The Conklusion Pedicle Screw System, including hooks, is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Device Description

The ConKlusion Pedicle Screw System is a spinal system that consists of a variety of hooks, screws, rods, connectors, and associated instruments. Fixation is provided by bone (pedicular) screws inserted into the vertebral body of the spine using posterior approach.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ConKlusion Pedicle Screw System. The acceptance criteria and the study proving the device meets them are focused on mechanical and functional safety for an orthopedic implant, rather than the performance of an AI or diagnostic device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Type)	Standard Met	Reported Device Performance
Static Compression Bending	ASTM F1717	Performed as designed and met, or exceeded, product specifications.
Static Tensile Bending	ASTM F1717	Performed as designed and met, or exceeded, product specifications.
Static Torsion	ASTM F1717	Performed as designed and met, or exceeded, product specifications.
Dynamic Compression Bending Fatigue	ASTM F1717	Performed as designed and met, or exceeded, product specifications.

Note: The text indicates that "All testing was conducted in accordance with ASTM F1717." While it states the device met or exceeded "all product specifications," the specific quantitative acceptance thresholds for each test (e.g., minimum load to failure, maximum deflection, number of cycles survived) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The sample size for each functional and mechanical test (compression bending, tensile bending, torsion, and compression bending fatigue) is not specified in the provided document. The document only states "Functional and Mechanical testing of the subject device consisted of three static mechanical tests and one dynamic test to evaluate the spinal implant assemblies."
Data Provenance: The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission. No country of origin for the data is explicitly mentioned, but the submitter is SIGNUS Medical, LLC, based in Chanhassen, MN, USA, and the FDA is the reviewing body, suggesting a US-based context for the testing. The testing is retrospective in the sense that it was completed prior to the submission for market clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by the specifications and standards (ASTM F1717) and the physical measurements of the device's performance under stress, pressure, and fatigue, not by expert human interpretation.

4. Adjudication Method

This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation (e.g., medical imaging reads) requires consensus or tie-breaking mechanisms. In mechanical testing, results are objectively measured against predefined engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The ConKlusion Pedicle Screw System is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not through human reader interpretation of cases.

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

Not applicable. This question pertains to AI algorithms. The device described is a physical pedicle screw system, not an algorithm. Its "standalone performance" refers to its mechanical integrity and function as tested in a lab.

7. The Type of Ground Truth Used

The ground truth used for the device's performance evaluation is based on defined engineering specifications and compliance with recognized industry standards (ASTM F1717). These standards dictate specific test parameters and success criteria for spinal implant assemblies. The "ground truth" is that the device must meet or exceed these physical, measurable requirements.

8. The Sample Size for the Training Set

This question is not applicable as the described study is for a physical medical device and its mechanical properties, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device and study.

Summary

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OCT 2 2 2003

SECTION 2. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:	SIGNUS Medical, LLC.
Contact Person:	Mr. Thomas Hoghaug, Managing DirectorSIGNUS Medical LLC6713 Lakeway DriveChanhassen, MN 55317Telephone: (952) 974-9456Fax: (952) 975-0465
Date Prepared:	May 5, 2003
Trade Name:	The ConKlusion Pedicle Screw System
Classification, Nameand Number:	Class IIPedicle Screw System21 CFR 888.3070
Product Code:	MNI and MNH
Predicate Device(s):	The subject device is substantially equivalent to the followingdevices:● Plus Pivot Link Universal System (K022271), manufactured bySpineVision, Inc.● Global Spinal Fixation System (K001668), manufactured byD.K.M Co., LTD.● Triple-Fix Spinal Fixation System (K992147), manufacturedby Advanced Spine Technology, Inc.
Device Description:	The ConKlusion Pedicle Screw System is a spinal system thatconsists of a variety of hooks, screws, rods, connectors, andassociated instruments. Fixation is provided by bone (pedicular)screws inserted into the vertebral body of the spine using posteriorapproach.
Intended Use:	The Conklusion Pedicle Screw System, including hook, is intendedto provide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the treatmentof the following acute instabilities or deformities of the thoracic,lumbar, and sacral spine: degenerative spondylolisthesis withobjective evidence of neurologicalimpairment, fracture.

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dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Functional and Mechanical testing of the subject device consisted of three static Safety Testing: mechanical tests and one dynamic test to evaluate the spinal implant assemblies. The three static mechanical tests are compression bending, tensile bending, and torsion. The dynamic test is compression bending fatigue. All testing was conducted in accordance with ASTM F1717. The result of the testing was successful. The device performed as designed and met, or exceeded, all product specifications.

SIGNUS Medical LLC considers the ConKlusion Pedicle Screw Conclusion: System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials、 and a indications for use.

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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 circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

SIGNUS Medical, LLC C/o Ms. Tracy L. Gray, R.N., B.S., RAC Senior Consultant Alquest, Inc. 4050 Olson Memorial Hwy., Suite 350 Minneapolis, Minnesota 55422

Re: K031455

Trade Name: Conklusion® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: September 8, 2003 Received: September 9, 2003

Dear Ms. Gray:

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.

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Page 2 - Ms. Tracy L. Gray, R.N., B.S., RAC

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 (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 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,

Mark N. Millers

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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Indications for Use Page .

Device Name: The Conklusion® Pedicle Screw System

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to S l ) with removal of the implants after the attainment of a solid fusion.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Wilkerson

vision Sion. ision of General, Restorative ad Neurologic

10(k) Number

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.