The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.

The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine,

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

Device Description

The Zodiac Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. This is a medical device, and the acceptance criteria and study described are for mechanical performance testing rather than an AI/ML-driven device with performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested AI-specific information (like sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, types of ground truth, etc.) is not applicable to this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and effectiveness for intended use	Mechanical and dynamic testing provides reasonable assurance of safety and effectiveness.
Compliance with recognized consensus standards	Performance testing was performed per recognized consensus standards and the guidance document, "Spinal System 510(k)s - Guidance for Industry and FDA Staff."
Adequacy of static performance characteristics	Testing documented static performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation.
Adequacy of fatigue performance characteristics	Testing documented fatigue performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation.
Substantial equivalence to predicate devices (mechanical performance)	The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices (K033090, K042673, K051286, K071890).

2. Sample size used for the test set and the data provenance

Not Applicable: This document focuses on mechanical testing of a physical medical device, not a data-driven AI/ML model where test set sample sizes and data provenance are relevant in the same way. The "test set" would refer to the physical devices or components subjected to mechanical stress. The document does not specify the number of devices tested, but it implies standard engineering testing procedures.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: "Ground truth" in the context of AI/ML refers to accurately labeled data. For mechanical testing, the "ground truth" is established by adherence to engineering standards and validated testing methodologies, not expert labeling. The experts involved would be engineers and regulatory bodies evaluating the test results against established safety and performance benchmarks.

4. Adjudication method for the test set

Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert labeling for AI/ML ground truth. For mechanical testing, adherence to standards and test protocols is the primary method of validation.

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: MRMC studies are specific to AI/ML devices that impact human reader performance (e.g., diagnostic image interpretation). This document is about a physical spinal fixation system.

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

Not Applicable: This refers to the performance of an AI algorithm on its own. The Zodiac® system is a physical implant, not an algorithm.

7. The type of ground truth used

Engineering Standards and Test Protocols: For mechanical devices, the "ground truth" is defined by established engineering and regulatory performance standards (e.g., ISO, ASTM, or FDA-recognized consensus standards for spinal implants) and rigorous test protocols. The device's performance is compared against these predefined physical limits and requirements.

8. The sample size for the training set

Not Applicable: "Training set" refers to data used to train an AI/ML model. This is a physical device, so no training set in that sense is involved.

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

Not Applicable: As there's no AI/ML training set, this question is irrelevant.

Summary

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Zodiac® Polyaxial Spinal Fixation System

Image /page/0/Picture/1 description: The image shows a logo with the Greek letter alpha at the top. Below the alpha is the text "Alphatec Spine" in a stylized font. The word "Alphatec" is larger and bolder than the word "Spine", making it the primary focus of the logo.

510(k) Number K091189

510(k) SUMMARY

JUL - 8 2009

Zodiac® Polyaxial Spinal Fixation System 510(k) SUMMARY April 2009

Company:

Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Direct: (760) 494-6769 (760) 431-0289 Fax:

Contact Person:	Paula Morgan, Regulatory Affairs Sr. Director
Trade/Proprietary Name:	Zodiac® Polyaxial Spinal Fixation System
Common Name:	Pedicle Screw Spinal Device
Classification Names:	Spinal Interlaminal Fixation OrthosisPedicle Screw Spinal System

Classification Number(s)/Product Code(s): 21 CFR 888.3050, 888.3070 KWP, MNI, MNH

Product Description:

Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiace Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

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Image /page/1/Picture/1 description: The image contains a handwritten Greek letter alpha. The letter is in lowercase and appears to be written with a thick marker or pen, giving it a bold appearance. The background is plain and white, which makes the letter stand out.

Althatee Spier

ge 2 of 2

The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine,

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),

a. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for: "

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scollosis,

kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

Substantial Equivalence:

The Zodiac® Polyaxial Spinal Fixation System additional components are substantially equivalent to the following predicate device:

Trade/Proprietary/Model Name	Manufacturer	510(k) No.
Zodiac® Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K033090
Zodiac® Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K042673
Zodiac® Stainless Steel Spinal Fixation System	Alphatec Spine, Inc	K051286
Zodiac® 4.0 Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	K071890

Performance Data:

I enormance Dava.
Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff. This testing documented both static and fatigue performance characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation. The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiae® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alphatec Spine, Inc. % Ms. Paula Morgan Regulatory Affairs Senior Director 5818 El Camino Real Carlsbad, California 92008

JUL = 8 2009

Re: K091189

Trade/Device Name: Zodiac® Polyaxial Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: June 8, 2009 Received: June 10, 2009

Dear Ms. Morgan:

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.

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 adversé 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.

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Page 2 - Ms. Paula Morgan

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,

Barbara Buckner
tor

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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Zodiac® Polyaxial Spinal Fixation System

Indications for Use

510(k) Number (if known): K091189

Device Name: Zodiac® Polyaxial Spinal Fixation System

Indications for Use:

The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine,

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),

as Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E z (EXT for MXM)
Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091189

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Image /page/5/Picture/2 description: The image shows a logo with the Greek letter alpha at the top. Below the alpha, the text "Alphatec Spine" is written in a stylized font. The text is slightly blurred, giving it a textured appearance.

In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis,

kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

X Prescription Use _ (Part 21 CFR 801 Subpart D) OR

Over-The Counter Use (Part 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)

en (EXT for MEM)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 091189

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.