The Zenith Pedicle 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 spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of implants after the attainment of a solid fusion.

Device Description

The Apollo Spine Zenith Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5.5mm, 6.5mm, 7.5mm and 8.5mm diameter sizes. All sizes are able to receive 5.5 mm connecting rods only. All implant components are fabricated from medical grade titanium alloy (TI-6AI-4V ELI) conforming to ASTM F136 or equivalent.

The Apollo Spine Zenith Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, components should not be reused.

AI/ML Overview

The provided text describes the Apollo Spine Zenith Pedicle System, a spinal implant system. The regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI/ML-driven device with performance criteria based on clinical or diagnostic accuracy.

Therefore, many of the requested criteria related to AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static Torsion per ASTM F 1717-04	Met applicable requirements.
Static Compression Testing per ASTM F 1717-04	Met applicable requirements.
Dynamic Compression Testing per ASTM F 1717-04 (including 2 runout samples to 5 million cycles)	Met applicable requirements.
Substantial Equivalence (overall)	Demonstrated suitability for intended use, substantially equivalent to publicly available data for predicate devices.

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

Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of AI/ML. The "samples" referred to are test articles (medical device components) used in mechanical testing. The dynamic compression testing included "2 runout samples to 5 million cycles," indicating at least two physical samples for that specific test.
Data Provenance: Not applicable in the AI/ML sense. The data is generated from laboratory mechanical testing of the device components.

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

Not applicable. This submission is for a physical medical device and relies on engineering standards (ASTM F 1717-04) for performance validation, not expert-derived ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. This relates to concordance among expert readers, which is irrelevant for mechanical testing.

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

No. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

The "ground truth" for this device's performance is adherence to the ASTM F 1717-04 standard for spinal implant mechanical testing and the demonstration of substantial equivalence to predicate devices based on the results of these tests and their known performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and does not involve a training set.

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

Not applicable. This is not an AI/ML device and does not involve a training set.

Summary

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

K102636

Apollo Spine Premarket Notification 510(k) Zenith Pedicle System

Page 7 +

MAR - 3 2011

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter Information

Submitter's Name:	Apollo Spine
Address:	3700 Campus Dr. Suite 105Newport Beach, CA 92660
Telephone:	949-645-1615
Fax:	949-757-0460
Contact Person:	Christine Santagate, STD Medical
Telephone :	781-828-4400
Fax :	781-344-5895
Date Prepared:	September 10, 2010
Device Trade Name:	Zenith Pedicle Screw System
Common/Usual Name:	Pedicle Screw Spinal System
Class:	II
Product Code(s):	MNH, MNI

Predicate Device (s):

Stryker Xia Pedicle Screw Spinal System, K013823 ●
Amedica Valeo Pedicle Screw System, K07343 .

Substantial Equivalence:

The Zenith Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and had the same indications for use, design, function, and materials used.

PREMARKET NOTIFICATION FOR THE APOLLO SPINE ZENITH PEDICLE SYSTEM

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

K102636 Page 2/3

Apollo Spine Premarket Notification 510(k) Zenith Pedicle System

Page 7-1

Device Description:

Indications For Use:

The Zenith Spinal 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 spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis).

PREMARKET NOTIFICATION FOR THE APOLLO SPINE ZENITH PEDICLE SYSTEM

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

Apollo Spine Premarket Notification 510(k) Zenith Pedicle System

Mechanical Test Data:

The following testing was performed on this device:

Static Torsion per ASTM F 1717-04 .
Static Compression Testing per ASTM F 1717-04 .
Dynamic Compression Testing per ASTM F 1717-04 .
- o Includes 2 runout samples to 5 million cycles

Conclusion:

ASTM Standard F 1717 was adhered to and all applicable requirements were met. Testing results demonstrate that the Zenith Pedicle Screw System is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use.

PREMARKET NOTIFICATION FOR THE APOLLO SPINE ZENITH PEDICLE SYSTEM

Page 7-4

{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 eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Apollo Spine, Inc. % STD Medical, Inc. Ms. Christine Santagate 75 Mill Street Stoughton, Massachusetts 02072

MAR - 3 2011

Re: K102636

Trade/Device Name: Zenith Pedicle System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: February 07, 2011 Received: February 08, 2011

Dear Ms. Santagate:

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

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

Page 2 - Ms. Christine Santagate

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Aing B. R
for

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

Enclosure

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

Apollo Spine Premarket Notification 510(k) Zenith Pedicle System September 10, 2010

Indications for Use Statement

510(k) Number (if known):

Device Name: Zenith Pedicle System

Indications for Use:

Prescription Use X (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)

oncurrence of CDRH, Office of Device Evaluation (ODE)

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

K102636 510(k) Number_

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.