The MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) 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 L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

Device Description

The MiRus™ Lumbar Interbody Fusion System consist of implants manufactured from VESTAKEEP®i4R PEEK per ASTM F2026 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Devices are offered in four configurations of various sizes to accommodate different patient anatomy and the surgical approaches listed: Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants will be provided non-sterile and are intended for single use only.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "MiRus™ Lumbar Interbody Fusion System." This document focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, primarily through comparison of indications for use, materials, technological characteristics, and particularly, mechanical performance.

It explicitly states: "The preclinical testing listed above that was performed on the MiRus™ Lumbar Interbody Fusion System...indicate that it is substantially equivalent to the predicate devices in mechanical performance."

Therefore, the acceptance criteria and the study that proves the device meets them are entirely based on mechanical testing, not on clinical performance or AI/human reader studies.

Here's the breakdown based on the provided text:

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

The acceptance criteria are established by the referenced ASTM standards, which outline specific mechanical tests and their requirements. The document does not provide a table with numerical criteria or directly compare the device's numerical performance against those criteria. Instead, it states the methodology used and the conclusion of acceptable performance.

Acceptance Criteria (Measured Values/Tests specified by ASTM Standards)	Reported Device Performance (Compliance)
Static Compression (per ASTM F2077-17)	Performed, indicates substantial equivalence in mechanical performance.
Dynamic Compression (per ASTM F2077-17)	Performed, indicates substantial equivalence in mechanical performance.
Static Shear (per ASTM F2077-17)	Performed, indicates substantial equivalence in mechanical performance.
Dynamic Shear (per ASTM F2077-17)	Performed, indicates substantial equivalence in mechanical performance.
Subsidence Testing (per ASTM F2267-04)	Performed, indicates substantial equivalence in mechanical performance.
Expulsion of the device (per widely accepted methodology)	Evaluated, indicates substantial equivalence in mechanical performance.

The crucial point is that the acceptance criterion is meeting the performance of the predicate device as demonstrated by these tests, rather than a specific numerical threshold explicitly listed in this document. The conclusion states "substantial equivalent" in mechanical performance, implying that the tested device performed comparably to the predicate under these standard tests.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the number of individual devices or test replicates used for each mechanical test. ASTM standards typically specify minimum sample sizes for such tests, but the exact numbers are not provided here.
Data Provenance: The tests were "performed on the MiRus™ Lumbar Interbody Fusion System," implying prospective testing of the new device's physical properties. The data does not originate from a specific country or clinical cohort; it's from laboratory mechanical testing.

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 type of device and study. The "ground truth" for mechanical testing is established by the physical properties and performance metrics defined by the ASTM standards, measured using calibrated equipment and standard methodologies. There are no human experts "establishing ground truth" in the way they would for image-based diagnostics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus building among human readers/experts, typically in clinical studies or image review. Mechanical testing relies on objective measurements that do not require human adjudication in this sense.

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. The device is an intervertebral body fusion system (an implant), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI-related performance improvements are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on established mechanical testing standards (ASTM F2077-17, ASTM F2267-04) and "widely accepted methodology" for expulsion testing. The performance of the predicate devices under these same conditions serves as the baseline for demonstrating substantial equivalence.

8. The sample size for the training set

This question is not applicable. This document describes the testing of a physical medical device (an implant), not an AI model requiring a training set.

9. How the ground truth for the training set was established

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

Summary

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March 13, 2019

Image /page/0/Picture/1 description: The image contains 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.

MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway SE. Suite 108 Marietta, Georgia 30067

Re: K182920

Trade/Device Name: MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 11, 2019 Received: February 12, 2019

Dear Mr. Bauman:

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

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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) 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 (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 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 Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known): K182920

Device Name

MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (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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510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

I. SUBMITTER	MiRus™, LLC2150 Newmarket Parkway SESuite 108Marietta, Georgia 30067Tel: (678)-324-6272Fax: (678) 401-5607
II. OFFICIAL CORRESPONDENT	Jordan BaumanDirector of Regulatory Affairs and QualityMiRus™, LLC2150 Newmarket Parkway SESuite 108Marietta, Georgia 30067Tel: (678)-324-6272Fax: (678) 401-5607
III. DATE PREPARED	December 18, 2018
IV. DEVICEName of Device	MiRus™ Lumbar Interbody Fusion Systemconsisting of: CALLISTO™ PEEK PosteriorLumbar Interbody Fusion (PLIF);HYPERION™ PEEK Transforaminal LumbarInterbody Fusion (TLIF); CALPYSO™ PEEKLateral Lumbar Interbody Fusion (LLIF);ANTARES™ PEEK Anterior LumbarInterbody Fusion (ALIF)
Common NameClassification NameRegulatory ClassProduct CodesSubmission Type	Intervertebral body fusion device21 CFR 888.3080Class IIMAXTraditional 510(k)
V. PREDICATE DEVICE	Amendia Interbody Fusion Devices(K160924- Primary Predicate)(K151310- Additional Predicate)(K151322- Additional Predicate)

VI. DEVICE DESCRIPTION

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various sizes to accommodate different patient anatomy and the surgical approaches listed: Posterior Lumbar Approach (PLIF), Transforaminal Lumbar Approach (TLIF), Lateral Lumbar Approach (LLIF), and Anterior Lumbar Approach (ALIF). The implants will be provided non-sterile and are intended for single use only.

VII. INDICATIONS FOR USE

VIII. PREDICATE DEVICE COMPARISON

The documentation provided shows that the MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF): HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF): ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics and labeling,

IX. PERFORMANCE DATA

Static and dynamic compression and static and dynamic shear were performed adhering to ASTM F2077-17. Subsidence testing was performed adhering to ASTM F2267-04. The Expulsion of the device was evaluated per widely accepted methodology. The preclinical testing listed above that was performed on the MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) indicate that it is substantially equivalent to the predicate devices in mechanical performance.

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X. CONCLUSONS

The MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF): CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF): ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF)does not raise any new questions of safety or efficacy when compared to the predicate device(s). The MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF) has demonstrated that it is substantially equivalent in mechanically performance, indications for used, intended use, technological characteristics, materials and labeling to legally marketed 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.