SCARLET® AC-T cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. SCARLET® AC-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.

Device Description

The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. Scarlet® AC-T is available in convex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heights in order to accommodate different patient anatomies. The Scarlet® AC-T fixation screws are available with diameters 3.0 mm and 3.5 mm and come in various sizes so as to accommodate different patient anatomies. The SCARLET® AC-T spacer and screws are made of Titanium alloy Ti6Al4V ELI conforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

AI/ML Overview

The provided text describes a 510(k) submission for the SCARLET® AC-T Secured Anterior Cervical Cage, specifically a "SPECIAL 510k DEVICE MODIFICATION" related to an "Extension of the range of SCARLET® AC-T screws."

This document is a regulatory filing for a medical device and not a study that proves a device meets acceptance criteria in the context of an AI/ML algorithm's performance. The information requested (acceptance criteria, study details, sample size, ground truth, expert qualifications, etc.) is typically found in performance studies for diagnostic or prognostic devices, especially those utilizing AI/ML.

The SCARLET® AC-T device is an intervertebral body fusion device made of titanium alloy, and the modification involves adding new screw sizes with a modified distal tip. The regulatory submission states that "No additional testing has been performed for the added Scarlet® AC-T fixation screws. A risk analysis was performed to determine that additional testing was not needed."

Therefore, I cannot provide the requested information because:

There are no acceptance criteria or reported device performance for an AI/ML algorithm. This document is for a physical orthopedic implant.
No study, as understood in the context of evaluating an AI/ML algorithm, was performed for this specific modification. The submission explicitly states no additional testing was done.
There is no "test set," "ground truth," or "experts" involved in determining the performance of a software or AI component. The evaluation here is based on substantial equivalence to existing predicate devices, considering material properties, design features, and a risk analysis.

In summary, the provided text does not contain the information needed to answer the prompt as it pertains to the performance evaluation of an AI or software device.

Summary

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March 4, 2019

SPINEART Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri Plan Les Ouates CH 1228 Geneva

Re: K190322

Trade/Device Name: SCARLET® AC-T Secured Anterior Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: February 11, 2019 Received: February 13, 2019

Dear Mr. Pennesi:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.

Melissa Hall -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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Indications for Use

510(k) Number (if known) K190322

Device Name

SCARLET® AC-T Secured Anterior Cervical Cage

Indications for Use (Describe)

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)

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K190322 Page 1 of 2

SPECIAL 510k DEVICE MODIFICATION Scarlet® AC-T

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510(k) SUMMARY

510k	510k SPECIAL - DEVICE MODIFICATION
Reason for submission	Extension of the range of SCARLET® AC-T screws
Submitted by	SPINEART
	3 Chemin du Pré Fleuri
	1228 PLAN LES OUATES
	GENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical Officer
	Phone: +41 22 570 1200 Fax: +41 22 594 8306
	Mail: fpennesi@spineart.com
	Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	February 8, 2019
Common Name	Intervertebral body fusion device
Trade Name	SCARLET® AC-T Secured Anterior Cervical Cage
Classification Name	Intervertebral fusion device with bone graft, cervical / Intervertebral fusion device
	with integrated fixation, cervical
Class	II
Product Code	ODP / OVE
CFR section	888.3080
Device panel	ORTHOPEDIC
Legally marketedpredicate devices	Primary predicate: SCARLET® AC-T Secured Anterior Cervical Cage (K172065)manufactured by SPINEART
	Additional predicates: SCARLET® AC-T Secured Anterior Cervical Cage (K143214and K141314) manufactured by SPINEART

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Indications for use	SCARLET® AC-T cages are indicated for use in skeletally mature patients withdegenerative disc disease (defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies) of thecervical spine. Patients should have at least six (6) weeks of non-operativetreatment prior to treatment with an intervertebral cage. SCARLET® AC-T cages areintended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitateintervertebral body fusion with autogenous bone graft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft.
	The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as astandalone system used with the two bone screws provided and requires noadditional supplementary fixation systems.When used without the two bone screws, SCARLET AC-T cages are to be used withsupplemental fixation which has been cleared by the FDA for use in the cervicalspine.
Descriptionofdevice	The Scarlet® AC-T is a box-shaped spacer with a central cavity that can be filled withautogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Scarlet® AC-T is available inconvex or lordotic profiles. Scarlet® AC-T comes in two footprints and six heightsin order to accommodate different patient anatomies. The Scarlet® AC-T fixationscrews are available with diameters 3.0 mm and 3.5 mm and come in varioussizes so as to accommodate different patient anatomies.The SCARLET® AC-T spacer and screws are made of Titanium alloy Ti6Al4V ELIconforming to ISO 5832.3 and ASTM F136. SCARLET® AC-T is single-use deviceprovided sterile (gamma radiation) and supplied with dedicated surgicalinstruments.Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testingto achieve the Endotoxin limit of 20 EU / device.
Technologicalcharacteristicscompared tothepredicate devices	Added Scarlet® AC-T fixation screws are 3.5 mm in diameter with a core diameter of2.1 mm for the first-intention screw and 2.6 mm for the revision screw. These addedScarlet® AC-T fixation screws present a modified distal tip to facilitate the insertioninto the bone.All other dimensions and features (material, hexalobe imprint, anti-backoutmechanism) are identical.As was established in this submission added Scarlet® AC-T fixation screws aresubstantially equivalent and has the same technological and mechanical characteristicsto predicate devices.
Discussion of Testing	No additional testing has been performed for the added Scarlet® AC-T fixation screws.A risk analysis was performed to determine that additional testing was not needed.
Conclusion	Based on the design features, technological characteristics, feature comparisons,indications for use, and non-clinical performance testing, the Scarlet® AC-T hasdemonstrated substantial equivalence to the identified predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.