The S-LIF™ Intervertebral Body Fusion Device is a spinal intervertebral body fusion device 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 S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

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.

Device Description

The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of body fusion donoo intents, using autogenous bone graft to facilitate fusion. Skeletally mature pationto, asing autogenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. The system is (DDD) at one of two of two of PEEK Optima®, with a fixed width and various comprised of dovious fiace of a vide of a wide variety of patients. lengins and heights to in the analoms on the superior and inferior surfaces that will resist device movement following implant

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the S-LIF™ Intervertebral Body Fusion Device:

Interpretation of the Provided Text:

The provided document is a 510(k) summary for a medical device. For such devices, particularly Class II, the "acceptance criteria" and "study" typically refer to the demonstration of substantial equivalence to a previously legally marketed device (predicate device), rather than a clinical trial demonstrating efficacy against a specific performance metric in a clinical context. The "studies" are primarily non-clinical bench testing to show that the new device performs comparably to the predicate and meets relevant engineering standards. This is a crucial distinction.

Therefore, the table will reflect the comparison against predicate devices and the type of testing performed, not clinical performance metrics in the way one might expect for a diagnostic AI device.

Acceptance Criteria and Device Performance for S-LIF™ Intervertebral Body Fusion Device

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Predicate Device Compliance/Performance (Baseline)	S-LIF™ Device Performance (Test Results)	Determination of Meeting Criteria
Indications for Use	Substantially Equivalent	K072289, K071795, K072791 (for DDD L2-S1, Grade I spondylolisthesis/retrolithesis, autogenous bone graft, supplemental fixation)	Matches predicate indications for use.	Met (Claimed substantially equivalent)
Function	Substantially Equivalent	K072289, K071795, K072791	Matches predicate operating principles.	Met (Claimed substantially equivalent)
Operating Principles	Substantially Equivalent	K072289, K071795, K072791	Matches predicate operating principles.	Met (Claimed substantially equivalent)
Materials	Substantially Equivalent	K072289, K071795, K072791 (PEEK Optima®)	PEEK Optima®	Met (Claimed substantially equivalent)
Mechanical Performance	ASTM F2077-03	Benchmarks/performance of predicate devices	Tested per standard	Met (Demonstrated substantial equivalence via testing)
Mechanical Performance	ASTM F2267-04	Benchmarks/performance of predicate devices	Tested per standard	Met (Demonstrated substantial equivalence via testing)
Mechanical Performance	ASTM Draft Standard F-04.25.02.02	Benchmarks/performance of predicate devices	Tested per standard	Met (Demonstrated substantial equivalence via testing)
FDA Guidance Document	Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007	Met by predicate and current standards	Found to meet criteria defined in the guidance document	Met

2. Sample Size for the Test Set and Data Provenance

Sample Size (Test Set): Not applicable in the context of clinical data. For the mechanical tests, the sample size would refer to the number of devices or test articles subjected to each standard. This information is not provided in the summary.
Data Provenance: The "data" in this context refers to the results of non-clinical mechanical testing. The origin would be the testing laboratory. This specific information (country, retrospective/prospective) is not provided as it's not a clinical study.

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

This question is not applicable to this type of device submission. There was no "ground truth" to be established by clinical experts in the context of this 510(k) summary, as it relied on non-clinical comparative testing and existing FDA guidance.

4. Adjudication Method for the Test Set

This question is not applicable as there was no clinical test set requiring expert adjudication. The "adjudication" was effectively by the comparison of test results to established engineering standards and predicate device performance.

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

No, an MRMC comparative effectiveness study was not done. This type of study (evaluating human reader performance with/without AI assistance) is characteristic of AI/CADe devices, not an intervertebral body fusion device.
"Clinical data was not required for this device."

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on:
- Engineering Standards: Established benchmarks and methodologies outlined in standards like ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02.
- Predicate Device Performance: The established performance and safety profiles of the legally marketed predicate devices (K072289, K071795, K072791).
- FDA Guidance: Compliance with the "Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007."

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set."

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

This question is not applicable as there was no training set for an AI/ML algorithm.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria was a non-clinical substantial equivalence comparison. This involved:

Documentation Review: Comparison of the S-LIF™ device's indications for use, function, operating principles, and materials (PEEK Optima®) to those of three predicate devices (SpineFrontier Inc., Dorado Intervertebral Body Cage K072289; Nuvasive CoRoent System K071795; Synthes Spine Oracle Spacer K072791). The conclusion was that these characteristics were "substantially equivalent."
Mechanical Bench Testing: The S-LIF™ Intervertebral Body Fusion Device underwent mechanical testing according to recognized ASTM standards:
- 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)

The overall conclusion was that the device met the criteria defined in the FDA's guidance document for intervertebral fusion devices and was "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."

Summary

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JUN 3 0 2010

, l

510(k) Summary 5.0

1. Sponsor

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

Primary Contact:	John Sullivan
Telephone:	1- 978-232-3990

May 29, 2009 Date Prepared:

2. Device Name and Classification:

Proprietary Name:	S-LIF™ Intervertebral Body Fusion Device,S-LIF™ IBC, S-LIF™ IBF
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

K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K071795 - Nuvasive CoRoent System K072791 - Synthes Spine Oracle Spacer

4. Device Description

SpineFrontier, Inc. S-LIF' Intervertebral Body Fusion Device - Abbreviated 510(k) June 28, 2010

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5. Intended Use

The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device 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 S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

6. Technological Characteristics

The SpineFrontier S-LIF™ Intervertebral Body Fusion Device 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 S-LIF™ Intervertebral Body Fusion Device 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). Inunical 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 -
ASTM Draft Standard F-04.25.02.02, Static Expulsion -

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

JUN 3 0 2010

SpineFrontier, Inc. % Mr. John Sullivan 500 Cummings Center Beverly, Massachusetts 01915

Re: K092815

Trade/Device Name: S-LIF™ Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 21, 2010 Received: June 21, 2010

Dear Mr. Sullivan:

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. John 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/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 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

sincerely yours,

Mark A. Milkeron

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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Indications for Use Statement 4.0

510(k) Number (if Known):

Indications For Use:

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

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

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

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092815

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.