When intended for pedicle screw fixation from T1 -S1, the Sequoia® Pedicle Screw System is 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondytolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scollosis, 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 autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity). degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

Device Description

The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods (varying lengths) and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening. SpeedLink II ™ Transverse Connectors are provided to increase rotational stiffness to the final construct.

AI/ML Overview

The provided document does not describe a study that uses acceptance criteria in the typical sense for evaluating device performance in a clinical or diagnostic context. Instead, this is a 510(k) summary for a medical device (Zimmer Spine Sequoia® Pedicle Screw System) seeking regulatory clearance based on substantial equivalence to predicate devices. The "performance testing" described is primarily bench testing and evaluations to confirm the updated device's equivalence in design, materials, and mechanical properties to previously cleared devices.

Therefore, many of the typical questions regarding acceptance criteria for diagnostic devices, sample sizes for test sets, expert ground truth, and comparative effectiveness studies are not applicable in this context.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of design, materials, function, intended use, and performance characteristics. The "performance" here refers to mechanical and physical properties relevant to a spinal implant, rather than diagnostic accuracy or clinical outcomes.

Acceptance Criteria Category	Reported Device Performance (as demonstrated for Substantial Equivalence)
Mechanical Performance (Implants)	Confirmed as suitable for intended use through bench testing (static compression bending, dynamic compression bending, and static torsion testing per ASTM F1717 & F1798 as applicable).
Human Factors (Instrument & Labeling Interaction)	Evaluated as substantially equivalent to predicate devices through cadaver lab testing regarding instrument design changes and labeling.
Biocompatibility	Materials confirmed as biocompatible after manufacturing (for minor design changes compared to predicates).
Sterilization, Dry Time, and Cleaning Instructions	Confirmed as substantially equivalent to predicate devices for steam sterilization, cleaning, and dry time instructions.
Design, Materials, Function, Intended Use	The current device shares the same technological characteristics (design, materials, sizes) and a subset of the indication for use as the predicate device.
Product Performance Specifications / Functional Technology	No changes to product performance specifications or device functional scientific technology compared to the predicate.

Study Information (Based on 510(k) Premarket Notification)

Since this is a submission for substantial equivalence of a modified medical device, the categories requested often pertain to diagnostic or AI-driven devices. The "studies" described here are engineering and physical tests.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of screws, rods, or connectors tested. The document generally states "components of the current Sequoia® Pedicle Screw System... were reviewed and tested."
- Data Provenance: The testing was "Bench testing" (mechanical simulation) and "Cadaver lab testing." This suggests laboratory-controlled environments. No country of origin for test data is explicitly mentioned, but the submitting company is Zimmer Spine, Inc. in Minneapolis, MN, USA. The testing appears to be prospective for the modified device to demonstrate its equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Establishment: For mechanical bench testing, "ground truth" would be established by engineering standards (e.g., ASTM F1717 & F1798). These standards define the test methods and expected performance characteristics, not by experts in the typical clinical sense.
- Expert Involvement: For "Cadaver lab testing... to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants," it would imply surgeons or medical professionals were involved in using the system on cadavers. However, the number and qualifications of these experts are not specified. The purpose was to confirm "substantial equivalence of the changes compared to the identified predicate devices," not to establish a new clinical ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for reconciling disagreements among expert readers in diagnostic image interpretation or similar qualitative assessments. The tests described are objective, quantitative engineering tests (bench testing) and human factors evaluations.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices. The device in question is a spinal implant for stabilization, not a diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This question pertains to AI algorithms. The device is a physical pedicle screw system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" or reference for performance is established by engineering standards (ASTM F1717 & F1798). The device's performance is compared against these standards and against the performance of the predicate devices.
- For biocompatibility, the ground truth is established by biocompatibility testing standards and regulatory requirements for medical device materials.
- For human factors/cadaver lab testing, the "ground truth" is likely the practical usability and equivalence observed by the participating professionals when installing the device compared to the predicate.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this physical medical device. This term applies to machine learning models.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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510(k) SUMMARY Zimmer Spine Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System

