Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products.

Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the FloSpine Ti-Largo™ Cervical Interbody System, which is a physical medical device (an intervertebral body fusion device made of titanium alloy).

Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth, expert adjudication, or training/test set sample sizes, as these concepts are not applicable to the presented document.

The document discusses performance data for the physical interbody system, which includes mechanical and sterilization testing to demonstrate substantial equivalence to predicate devices.

Here's what I can extract regarding the physical device's performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted but does not explicitly state the numerical acceptance criteria for each test or the specific reported device performance values (e.g., actual compression strength in Newtons or number of cycles to failure). It simply states that the outcomes met "all acceptance criteria."

Test Category	Test Standard/Type	Reported Performance
Mechanical Testing	Static Compression	Met acceptance criteria
	Dynamic Compression Fatigue	Met acceptance criteria
	Static Torsion	Met acceptance criteria
	Dynamic Torsion Fatigue	Met acceptance criteria
	Static Expulsion	Met acceptance criteria
	Subsidence	Met acceptance criteria
	Wear Debris Analysis	Met acceptance criteria
Sterilization	Gamma Radiation (SAL 10⁻⁶)	Validated based on VDmax method (ANSI/AAMI/ISO 11137-1 and 11137-2)

2. Sample size used for the test set and the data provenance: Not applicable. These are mechanical and sterilization tests, not studies on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert adjudication are not relevant for mechanical and sterilization testing of a physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical and sterilization testing.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

FloSpine, LLC % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame -de-L`lle-Perrot, Quebec J7W3J6 Canada

Re: K223231

Trade/Device Name: Ti-Largo™ Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 24, 2023 Received: January 25, 2023

Dear Dr. Poggie:

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

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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 (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 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,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K223231

Device Name Ti-LargoTM Cervical Interbody System

Indications for Use (Describe)

Ti-Largon™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

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.

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510(k) SUMMARY for the Ti-Largo™ Cervical Interbody System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Ti-Largo™ Cervical Interbody System.

A. SUBMITTERS INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, NDIP, Québec, J7W 3J6, CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Fax Number:	514-901-0796
Date of Submission:	October 18, 2022

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	FloSpine, LLC
Manufacturer Address:	3651 FAU Blvd, Suite 400
	Boca Raton, FL 33431 USA
Registration Number:	3010125671
Contact Name:	Peter Harris
Title:	President / CEO
Device Trade Name:	Ti-Largo™™ Cervical Interbody System
Device Common Name:	Intervertebral body fusion device
Classification Name:	Intervertebral Body Fusion Device - Cervica
Classification Code:	ODP
Classification Panel:	Orthopedic
Regulation Number:	21 CFR sections 888.3080

PRIMARY PREDICATE DEVICE

K193255	FloSpine Largo™ PEEK Interbody System
PREDICATE DEVICE
K193359	Additive Implants, Inc., SureMAX Family of Cervical Spacers

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DEVICE DESCRIPTION

INDICATIONS FOR USE

Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

TECHNOLOGICAL CHARACTERISTICS

The Ti-Largo™ Cervical Interbody System has similar technological characteristics as the primary predicate and predicate devices, including the materials, design, function, range of sizes, manufacturing processes, surgical technique, and indications for use.

The indications for use for the subject and primary predicate devices are identical except for the tradename of the implant. The general shape, footprints, thickness, and lordosis options are the same or similar for the subject and predicate and devices; the additively manufactured titanium material is the same (ADM, grade 23 titanium alloy powder per F3001) to that of the predicate device. The minor differences in manufacturing and technology were assessed per the FDA guidance document for spinal devices with the outcomes of mechanical and physical testing all acceptance criteria and supportive of substantial equivalence.

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PERFORMANCE DATA

The following tests were performed:

1. Static Compression per ASTM 2077
Dynamic Compression fatigue per ASTM F2077 2.
1. Static Torsion per ASTM 2077
Dynamic Torsion fatigue per ASTM F2077 4.
1. Static Expulsion
1. Subsidence per ASTM F2267
1. Wear Debris Analysis

Sterilization validation with SAL of 10° is based on the VDmax method recommended by the ISO and AAMI (ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2).

CONCLUSIONS

The data presented in this 510(k) notification show the Ti-Largo™ Cervical Interbody System to be substantially equivalent to the cited legally marketed predicate devices. It has the same or similar technological characteristics, materials, sizes, manufacturing processes, and principles of operation as the predicate devices. Therefore, The Ti-Largo™ Cervical Interbody System is substantially equivalent to the 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.