When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

Device Description

The existing, commercially available Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System ("PathFinder NXT System") consists of various screws, rods and associated accessories and is intended to provide temporary stabilization following surgery to fuse the spine. The PathFinder NXT screws are polyaxial cannulated designs with a range of spinal rod lengths. The PathFinder NXT System allows the surgeon to place polyaxial pedicle screws either through an open or mini-open procedure. The percutaneous insertion rods are for minimally invasive procedures. The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions and intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.

Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System to demonstrate its substantial equivalence to predicate devices, rather than an AI/ML device. Therefore, many of the requested fields, such as those pertaining to AI/ML specific studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth for training set) are not applicable to this submission.

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to legally marketed predicate devices in terms of design, materials, function, and intended use. The study focuses on performance testing to confirm this equivalence.

Here's a summary based on the provided text, with "N/A" for fields not relevant to this type of medical device submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstrates Substantial Equivalence via)	Reported Device Performance
Bench Testing (per ASTM F1717 & F1798 standards):	- Implants, polyaxial screws, and rods confirmed to have product performance suitable for intended use.
- Static compression bending
- Static torsion testing
- Dynamic compression bending
- Static axial grip
- Static torsion grip
- Static flexion-extension bending
Cadaver Lab Testing (Human Factors):	- Evaluated human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants. Confirmed substantial equivalence of these changes compared to predicate devices.
Biocompatibility Testing:	- Ensured the subject device materials are biocompatible after manufacturing, based on minor design changes made in comparison to predicate devices.
Sterilization, Dry Time, and Cleaning Testing:	- Ensured the subject device's steam sterilization, cleaning, and dry time requirements and instructions are substantially equivalent to the predicate devices.
Overall Substantial Equivalence:	- Zimmer Spine considers the subject device's product performance to be substantially equivalent to its predicate devices because there are no changes to the product performance specifications or device functional scientific technology compared to the predicate PathFinder NXT® Minimally Invasive Pedicle Screw System and Sequoia® Pedicle Screw System.

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: Not explicitly stated for specific tests (e.g., number of screws, rods tested). The document mentions "components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System" were reviewed and tested.
Data Provenance: Not specified, but generally, bench and cadaver lab testing for FDA submissions are conducted by manufacturers or contracted labs, likely within the United States or other regulated regions. The nature of the tests (bench, cadaver) is inherently prospective within a controlled lab environment.

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. This is a physical device and not an AI/ML system requiring expert-derived ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering standards and functional performance. However, cadaver lab testing would involve surgical experts for evaluation. The qualifications of these experts are not detailed.

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

Not applicable. This is not an AI/ML system requiring adjudication of interpretations. Performance is measured against engineering standards and functional requirements.

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

Not applicable. This is not an AI/ML system.

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

Not applicable. This is not an AI/ML system. The device itself is a "standalone" surgical implant system.

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

The "ground truth" for this medical device's performance testing is based on:
- Engineering Standards: Adherence to established ASTM F1717 and F1798 standards for mechanical performance.
- Biocompatibility Standards: Ensuring materials meet medical-grade biocompatibility requirements.
- Functional Equivalence: Demonstrating that changes to the device (e.g., instrument design, labeling) do not negatively impact the intended function or safety when compared to predicate devices, including evaluation in cadaver labs for human factors.

8. The sample size for the training set

Not applicable. This is not an AI/ML system that uses a training set.

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

Not applicable. This is not an AI/ML system.

Summary

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

Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary

Image /page/0/Picture/3 description: The image shows a logo with the letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font. The logo appears to be a trademark for a company or product. The image is in black and white.

SDIne

510(k) SUMMARY

Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System

2184052

Jonathan Gilbert

Screw System

Class III

NKB. MNH. MNI

21 CFR § 888.3070

Pedicle screw spinal system

Date of Summary Preparation:

Submitter:

September 12, 2013

Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, MN 55439

Regulatory Affairs Director

Office: 952.830.6385 Fax: 952.837.6985

Spinal Pedicle Fixation

Email: Jonathan.Gilbert@Zimmer.com

Orthosis, Spinal Pedicle Fixation, For

Degenerative Disc Disease; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis,

PathFinder NXT® Minimally Invasive Pedicle

Establishment Registration Number:

Company Contact:

Trade Name:

Device Name (Common Name):

Device Classification:

Product Code(s):

Regulation Number:

Regulation Description:

Predicate Devices:

