The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Device Description

The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).

AI/ML Overview

This is a 510(k) summary for a medical device called FBC 921™ (ALIF), an intervertebral body fusion device. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as pass/fail thresholds for specific quantitative metrics that are then directly compared to "reported device performance" in a separate column. Instead, it describes compliance with recognized standards and a general conclusion of meeting or exceeding predicate device performance.

However, based on the non-clinical performance data section, we can infer the types of tests conducted and the implicit acceptance criteria:

Acceptance Criteria (Inferred from Test Standards)	Reported Device Performance
Chemical composition, mechanical, and metallographic properties in accordance with ASTM F2924-14 and ASTM E8/E8M.	Performed in accordance with ASTM F2924-14 and ASTM E8/E8M.
Static and dynamic axial compression (per ASTM F2077)	Tests performed; overall conclusion: "The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks."
Static and dynamic shear compression (per ASTM F2077)	Tests performed; overall conclusion: "The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks."
Static torsion (per ASTM F2077)	Tests performed; overall conclusion: "The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks."
Subsidence (per ASTM F2267)	Tests performed; overall conclusion: "The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks."
Expulsion (per internal protocol)	Tests performed; overall conclusion: "The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks."
Characterization of particulate wear debris (per ASTM F1877)	Carried out using SEM/EDS techniques. (Implied acceptance: acceptable wear debris characteristics, not explicitly quantified.)
Microscopic analysis of parts following dynamic testing for contact at intended areas.	Conducted for contact at all three intended areas: (1) front of column with locking screw, (2) back of column with top, and (3) posteriorly. (Implied acceptance: satisfactory contact, not explicitly quantified.)
Pressure film study to evaluate contact between top and bottom components at different lordotic angles.	Conducted to evaluate contact. (Implied acceptance: satisfactory contact, not explicitly quantified.)
Assessment of potential for locking screw loosening.	Conducted. (Implied acceptance: no unacceptable loosening, not explicitly quantified.)
Dynamic testing in torsion (axial rotation) to +/- 4Nm for 1 million cycles.	Performed for 1 million cycles. (Implied acceptance: device integrity maintained, not explicitly quantified.)
Bacterial endotoxin testing per USP 39 NF 34 (2016) to achieve Endotoxin limit of 20 EU / device.	Performed; result shows compliance ("achieve the Endotoxin limit of 20 EU / device" is stated as the goal, and the conclusion implies this was met).

2. Sample Size Used for the Test Set and the Data Provenance

The document describes non-clinical (mechanical and material) testing. It does not mention a "test set" in the context of patient data or clinical images. The tests performed are on the device itself (e.g., in a lab setting). Therefore, questions regarding data provenance (country, retrospective/prospective) are not applicable here.

Sample Size for Test Set: Not specified in terms of patient data. For mechanical testing, industry standards typically dictate the number of samples, but specific counts are not provided in this summary.
Data Provenance: Not applicable as no clinical data is presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this 510(k) summary. This document details non-clinical, mechanical, and material testing of an implantable device to demonstrate substantial equivalence to predicate devices. It does not involve a "test set" in the context of expert-labeled clinical data for an AI/algorithm (which is what this question implies).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable for the same reasons as point 3. There is no clinical test set requiring expert adjudication.

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

This question is not applicable. This is a 510(k) for an implantable medical device (spinal fusion system), not an AI/CADe/CADx device that would assist human readers in interpreting medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM standards) and internal protocols, along with the performance characteristics of the predicate devices. The FBC 921™'s performance is compared against these standards and predicate device performance to show it "meets or exceeds" them.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" mentioned or implied, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

FBC Device ApS Finn Christensen, M.D., Ph.D. CEO Viengevej 100 Risskov, 8240 Dk

Re: K180695

Trade/Device Name: FBC 921™ (ALIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: June 7, 2018 Received: June 8, 2018

Dear Dr. Christensen:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

July 12, 2018

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Page 2 - Dr. Finn Christensen

K180692

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,

Image /page/1/Picture/6 description: The image shows the name "Melissa Hall-S" in a large, bold font. The text is black and appears to be the main focus of the image. There is a faint, light blue watermark in the background, partially obscuring the text.

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) K180695

Device Name FBC 921™ (ALIF)

Indications for Use (Describe)

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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Traditional 510k FBC 921™ (ALIF)

Image /page/3/Picture/2 description: The image shows the logo for "fbc device". The letters "fbc" are in black, while the "d" in "device" is in teal. The rest of the letters in "device" are in black, and there is a registered trademark symbol next to the word.

510(k) SUMMARY

Submitted by	FBC Device ApsViengevej 100DK-8240 RisskovDENMARK
Contacts	Pr. Finn Bjarke Christensen MD, PhD (CEO) Phone +45 2344 2012 e-mailfinn@fbcdevice.com ; Dr Bruce ROBIE PhD (COO) Phone +1.201.757.1581, +45 40783167(when in Europe) e-mail bruce@fbcdevice.com Regulatory contact : Dr IsabelleDRUBAIX PhD (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	July 11, 2018
Common Name	Intervertebral body fusion device
Trade Name	FBC 921™ (ALIF)
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: Lanx Fusion System manufactured by Lanx, LLC (K102738)Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); InfixAnterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB SpinalImplant Products manufactured by 4WEB, INC (K112316, K142112); Alif InterfixatedSystem manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured SpacerSystem manufactured by Synthes (USA) (K150673)Reference Device: Pyramid Anterior Plate Fixation System manufactured by MedtronicSofamor Danek, INC (K013665)
Indications for use	The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bonegraft in skeletally mature patients with degenerative disc disease ("DDD ") at one or twocontiguous spinal levels from L2-S1. DDD is defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies. These patientsshould have had six months of non-operative treatment. These DDD patients may havehad a previous non-fusion spinal surgery at the involved spinal level(s) and may have upto Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device isintended to be used with posterior supplemental spinal fixation systems that have beencleared for use in the lumbosacral spine.
Description of the device	The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).
Technologicalcharacteristics comparedto the predicate devices	As was established in this submission, the FBC 921™ is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. FBC 921™ was shown to be substantially equivalent and have the same or similar technological characteristics to its predicate devices through comparison in areas including intended use, indications for use, function, material composition and manufacturing process, design, range of sizes and mechanical performance.
Non-clinical performancedata	Nonclinical testing was performed to demonstrate that the FBC 921™ is substantially equivalent to other predicate devices.The characterization of the chemical composition, mechanical and metallographic properties was performed in accordance with ASTM F2924-14 and ASTM E8/E8M. Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the FBC 921™. The following mechanical tests were performed: Static and dynamic axial compression (per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal protocol). The characteristics of any particulate wear debris (per ASTM F1877) generated during the mechanical test were carried out using SEM/EDS (scanning electron microscopy/energy dispersive spectrometry) techniques. Microscopic analysis was conducted of parts following dynamic testing to assess contact at all three intended areas of contact: (1) on the front of the column with the locking screw, (2) on the back of the column with the top, and (3) posteriorly. A pressure film study was conducted to evaluate contact between the top and bottom components at different lordotic angles. Lastly, assessment of the potential for locking screw loosening was conducted. In addition, dynamic testing in torsion (axial rotation) was performed to +/- 4Nm for 1 million cycles.The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks. Therefore, the FBC 921™ is substantially equivalent to the predicate devices. Bacterial endotoxin testing per USP 39 NF 34 (2016) for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Conclusion	Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the FBC 921™ has 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.