The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Dorado ALIFT, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients mav 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. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Device Description

The SpineFrontier Lumbar IBF System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier Lumbar IBF System. This is a premarket submission and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics in the way a clinical trial for a new drug or novel medical device would.

Therefore, many of the requested sections about acceptance criteria and study details (like sample sizes, ground truth establishment for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission as the device is not an AI/ML-based diagnostic or prognostic device.

Here's an analysis of the provided information in relation to your questions:

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

Since this is a 510(k) submission for an intervertebral fusion device, the "acceptance criteria" are related to mechanical performance and demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/ML systems (e.g., sensitivity, specificity, AUC). The reported "performance" is that the device meets the criteria of established mechanical testing standards.

Acceptance Criteria (Demonstrates Substantial Equivalence via Mechanical Testing)	Reported Device Performance
Meet criteria defined in FDA Guidance Document: Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007	Met criteria defined in the guidance document.
Conform to ASTM F2077-03 standards (Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression)	Demonstrated compliance with ASTM F2077-03.
Conform to ASTM F2267-04 standards (Subsidence Under Static Axial Compression)	Demonstrated compliance with ASTM F2267-04.
Conform to ASTM Draft Standard F-04.25.02.02 (Static Expulsion)	Demonstrated compliance with ASTM Draft Standard F-04.25.02.02.
Comparison of indications for use, function, operating principles, and materials to predicate devices	Showed substantial equivalence to predicate devices in these characteristics.

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

Not applicable. This submission relies on mechanical testing against recognized standards, not a clinical test set of patient data. The "sample size" would refer to the number of devices tested mechanically, but specific numbers are not provided in this summary.

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. Ground truth in the context of diagnostic/prognostic AI is not relevant for this device. Mechanical integrity is assessed against engineering standards.

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

Not applicable. Adjudication methods are typically employed when there is human interpretation or classification involved, common in clinical studies or AI evaluations. This is a mechanical device.

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 not an AI system, so MRMC studies involving human readers and AI assistance are irrelevant.

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

Not applicable. This device is a physical intervertebral fusion system, not an algorithm.

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

Not applicable directly in the sense of clinical "ground truth." The "ground truth" for this device's evaluation is adherence to established mechanical performance standards as outlined in the ASTM documents and the FDA's guidance for intervertebral fusion devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this context means demonstrating substantial equivalence for 510(k) clearance) is a mechanical testing evaluation.

Study Design: The SpineFrontier Lumbar IBF System underwent mechanical testing to assess its performance.
Methodology: The device was evaluated in accordance with the "FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007." This guidance document defines the relevant performance criteria for such devices.
Specific Tests Conducted:
- ASTM F2077-03: Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04: Subsidence Under Static Axial Compression
- ASTM Draft Standard F-04.25.02.02: Static Expulsion
Results/Conclusion: The device was "found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing)." The submission explicitly states, "Clinical data was not required for this device."

In essence, the "study" was a series of engineering and materials tests designed to show that the proposed device performs mechanically at least as safely and effectively as legally marketed predicate devices, thereby establishing substantial equivalence as required for 510(k) clearance.

Summary

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SEP.

2 8 2011

5.0 510(k) Summary

1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

Primary Contact:	Hannah Foley
Telephone:	1- 978-232-3990

Mav 9, 2011 Date Prepared:

2. Device Name and Classification:

Proprietary Name:	SpineFrontier Lumbar IBF System
Common/Usual Name:	Intervertebral Fusion Device With Bone Graft,Lumbar
Classification Name:	Intervertebral Fusion Device With Bone Graft,Lumbar, (21 CFR 888.3080), Class II
Product Code:	MAX

3. Predicate Devices

This 510(k) submission provides notice of design changes being implemented to SpineFrontier's Dorado, Dorado Wide, and SLIF intervertebral body fusion devices and to create the SpineFrontier Lumbar IBF System. These modifications do not alter the fundamental technology of the predicate device or the devices' intended use.

K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide IBF K092815 - SpineFrontier Inc., S-LIF IBF K071724 - Spinal Elements, Lucent

4. Device Description

1. Intended Use

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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIF, Dorado ELIF, Dorado ALIF, Dorado TILT, Dorado TLIF, Dorado Wide, and Ursa S-LIF) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with 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 SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

6. Technological Characteristics

The SpineFrontier Lumbar Intervertebral Body Fusion Device System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.

7. Basis for Substantial Equivalence

The SpineFrontier Lumbar 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; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Clinical data was not required for this device. Mechanical testing includes performance assessments per the following recognized 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
ASTM Draft Standard F-04.25.02.02, Static Expulsion -

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、 ! . : . . Document Control Room - WOnb-Group Silver Spaing MHz 20093-000)2

SpineFrontier, Inc. % Ms. Hannah Foley Manager of OA and Regulatory Compliance 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

SEP 2 8 2011

Re: K111553

Trade/Device Name: Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 07. 2011 Received: September 09, 2011

Dear Ms. Foley:

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 -- Ms. Framman Polev

comply with all the Act s requirements, including, bat 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 vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Abouti-DA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarker 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/Indusury/default.htm.

Sincerely yours.

Ernst Keith

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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510(k) Number (if Known):

SpineFrontier Lumber Interbody Fusion Device System Device Name:

Indications For Use:

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Prescription Use: X

Over-The-Counter Use: (Part 21 CFR 807.109)

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

'LE W'H U: THU TA ® TRA TP 에 대 유 파 파 파 파 파 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 Concurrence of CDRH, Office of Device Evaluation (ODE)

Director Sign-Off

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

KIII 553 510(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.