When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

Device Description

The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.

AI/ML Overview

This document describes a 510(k) premarket notification for the Modified VertiFlex® Spinal Screw System. It is focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria for a new medical AI device.

Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Composition	Composed of titanium alloy conforming to ASTM F136-02 (screws) and titanium conforming to ASTM F67-06 or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02 (rods).
Design Characteristics	Designed as a posterior, non-cervical instrumentation system with polyaxial or monoaxial (fixed) top-loading pedicle screws and connecting rods. Available in a range of diameters, lengths, and styles (rigid/semi-rigid rods, straight/curved rods) to accommodate anatomical requirements and surgical methods.
Biomechanical Performance	Non-clinical tests, including biomechanical studies and those conducted in accordance with ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), demonstrated substantial equivalence to commercially-available predicate devices in terms of performance.
Indications for Use (as a pedicle screw fixation system)	Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar, and sacral spine, specifically: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). Additional Indication: Patients receiving fusions with autogenous graft, having the device fixed or attached to the lumbar or sacral spine, and having the device removed after solid fusion mass development.
Sterilization	Offered non-sterile, intended to be sterilized by the user before use.

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

Not Applicable. This is a submission for a spinal implant device, not an AI or diagnostic device that uses a test set of data. The "testing" refers to biomechanical bench testing.

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

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

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 not an AI device.

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

Not Applicable. This is not an AI device.

7. The type of ground truth used

For the biomechanical performance, the "ground truth" would be established by the industry standard test methods (e.g., ASTM F1717) which define specific loads, cycles, and failure criteria for spinal implant constructs. The performance of the modified device was compared to predicate devices under these controlled conditions. The "ground truth" for substantial equivalence lies in meeting general device characteristics and performance benchmarks of commercially available predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI device.

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

Not Applicable. This is not an AI device.

Summary of the Study:

The study proving the device meets its acceptance criteria is primarily a non-clinical biomechanical study and a comparison of design characteristics and materials to legally marketed predicate devices.

Study Type: Non-clinical (biomechanical studies and material/design comparisons). The document explicitly states: "No clinical testing was conducted to support this submission."
Purpose: To demonstrate "substantial equivalence" of the Modified VertiFlex® Spinal Screw System to existing, commercially available predicate devices in terms of design, materials, indications, and performance.
Methodology:
- Material and Design Comparison: The device's materials (titanium alloy, titanium) and design features (posterior, non-cervical, pedicle screws, connecting rods, polyaxial/monoaxial, range of sizes, conventional/minimally-invasive implantation) were compared directly to those of listed predicate devices (e.g., VertiFlex® Spinal Screw System, Isobar® TTL System, Dynesys™ System, N Fix II (N Flex) System, CD HORIZON® System, AccuFlex™ (Protex™) System, ZODIAC® DYNAMO™ System).
- Biomechanical Testing: Non-clinical tests, including those performed in accordance with recognized standards like ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), were conducted. These tests would simulate physiological loads and assess the mechanical integrity and fatigue life of the implant constructs.
Acceptance Criteria for Substantial Equivalence: The modified device was deemed substantially equivalent if its design, materials of composition, indications, performance (as demonstrated by biomechanical testing), and other features were comparable to the predicate devices. The specific quantitative acceptance criteria for the biomechanical tests are not detailed in this summary but would be defined within the ASTM F1717 standard and the company's internal testing protocols, ensuring the device performs similarly or superiorly to the predicates.
Conclusion: The results of the non-clinical tests and comparisons demonstrated the "substantial equivalence" of the Modified VertiFlex® Spinal Screw System to the identified predicate devices, as stated in Section 5.9.

Summary

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K073143

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APR - 7 2008

5.0 510(k) SUMMARY

In accordance with Title 21 Code of Federal Regulations (21 CFR). Part 807, and in particular, §807.92, the following 510(k) summary is provided for the Modified VertiFlex® Spinal Screw System:

5.1 Submitted By:

VertiFlex®, Incorporated 1351 Calle Avanzado San Clemente, California 92673 Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance

Date Prepared: November 2, 2007

5.2 Device Name

Trade or Proprietary Name: Modified VertiFlex® Spinal Screw System Common or Usual Name: Pedicle Screw System Classification Name: Pedicle Screw Spinal System Classification Regulation: 21 CFR, §888.3070 Product Codes: MNH, MNI, NKB

5.3 Predicate Devices

The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate device:

VertiFlex® Spinal Screw System - (VertiFlex®, Inc.; K062670) Isobar® TTL System - (Scient'x; K991326, et seq) Dynesvs TM System - (Zimmer Spine: K031511, et seq) N Fix II (N Flex) System -- (N Spine; K061774) CD HORIZON® System - (Medtronic; K063670 & K060615) AccuFlex™ (ProtexTM) System -- (Globus Medical; K0520690 ZODIAC® DYNAMO™ System - Alphatec; K072081)

Device Description 5.4

The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimallyinvasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.

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073143

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ર્સ્ડ Intended Use

5.6 Comparison to Predicate Devices

Testing and comparisons of design characteristics and features have established that the subject Modified VertiFlex® Spinal Screw System is substantially equivalent in design, materials of composition, indications, performance, and other features, to other commercially-available predicate pedicle screw systems having semi-rigid rods.

5.7 Summary of Non-Clinical Tests

Non-clinical tests, including biomechanical studies, and those conducted in accordance with such recognized standards as ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commerciallyavailable predicate devices in terms of performance.

Summary of Clinical Tests 5.8

No clinical testing was conducted to support this submission.

5.9 Conclusions

The results of testing and comparisons have established the substantial equivalence of the subject device to the identified predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Public Health Service

APR - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VertiFlex™, Inc. % Mr. Steve Reitzler VP. Regulatory and Quality Assurance 1351 Calle Avandazo San Clemente, California 92673

Re: K073143

Trade/Device Name: Modified VertiFlex™ Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NKB, MNI, MNH Dated: March 24, 2008 Received: March 27, 2008

Dear Mr. Reitzler:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2- Mr. Steve Reitzler

The 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 vours.

Anuley B. Baran

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K073143

Device Name: Modified VertiFlex™ Spinal Screw System

Indications for Use:

Prescription Use ﮨﮯ (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)

Neil R.P. Gdl forman

Division of General. Restorative. and Neurological Devices

510(k) Number Ko73143

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.