The Leva™ Spacer 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 radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Device Description

The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

AI/ML Overview

This document is a 510(k) summary for the Leva™ Spacer System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria related to a diagnostic or AI algorithm.

Therefore, many of the requested criteria for AI or diagnostic devices (such as reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) are not applicable to this submission content.

However, I can extract information relevant to the device's performance data based on the provided text, which serves as the "study that proves the device meets acceptance criteria" in the context of a 510(k) for a physical medical implant.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Demonstrated Equivalence)
Static Axial Compression (ASTM F2077)	Met (Compared to previously tested constructs)
Dynamic Axial Compression (ASTM F2077)	Met (Compared to previously tested constructs)
Static Compression Shear (ASTM F2077)	Met (Compared to previously tested constructs)
Dynamic Compression Shear (ASTM F2077)	Met (Compared to previously tested constructs)
Subsidence (ASTM F2267)	Met (Compared to previously tested constructs)
Oblique Compressive Shear (ASTM F2077)	Demonstrated substantial equivalence (via Finite Element Analysis & mechanical testing)
Subsidence (ASTM F2267)	Demonstrated substantial equivalence (via Finite Element Analysis & mechanical testing)

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

Sample Size: Not explicitly stated. The tests refer to "constructs previously tested" and "mechanical testing," which implies physical samples were used, but the number of samples is not provided.
Data Provenance: Not specified, but generally, such biomechanical testing is conducted in a laboratory setting, not with human patient data or specific country of origin. It would be prospective testing of device prototypes.

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

Not applicable. This relates to diagnostic/AI performance, not the biomechanical testing of an implant. The "ground truth" here is the physical performance under specified load conditions, as defined by ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. This relates to diagnostic/AI performance. The "adjudication" for mechanical testing would be the compliance of test results with the specified ASTM standards and internal acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical intervertebral body fusion device, not a diagnostic or AI system.

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

Not applicable. This is a physical intervertebral body fusion device.

7. The Type of Ground Truth Used

For the biomechanical tests, the "ground truth" is the established performance metrics and acceptance limits defined by the referenced ASTM international standards (ASTM F2077, ASTM F2267) for intervertebral body fusion devices. These standards specify how to conduct the tests and what constitutes acceptable performance for such devices.

8. The Sample Size for the Training Set

Not applicable. This typically refers to machine learning models. For a physical device, "training set" doesn't directly apply in the same way. The design iterations and preliminary testing during development could be considered analogous, but no specific "training set size" is provided.

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

Not applicable. As above, for a physical device, there isn't a "training set" in the context of ground truth establishment similar to AI/diagnostic devices. The design process and adherence to engineering principles and regulatory standards guide the development and testing.

Summary

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

July 9, 2015

Spine Wave, Incorporated Ms. Gail Yaeker-Daunis, RAC, MBA Senior Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K151581

Trade/Device Name: Leva™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 9, 2015 Received: June 11, 2015

Dear Ms. Yaeker-Daunis:

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 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

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Page 2 - Ms. Gail Yaeker-Daunis

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 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/Resourcesfor You/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 vours.

Lori A. Wiggins -S

for 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)

K151581

Device Name Leva™ Spacer System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Leva™ Spacer System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Gail Yaeker-Daunis
Date Prepared:	June 9, 2015

2. Device Information

Trade Name:	Leva™ Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	Class II (special controls) per 21 CFR 888.3080
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Product Code:	MAX

3. Purpose of Submission

The purpose of this submission is to gain clearance for a line addition to the Leva™ Spacer System, to add additional implant sizes and associated instruments.

4. Predicate Device Information

The Leva™ Spacer System described in this submission is substantially equivalent to the following predicates:

Primary Predicate Device	Manufacturer	510(k) No.
LevaTM Spacer System	Spine Wave, Inc.	K141980 andK150285

5. Device Description

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accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

6. Indications for Use

The Leva™ Spacer 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 I spondylolisthesis or retrolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral body fusion device.

7. Comparison of Technological Characteristics

The substantial equivalence of the Leva™ Spacer System to the predicates is shown by similarity in intended use, indications for use, materials and performance.

8. Performance Data

The modified implants were compared to constructs previously tested in static and dynamic axial compression (ASTM F2077), static and dynamic compression shear (ASTM F2077), and subsidence (ASTM F2267). Finite Element Analysis and mechanical testing which included oblique compressive shear (ASTM F2077) and subsidence (ASTM F2267) demonstrated substantial equivalence to the predicate devices.

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Leva™ Spacer System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.

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.