The SpineSelect Polyscrew Pedicle Screw System is intended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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.

Device Description

The SpineSelect Polyscrew Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 5.5-7.5 mm and in lengths from 30-55 mm. Rods are available in 5.5mm diameter either straight or precurved. The straight rods range in lengths from 30-400 mm, whereas the pre-curved rods range in length from 30-150mm. The system includes a screw assembly which includes a polyscrew (solid or cannulated), a saddle and tulip head, Rods are locked in place with a set screw. Associated instrumentation to complete the procedure are provided.

AI/ML Overview

The provided text is a 510(k) summary for the SpineSelect Polyscrew Pedicle Screw System, a medical device. It details the device's indications for use, description, and comparison to predicate devices, but does not describe a study involving an AI/algorithmic device or human readers interpreting data. Instead, it focuses on the mechanical performance of a physical implantable device.

Therefore, I cannot provide information on:

Acceptance criteria and reported device performance related to an algorithm's output. The acceptance criteria discussed are for the mechanical performance of the pedicle screw system, not an algorithm's performance.
Sample size used for the test set and data provenance. No such test set is described for an AI device.
Number of experts used to establish ground truth and their qualifications. Not applicable to a mechanical device submission.
Adjudication method for the test set. Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable.
Standalone (algorithm only) performance. Not applicable as this is a physical device.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an algorithm. Not applicable.
Sample size for the training set and how ground truth was established for the training set. Not applicable.

Based on the provided text, the relevant information regarding acceptance criteria and the study that proves the device meets those criteria is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Standard)	Reported Device Performance
Pre-clinical static compression bending	"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)
Pre-clinical dynamic compression bending	"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)
Pre-clinical static torsion bending	"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)

2. Study that Proves the Device Meets Acceptance Criteria:

Study Type: Pre-clinical mechanical testing.
Methods: The testing performed includes "static and dynamic compression bending and static torsion bending per ASTM F1717-10." ASTM F1717-10 is a standard specification for spinal implant constructs in a corrosive environment intended for internal fixation.
Conclusion: SpineSelect concluded that the SpineSelect Polyscrew Pedicle Screw System is "substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness." This implies that the device's mechanical test results were comparable to or better than those of the predicate devices.

Missing Information (as per the prompt's request for AI-related details):

As this submission is for a physical pedicle screw system and not an AI or algorithmic device, the specific details requested regarding test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not available and not applicable to this document.

Summary

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

510(k) Summary

Date Prepared:	September 26, 2013
Submitter Contact:	John Eckman, President
	SpineSelect, LLC
	408 Council Circle
	PO Box 3660
	Tupelo, MS 38801
	john.eckman@spineselect.com
Regulatory Contact:	Rich Jansen, Pharm. D.
	Silver Pine Consulting, LLC
	richj@s-pineconsulting.com
Trade Name:	SpineSelect Polyscrew Pedicle Screw System
Product Class:	Class III
Classification:	888.3070 Pedicle Screw Spinal System
Common Name:	Pedicle Screw System
Product Codes:	MNI, MNH, NKB
Panel Code:	87

Indications for Use:

Device Descriptions:

JAN 1 3 2014

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

Predicate Device(s): 、

The SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the Moss Miami System (DePuy Spine) (K022623 and others), Optima Spinal System (U&I) (K031585) and Xia Spinal System (Stryker) (K001319 and others).

Performance Standards:

The pre-clinical testing performed includes static and dynamic compression bending and static torsion bending per ASTM F1717-10.

Conclusion:

SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness.

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

Image /page/2/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 13, 2014

SpineSelect, LLC % Rich Jansen. Pharm.D. Silver Pine Consulting, LLC 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K133066

Trade/Device Name: SpineSelect Polyscrew Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: November 5, 2013 Received: November 6, 2013

Dear Dr. Jansen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Rich Jansen, Pharm.D.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronald#AJean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K133066

Prescription Use _ V (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 OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Zane W. Wyatt-S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133066

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.