For clarification purposes, this is the initial submission for this device modification and has not previously been submitted/withdrawn via a 510(k), PMA or de novo pathway. The modified PathFinder NXT® Minimally Invasive Pedicle Screw System is claimed to be substantially equivalent to the following legally marketed predicate devices:

PathFinder NXT® Minimally Invasive PedicleScrew SystemPredicate Device Name	SubmissionID Number	Clearance Date
PathFinder NXT® Minimally Invasive PedicleScrew System	K121671	July 18, 2012
PathFinder NXT® Minimally Invasive PedicleScrew System	K100845	September 21, 2010

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

PathFinder NXT® Minimally Invasive PedicleScrew SystemPerformance Predicate Device Name	SubmissionID Number	Clearance Date
Sequoia® Pedicle Screw System includingSpeedLink II™ Transverse Connector System	K082032	October 6, 2008
Synergy D2 Spinal Implant	K984578	March 23, 1999
Titanium TSRH® Spinal System (Screws)	K946348	August 7, 1995

Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary

General Device Description:

Additionally, the PathFinder NXT System includes instrumentation to facilitate the implantation of the PathFinder NXT implants.

Indications for Use:

As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

Summary of Technological Characteristics:

The subject Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System shares the same technological characteristics as its predicate device, Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System. The characteristics include the same design, same materials, same range of sizes, substantially equivalent performance characteristics and the same intended use.

The subject and predicate PathFinder NXT® Minimally Invasive Pedicle Screw System both consist of polyaxial screws, titanium rods, and the instruments necessary to implant the spinal system. All implant components are made from medical grade titanium alloy (Ti6Al4V ELI) per ASTM F136 and unalloyed titanium per ASTM F67.

The PathFinder NXT® Minimally Invasive Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section above. The PathFinder NXT® Minimally Invasive Pedicle Screw System consisting of polyaxial screws and titanium rods is intended to provide temporary stabilization following surgery to fuse the spine. The subject and predicate systems are provided non-sterile, are for single use only and are intended to be removed after solid fusion has occurred.

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

Zimmer Spine - 510(k) - PathFinder NXT System - Section 5. 510(k) Summary

Summary of Performance Testing:

The PathFinder NXT® Minimally Invasive Pedicle Screw System is substantially equivalent to the predicate devices in design, materials, function and intended use.

The performance testing included components of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the subject PathFinder NXT® Minimally Invasive Pedicle Screw System to be substantially equivalent to its predicate devices, PathFinder NXT® Minimally Invasive Pedicle Screw System, Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, Synergy D2 Spinal Implant and Titanium TSRH® Spinal System (Screws).

Bench testing (static compression bending, static torsion testing, and dynamic . compression bending per ASTM F1717 and static axial grip, static torsion grip, and static flexion-extension bending per ASTM F1798) for implants, polyaxial screws, and rods confirmed the product performance of the subject PathFinder NXT® Minimally Invasive Pedicle Screw System is suitable for its intended use.
Cadaver lab testing of the subject PathFinder NXT® Minimally Invasive Pedicle Screw . System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
Biocompatibility testing ensured the subject PathFinder NXT® Minimally Invasive Pedicle . Screw System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
Sterilization. Dry Time and Cleaning testing ensured the subject PathFinder NXT® . Minimally Invasive Pedicle Screw System steam sterilization, cleaning and dry time requirements and instructions are substantially equivalent to the predicate devices.

. Substantial Equivalence:

Zimmer Spine considers the subject PathFinder NXT® Minimally Invasive Pedicle Screw System product performance to be substantially equivalent to its predicate devices, PathFinder NXT® Minimally Invasive Pedicle Screw System and Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System because there are no changes to the product performance specifications or device functional scientific technology.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 25, 2013

Zimmer Spine, Incorporated Mr. Jonathan Gilbert Director, Regulatory Affairs 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K132884

Trade/Device Name: PathFinder NXT® Minimally Invasive Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: September 12, 2013 Received: September 13, 2013

Dear Mr. Gilbert:

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. Iisting 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

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

Page 2 - Mr. Jonathan Gilbert

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nielkerson -S

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

Enclosure

{5}------------------------------------------------

Zimmer Spine - 510(k) - PathFinder NXT System - Section 4. Indications for Use Statement

Indications for Use

K132884

510(k) Number (if known):

Device Name:

Zimmer Spine PathFinder NXT® Minimally Invasive Pedicle Screw System

Indications for Use:

When intended for pedicle screw fixation from T1-S1, the indications include immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondviolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or fordosis), tumor and failed previous fusion.

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

(21 CFR 801 Subpart C)

Over-the Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132884

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.