The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
SteriSpine™PS System is intended for posterior, non-cervical pedicle and non-pedicle fixation 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; tumor; pseudoarthrosis; and failed previous fusion.

Device Description

SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module).
The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the SteriSpine™PS Pedicle Screw:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (SteriSpine™PS Pedicle Screw), the acceptance criteria are not presented in a quantitative, pass/fail manner. Instead, the study focuses on demonstrating substantial equivalence to predicate devices. The performance is reported in terms of comparability to established predicate devices under specific mechanical tests.

Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Comparable mechanical properties to predicate devices (K112453, K121299, K130632) as per ASTM F1717 and ASTM F1798.	Results demonstrate comparable mechanical properties to the predicate device.
Compliance with Special Control for Pedicle Screw Spinal Systems and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document".	SteriSpine™PS conforms to special control and the relevant guidance document.

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

The document does not explicitly state a "test set" in the context of clinical trials or data analysis that would typically have a defined sample size and provenance. Instead, it refers to:

Mechanical Testing: Performed on the device itself. The sample size for each specific mechanical test (e.g., number of constructs tested for static compression) is not specified.
Cadaver Testing: Performed to validate the instrumentation. The number of cadavers or tests is not specified.
Clinical Data: "Clinical data from a review of the literature has been presented in the class III summary." This indicates a retrospective literature review rather than a prospective clinical study with a defined sample size. The provenance of this literature data (e.g., country of origin) is not specified.

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

Since there is no "test set" in the typical sense of human-reviewed data, and the primary assessment is mechanical and literature-based, this information is not applicable to this submission. Ground truth, if considered, would be derived from the mechanical standards and the documented performance of the predicate devices.

4. Adjudication Method for the Test Set

As there is no "test set" requiring human review or ground truth establishment in this context, the adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The submission primarily relies on mechanical testing and a literature review for clinical data. This type of study would typically be relevant for imaging or diagnostic AI devices where human reader performance is being evaluated.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This device is a physical pedicle screw system, not an algorithm or software-only device.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" implicitly refers to:

Engineering Standards: Adherence to ASTM F1717 and ASTM F1798.
Reference Device Performance: The established mechanical properties of the legally marketed predicate devices (K112453, K121299, K130632).

For the clinical data, the "ground truth" is derived from:

Clinical Literature: Published evidence regarding the performance and safety of similar pedicle screw systems.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical implant, not an AI/ML algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

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

This information is not applicable for the reasons stated in point 8.

Summary

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510(k) SUMMARY

JUN 0 4 2014

510k	SPECIAL
Submitted by	Safe Orthopaedics
	Parc des Bellevues
	Allée R. Luxembourg - Le Californie
	95610 Eragny sur Oise - FRANCE
	Phone: +33 (0) 1 34 21 50 00
Contacts	Pierre DUMOUCHEL – Quality affairs & Regulatory affairs Director
	p.dumouchel@safeorthopaedics.com
	Regulatory contact : Isabelle DRUBAIX (Idée Consulting)
	idee-consulting@nordnet.fr
Date Prepared	April 30th 2014
Common Name	Pedicle screw spinal system
Trade Name	SteriSpine™PS Pedicle Screw
Classification Name	Pedicle screw spinal system
Class	III
Product Code	NKB, MNI, MNH, KWP
CFR section	888.3070
Device panel	Orthopedic
Legally marketedpredicate devices	Sterispine™ PS Pedicle Screw K112453, K121299 and K130632manufactured by SAFE ORTHOPAEDICS
Indications for use	The SteriSpine™PS system is intended to provide immobilization and
	stabilization of spinal segments in skeletally mature patients as an
	adjunct to fusion.
	SteriSpine™PS System is intended for posterior, non-cervical pedicle
	and non-pedicle fixation 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;
	tumor; pseudoarthrosis; and failed previous fusion.
Description of thedevice &TechnologicalCharacteristics	SteriSpineTMPS system includes Pedicle Screws and Rods. Componentsof SteriSpineTMPS system are made of Titanium Ta6V Eli gradeconforming to ASTM F136. Components added within this submissioninclude multi-axial extended head screws and multi axial extended headcannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm),additional lengths for straight and prebent rods ø5.5mm, additionalsurgical instruments (screw head breakage tip, set screw holder andracking compression pliers, Ratchet module).The SteriSpineTMPS range of products is supplied sterile with a sterilesingle-use set of surgical instruments.
Discussion of Testing	SteriSpineTMPS conforms to special control established for Pediclescrew spinal system and to « Spinal System 510(k)s - Guidance forIndustry and FDA Staff Document » issued on: May 3, 2004.Mechanical testing was conducted per ASTM F1717 Standard TestMethods for Spinal Implant Constructs in a Vertebrectomy Model andASTM F1798 Standard Guide for Evaluating the Static and FatigueProperties of Interconnection Mechanisms and Subassemblies Used inSpinal Arthrodesis Implants. Testing according to ASTM F1717 includesStatic Compression, Static Torsion and Dynamic Compression. Testingaccording to ASTM F1798 includes Static slipping, Static bending andStatic rotation. Results demonstrate comparable mechanical propertiesto the predicate device. Cadaver testing performed to validate theinstrumentation have been presented.No additional testing has been performed for the added components.Clinical data from a review of the literature has been presented in theclass III summary.
Conclusion	The extended range of SteriSpineTMPS system is substantially equivalentto its predicate devices SteriSpineTMPS system (K112453, K121299 andK130632) in terms of intended use, material, design, mechanicalproperties and function.Verification Activity and Validation Activity demonstrate thatcomponents added to SteriSpineTMPS system are substantiallyequivalent to predicates.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three parallel lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

June 4, 2014

Safe Orthopaedics Mr. Pierre Dumouchel Quality Affairs & Regulatory Affairs Director Parc des Bellevues - Allée R. Luxembourg - Bat. Californie 95610 Eragny sur Oise - FRANCE

Re: K140802

Trade/Device Name: SteriSpine™ PS Pedicle Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNI, MNH, KWP Dated: May 6. 2014 Received: May 9. 2014

Dear Mr. Dumouchel:

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 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. Pierre Dumouchel

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140802

Device Name SteriSpine™ PS Pedicle Screw

Indications for Use (Describe)

The SteriSpine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion.

SteriSpine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation 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; tumor; pseudoarthrosis; and failed previous fusion.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY ·

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Zane W. Wyatt Division of Orthopedic Devices

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.