PROW FUSION-V is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

Device Description

PROW FUSION-V is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-V is provided in different shapes to fit the anatomical needs of a wide variety of patients and can expand to the desired height or the desired lordosis.

Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion. The devices require the use of commercially available supplemental spinal fixation systems.

PROW FUSION-V is manufactured from titanium alloy per ASTM F136.

PROW FUSION-V is to be filled with autogenous bone graft material.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called "PROW FUSION-V." This type of document is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for an intervertebral body fusion device focuses heavily on mechanical testing and material equivalence rather than clinical study results involving human patients or complex AI algorithm performance. The "Performance Data" section explicitly states that mechanical testing (static and dynamic compression, compression-shear, subsidence) was conducted according to ASTM standards and FDA guidance. A cadaveric study was also done.

Therefore, the information required to answer your specific questions relating to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for training sets, and expert adjudication as would be found in a study validating a diagnostic AI/ML device, is not present in this document.

Based on the provided document, here's what can be inferred about the "acceptance criteria" and "study" for this type of device:

Acceptance Criteria and Device Performance (Based on the document's focus)

Given that this is a 510(k) for an intervertebral body fusion device, the acceptance criteria relate to its mechanical properties and biocompatibility, demonstrating that it functions similarly to predicate devices.

Acceptance Criteria (Implied for a 510(k) spinal implant)	Reported Device Performance (from "Performance Data" section)
Mechanical Performance:
Static Compression Strength (ASTM F2077)	Demonstrated in accordance with ASTM F2077
Dynamic Compression (Fatigue) (ASTM F2077)	Demonstrated in accordance with ASTM F2077
Static Compression-Shear (ASTM F2077)	Demonstrated in accordance with ASTM F2077
Dynamic Compression-Shear (Fatigue) (ASTM F2077)	Demonstrated in accordance with ASTM F2077
Subsidence (ASTM F2267)	Demonstrated in accordance with ASTM F2267
Max Expansion Force	Testing performed
Device Functionality in Use:
Proper Placement	Evaluated in cadaveric study
Graft Containment	Evaluated in cadaveric study
No damage to vertebral endplate	Evaluated in cadaveric study
Material Properties/Biocompatibility:
Manufactured from medical-grade material (ASTM F136)	Manufactured from titanium alloy per ASTM F136
Wear Particle Assessment	Testing performed
Substantial Equivalence:
Similar technical characteristics, performance, and intended use as predicates	Claimed: "PROW FUSION-V is similar to the predicates with respect to technical characteristics, performance and intended use."

Absence of Information for AI/ML Device Validation Questions:

The following information is not available in the provided document, as it pertains to the validation of AI/ML algorithms, which is not the subject of this 510(k) for an intervertebral body fusion device.

Sample sizes used for the test set and the data provenance: Not applicable to this type of mechanical and cadaveric testing. No "test set" in the context of an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a spinal implant is defined by its mechanical properties and successful implantation in cadavers, not expert interpretation of diagnostic images.
Adjudication method for the test set: Not applicable.
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 diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, ground truth is largely defined by engineering standards (e.g., ASTM F2077, ASTM F2267 for mechanical properties) and anatomical/surgical considerations (evaluated in cadaveric study). It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML sense.
The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is for a physical medical device (spinal implant) and its regulatory submission (510(k)) primarily relies on non-clinical (mechanical and cadaveric) testing to demonstrate substantial equivalence, rather than clinical studies or AI/ML algorithm validation. Therefore, most of your specific questions related to AI/ML device validation cannot be answered from this text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.

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

July 11, 2016

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

Re: K153786

Trade/Device Name: PROW FUSION-V Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2016 Received: June 15, 2016

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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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/ResourcesforYou/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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known)

K153786

Device Name

PROW FUSION-V

Indications for Use (Describe)

PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for NLT Spine. The logo features a stylized spine graphic on the left, with the text "NLT SPINE" in a bold, sans-serif font to the right. Below "NLT SPINE" is the text "NonLinear Technologies" in a smaller, lighter font. The spine graphic is composed of several blue squares stacked vertically, with a curved gray line running along the side to represent the natural curve of the spine.

510(k) SUMMARY

NLT SPINE's PROW FUSION-V

As required by 21 C.F.R. § 807.92

Sponsor:

NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba Israel 4464103

Contact Person:

Eti Zinger VP Regulatory Affairs NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com

Date Prepared: July 7, 2016

Name and Classification:

Name of Device:	PROW FUSION-V
Common or Usual Name:	Intervertebral body fusion device
Classification Name:	Intervertebral body fusion device
Classification:	21 CFR §880.3080
Product Code:	MAX
Class:	II

Primary Predicate Device:

Globus Medical, CALIBER Spacer (K123231)

Additional Predicate devices:

SpineSource, Inc. L-Varlock Lumbar Cage (K080537); NuVasive CoRoent System (K141665) Globus Medical, RISE Spacer (K113447)

Intended Use / Indications for Use

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for NLT Spine NonLinear Technologies. The logo features a stylized spine graphic on the left, with a curved line and blue squares representing vertebrae. To the right of the spine graphic, the text "NLTSPINE" is displayed in a bold, sans-serif font, with "NonLinear Technologies" written in a smaller font size below it.

PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

Technological Characteristics

PROW FUSION-V is manufactured from titanium alloy per ASTM F136.

PROW FUSION-V is to be filled with autogenous bone graft material.

Performance Data

Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear according to ASTM F2077 and subsidence according to ASTM F2267 was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007 to demonstrate substantial equivalence to the predicate. Cadaveric study conducted to evaluate proper placement of the device, graft containment and no damage to the vertebral endplate. In addition, max expansion force and wear particle assessment testing were also performed.

Substantial Equivalence

PROW FUSION-V is similar to the predicates with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject PROW FUSION-V to the predicate devices.

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.