A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.

Device Description

The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called A-CIFT™ SoloFuse™, an intervertebral body fusion device. The purpose of this submission is to introduce a new material (PEEK-OPTIMA HA Enhanced) for an already cleared device.

Based on the provided text, there is no information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance or algorithm performance. The document focuses on showing substantial equivalence to a predicate device, primarily through a change in material and a "Failure Effects Analysis" (FEA) instead of mechanical testing.

Here's an analysis of what information is not present related to your request:

A table of acceptance criteria and the reported device performance: This is not provided. The submission focuses on substantial equivalence based on design changes (material), not a new performance evaluation against specific criteria.
Sample size used for the test set and the data provenance: Not applicable as no new performance testing study is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document states, "No performance testing is being included as part of this submission."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI/algorithm-based diagnostic or therapeutic tool.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The submission for the A-CIFT™ SoloFuse™ is a 510(k) premarket notification to introduce a new material (PEEK-OPTIMA HA Enhanced) for an existing device. It relies on the concept of substantial equivalence to previously cleared predicate devices (K151198 and K142026).

The document explicitly states: "No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design."

Therefore, the submission does not include:

Acceptance criteria for device performance.
New studies with test sets, training sets, expert ground truth establishment, or MRMC studies.

Instead, the conclusion is based on "overall technology characteristics and mechanical performance data" (which, for this submission, appears to be primarily the FEA and comparison to the predicate) leading to the conclusion that the device is "safe and effective and substantially equivalent to the previously cleared product."

Summary

{0}------------------------------------------------

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

May 8, 2018

SpineFrontier, Inc. % Meredith L May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K172484

Trade/Device Name: A-CIFTTM SoloFuse™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: April 13, 2018 Received: April 17, 2018

Dear Meredith May

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);

{1}------------------------------------------------

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K172484

Device Name

A-CIFT™ SoloFuse™

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Submitter's Name:	SpineFrontier, Inc.
Submitter's Address:	350 Main Street, 3rd FloorMalden, MA 02148
Submitter's Telephone:	978.232.3990 x275
Company Contact Person:	Director of Innovation
Contact Person:	Meredith L May MS, RACEmpirical Consulting LLC719-337-7579
Date Summary was Prepared:	13 December 2017
Trade or Proprietary Name:	A-CIFT™ SoloFuse™
Common or Usual Name:	Intervertebral Body Fusion Device
Classification:	Class II per 21 CFR §888.3080
Product Code:	OVE, ODP
Classification Panel:	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The spacers are manufactured from PEEK-OPTIMA HA Enhanced and PEEK-OPTIMA® LT1 (ASTM F2026) and Tantalum (ASTM F560-05) markers. The bone screws are manufactured from titanium alloy meeting requirements of ASTM F136.

{4}------------------------------------------------

510kNumber	Trade or Proprietary or Model Name	Manufacturer	PredicateType
K151198	A-CIFTTM SoloFuseTM	SpineFrontier	Primary
K142026	Arena-C® HA PEEK Cervical IBFD	SpineFrontier	Additional

Table 5-1: Predicate Devices

PERFORMANCE TESTING SUMMARY

No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design.

REASON FOR SUBMISSION

The purpose of this submission is to manufacture the SpineFrontier, Inc. A-CIFT™ SoloFuse™ from PEEK-OPTIMA HA Enhanced.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the SpineFrontier, Inc. A-CIFT™ SoloFuse™ is safe and effective and substantially equivalent to the previously cleared product.

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.