The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Device Description

The SHARK implant (PLIF) consists of rectangular blocks with a tapered nose. The BULLSHARK implant (PLIF) is rectangular in shape with a conical nose. Both devices have parallel configurations of various heights.

The TIGER implant (TLIF) consists of banana shaped blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft and facilitate fusion.

The GREAT WHITE implants (ALIF) are oval shaped blocks, which are available in a two lordotic configurations (7° and 13°) of various heights. The hollow cylinders allow for placement of bone graft and facilitate fusion.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

AI/ML Overview

The provided text is a 510(k) summary for the "Spine 360 Interbody Fusion System," which is a medical device. This document focuses on demonstrating substantial equivalence to previously approved devices, not on proving that the device meets specific performance criteria through clinical studies or extensive testing that would generate acceptance criteria and reported performance in the way an AI/software device would.

Therefore, many of the requested elements for an AI or software device (like sample size for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, etc.) are not applicable to this type of device submission.

However, I can extract the information that is relevant to the provided document:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The core "acceptance criteria" for a 510(k) submission like this is substantial equivalence to predicate devices. This means demonstrating that the new device is as safe and effective as a legally marketed device that is already on the market. The reported "performance" is primarily a comparison of key features and the results of non-clinical (bench) testing against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Characteristic	Acceptance Criteria (demonstrate equivalence to predicates)	Reported Device Performance (Spine 360 System)
Intended Use	Per 21 CFR 888.3080 (Lumbar Intervertebral Body Fusion)	Per 21 CFR 888.3080 (Lumbar Intervertebral Body Fusion)
Material Composition	PEEK materials suitable for surgical implants (e.g., PEEK Optima LT1)	PEEK-OPTIMA LT1 polymer (ASTM F2026), Tantalum (ASTM F560)
Bone Graft Cavity	Presence of a bone graft cavity	Yes
Ridges	Presence of ridges	Yes
X-ray Markers	Presence of X-ray markers	Yes
Sterility	Provided non-sterile, steam sterilized at hospital (or gamma sterilized)	Provided non-sterile, steam sterilized at hospital
Mechanical Performance (Static Compression)	Meet requirements of ASTM F2077	Testing performed per ASTM F2077
Mechanical Performance (Dynamic Compression)	Meet requirements of ASTM F2077	Testing performed per ASTM F2077
Subsidence Resistance	Meet requirements of ASTM F2267	Testing performed per ASTM F2267
Design Characteristics	Rectangular/conical (PLIF), banana (TLIF), oval (ALIF) shapes with various heights and large bone graft windows.	SHARK (PLIF) - rectangular blocks, tapered nose; BULLSHARK (PLIF) - rectangular, conical nose; TIGER (TLIF) - banana shaped; GREAT WHITE (ALIF) - oval, 7°/13° lordosis. All with bone graft windows.

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

Sample Size for Test Set: This is a non-clinical device. The "test set" consists of the physical devices themselves and test coupons for material characterization. The document does not specify a numerical sample size for the mechanical testing, but these tests are typically performed on a statistically relevant number of units.
Data Provenance: The mechanical tests (static compression, dynamic compression, subsidence) are bench tests conducted in a laboratory setting, not on patient data. The origin of the data is therefore the testing facility. The document does not specify the country of origin of the testing.

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. For a physical implant device, ground truth as it pertains to AI/software evaluation (e.g., expert consensus on medical images) is not relevant. The "ground truth" for material properties and mechanical performance is established by recognized ASTM standards and physical measurements.

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

Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of medical data, which is not part of this device submission.

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. This is a physical interbody fusion system, not an AI or imaging software. MRMC studies are not applicable.

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

Not Applicable. This is a physical implant.

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

The "ground truth" for this device's performance is derived from:
- Material Specifications: Compliance with ASTM F2026 (for PEEK) and ASTM F560 (for Tantalum) standards.
- Mechanical Testing Standards: Adherence to ASTM F2077 (static and dynamic compression) and ASTM F2267 (subsidence) test methods and their implied performance requirements.
- Substantial Equivalence: Comparison against the design, materials, intended use, and performance of legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This device does not use machine learning, so there is no training set.

