Ti™ incorporates a titanium plasma spray coating.
Safety and Efficacy (for expanded indications)	A comprehensive clinical literature review and "PearlDiver reimbursement" analysis were conducted to assess the safety and efficacy of allograft in conjunction with this device in the lumbar spine. This review concluded that there were no additional risks due to the modified indications. Biomechanical studies (previously conducted for predicate devices, as no design changes were made for this submission) were cited to demonstrate equivalence to interbody cages with supplemental fixation.
No New Mechanical Tests Required (due to no design changes)	No new mechanical tests were performed for this specific submission because there were no design changes to the device itself; the changes were related to the type of bone graft. (Presumably, previous mechanical testing for the predicate devices was sufficient).

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

Test Set Sample Size: Not applicable in the context of a traditional clinical trial with a "test set" for performance metrics. This 510(k) relies on a literature review and comparative analysis to predicate devices.
Data Provenance:
- Literature Review: The text mentions a "comprehensive, clinical literature review." The specific countries of origin or whether these studies were retrospective or prospective are not detailed in the provided document.
- PearlDiver Reimbursement: This refers to a healthcare claims database, which typically contains retrospective data (claims submitted after services are rendered) from the United States.

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)

Not applicable. There was no "test set" in the sense of patient data requiring expert ground truth labeling for algorithm performance. The evaluation was a regulatory assessment based on equivalence to predicate devices and a literature review.

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

Not applicable. As there was no test set for performance comparison, no adjudication method was used. The regulatory review process itself involves expert reviewers (FDA staff), but this is not a clinical "test set" 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 an intervertebral body fusion cage, not an AI or imaging diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant to this device's regulatory submission.

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

Not applicable. This is a surgical implant, not a software algorithm.

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

Not applicable directly to a "ground truth" for a performance study. However, the basis for the safety and efficacy assessment for the expanded indication of using allograft relied on:

Clinical Literature Review: Implies published studies where outcomes were determined by standard clinical endpoints, potentially including expert assessment, imaging, and patient-reported outcomes.
PearlDiver Reimbursement Data: Provides real-world evidence of healthcare utilization and potentially associated diagnoses/procedures.
Predicate Device Performance: The "ground truth" for the core device performance (structural integrity, fusion rates, etc.) would have been established through prior studies and regulatory clearances of the predicate devices.

8. The sample size for the training set

Not applicable. This is a medical device (implant), not an AI model that requires a training set.

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

Not applicable. As noted above, this device does not involve a training set.

Summary of the 510(k) Submission's Core Argument:

The 510(k) submission for Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ sought to expand the marketing indications to include the use of allograft (allogenic bone graft) in addition to autograft.

The core "study" proving "acceptance" (i.e., substantial equivalence) was a comparison to legally marketed predicate devices (K141942, K101301, K073109) and a literature review, supported by biomechanical studies (presumably conducted for previous submissions of the predicate devices or the current device under its prior indications).

The argument was that:

The device design and materials have not changed from the predicate, thus existing mechanical data applies.
The expanded use of allograft does not introduce new safety or effectiveness concerns compared to autograft in the context of this device, based on existing clinical literature and reimbursement data.
Therefore, the device with the expanded indication is substantially equivalent to the predicate devices.

Summary

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

June 8, 2015

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

Re: K150643

Trade/Device Name: Centinel Spine STALIF TT™, STALIF MIDLINE 9, MIDLINE II™ and MIDLINE II-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 11, 2015 Received: March 12, 2015

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

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Page 2 – Mr. Justin Eggleton

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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) K150643

Device Name

Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™

Indications for Use (Describe)

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

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)

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510(k) Summary

Device Trade Name:	Centinel Spine STALIF TTTM, STALIF MIDLINE®, MIDLINEIITM, and MIDLINE II-TiTM
Manufacturer:	Centinel Spine, Inc.900 Airport Road, Suite 3BWest Chester, PA 19380
Contact:	Mr. John ParryGroup Manager, Lumbar TechnologiesPhone: (484) 887.8813
Prepared by:	Mr. Justin EggletonMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800jeggleton@mcra.com
Date Prepared:	June 4, 2015
Classifications:	21 CFR §888.3080, Intervertebral Body Fusion Device.
Class:	II
Product Codes:	OVD
Primary Predicate Device:	K141942, (Centinel Spine MIDLINE IITM, and MIDLINE II-TiTM)
Additional PredicateDevices:	K101301, K073109 (Centinel Spine STALIF TTTM, STALIFMIDLINE®)

Indications For Use:

The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 anterior approach.

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The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIF TT™. STALIF MIDLINE@. MIDLINE III™. and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.

Device Description:

The purpose of the subject 510(k) was to expand the indications to include use with allograft (i.e., allogenic bone graft composed of cancellous and/or corticocancellous bone graft).

Predicate Device (Summary of Technological Characteristics):
The subject STALF TTT", STALIF MIDLINE®, MIDLINE III™ Interbody Fusion Device System is substantially equivalent to the predicate MIDLINE™MIDLINE II-Ti™ Interbody Fusion Device System (K141942), STALIF MIDLINE® (K101301) and STALIF TTM (K073109) with respect to indications, design, function, and materials.

Substantial Equivalence:

The subject and predicate STALIF TT™, STALIF MIDLINE®, MIDLINE III™, and MIDLINE II-Ti™ Device Systems are similar in design, material, and indicated use. A comprehensive, clinical literature review and PearlDiver reimbursement were conducted to assess the safety and efficacy of allograft used in conjunction with this device in the lumbar spine. This review concluded that there were no additional risks due to the modified indications for this device. Biomechanical studies were performed to demonstrate equivalence to interbody cages with supplemental fixation. No new mechanical tests were performed since there were no design changes to the device.

Conclusion:

The Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE III™, and MIDLINE II-Ti™ have been modified to expand the indications to permit use with allograft (i.e., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The 510(k) demonstrates substantial equivalence to predicate 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.