The Scarlet® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.

When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

The Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Device Description

The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-T spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished.

The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant.

When used with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out.

The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The subject product line extension consists of an extended range of titanium alloy spacers intended to be used with the three unicortical cancellous bone screws previously approved (K181818).

Scarlet® AL-T product line extension comprises a range of hyperlordotic intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.

AI/ML Overview

The provided text describes a medical device, the Scarlet® AL-T intervertebral body fusion device, and its substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of AI performance, human reader improvement with AI assistance, or standalone algorithm performance.

The document is a 510(k) summary for a spinal implant, which means the "acceptance criteria" are related to mechanical and biological performance, and the "study" is non-clinical testing. It explicitly states, "Based on the static testing results and engineering analysis it has been determined that dynamic testing was not necessary." This further confirms the absence of clinical trials or AI-related performance studies.

Therefore, I cannot fulfill the request for information regarding AI performance, human reader improvement, standalone performance, or sample sizes related to such studies, as this information is not present in the provided text.

Here is a partial answer based only on the information available in the document, focusing on the mechanical acceptance criteria and the non-clinical study conducted:

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

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Static Axial Compression (ASTM F2077-18)	Comparable to predicate device	Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Mechanical Performance	Static Shear-compression (ASTM F2077-18)	Comparable to predicate device	Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Mechanical Performance	Static Torsion (ASTM F2077-18)	Comparable to predicate device	Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Mechanical Performance	Subsidence (ASTM F2267-04)	Comparable to predicate device	Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Mechanical Performance	Expulsion (ASTM Draft F-04.25.02.02)	Comparable to predicate device	Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818).
Biocompatibility	Bacterial Endotoxin Testing (USP standard)	Endotoxin limit of < 20 EU/device	Achieves the Endotoxin limit of 20 EU / device.

2. Sample sized used for the test set and the data provenance
The document does not specify the sample size (number of units tested) for each non-clinical test. The "data provenance" is implied to be laboratory testing conducted by the manufacturer (Spineart). This is a non-clinical, in-vitro study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical mechanical and biocompatibility study, not an AI or diagnostic study involving expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a non-clinical mechanical testing report.

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
No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, not an AI or diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical spinal implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this non-clinical study is defined by the established mechanical testing standards (e.g., ASTM F2077-18, ASTM F2267-04, ASTM Draft F-04.25.02.02, USP standard) and the performance of the predicate device (Scarlet® AL-T K181818).

8. The sample size for the training set
Not applicable. This is a non-clinical mechanical and biocompatibility study, not an AI study involving a training set.

9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of non-clinical study.

Summary

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January 22, 2020

Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri 1228 Plan Les Ouates, Geneva SWITZERLAND

Re: K192993

Trade/Device Name: Scarlet AL-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 22, 2019 Received: October 25, 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 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Brent Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192993

Device Name Scarlet® AL-T

Indications for Use (Describe)

When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.

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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Image /page/3/Picture/0 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a butterfly above the word. The butterfly and the "art" portion of the word are purple, while the "spine" portion of the word is black.

K192993 510(k) SUMMARY

510k	TRADITIONAL
Basis for submission	New devices - Product Line Extension
Submitted by	SPINEART
	3 Chemin du Pré Fleuri
	1228 PLAN LES OUATESGENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical Officer
	Phone: +41 22 570 1200 Fax: +41 22 594 8306
	Mail: fpennesi@spineart.comRegulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	December 19, 2019
Common Name	Intervertebral body fusion device
Trade Name	Scarlet® AL-T
Classification Name	Intervertebral Fusion Device with Integrated Fixation Lumbar
Class	II
Product Code	OVD
CFR section	888.3080
Device panel	ORTHOPEDIC
Legally marketedpredicate devices	Primary predicate: Scarlet® Al-T manufactured by Spineart (K181818)
	Additional predicate: NuVasive BASE Interfixated Titanium System manufactured by NuVasive,Incorporated (K170592)
Indications for use	The Scarlet® AL-T system is indicated for intervertebral body fusion procedures in skeletally maturepatients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levelsfrom L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed bypatient history and radiographic studies. These DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used withautogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bonegraft to facilitate fusion. Patients should have at least six (6) months of non-operative treatmentprior to treatment with an intervertebral cage.When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system.When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), theScarlet® AL-T interbody device must be used with supplemental internal spinal fixation system thathas been cleared by the FDA for use in the lumbosacral spine.The Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation bythe mean of the bone screws provided and ALSO additional supplemental fixation system that hasbeen cleared by the FDA for use in the lumbosacral spine.
Descriptionofthedevice	The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device with integratedfixation intended to provide mechanical support to the lumbar spine and maintain adequate discspace until fusion occurs. The Scarlet® AL-T system comprises a range of intervertebral spacersimplanted via an anterior approach, and having various sizes, heights, footprints and lordosis so asto adapt individual pathology and different patient's anatomical conditions. The interbody deviceis a box-shaped spacer with a large central cavity that can receive bone graft intended to promoteintervertebral fusion. The Scarlet® AL-T spacers are all made from medical grade titanium alloyconforming to ASTM F136 standard and are produced by additive manufacturing (SLM) accordingto ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished.
	The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and
	porous structures along with superior and inferior rough surfaces intended to increase implant
	stability into the intervertebral space and bony integration throughout the implant.
	When used with its integrated fixation, the spacer is crossed by three (3) bone screws protruding
	into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that
	prevent backing out.
	The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with
	dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as
	specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU /
	device.
	The subject product line extension consists of an extended range of titanium alloy spacers intended
	to be used with the three unicortical cancellous bone screws previously approved (K181818).
	Scarlet® AL-T product line extension comprises a range of hyperlordotic intervertebral spacers
	implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as
	to adapt individual pathology and different patient's anatomical conditions. The Scarlet® AL-T
	Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the
Technologicalcharacteristicscompared tothe	bone screws provided and ALSO additional supplemental fixation system that has been cleared by
predicate devices	the FDA for use in the lumbosacral spine.
	Except for the lordosis, the Scarlet® AL-T hyperlordotic implants present the same design features,
	anti-backout mechanism, integrated fixation and bone screws as the cleared Scarlet® AL-T devices
	(K181818). The Scarlet® AL-T hyperlordotic implants are manufactured using the same
	manufacturing technology, i.e. additive manufacturing (SLM) as predicate device Scarlet® AL-T
	(K181818). Except for the dedicated trial devices and implant holder, the Scarlet® AL-T
	hyperlordotic implants share the same surgical instrumentation as predicate device Scarlet® AL-T
	(K181818).
Discussion of Testing	The following non-clinical tests were conducted on the Scarlet® AL-T hyperlordotic cages: Static
	Axial Compression according to ASTM F2077-18, Static Shear-compression according to ASTM
	F2077-18; Static Torsion according to ASTM F2077-18, Subsidence according to ASTM F2267-04 and
	Expulsion according to ASTM Draft F-04.25.02.02. Results demonstrate comparable mechanical
	properties to the predicate device Scarlet® AL-T (K181818).
	Based on the static testing results and engineering analysis it has been determined that dynamic
	testing was not necessary.
Conclusion	Based on the design features, technological characteristics, feature comparisons, indications for
	use, and non-clinical performance testing, the Scarlet® AL-T hyperlordotic cages have
	demonstrated substantial equivalence to the identified predicate devices.

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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.