VERTEBRON PSS PEDICLE SCREW SYSTEM by VERTEBRON, INC.

The Vertebron PSS Pedicle Screw System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (2.0. , fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML-based medical devices.

The document K033352 is a 510(k) summary for a non-AI/ML medical device, specifically a Spinal Rod System (Vertebron PSS Pedicle Screw System). This device is a traditional hardware implant for spinal fusion.

Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment for AI, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and are not present in the provided submission.

Here's a breakdown of the information that is available based on the request:

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

Acceptance Criteria: The submission states that the device was tested "in accordance with the requirements prescribed in ASTM F1717." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which outlines mechanical testing protocols (e.g., static and dynamic compression bending, torsion). The specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived, failure load) are not detailed in this summary.
Reported Device Performance: "The device was found to perform comparably to other spinal rod systems." This is a qualitative statement of performance relative to predicate devices, but specific quantitative results against the ASTM F1717 criteria are not provided in this summary.

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 / Not provided. For a physical implant, testing involves mechanical samples of the device itself, not patient data in the typical sense of an AI/ML ground truth test set. The number of physical units tested is not specified.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement instruments, not by medical experts interpreting data.

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

Not applicable. This relates to human interpretation of data, which is not relevant for mechanical device 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

Not applicable. This study design is specifically for evaluating the impact of AI on human interpretation of medical images/data. This device is a physical implant.

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

Not applicable. There is no algorithm; this is a physical medical device.

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

The "ground truth" for this device would be its mechanical properties and performance as defined by the ASTM F1717 standard. This is based on engineering specifications and physical measurements, not clinical or pathology data.

8. The sample size for the training set

Not applicable. There is no "training set" for physical mechanical testing.

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

Not applicable.

Summary

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K033352
1f 1

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

	SUBMITTER	Vertebron, Ltd.Stratford, CT 06614
	CONTACT PERSON	Bruce KhaliliVice President, Research & Development
	DATE PREPARED	October 15, 2003
	CLASSIFICATION	Spinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation OrthosisSpondylolithesis Spinal Fixation Device SystemPedicle Screw Spinal System
	COMMON NAME	Spinal Rod System
	PROPRIETARY NAME	Vertebron PSS™ Pedicle Screw System
	PREDICATE DEVICES	U.S. Surgical/S.D.I. K970635 (et al)Depuy/Acromed K030383 (et al)Sofmor/Danek K022778 (et al)
	DEVICE DESCRIPTION	The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.
	TESTING	The device has been tested in accordance with the requirements prescribed in ASTM F1717. The device was found to perform comparably to other spinal rod systems.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2,5 2004

Mr. Bruce Khalili Vice President, Rescarch and Development Vertebron, Inc. 136 Albert Avenue Stratford, Connecticut 06614

Re: K033352

R05552
Trade/Device Name: VERTEBRON™ PSS Pedicle Screw System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Namber - Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNII, KWQ, KWP Dated: January 16, 2004 Received: January 20, 2004

Dear Mr. Khalili:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed four been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togens) and entitled Device Amendments, or to eonimer or provision to ria) 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and connetter for , market the device, subject to the general controls provisions of the Act. The r ou may, attererer, missions 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 may or babyer to back as a sateral 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 r read to a receded 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 or uny 1 ederal button and 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.

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Page 2 - Mr. Bruce Khalili

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse over finding of substantial equivalence of your device to a legally prematication: The PDF Internations sification 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), please If you desire specific acries in (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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

Sincerely yours,

Mark N Melkerson

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

Mark N Milken

Division of General, Restorative, and Neurological Levices

K033352
510(k) Number

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Indications for Use

510 (k) Number (if known): K033352

Device Name: VERTEBRON PSS Pedicle Screw System

Indications For Use:

AND/OR Over-The-Counter Use NO Prescription Use YES i (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ! F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

to
Muhi N Millenn
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
K033352

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.