When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal Fixation System is indicated as an adjunct to fusion for the following indications:

Deqenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic . studies):
. Degenerative spondylolisthesis with objective evidence of neurologic impairment;
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; .
Fracture ●
. Dislocation
Scoliosis .
Kyphosis .
. Spinal tumor
. Failed previous fusion (pseudarthrosis)

Device Description

The Erisma® LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists in the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The Erisma® LP spinal system is composed of rods (straight or pre-bent) fixed on the spine with pedicle screws. The Erisma® LP includes monoaxial and polyaxial pedicle screws (cannulated or not), monoaxial and polyaxial pedicle screws with breaking tabs, as well as transverse link which connects two rods altogether.

The implants used in the Erisma® LP system are available in a variety of diameters and lengths to accommodate patient anatomy and are made of medical grade titanium alloy per ASTM F136 or cobalt-chromium allov per ASTM F1537.

The Erisma® LP procedures are performed using a set of surgical instruments common for posterior spinal fixation approach. Most of the instruments provided are common surgical tools used in these types of posterior fixation of the spine.

AI/ML Overview

This document describes the Clariance SAS Erisma® LP Spinal Fixation System, a medical device for spinal surgery. The information provided is from an FDA 510(k) summary. I will extract the requested information based on the provided text.

Based on the provided text, the Erisma® LP Spinal Fixation System is a mechanical device (spinal fixation system), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the typical acceptance criteria and study characteristics for AI/ML devices (like human reader performance, ground truth establishment, training sets, etc.) are not applicable to this submission.

The acceptance criteria and study described here relate to the mechanical performance and material characteristics of the spinal fixation system.

Here's the breakdown of the requested information, adapted for a mechanical device:

A table of acceptance criteria and the reported device performance

Acceptance Criterion	Reported Device Performance
Dynamic Axial Compression per ASTM F1717	Performed and characterized the modification. The submission indicates the performance demonstrates the modified device is as safe and effective as the predicate device. Specific numerical results are not provided in this summary.
Substantial Equivalence to predicate devices (K153326 and K130877)	Achieved. The modified device has the same intended use, similar indications, principles of operation, and technological characteristics. Performance data supports that it is as safe and effective.
Material Composition	Cobalt-chromium alloy per ASTM F1537 (for new rods); medical grade titanium alloy per ASTM F136 (for other components).
Dimensions and Design	Rods have similar dimensions and design as those already cleared under K153326 for the Erisma® LP predicate device.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific numbers are not provided in this summary. Mechanical testing typically involves a set number of samples required by the standard (ASTM F1717).
- Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. There is no indication of country of origin for the test data or whether it was retrospective or prospective, as these terms are usually applied to clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. For mechanical testing of a spinal fixation system, "ground truth" is established by the test standard (e.g., ASTM F1717) and the physical properties of the materials and design, not by expert consensus in the typical sense of clinical image review. The acceptance is based on meeting the performance requirements defined by the standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in clinical studies (e.g., image interpretation). This is a mechanical device performance study, where acceptance is based on objective measurements against a standard.
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
- Not Applicable. This is a mechanical device, not an AI/ML device, so MRMC studies involving human readers are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Standard Compliance/Predicate Equivalence: The "ground truth" for this device's performance is its compliance with recognized mechanical testing standards (e.g., ASTM F1717) and demonstrating substantial equivalence in performance and characteristics to legally marketed predicate devices.
The sample size for the training set
- Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established
- Not Applicable. As there is no training set for a mechanical device, this question is not relevant.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

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

February 14, 2017

CLARIANCE SAS % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K170163

Trade/Device Name: Erisma® LP Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 18, 2017 Received: January 18, 2017

Dear Ms. Hogan:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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/ResourcesforYou/Industry/default.htm.

Sincerely.

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 Statement

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 on last page

510(k) Number (if known) K170163 Device Name

Erisma® LP Spinal Fixation System

Indications for Use (Describe)

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma" LP Spinal Fixation System is indicated as an adjunct to fusion for the following indications:

Deqenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic . studies):
. Degenerative spondylolisthesis with objective evidence of neurologic impairment;
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; .
Fracture ●
. Dislocation
Scoliosis .
Kyphosis .
. Spinal tumor
. Failed previous fusion (pseudarthrosis)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

Erisma® LP Spinal Fixation System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CLARIANCE SAS 18, rue Robespierre 62217 Beaurains, France

Phone: +33(0)3 2116 1215 Facsimile: +33(0)3 2115 5073

Contact Person:	Pascal ROKEGEM, Chief Technology Officer
Consultant:	Janice Hogan, Regulatory Counsel at Hogan Lovells US LLP
Date Prepared:	February 10, 2017

Name of Device and Name

Erisma® LP Spinal Fixation System

Common or Usual Name

Thoracolumbosacral Pedicle Screw System

Classification Name

Class II, 21 CFR 888.3070 - NKB

Predicate Devices

Erisma® LP manufactured by CLARIANCE SAS (K153326, K120469): primary predicate Expedium® manufactured by DePuy Spine (K130877): additional predicate (CoCr rods)

Purpose of the Special 510(k) notice.

The modified Erisma® LP is a modification to the 510(k) approved Erisma® LP predicate (K153326). The modification consists in the addition of straight and pre-bent rods made from medical grade cobalt-chromium alloy per ASTM F1537. These rods have similar dimensions and design as those already cleared under K153326 for the Erisma® LP predicate device.

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Intended Use / Indications for Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated as an adjunct to fusion for the following indications:

Degenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies);
Degenerative spondylolisthesis with objective evidence of neurologic impairment; ●
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) ● vertebral joint;
Fracture .
Dislocation
Scoliosis ●
Kyphosis ●
Spinal tumor ●
Failed previous fusion (pseudarthrosis) .

Device Description

Technological Characteristics

The proposed modification to the 510(k) cleared Erisma® LP device (K153326) consist in the addition of rods (straight and pre-bent) made of medical grade cobalt-chromium allov per ASTM F1537. The proposed rods are made from the same material as the additional predicate device. These rods vary in size and geometries and are equivalent to those cleared for the company's Erisma® LP predicate device (K153326). The proposed modification is present in the reference device and does not raise different types of safety or effectiveness questions.

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Performance Data

Dynamic Axial Compression testing per ASTM F1717 was performed to characterize the subject modification addressed in this notification.

Substantial Equivalence

The modified Erisma® LP has the same intended use and similar indications, principles of operation, and technological characteristics as 510(k) approved Erisma® LP (K153326). The minor difference in the technological characteristics of the modified Erisma® LP does not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified Erisma® LP is as safe and effective as company's Erisma® LP predicate device (K153326). Thus, the modified Erisma® LP is substantially equivalent to its predicate devices.

Conclusions

The Erisma® LP Spinal Fixation System is substantially 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.