The ResCUBE System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and in the repair of bone fractures. The indications for use include the following applications:

Spinal trauma surgery, that can be treated with sublaminar, interspinous or facet wiring techniques.
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis and spondylolisthesis.
Spinal degenerative surgery, as an adjunct to spinal fusions.

Device Description

The ResCUBE™ Ligament Fixation System (ResCUBE System) is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The ResCUBE System consists of the following components: a ligament allowing correction and stabilization of the levels, after tensioning; a malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath; and a low-profile connector holding the tension on the ligament.

AI/ML Overview

The provided text is a 510(k) Summary for the ResCUBE™ Ligament Fixation System. It details information typically provided to the FDA for medical device clearance. However, it does not contain the specific type of acceptance criteria and study data related to AI/algorithm performance that you are asking for.

The document discusses performance testing for the ResCUBE System, but this refers to physical bench testing of the device's mechanical properties, not the performance of an AI or algorithmic component.

Therefore, most of the information requested in your prompt regarding acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as it appears the ResCUBE™ Ligament Fixation System is a physical medical implant, not an AI-powered device.

Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standards Met)	Reported Device Performance
IEC 62366: 2007	Complies with predetermined specifications and standards.
ISO 14630: 2012	Complies with predetermined specifications and standards.
Predetermined Specifications	Meets a set of undisclosed internal specifications for static and dynamic tension testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as the testing refers to physical device performance and not data-driven AI performance.

3. 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)

This information is not provided as the ground truth for physical device testing is typically based on engineering specifications and direct measurements, not expert consensus on interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. This concept generally applies to human review of data, which is not the focus of this device's performance testing.

5. 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

A MRMC study was not done, as this device is a physical implant and does not involve AI assistance for human readers.

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

This information is not applicable as the device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for the performance testing mentioned (static and dynamic tension testing) is likely based on engineering specifications and direct physical measurements against established standards (IEC 62366: 2007, ISO 14630: 2012) and the manufacturer's own predetermined specifications.

8. The sample size for the training set

This information is not applicable as there is no training set for a physical implant device without AI components.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a physical implant device without AI components.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 29, 2018

Cousin Biotech S.A.S. Mr. Franck Pelletier Regulatory Affairs Director 8 Rue De L'abbe Bonpain Wervicq-Sud 59117 FRANCE

Re: K181799

Trade/Device Name: ResCUBE™ Ligament Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: June 29, 2018 Received: July 5, 2018

Dear Mr. Pelletier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -S

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

Enclosure

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

Indications for Use

510(k) Number (if known) K181799

Device Name ResCUBETM Ligament Fixation System

Indications for Use (Describe)

1. Spinal trauma surgery, that can be treated with sublaminar, interspinous or facet wiring techniques.

Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis and spondylolisthesis.
Spinal degenerative surgery, as an adjunct to spinal fusions.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary provided in accordance with 21 CFR §807.92(C)

Submission Date:	June 29, 2018
Submitter:	Cousin Biotech S.A.S.8 Rue De L'abbe Bonpain59117 Wervicq-Sud, France
Submitter Contact:	Ms. Mathilde ColletRegulatory Affairs EngineerPhone: +011 33 (3) 20144130Email: m.collet@cousin-biotech.com
ApplicationCorrespondent:	Mr. Franck PelletierRegulatory Affairs DirectorPhone: +011 33 (3) 20144119Email: f.pelletier@cousin-biotech.com
Manufacturing Site:	Cousin Biotech S.A.S.Allée des rosesF-59117 Wervicq-Sud, France
Trade Name:	ResCUBE™ Ligament Fixation System
Classification Name:	Bone Fixation Cerclage, Sublaminar
ClassificationRegulation:	21 CFR §888.3010 – Bone Fixation Cerclage, Class II
Product Code:	OWI
SubstantiallyEquivalent Devices:	K172206 - Cousin Biotech S.A.S. - NAJA™ Ligament CorrectionSystem (Primary)K922952, K941213 - Pioneer Surgical (now RTI Surgical) - SongerSpinal Cable (Additional Predicate)K153348 - Implanet S.A. - JAZZ LOCK (Additional Predicate)
Device Description:	The ResCUBE™ Ligament Fixation System (ResCUBE System) is atemporary spinal implant intended to provide temporary stabilization asa bone anchor during the development of solid bony fusion and aid inthe repair of bone fractures. The ResCUBE System consists of thefollowing components: a ligament allowing correction and stabilizationof the levels, after tensioning; a malleable leader allowing guidance ofthe ligament during surgery and attached to the ligament by a PETsheath; and a low-profile connector holding the tension on the ligament.

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

510(k) Summary provided in accordance with 21 CFR §807.92(C)

Intended Use:	The ResCUBE System is a temporary implant for use in orthopedicsurgery. The system is intended to provide temporary stabilization as abone anchor during the development of solid bony fusion and aid in therepair of bone fractures. The indications for use include the followingapplications:
	1. Spinal trauma surgery, that can be treated with sublaminar,interspinous or facet wiring techniques.
	2. Spinal reconstructive surgery, incorporated into constructs for thepurpose of correction of spinal deformities such as scoliosis, kyphosisand spondylolisthesis.
		3. Spinal degenerative surgery, as an adjunct to spinal fusions.
TechnologyComparison:	The ResCUBE System employs the same technological characteristicsas the primary predicate device.
	Characteristic	Cousin Biotech S.A.S. / NAJATMLigament Correction System(K172206)	Cousin Biotech S.A.S. / ResCUBETMLigament Fixation System(Proposed Device)
	ImplantComponents	Connector (with lateral hooks)with screw.	Connector (without lateral hooks) withscrew.
		Ligament with metal guide andPET sheath, but no buckle.	Ligament with metal guide and PETsheath, but no buckle.
		(Ligament has a stiff section onone end for guiding the bandthrough the spine.)	(Ligament has a stiff section on one endfor guiding the band through the spine.)

Titanium alloy connector is

available in two (2) sizes of 5.5

and 6.0 mm compatible with the

TA6V ELI titanium alloy (ASTM

same diameter rod constructs.

F136 and ISO 5832-3).

304L stainless steel.

PET sheath.

Yes

Sizes

Metal Clamp and Screw

(Connector)

Shipped Sterile

Guide

Titanium alloy connector is available in

one (1) size because it is not used with

TA6V ELI titanium alloy (ASTM F136

rods. The body of the ResCUBE

and ISO 5832-3).

304L stainless steel.

PET sheath.

Yes

connector is identical to the NAJA connector less the lateral hooks.

{5}------------------------------------------------

510(k) Summary provided in accordance with 21 CFR §807.92(C)

Summary of Performance Testing:

Performance Testing– Bench	Static and dynamic tension testing were performed on ResCUBESystem. The ResCUBE System was tested for performance inaccordance with its predetermined specifications and the followingstandards:
	• IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices; and
	• ISO 14630: 2012, Non-active surgical implants – Generalrequirements.
	Test results indicate that the ResCUBE System complies with itspredetermined specifications and with the standards.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of ResCUBE System. Theresults of these activities demonstrate that ResCUBE System is as safe,as effective, and perform as well as or better than the predicate devices.
	Therefore, the ResCUBE System is considered substantially equivalentto the predicate devices.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.