The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).

The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.

Device Description

The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.

AI/ML Overview

This is a 510(k) summary for a spinal intervertebral body fusion device, not an AI/ML device. Therefore, the requested information regarding AI/ML acceptance criteria, study details, and expert evaluation is not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, operating principles, materials, and mechanical testing, rather than performance against specific AI/ML metrics.

Here's a breakdown of the relevant information provided, adapted to the context of a medical device submission:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices and meeting established mechanical testing standards. The "device performance" in this context refers to its mechanical properties.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance/Conclusion
Substantial Equivalence	Comparison of Intended Use	Shares same intended use as predicates
	Comparison of Technological Characteristics	Shares same characteristics as predicates
	Comparison of Operating Principles	Shares same operating principles as predicates
	Comparison of Materials	Shares same materials (Solvay Zeniva ZA-500 PEEK) as predicates
Mechanical Testing	ASTM F2077-03 (Static and Dynamic Axial Compression, Static Torsion, Static and Dynamic Shear Compression)	Demonstrated substantially equivalent performance
	ASTM F2267-04 (Subsidence Under Static Axial Compression)	Demonstrated substantially equivalent performance
	ASTM Draft Standard F-04.25.02.02 (Static Expulsion)	Demonstrated substantially equivalent performance
	ASTM F1877 (Wear Debris Characterization)	Demonstrated substantially equivalent performance
Regulatory Guidance	FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007	Found to meet criteria defined in the guidance document

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of mechanical testing. Mechanical tests typically involve a defined number of device units or test articles run according to the specific ASTM standard. The document does not specify the exact number of units tested for each standard, but it refers to the standard methods which dictate such details.
Data Provenance: Not applicable in the context of mechanical testing. The data provenance would be from the laboratory conducting the ASTM standard tests.
Retrospective/Prospective: Not applicable. These terms relate to clinical study design, which was not required for this device type.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. "Ground truth" in this context refers to the outcome of mechanical testing against established standards, not expert labels of clinical data. The standards themselves (e.g., ASTM F2077-03) define the "truth" for performance.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions on clinical data. For mechanical testing, the results are quantitative measurements against defined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is specifically for evaluating the impact of an AI system on human reader performance. This submission is for a physical medical device (spinal implant), not an AI/ML diagnostic or assistive tool. Clinical data, including MRMC studies, was explicitly "not required for this device."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No. This concept applies to AI algorithms. This device is a physical implant.

7. Type of Ground Truth Used:

Mechanical Test Standards and Predicate Device Performance: The "ground truth" for this submission is established through adherence to recognized ASTM mechanical testing standards and by demonstrating comparable performance to legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of a physical medical device. This term is specific to AI/ML model development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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K111512

510(k) Summary

OCT 2 6 2011

Submitted By

Thompson MIS 45 Stiles Rd, Suite 210 Salem, NH 03079

Contact:	Frank Sullivan
Telephone:	603-912-5306
Date Prepared:	October 4, 2011

Device Name and Classification:

Common Name: Intervertebral Fusion Device with Bone Graft, Lumbar

Proprietary Name: BoneBac™ T-PLIF Intervertebral Body Fusion Device System

Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar

Requlation and Classification: 21 CFR 888.3080, Class II

Product Code: MAX

Predicate Devices

K100042 - DiFusion Technologies XIPHOS IBF System K071724 - Spinal Elements Lucent K072791 - Synthes Opal K071795 - Nuvasive Coroent K080537 - Kiscomedica L-Varlock

Device Description

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Intended Use

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.

Technological Characteristics

The BoneBac™ T-PLIF Intervertebral Body Fusion Device System was shown to share the same technological characteristics with predicate devices through comparison of indications for use, function, operating principles, and materials.

Basis for Substantial Equivalence

The BoneBac™ T-PLIF Intervertebral Body Fusion Device System was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document. The system shares the same intended use, technological characteristics, operating principles, and materials with predicate devices. Mechanical testing demonstrates substantially equivalent performance. Clinical data was not required for this device. Mechanical test comparisons were conducted per the following standard test methods:

ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
ASTM F2267-04, Subsidence Under Static Axial Compression ﺘ
ASTM Draft Standard F-04.25.02.02, Static Expulsion -
ASTM F1877 Wear Debris Characterization -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three flowing lines representing the department's services.

Public Health Service

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

OCT 2 6 2011

Thompson MIS, Inc. % Mr. Frank Sullivan 45 Stiles Road, Suite 210 Salem, New Hampshire 03079

Re: K111512

Trade/Device Name: BoneBac" T-PLIF Intervertebral Body Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 04, 2011 Received: October 05, 2011

Dear Mr. Sullivan:

な

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

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Page 2 -- Mr. Frank Sullivan

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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000014

4.0	Indications for Use Statement
------------	--------------------------------------

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Indications For Use:

The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative tor doo in othershy maxine ended for the treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K 111512 510(k) Number_

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.