When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine(T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1.

Device Description

The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. These device components are for single use. Cementless or cement fixation is not applicable to these components. The components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).

AI/ML Overview

Based on the provided text, the "Aurora Titanium Spinal Rod System" is a spinal fixation device. The document is a 510(k) submission to the FDA, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparison to existing devices rather than new clinical trials with acceptance criteria and performance metrics against ground truth.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable to this document as it describes a substantial equivalence determination based on predicate devices, material specifications, and intended use, not a clinical study with detailed performance data, sample sizes, and ground truth adjudication.

However, I can extract information related to the device's intended use and the specific conditions under which its pedicular screw system was deemed substantially equivalent.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: For the pedicular screw system, the FDA's acceptance criteria for substantial equivalence are implicitly linked to the specific indications for use and warnings outlined in the letter. These are not performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather conditions for marketing.
Reported Device Performance: This document does not contain reported device performance data as would be found in a clinical study (e.g., success rates, complication rates, effectiveness outcomes). The 510(k) process primarily evaluates safety and equivalence, often through bench testing, material specifications, and comparison to predicates, rather than extensive clinical performance data against specific acceptance criteria.

Feature Area	Implicit Acceptance Criteria (for Pedicular Screw System)	Reported Device Performance
Legally Marketed	Substantial equivalence to predicate device in terms of safety and effectiveness for specific indications.	The FDA determined the device system is substantially equivalent for the specified indications.
Indications for Use (Pedicular Screw System)	Intended only for patients with: (a) severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) receiving fusions using autogenous bone graft only; (c) device fixed to lumbar and sacral spine; and (d) device removed after solid fusion mass develops.	The device's intended use and labeling were reviewed and found to align with these specific conditions for pedicular screw fixation. No performance metrics are reported.
Material	Conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).	The document states the material "conforms to MATERIALS: ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V)". No test results are provided.
Compatibility	Not designed to be used with any other system except the bolts of the UlTium Spinal Plating System.	This is a design specification and a warning on use. No testing results are provided.

No specific study proving the device meets these (implicit) acceptance criteria is described in detail within this document. The FDA's 510(k) clearance is a determination of substantial equivalence based on the submitted information, which typically includes bench testing, material characterization, and comparisons to predicate devices, rather than a prospective clinical trial.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This document does not describe a clinical "test set" or clinical study with patient data in the context of evaluation against acceptance criteria. The 510(k) submission relies on demonstrating equivalence to predicate devices, material specifications, and safety. Any testing would typically be bench testing on the device itself, not a patient study with a "test set."

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. No clinical test set with ground truth established by experts is described.

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

Not Applicable. No clinical test set with adjudication is described.

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 a spinal implant, 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 a spinal implant, not an AI algorithm.

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

Not Applicable. No clinical ground truth data is described in this document. The "ground truth" for the 510(k) submission is the demonstration of equivalence to legally marketed predicate devices, adherence to material standards, and acceptable risk profiles based on design and proposed labeling.

8. The sample size for the training set:

Not Applicable. No training set for an algorithm is discussed.

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

Not Applicable. No training set or ground truth establishment for a training set is discussed.

Summary

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MAR 1 0 1998 _

Aurora Titanium Spinal Rod System

FAX NO. 203 845 4503

IX.	Summary of Safety and Effectiveness
SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856
CONTACT PERSON:	Sharon L. Murphy
DATE PREPARED:	December 17, 1997
CLASSIFICATION NAME:	Spinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation OrthosisSpondylolisthesis Spinal Fixation Device System
COMMON NAME:	Titanium Spinal Rod System
PROPRIETARY NAME:	Aurora Titanium Spinal Rod System
	PREDICATE DEVICES:♦ USSC's (formerly Smith & Nephew's) Aurora TitaniumSpinal Rod System (K970635)♦ USSC's (formerly Smith & Nephew's) Rogozinski SpinalRod System♦ Smith & Nephew's Richard's Universal Connector♦ Danek's Paragon Bolt Connector♦ AcroMed® Isola System♦ Smith and Nephew's Richard's UlTium Plating System
	INTENDED USE:The components of the Titanium Spinal Rod System are indicatedfor spinal fixation. When used as an anterolateral/anterior systemconsisting of rods and screws, the levels of attachment are thelumbar, thoracic and cervical spine. The points of attachment andmethods are screw fixation to the anterolateral vertebral bodies ofthe lumbar and thoracic spine(T6-L5) and the anterior vertebralbodies of the cervical spine. The indications are degenerativedisc disease defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies, spondylolisthesis, fracture, spinal stenosis, deformities(i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multi-operated back or revision of previous surgery.

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K974734

Page 2012

Aurora Titanium Spinal Rod System

discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scollosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/illac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is (a) having severe spondylolisthesis intended for patients: (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1.

These device components are for single use. Cementless or cement fixation is not applicable to these components.

The components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System.

The material used is implant grade material that conforms to MATERIALS: ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).

K974734/S1 United States Surgical Corporation

firmed by
cture, spina

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 1998

Ms. Sharon L. Murphy Requlatory Affairs Program Manager United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re : K974734 Aurora Titanium Spinal Rod System ------Regulatory Class: II Product Codes: MNH, KWP, and KWQ Dated: December 17, 1997 Received: December 18, 1997

Dear Ms. Murphy:

We have reviewed your Section 510 (k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act (Act) . . This decision is based on your device system being found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below -------------------------------------------------------------------------------------------------------------------------------------------------

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.

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Page 2 - Ms. Sharon L. Murphy

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. All labeling for this device, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
1. You may not label or in anyway promote this device system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:

WARNINGS :

When used as a pedicle screw system, this device . system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
◆ Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may require additional surgery, include:

device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

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Page 3 - Ms. Sharon L. Murphy

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review-boards-(IRBs) and the ---Food and Drug Administration (FDA) prior to conducting an investiqation.
Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 ----through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system

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Page 4 - Ms. Sharon L. Murphy

consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of ______________________________________________________________________________________________________________________ Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia' M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aurora Titanium Spinal Rod System

IV. Indications for Use

510(k) Number (if known):

Aurora Titanium Spinal Rod System Components Device Name:

Indications For Use:

The components of the Titanium Spinal Rod System are indicated for spinal fixation.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacralifiliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the levels of pedicle screw fixation may be L3-S1.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (QDE)
--------------------------------------------------------

Prescription Use:	X
Use:

OR Over-The-Counter

	(Per 21 CFR 801.109)
--	----------------------

Division Sign-Off
Division of General Restorative Devices
510(k) Number	K974734

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.