When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMIS™ systems are indicated for:
• Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors
• Failed previous fusion (pseudoarthrosis)
The U.L.I.S.™ and LUMIS™ systems are pedicle screw systems indicated for skeletally mature patients who:
• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.
In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems 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 (T10-S1):
• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• Fracture
• Spinal tumor
• Failed previous fusion (pseudoarthrosis)

Device Description

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
The purpose of this submission is to include new devices: the U.L.I.S.™ Multi-Axial Reduction Screws, additional instruments to the U.L.I.S.™ System; additional lengths for the LUMIS™ Spinal Rods; and the use of LUMIS™ Spinal Rods with U.L.I.S.™ System.

AI/ML Overview

This document is a 510(k) summary for medical devices (pedicle screw fixation systems), which primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving that the device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a traditional medical device submission, not an AI/ML product:

A table of acceptance criteria and the reported device performance: This document does not present performance metrics or Acceptance Criteria for an AI/ML device. It discusses mechanical performance testing for the pedicle screw system, but that is not relevant to AI/ML acceptance criteria.
Sample sized used for the test set and the data provenance: No test set for an AI/ML model is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts for ground truth establishment for an AI/ML model are mentioned.
Adjudication method for the test set: No adjudication method for an AI/ML model's test set is mentioned.
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 MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for an AI/ML model is mentioned.
The sample size for the training set: No training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: No ground truth for an AI/ML model's training set is mentioned.

In summary, the provided text is a 510(k) submission for a pedicle screw fixation system, not a submission for an AI/ML powered medical device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not present. The document states: "No clinical data is presented." and "No mechanical data is presented: no mechanical test is required for the added components." indicating that the submission relies on engineering analysis and validation/verification to support substantial equivalence to existing predicate devices.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of a stylized human figure with three faces in profile, stacked one behind the other.

April 4, 2016

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

SpineVision, S.A. Ms. Helene Plas Quality Assurance and Regulatory Affairs Manger 10 rue de la Renaissance Bâtiment E 92160 Antony FRANCE

Re: K160124

Trade/Device Name: SpineVision LUMIS™ Cannulated Pedicle Screw Fixation System, SpineVision U.L.I.S.™ Pedicle Screw Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWO, KWP Dated: February 19, 2016 Received: March 7, 2016

Dear Ms. Plas:

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

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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K160124

Device Name

Spine Vision LUMISTM Cannulated Pedicle Screw Fixation System Spine Vision U.L.I.S.TM Pedicle Screw Fixation System

Indications for Use (Describe)

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S.™ and LUMISTM systems are indicated for:

· Degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

· Spondylolisthesis
· Fracture
· Spinal stenosis
· Tumors
· Failed previous fusion (pseudoarthrosis)

The U.L.I.S. TM and LUMISTM systems are pedicle screw systems indicated for skeletally mature patients who:

· have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
· receive fusions using autogenous bone graft only;
· have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
· have the device removed after the development of a solid fusion.

In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):

· Degenerative spondylolisthesis with objective evidence of neurologic impairment
· Fracture
· Spinal tumor
· Failed previous fusion (pseudoarthrosis)

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)

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510(k) SUMMARY

Date	February 19, 2016
Submitter	SpineVision, S.A.10 rue de la RenaissanceBâtiment E92160 AntonyFranceTel. +33(0)1 53 33 25 25Fax +33(0)1 53 33 25 39
SpineVision Contact	Helene PLAS, QA&RA ManagerTel: +33 1 53 33 25 25Fax : + 33 1 53 33 25 39corp.quality@spinevision.com
Trade Name	SpineVision LUMIS™ Cannulated Pedicle Screw Fixation SystemSpineVision U.L.I.S.™ Pedicle Screw Fixation System
Common NameClassification Name	Pedicle Screw Spinal System
Product code	MNI, MNH, KWQ, KWP
CFR section	888.3070, 888.3050
Legally marketedpredicate devices	Primary Predicate:U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation System(K133575)Additional predicates:U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation System(K130302/K112607)Xia Spinal System (K050461/K052761/K060361/K060748/K071373/K113666)VIPER® System, VIPER®2 system (K061520/K111571/K090648/K102701)EXPEDIUM® Spine System (K041119/K062174/K090230/K090799)
Description	The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods. Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied non-sterile.
	The purpose of this submission is to include new devices:the U.L.I.S.™ Multi-Axial Reduction Screws, additionalinstruments to the U.L.I.S.™ System; additional lengths forthe LUMIS™ Spinal Rods; and the use of LUMIS™ SpinalRods with U.L.I.S.™ System.
Material	Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO5832-3).
Intended use/Indications for Use	When used for anterior screw fixation or as a posterior,non-pedicle system of the non-cervical spine, the U.L.I.S.™and LUMIS™ systems are indicated for:• Degenerative disc disease (discogenic back pain withdegeneration of the disc confirmed by history andradiographic studies)• Spondylolisthesis• Fracture• Spinal stenosis• Tumors• Failed previous fusion (pseudoarthrosis)The U.L.I.S.™ and LUMIS™ systems are pedicle screwsystems indicated for skeletally mature patients who:• have severe spondylolisthesis (Grades 3 and 4) at theL5-S1 vertebra;• receive fusions using autogenous bone graft only;• have the device fixed or attached to the lumbar andsacral spine (L3 to sacrum); and• have the device removed after the development of asolid fusion.In addition, the U.L.I.S.™ and LUMIS™ systems are pediclescrew systems intended to provide immobilization andstabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities ofthe thoracic, lumbar, and sacral spine (T10-S1):• Degenerative spondylolisthesis with objective evidenceof neurologic impairment• Fracture• Spinal tumor• Failed previous fusion (pseudoarthrosis)

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Summary ofTechnologicalCharacteristics	The SpineVision Universal Lumbar Intuitive System(U.L.I.S.™ System), and Lumbar Universal MinimallyInvasive System (LUMIS™ System) instrumentations aremanufactured in Titanium Ti-6Al-4V ELI complying withASTM F136. The devices provide correction and rigidstabilization of the spine during development of solid bonefusion following corrective spine surgery for a number ofindications (listed above).
Performance data	The SpineVision® Universal Lumbar Intuitive System(U.L.I.S.™ System), and Lumbar Universal MinimallyInvasive System (LUMIS™ System) conform to specialcontrol established for Pedicle Screw Spinal System and to"Spinal System 510(k)s - Guidance for Industry and FDAStaff Document" issued on May 3, 2004.No mechanical data is presented: no mechanical test isrequired for the added components. Performanceevaluations were previously conducted on constructs,representing the worst case components (static anddynamic axial compression and static torsion per ASTMF1717).Engineering analysis and designvalidation/verification were used to support substantialequivalence of the proposed components.
Substantialequivalence	No clinical data is presented.SpineVision Universal Lumbar Intuitive System (U.L.I.S.™System), and Lumbar Universal Minimally Invasive System(LUMIS™ System) are substantially equivalent to theirpredicate devices in terms of intended use, material,design, mechanical properties and function.
Conclusion	SpineVision Universal Lumbar Intuitive System (U.L.I.S.™System), and Lumbar Universal Minimally Invasive System(LUMIS™ System) are equivalent to the predicate devices.

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.