Rampart™ L is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative studies. Rampart™-L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Description

Rampart™-L is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. The device is made of PEEK-OPTIMA LT1 with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

AI/ML Overview

Based on the provided document, the device in question is the Rampart™ L Lumbar Interbody Fusion Device. This document is a 510(k) premarket notification letter from the FDA, evaluating the substantial equivalence of new sizes (18mm and 22mm wide) of the device to an already cleared predicate device (12mm wide Rampart™-L).

Therefore, the document does not describe a study proving a new device meets acceptance criteria through performance evaluation. Instead, it describes how new sizes of an existing device are determined to be substantially equivalent to a previously cleared device. This means that extensive performance studies (such as those involving AI or human reader improvement, which are typical for new medical software or diagnostic devices) were not performed for this submission, as the core technology and function remain the same.

Here's a breakdown of the requested information based on the document:

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

The document does not specify "acceptance criteria" in the sense of performance metrics for a new device's function (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria for this submission are based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (for Substantial Equivalence to Predicate)	Reported Device Performance/Assessment (for 18mm and 22mm Rampart™-L)
Same or equivalent: Intended Use	Same Intended Use as predicate device
Same or equivalent: Indications for Use	Same Indications for Use as predicate device
Same or equivalent: Fundamental Scientific Technology	Same Fundamental Scientific Technology as predicate device
Same or equivalent: Principle of Operation	Same Principle of Operation as predicate device
Same or equivalent: Device Design	Same Device Design as predicate device
Same or equivalent: Materials of Construction	Same Materials of Construction as predicate device
Same or equivalent: Lengths	Same Lengths as predicate device
Same or equivalent: Heights	Same Heights as predicate device
Not a new worst-case device configuration compared to predicate	Spineology confirmed subject devices do not represent a new worst-case device configuration.
Predicate performance data and risk mitigation measures support safe and effective use.	Assessment confirmed predicate data and risk mitigation support safe and effective use of 18mm and 22mm devices.

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

Sample Size for Test Set: Not applicable. This submission is for new sizes of an existing device, and "new performance testing was not performed." The assessment relied on comparison to the predicate device's existing performance data and design characteristics.
Data Provenance: Not applicable in the context of new performance data. The document refers to "Review of predicate performance data" and "Review of predicate risks and risk mitigation measures," implying the data originates from the studies previously conducted for the 12mm Rampart™-L predicate device. The provenance of that original data (country, retrospective/prospective) is not disclosed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment was created for this submission. The evaluation was based on demonstrating design and functional equivalence to a predicate, relying on pre-existing data for the predicate.

4. Adjudication method for the test set

Not applicable. There was no new test set requiring 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

Not applicable. This device is an implanted medical device (intervertebral body fusion device), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.

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

Not applicable. This refers to an algorithm's performance, which is not relevant for an intervertebral body fusion device.

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

Not applicable for this submission. The "ground truth" for the substantial equivalence determination relied on the physical and functional characteristics of the devices and reference to the established safety and effectiveness of the predicate. For the predicate device, it would have relied on mechanical testing, biocompatibility, and potentially clinical outcomes data, but this document does not detail those.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Spineology, Inc. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 St. Paul. Minnesota 55128-5455 July 24, 2017

Re: K171724

Trade/Device Name: Rampart™ L Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 26, 2017 Received: June 27, 2017

Dear Ms. Hauge:

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171724 Page 1 of 1

Device Name Rampart™ L Lumber Interbody Fusion Device

Indications for Use (Describe)

Rampart™ L is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and six months of non-operative studies. Rampart™-L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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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Date Prepared:	June 09, 2017	K171724Page 1 of 2
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com
Device Name and Classification
Trade Names:	Rampart™ L Lumbar Interbody Fusion System
Common Name:	Intervertebral body fusion device
Product Code:	MAX
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3080
Panel:	Orthopedic
Predicate DevicePrimary:	K133371	Rampart™ L Lumbar Interbody Fusion Device (Spineology Inc.)

Purpose of Submission A.

Currently, the FDA-cleared Rampart™-L system includes 12mm wide implantable devices. The purpose of this submission is for the expansion of the Rampart™-L product line to include 18mm and 22mm wide implantable devices. All other primary technological characteristics of the subject 18mm and 22mm devices remain unchanged from the 12mm predicate device.

B. Device Description

C. Indications for Use

Rampart™-L is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative studies. Rampart™-L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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D. Comparison to Predicate

When compared to the predicate device, the subject Rampart™-L device has the same or equivalent:

Intended Use
Indications for Use
Fundamental Scientific Technology
Principle of Operation
Device Design
Materials of Construction ●
Lengths
Heights

ட். Non-Clinical Testing

New performance testing was not performed for the subject 18mm and 22mm Rampart™-L devices. In order to confirm the safety and effectiveness of the subject 18mm and 22mm Rampart™-L devices as well as their substantial equivalence to the predicate 12mm Rampart™-L device, Spineology conducted a thorough assessment which included the following activities:

Comparison of intended use
Comparison of the technological characteristics; including primary design features and materials of construction
Comparison of the areas and volume; including through growth area, surface contact area, and bone graft volume
o Review of predicate performance data
Review of predicate risks and risk mitigation measures

Based on this assessment, Spineology confirmed that the subject 18mm and 22mm Rampart™-L devices are substantially equivalent to the predicate device, do not represent a new worst-case device configuration when compared to the predicate device, and the predicate performance data and risk mitigation measures support the safe and effective use of these devices.

F. Conclusion

Based on the same indications for use, similar technological characteristics, and comparison to the predicate device, the 18mm and 22mm Rampart™-L devices have been shown to be substantially equivalent to the legally marketed predicate device.

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.