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

Not Applicable. As there is no training set, this question is not applicable.

Summary of the Study (or Basis for Clearance):

The "study" in this context is the non-clinical testing and comparison to predicate devices for demonstrating substantial equivalence.

Non-Clinical Test Summary: The application included non-clinical tests:
- Static and dynamic compression testing according to ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices."
- Subsidence testing according to ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression."
Clinical Test Summary: "No clinical studies were performed."
Basis for Clearance: The Spine 360 Interbody Fusion System was found "substantially equivalent" to predicate devices (BRANTIGAN I/F CAGE (P960025) and Lucent Straight Intervertebral Body Fusion Device (K072120)) based on:
- Identical intended use (intervertebral body fusion for DDD in lumbar spine).
- Similar design, materials (predominantly PEEK Optima LT1 and tantalum markers), and function.
- Successful completion of non-clinical mechanical testing demonstrating performance comparable to what is expected for such devices and predicates.

Summary

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K 102 322

page lot of 2

510(k) Summary for the Spine 360 Interbody Fusion System

JAN - 7 2011

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Spine 360 Interbody Fusion System.

Date Prepared: December 2, 2010

1. Submitter: Contact Person: J.D. Webb Spine 360 5000 Plaza on the Lake, Suite 305 The OrthoMedix Group, Inc. Austin, TX 78746 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
1. Trade name: Spine 360 Interbody Fusion System Common Name: intervertebral body fusion device Classification Name: intervertebral body fusion device - lumbar 21 CFR section 888.3080 MAX Class II

ന് Predicate or legally marketed devices which are substantially equivalent:

Spine 360 Interbody Fusion System is substantially equivalent to the following devices.
- BRANTIGAN I/F CAGE (P960025) .
- . Lucent Straight Intervertebral Body Fusion Device (K072120)

4. Description of the device:

Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.

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5. Substantial equivalence claimed to predicate devices

JAN - 7 2911

Spine 360 Cervical Interbody Fusion System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the Spine 360 Cervical Interbody Fusion System to these predicate devices.

Device	Spine 360	Crystal CervicalCage	BAK/C Vista	BRANTIGAN	Lucent
510(k) number	--	K073351	P980048 S3	P960025	K072120
Intended use	Per 888.3080	Per 888.3080	Per 888.3080	Per 888.3080	Per 888.3080
Bone graftcavity	Yes	Yes	Yes	Yes	Yes
Ridges	Yes	Yes	Yes	Yes	Yes
X-ray markers	Yes	Yes	Yes	Yes	Yes
Raw material	PEEK OptimaLT1	PEEK OptimaLT1	carbon-fiberreinforced PEEK-OPTIMA® LT1polymer	70% (poly etherketone etherketone ketone)(PEKEKK), 30%polyacrylonitrilecarbon	PEEK OptimaLT1
Sterility	Provided non-sterileSteam sterilizedat hospital	Provided non-sterileSteam sterilizedat hospital	Providedgammasterilized	Providedgammasterilized	Provided non-sterileSteam sterilizedat hospital

6. Intended Use:

The Spine 360 Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Spine 360 Lumbar Interbody Fusion System implants are to be used with autogenous bone graft. The Spine 360 Lumbar Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.

7. Non-clinical Test Summary:

The following tests were conducted:

Static and dynamic compression testing per ASTM F2077 "Test Methods for Intervertebral Body . Fusion Devices"
Subsidence per ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion . Device Under Static Axial Compression".

8. Clinical Test Summary

No clinical studies were performed
Comparison of the technological characteristics of the device to predicate and legally marketed devices: த் Spine 360 Interbody Fusion System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Spine 360 % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

JAN - 7 201

Re: K102322

Trade/Device Name: Spine 360 Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 02, 2010 Received: December 07, 2010

Dear Mr. Webb:

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

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Page 2 – Mr. J.D. Webb

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.

Sincerely yours,

Mark A. Milliman

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

K102322 510(k) Number (if known):

JAN - 7 2011

Device Name: Spine 360 Lumbar Interbody Fusion System

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K102322 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.