The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle 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 (i.e., 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 (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds both adjustable and fixed cross connectors.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VERTEBRON PSS™ Pedicle Screw System, specifically focusing on the addition of adjustable and fixed cross connectors. The submission primarily addresses substantial equivalence to predicate devices and describes the mechanical testing performed.

However, the provided text does not contain information related to a study proving the device meets acceptance criteria in terms of clinical performance, diagnostic accuracy, or human reader improvement, as typically seen in studies for AI/software as a medical device (SaMD). The acceptance criteria outlined are based on mechanical testing for substantial equivalence.

Therefore, I will extract the relevant information from the document regarding the acceptance criteria and the "study" (mechanical testing) that demonstrates equivalence. Many of the questions in your prompt are not applicable to this type of device submission (mechanical implant) and the information provided.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (What was tested)	Reported Device Performance (Result)
Mechanical integrity of the VERTEBRON PSS™ Pedicle Screw System with cross connectors	Demonstrated substantial equivalence to predicate devices as per ASTM 1717 testing.

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

Sample Size: Not explicitly stated in the provided text. Mechanical testing often involves a smaller number of physical samples compared to clinical trials or AI model evaluations.
Data Provenance: The "study" was mechanical testing performed by VERTETEBRON Inc. It's not clinical data, so country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. This was mechanical testing according to a standard (ASTM 1717), not an expert-driven ground truth establishment.

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

Not applicable. Adjudication methods are relevant for expert-driven ground truth, not for standardized 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 a mechanical implant device, not an AI or diagnostic device that would involve human readers or AI assistance for interpretation.

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

Not applicable. This is a mechanical implant device.

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

The "ground truth" here is compliance with the ASTM 1717 standard for mechanical testing, demonstrating substantial equivalence to predicate devices. It is not a clinical ground truth.

8. The sample size for the training set:

Not applicable. This is a mechanical implant device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a mechanical implant device.

Summary of the Study (Mechanical Testing):

The study referenced is "Testing in accordance with ASTM 1717". This standard applies to the "Standard Test Method for Spinal Implant Constructs in a Corpectomy Model." The purpose of this testing was to demonstrate that the modified VERTEBRON PSS™ Pedicle Screw System (with cross connectors) is substantially equivalent in its mechanical performance to the previously cleared VERTEBRON PSS™ Pedicle Screw System (without cross connectors) and other predicate devices (Optima Spinal Fixation System; U&I America).

The acceptance criteria implicitly revolve around meeting the performance benchmarks or being within acceptable tolerance levels as compared to the predicate devices when tested under the ASTM 1717 protocol. The "reported device performance" is that it did demonstrate substantial equivalence.

Summary

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FEB - 1 2005

Exhibit C

VERTEBRON PSS™ Pedicle Screw System Special 510(k) Summary - K043152 December 2004

Summary of Safety and Effectiveness VIII.

VERTEBRON Inc. SUBMITTER: 400 Long Beach Blvd. Stratford, CT 06615 (203) 380-9340
Luis Nesprido CONTACT PERSON: Regulatory Affairs Manager
December 2004 DATE PREPARED:
21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis CLASSIFICATION NAME: 21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis 21 CFR §888.3070 Pedicle Screw Spinal System
Pedicle Screw Spinal System COMMON NAME:
VERTEBRON PSS™ Pedicle Screw System PROPRIETARY NAME:
VERTEBRON PSS™ Pedicle Screw System K033352 PREDICATE DEVICES:
The VERTEBRON PSS™ Pedicle Screw System is DEVICE DESCRIPTION: comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds both adjustable and fixed cross connectors.
The VERTEBRON PSS™ Pedicle Screw System is INTENDED USE: intended for noncervical, nonpedicle 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 (i.e., fracture or dislocation);

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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 for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The material used is medical grade titanium material that MATERIALS: conforms to ASTM F136.

SUBSTANTIAL EQUIVALENCE:

Testing in accordance with ASTM 1717 was performed and demonstrated that the VERTEBRON PSS™ Pedicle Screw System with cross connectors is substantially equivalent to the VERTEBRON PSS™ Pedicle Screw System without cross connectors (K033352), and Optima Spinal Fixation System; U&I America (K024096), which have received market clearance by the FDA.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three stylized lines representing the head, body, and legs.

Public Health Service

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Luis Nesprido Regulatory Affairs, Manager Vertebron, Inc. 400 Long Beach Blvd. Stratford, Connecticut 06615

Re: K043152

Trade/Device Name: Modification to VERTEBRON PSS™ Pedicle Screw System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, and 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis, and Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: MNH, MNI, KWQ, and KWP Dated: January 7, 2005 Received: January 10, 2005

Dear Mr. Nesprido:

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 se 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. Nesprido

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0120. 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 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 vours.

R. Mark A. Millican

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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EXHIBIT A

Indications for Use V.

510(k) Number (if known): K043152

VERTEBRON PSS™ Pedicle Screw System Device Name: Indications For Use:

Prescription Use: __ x (Per 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)

Mark A. Miller

510(k) Number K043152

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.