When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Device Description

The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol -- NiTi) as described by ASTM F2063. Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use any of the VERTEX™ Reconstruction System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopaedic and neurosurgical implants, none of the VERTEX™ Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the VERTEX™ Reconstruction System:

Based on the provided documents, it is important to note that the VERTEX™ Reconstruction System is a physical medical device (spinal implant system) and not a software or AI-powered diagnostic tool. Therefore, the questions related to AI-specific metrics, ground truth establishment for algorithms, training sets, and human reader improvement with AI assistance are not directly applicable.

The "study" mentioned for this device is a "mechanical test data" to demonstrate substantial equivalence to previously marketed devices. This is a common requirement for physical medical devices to ensure their structural and functional integrity.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance (Summary)
Substantial Equivalence	Demonstrated through comparison to legally marketed predicate devices.
Mechanical Integrity	Mechanical test data was provided in support of the notification. (Specific criteria and detailed results are not provided in this summary but would have been part of the full submission).
Material Compatibility	Fabricated from medical grade titanium, titanium alloy (ASTM F67, F136, ISO 5832-3, 5832-2), and Shape Memory Alloy (Nitinol - NiTi, ASTM F2063). Explicitly states Nitinol is compatible with titanium/titanium alloy only, not stainless steel.
Intended Use/Indications	Device is cleared for promoting fusion of the cervical and thoracic spine (C1-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors. Specific limitations are detailed for multi-axial screws (T1-T3 only, not cervical).
Manufacturing Standards	Expected to comply with Good Manufacturing Practice requirements (21 CFR Part 820).
Labeling Requirements	Expected to comply with labeling regulations (21 CFR Part 801).

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

The document states, "Mechanical test data was provided in support of this notification." It does not specify:

Sample size: The number of implant components tested.
Data provenance: The origin of the testing data (e.g., in-house lab, third-party lab, country of origin).
Retrospective or Prospective: This distinction is more relevant for clinical studies or data analysis rather than mechanical testing of a device's physical properties. Mechanical tests are typically performed prospectively on representative samples of the device.

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)

This question is not applicable to the VERTEX™ Reconstruction System as it is a mechanical device. "Ground truth" in this context would relate to the physical properties and performance of the device under specific loads and conditions, which are measured objectively, not established by expert human interpretation in the sense of diagnostic imaging. The experts involved would be engineers and material scientists responsible for designing, manufacturing, and testing the device, confirming adherence to specifications and relevant ASTM/ISO standards.

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

Not applicable. Mechanical test results are objective measurements (e.g., force, displacement, stress, strain) and do not involve human adjudication in the way diagnostic interpretations do. The "adjudication" would be in the form of comparing test results against pre-defined engineering acceptance criteria.

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. The VERTEX™ Reconstruction System is a physical medical device for spinal reconstruction, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant to this device.

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

Not applicable. This device is not an algorithm.

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

For mechanical devices, the "ground truth" for demonstrating performance is derived from:

Engineering Specifications: Adherence to design tolerances and material properties.
ASTM/ISO Standards: Compliance with recognized international and national standards for strength, fatigue, corrosion resistance, etc., relevant to spinal implants.
Predicate Device Data: Performance comparable to existing, legally marketed devices.

8. The sample size for the training set

Not applicable. This concerns AI algorithms.

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

Not applicable. This concerns AI algorithms.

Summary

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

CONFIDENTIAL

K003780
10F2

VERTEXTM Reconstruction System 510(k) Summary (K003780) July 2001

I. Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133
II. Product Name:	VERTEX™ Reconstruction System
Classification Name:	Spinal Interlaminal Fixation Orthosis

Description: III.

SEP 2 8 2001

1/2

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

CONFIDENTIAL

Indications IV

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Substantial Equivalence: V.

The VERTEX™ Reconstruction System was claimed to be substantially equivalent to other commercially marketed systems.

Mechanical test data was provided in support of this notification.

20F

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K003780

Trade/Device Name: VERTEX™ Reconstruction System Regulation Number: 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: KWP Dated: June 10, 2001 Received: July 12, 2001

Dear Dr. Treharne:

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 such 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); 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.

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

Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in yours finding of substantial equivalence of your device to a legally premaince notificated on " results in a classification for your device and thus, 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Fall States of Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 4 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

to Mark N Milkerson

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

Enclosure

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Page 1 of 1 July 2001

K003780 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

VERTEXTM Reconstruction System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX™ Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format

1-2-96)

Mark N. Melkerson

ivision Sign-( General, Restorative Neurological Devices K003780

510(k) Number -

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.