The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

Device Description

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK enriched with carbon fibers (CFPEEK) and titanium alloy. The implant features multiple CFPEEK mid segments and titanium end segments. The segments are serrated on the superior and inferior surfaces and are attached with titanium pins.

The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by ultra high molecular weight poly ethylene (UHMWPE) suture. The suture is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.

AI/ML Overview

The NLT SPINE Prow Fusion device is an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance	Study that Proves Device Meets Criteria
Mechanical Performance	ASTM F2077	"Equivalent performance and safety as compared to the claimed predicates"	Conducted and compared to predicate devices	Performance data per ASTM F2077
	- Static axial compression	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	- Static compression shear	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	- Static torsion	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	- Dynamic axial compression	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	- Dynamic compression shear	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	- Dynamic torsion	Comparable to predicate devices	Met requirements	Performance data per ASTM F2077
	ASTM F2267 (Subsidence)	Comparable to predicate devices	Met requirements	Performance data per ASTM F2267
	Expulsion Testing	Comparable to predicate devices	Met requirements	Expulsion and wear testing
	Wear Testing	Comparable to predicate devices	Met requirements	Expulsion and wear testing
Clinical/Usability	Cadaver Testing	"Can be used as intended by the intended user population per its labeling following a standard training program."	Demonstrated substantial equivalence to predicates	Cadaver testing
Substantial Equivalence	Overall Safety & Effectiveness	"As safe and effective as its predicate devices."	"Substantially similar indications for use and technological characteristics," and "equivalent performance and safety as compared to the claimed predicates."	Comparison to predicate devices, performance testing

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

The document does not explicitly state the specific sample sizes for each mechanical test (ASTM F2077, F2267, expulsion, wear testing). These are typically laboratory studies, and the provenance would be laboratory-generated data, not human patient data, unless explicitly stated otherwise.

For the cadaver testing, the sample size is also not specified. Cadaver testing is a prospective evaluation of device usability. The geographic origin of the cadavers or the testing facility is not provided.

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

This information is not provided in the document. For mechanical testing, the "ground truth" is defined by the ASTM standards themselves and the test results obtained. For cadaver testing, the "ground truth" (that the device can be used as intended) would be established by the observations and assessments of the performing surgeons or evaluators, whose specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. For mechanical testing, adjudication typically involves adherence to standard operating procedures and data analysis. For cadaver testing, the method of assessing "can be used as intended" is not described, so an adjudication method is not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and mechanical testing, not through a human-in-the-loop study comparing human reader performance with and without AI assistance.

6. If a Standalone Performance Study Was Done:

Yes, standalone performance (algorithm only performance, in this context, refers to the device's mechanical and functional performance independent of a specific human-in-the-loop clinical trial) was done. The ASTM F2077 and F2267 tests, expulsion, and wear testing evaluate the device's inherent mechanical properties and durability.

7. The Type of Ground Truth Used:

Mechanical Performance Tests (ASTM F2077, F2267, expulsion, wear): The ground truth is based on engineering principles and established industry standards for intervertebral body fusion devices, with "acceptance" being defined by meeting requirements comparable to predicate devices.
Cadaver Testing: The ground truth is based on the functional demonstration of the device's intended use by the intended user population, verifying that the device can be properly implanted and functions as expected in a simulated surgical environment.

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/ML (Artificial Intelligence/Machine Learning) device requiring a "training set" in the conventional sense. The "training" for this device would refer to the standard engineering design and iterative testing processes, not a dataset for an algorithm.

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

This information is not applicable, as there is no "training set" in the AI/ML context for this device. The design and validation of the device rely on engineering principles, material science, and established biomechanical testing methods.

Summary

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NOV - 8 2011 K112359 Page 1/2

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NLT SPINE Prow Fusion Traditional 510{k} Premarket Notification

510(k) Summary

Sponsor:

NLT SPINE Ltd. 6 Yoni Nethanyahu St. Or-Yehuda Israel

Contact Person:

Eti Zinger Requlatory Affairs Director NLT SPINE Ltd. Tel: +972-3-6343321 Fax: +972-3-6341599 Eti.z@nlt-spine.com

Date Prepared: November 1, 2011

Name of Device: Prow Fusion

Common or Usual Name: Intervertebral body fusion device

Intervertebral body fusion device Classification Name: 21 CFR §880.3080 Product Code MAX

Predicate Devices

· Custom Spine Pathway AVID (K090566)
· Integra Spine Vu aPOD (K080822)

Intended Use / Indications for Use

The Prow Fusion is intended to be used for spinal fusion.

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K112359 Page 2/2

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Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

Technological Characteristics

Performance Data

Performance data per ASTM F2077 (Static axial compression, static compression shear, static torsion, dynamic axial compression, dynamic compression shear and dynamic torsion) and ASTM F2267 (Subsidence), expulsion and wear testing was conducted following a recognized protocol and compared to the predicate devices. In addition, cadaver testing demonstrated the Prow Fusion is substantially equivalent to its predicates, as it was shown that the device can be used as intended by the intended user population per its labeling following a standard training program.

Substantial Equivalence

The Prow Fusion is as safe and effective as its predicate devices. The Prow Fusion has substantially similar indications for use and technological characteristics as compared to the predicate devices. Any minor differences between the device and predicates do not raise new questions of safety and effectiveness. Further, performance testing has established that the Prow Fusion has equivalent performance and safety as compared to the claimed predicates. Thus, the device is substantially equivalent to its predicate devices.

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

NOV - 8 2011

NLT Spine Ltd. % Hogan and Lovells US, LLP John J. Smith, M.D., J.D. 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K112359

Trade/Device Name: Prow Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 16, 2011 Received: August 16, 2011

Dear Dr. Smith:

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

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Page 2 - John J. Smith, M.D., J.D.

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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm1.

Sincerely yours,

For

Mark N. Malkerson

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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4.0 Statement of Indications for Use

510(k) Number (if known): K112359

Device Name: Prow Fusion

Indications for Use:

The Prow-Fusion Intervertebral body fusion device is intended for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s).

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device.

The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

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

Over-The-Counter Use (21 CFR 801 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

KII 2359 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.