Date of Summary Preparation:	August 29, 2013
Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439	SEP 0 4 2013
Establishment Registration Number:	2184052
Company Contact:	Jonathan GilbertRegulatory Affairs DirectorEmail: jonathan.gilbert@zimmer.comOffice: 952.830.6385Fax: 952.837.6985
Trade Name:	Zimmer Spine Sequoia® Pedicle Screw Systemincluding SpeedLink II™ Transverse Connector System
Device Name (Common Name):Disease:	Orthosis, Spinal Pedicle Fixation, For Degenerative DiscOrthosis, Spondylolisthesis Spinal Fixation; Orthosis, SpinalPedicle Fixation
Device Classification:	Class III and Class II
Product Code(s):	NKB, MNH, MNI
Regulation Number:	21 CFR §888.3070
Regulation Description:	Pedicle screw spinal system

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 Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System is claimed to be substantially equivalent to the following legally marketed predicate devices:

Sequoia® Pedicle Screw SystemPredicate Device Name	Submission IDNumber	Clearance Date
Sequoia® Pedicle Screw System includingSpeedlink Transverse Connector System	K082032	October 6, 2008
Modification To Incompass Spinal Fixation System	K023644	November 25, 2002
Synergy D2 Spinal Implants	K984578	March 23, 1999
Titanium TSRH(R) Spinal System (Screws)	K946348	August 7, 1995

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General Device Description:

The Sequoia® Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions (see indications below). This system is 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.

SpeedLink II ™ Transverse Connectors are provided to increase rotational stiffness to the final construct.

Indications for Use:

Summary of Technological Characteristics:

The current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System shares the same technological characteristics as the predicate device Sequoia® Pedicle Screw System including Speed ink IIM Transverse Connector System. The characteristics include the same design, same materials, and same range of sizes, substantially equivalent performance characteristics and a subset of the indication for use.

The current and predicate Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System both consist of open style polyaxial screws, titanium rods, connectors and the instruments/accessories necessary to implant the spinal system. All implant components are made from a titanium alloy (Ti-6Al-4V) and Unalloyed Titanium (CP Ti).

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Zimmer Spine- 510(k)-Sequoia® Pedicle Screw System-Section 5.510(k) Summary

The Sequoia® Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section above. The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u- shaped opening. The use of the SpeedLine II™ Transverse Connectors as a construct component during implementation of the Sequoia® Pedicle Screw System is at the discretion of the surgeon and is not required. This system is 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. The current and predicate systems are provided nonsterile, are for single use only and are intended to be removed after solid fusion has occurred.

Summary of Performance Testing:

The Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System is substantially equivalent to the predicate devices in design, materials, function and intended use.

The performance testing included components of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System to be substantially equivalent to their predicate devices. Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System.

. Bench testing (static compression bending, dynamic compression bending, and static torsion testing per ASTM F1717 & F1798 as applicable) for implants. polyaxial screws, titanium rods, and connectors, confirmed the product performance of the current Sequoia® Pedicle Screw System including SpeedLink II ™Transverse Connector System is suitable for its intended use.
. Cadaver lab testing of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector 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 current Sequoia® Pedicle Screw System . including SpeedLink !! ™Transverse Connector 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 current Sequoia® Pedicle Screw System including SpeedLink ||™ Transverse Connector System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices.

Substantial Equivalence:

Zimmer Spine considers the current Sequoia® Pedicle Screw System including SpeedLink IITM Transverse Connector System product performance to be substantially equivalent to their cleared predicate device, 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.

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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 eagle or bird symbol, composed of three curved lines, positioned to the right of the text. The text, arranged in a circular fashion around the bird, reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring MI) 20993-0002

September 4, 2013

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

Re: K131980

Trade/Device Name: Zimmer Spine Sequoiad Pedicle Screw System including SpeedLink II" Transverse Connector System. Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNH, MNI Dated: July 5, 2013 Received: July 8, 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 10 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

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Page 2 - Mr. Jonathan Gilbert

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 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/dcfault.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 vours.

Mark N. Melkerson -S

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

Enclosure

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Zimmer Spine - 510(k) - Sequoia® Pedicle Screw System

Indications for Use

510(k) Number (if known): K131980

Device Name: Zimmer Spine Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System

Indications for Use:

When intended for pedicie screw fixation from T1 -S1, the Sequoia® Pedicle Screw System is intended to provide immobilization 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, and/or lordosis), turnor and failed previous fusion.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

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

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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131980

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.