The Rubicon Lumbar Interbody Fusion is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) 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. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Description

The Rubicon Lumbar Interbody Fusion System consists of cages of various lengths, widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Rubicon Lumbar Interbody Fusion System is to be used with supplemental fixation. The leading edge consists of bullet nose. The cephalad/caudal opening is large to allow for bone through growth. In addition, there are 2 large holes on each side to facilitate bone and to aid in visualizing the fusion mass. The teeth are slanted away from the direction of insertion of the implant to minimize implant migration. The superior and inferior surfaces are convex to better fit the vertebral endplates.

The device is offered in 3 general configurations, specifically shaped for posterior, transforaminal or lateral surgical approaches. The posterior approach configuration is available in 508 possible sizes, with lengths from 22mm, widths from 8mm to11mm, heights from 7mm to 16mm and lordosis angles of 0°, 4° and 8°. The transforaminal approach configuration is available in 720 possible sizes, with lengths from 22mm to 36mm, widths from 9mm to 12mm, heights from 7mm to 18mm and lordosis angles of 0°, 4° and 8°. The lateral approach configuration is available in 330 possible sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°.

The Rubicon Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.

AI/ML Overview

The provided text describes a medical device, the Rubicon Lumbar Interbody Fusion System, and its substantial equivalence to predicate devices, enabling its market clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through the analysis of data, sample sizes, expert involvement, or statistical methods as typically found in an AI/ML device submission.

The document focuses on:

Regulatory Clearance (510(k) pathway): Demonstrating "substantial equivalence" to legally marketed predicate devices. This pathway does not typically require de novo clinical performance studies or statistical hypothesis testing against acceptance criteria in the same way an AI/ML device would.
Device Description and Indications for Use: What the device is and what it's used for.
Technological Characteristics Comparison: Highlighting similarities with existing devices.
Non-Clinical (Bench) Testing: Listing mechanical tests performed (e.g., Static Compression, Dynamic Compression, Subsidence, Expulsion) as per ASTM standards for intervertebral body fusion devices. These are engineering performance tests, not clinical performance studies involving interpretation of medical images or patient outcomes.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/ML device. The document simply doesn't contain that type of data.

To answer your prompt directly based on the provided text:

Based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device's performance.

The document is a 510(k) premarket notification for a physical medical device (Lumbar Interbody Fusion System) and focuses on demonstrating substantial equivalence to predicate devices through design description, indications for use, and mechanical (bench) testing. It does not involve AI or machine learning, nor does it present clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses typically associated with AI/ML device evaluation.

Therefore, the following points cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not present, as this is not an AI/ML device.
Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML performance testing. The "test set" here refers to mechanical samples for engineering tests, not a dataset for AI evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image findings) is not relevant to this device's evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

The document states that the non-clinical tests performed were:

Static Compression ASTM F2077-11
Dynamic Compression ASTM F2077-11
Static Compression Shear - ASTM F2077-14
Dynamic Compression Shear ASTM F2077-14
Subsidence ASTM F2267-04
Expulsion

These are mechanical engineering tests designed to evaluate the physical integrity and performance of the implant under various forces, as specified by ASTM standards for intervertebral body fusion devices. The conclusion from these non-clinical tests was that "Rubicon believes that the subject Rubicon Interbody Fusion System is substantially equivalent to the predicate systems it was compared to," meaning its mechanical performance is comparable to already marketed devices.

Summary

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

Rubicon Spine, LLC Mike Boyer President 2955-B Bee Ridge Road Sarasota, Florida 34239

Re: K181030

Trade/Device Name: Rubicon Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 25, 2018 Received: June 28, 2018

Dear Mr. Boyer:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

July 17, 2018

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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,

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) K181030

Device Name

Rubicon Lumbar Interbody Fusion System

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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510(k) Summary

Prepared April 6, 2018

1. Company:	Rubicon Spine, LLC2955-B Bee Ridge RoadSarasota, FL 34239 Tel: 888-515-2532FAX: 888-292-4691
2. Contact:	Mike BoyerPresidentRubicon Spine, LLC2955-B Bee Ridge RoadSarasota, FL 34239Tel: 888-515-2532FAX: 888-292-4691
3. Common Name	Intervertebral Fusion Device with Bone Graft, Lumba
4. Trade Name	Rubicon Lumbar Interbody Fusion System
5. Proprietary Name:	Rubicon Lumbar Interbody Fusion System
6. Classification Name:	Intervertebral Body Fusion Device (21 CFR888,3080): Class II Product Code MAX

7. Product Description:

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sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°.

The Rubicon Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.

8. Indications for Use:

The Rubicon Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) 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. Patients should have received 6 months of nonoperative treatment prior to treatment with the device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

9. Summary of Technological Characteristics

The Rubicon Lumbar Interbody Fusion System consists of a series of PEEK lumbar cages. These cages are intended to be placed between two lumbar or a sacral and lumbar vertebrae using instruments provided. The proposed devices are the same as current interbody cages already on the market with the only difference being minor variations in the shape.

Rubicon has determined that the minor differences between the proposed interbody fusion cages and the predicate devices will not impact the safety or effectiveness of the interbody fusion cages for their intended use. Analysis has shown that the proposed lumbar caqes are equivalent to the predicate lumbar cages.

10. Identification of Leqally Marketed Predicate Device

Documentation was provided which demonstrates that the subject Rubicon Interbody Cage System is substantially equivalent to several predicate devices that are currently on the market in the US, including the following:

Primary Predicate

· Integrity Spine Lumbar Interbody Fusion System (K151819. November 10. 2015)
Additional Predicates
· Vertebron Interbody Fusion System (K073502, March 24, 2008)
· Synthes Opal and Oracle Spacer (K072791, December 26, 2007)
· Stryker AVS PL Spacer (K090816, April 24, 2009)
· Stryker AVS TL Spacer (K083661, February 27, 2009)
· Synthes TPAL Spacer (K100089, May 13, 2010)
· Stryker AVS ARIA Spacer (K101051 August 12, 2010)
InFront Lumbar Interbody Fusion System (K141443, August 28, 2014)

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11. Brief Discussion of Non-Clinical Tests Submitted

The subject Rubicon Lumbar Interbody Fusion System and the predicate cage systems are identical in their indications for use, performance specifications and fundamental technological characteristics. The subject cage system was tested as described in "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" with the following tests being performed:

Static Compression ASTM F2077-11 ●
Dynamic Compression ASTM F2077-11 •
o Static Compression Shear - ASTM F2077-14
Dynamic Compression Shear ASTM F2077-14 .
Subsidence ASTM F2267-04 ●
. Expulsion

12. Conclusions from Non-Clinical Tests

Based on the results of the testing and comparisons performed, Rubicon believes that the subject Rubicon Interbody Fusion System is substantially equivalent to the predicate systems it was compared to.

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.