The FUSE Cage is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Description

The FUSE™ Cage is a titanium interbody cage of various widths and heights, which can be inserted between two lumbar or lumbosacral 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 implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally invasive. The implants can be implanted unilaterally. FUSE™ implants consist of pure titanium according to the standard ISO 5832-2 or ASTM F67. It is not allowed to use FUSE™ cages in direct connection with components of other manufacturers. FUSE™ cages are for single use only.

AI/ML Overview

This document, a 510(k) Premarket Notification for the FUSE™ Spinal System, describes the process for demonstrating substantial equivalence to a previously cleared device, not the rigorous performance testing typically associated with an AI/ML device where the criteria listed in your prompt would be highly relevant.

Therefore, the information provided does not contain the details necessary to fill out many parts of your requested output table and descriptions. This is because a 510(k) for a hardware device like an intervertebral body fusion device focuses on:

Comparison to a predicate device: Showing that the new device is as safe and effective as a device already on the market.
Biocompatibility: Ensuring materials are safe for biological contact.
Mechanical Testing: Demonstrating the physical strength and integrity of the device.
Non-Pyrogenicity Endotoxin Testing: Confirming the absence of bacterial toxins.

There is no AI/ML component mentioned in this document, no diagnostic/interpretive function, and consequently, no need for the type of clinical performance study with human readers, ground truth establishment, or multi-reader multi-case studies you've inquired about.

Therefore, I will provide the information that is available from the document and explicitly state where the information requested is not applicable (N/A) or not provided (NP) based on the nature of this submission.

Device Name: FUSE™ Spinal System
Device Type: Intervertebral Body Fusion Device (Hardware)
FDA Submission Type: 510(k) Premarket Notification for Substantial Equivalence

1. Acceptance Criteria and Reported Device Performance

Given that this is a hardware device undergoing a 510(k) for substantial equivalence, the "acceptance criteria" are primarily related to mechanical performance, biocompatibility, and non-pyrogenicity, demonstrated through testing and engineering rationale, rather than diagnostic accuracy metrics.

Acceptance Criterion (Hardware)	Reported Device Performance (Reference)
Mechanical Strength	Documented in a "confirmatory engineering rationale" to demonstrate substantial equivalence to the predicate, particularly concerning ASTM F2077.
Expulsion Resistance	Documented in a "confirmatory engineering rationale" to demonstrate substantial equivalence to the predicate.
Biocompatibility	Materials (pure titanium, stainless steel) are "identical to the primary predicate devices" and have "a long clinical history of safe and effective use." No additional testing required.
Non-Pyrogenicity (Endotoxin)	Worst-case subject implants met the 20 endotoxin units (EU)/device pyrogen limit specification as per ANSI/AAMI ST72 and USP <161>.

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

Test Set Sample Size: Not applicable. For hardware testing, "samples" refer to units tested mechanically or for material properties, not patient data sets. The document mentions "worst case subject implants" for endotoxin testing but does not specify a number. Mechanical testing usually involves a defined number of physical units.
Data Provenance: Not applicable in the context of clinical data for AI/ML validation. This submission relies on engineering analyses, material science data, and existing clinical history of predicate devices/materials.

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

Not applicable. There is no "ground truth" to establish in the context of patient data, as this is a hardware device submission. The "ground truth" for its safety and effectiveness is established through engineering principles, material standards, and comparison to existing, cleared devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of clinical cases requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML diagnostic device; therefore, an MRMC study is not relevant or performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The device is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's safety and effectiveness relies on:
- Compliance with industry standards (e.g., ASTM F2077, ANSI/AAMI ST72, USP <161>).
- Engineering rationale and risk analysis.
- Long clinical history of the materials (pure titanium, stainless steel) and the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

Summary of Device and Acceptance:

The FUSE™ Spinal System, an intervertebral body fusion device, gained 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (FUSE Spinal System K121288) and Capstone Control™ Spinal System (K120368). The acceptance criteria for this hardware device focused on:

Mechanical strength and expulsion resistance: Verified via a "confirmatory engineering rationale" against ASTM F2077 standards, claiming the new lengths (28mm and 31.5mm) do not introduce a "new worst case scenario" compared to the 24.5mm predicate.
Biocompatibility: Demonstrated by using materials (pure titanium and stainless steel) identical to the predicate devices, benefiting from their established "long clinical history of safe and effective use."
Non-pyrogenicity: Verified through bacterial endotoxin testing (LAL test) on "worst case subject implants," successfully meeting the 20 EU/device pyrogen limit, adhering to ANSI/AAMI ST72 and USP <161> standards.

The study presented is a technical justification and comparison to a predicate, not a clinical performance study involving patient data, human readers, or AI/ML algorithms.

Summary

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

Medtronic Sofamor Danek Mr. Ankit Shah Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38125

June 13, 2017

Re: K171468

Trade/Device Name: FUSE™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 17, 2017 Received: May 18, 2017

Dear Mr. Shah:

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 (reporting of medical device-

Image /page/0/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized caduceus-like symbol, consisting of three intertwined figures resembling human profiles, which are meant to represent health and well-being.

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number ( if known )	K171468	Page 1 of 1
Device Name	K171468FUSET™ Spinal System
Indications for Use (Describe)	The FUSE Cage is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FUSE™ Spinal System 510(k) Summary May 2017

I. Submitter:	Medtronic Sofamor Danek USA, Inc
	1800 Pyramid Place
	Memphis, Tennessee 38132
Contact:	Ankit K. Shah
	Sr. Regulatory Affairs Specialist
	Telephone: (901) 344-1272
	Fax: (901) 346-9738
Date Prepared	May 17, 2017
II. Device
Proprietary Trade Name	FUSE™ Spinal System
Common Name	Intervertebral Body Fusion Device
Classification Names	Intervertebral Fusion with Bone Graft,
	Lumbar
Classification	Class II (Implants and Instruments)
Product Code	MAX (21 CFR 888.3080)
Predicates	FUSE Spinal System K121288,
	S.E. 06/29/2012 (Primary Predicate)
	Capstone Control™ Spinal SystemK120368, S.E. 04/09/2012, (AdditionalPredicate)

III. PRODUCT DESCRIPTION:

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implanted via a posterior or transforaminal approach and the procedure may be open or minimally invasive. The implants can be implanted unilaterally. FUSE™ implants consist of pure titanium according to the standard ISO 5832-2 or ASTM F67. It is not allowed to use FUSE™ cages in direct connection with components of other manufacturers. FUSE™ cages are for single use only.

IV. INDICATIONS FOR USE:

V. Comparison of Technological Characteristics

The subject FUSE™ Spinal System has the same indications, intended use, fundamental scientific technology and material as the previously FDA cleared predicate 1 (primary predicate) Fuse Cage (K121288, S.E. 06/29/2012) and Capstone Control™ Spinal System K120368, S.E. 04/09/2012.

VI. Performance Data

Biocompatibility

Identical to the primary predicate devices the implants in the subject FUSE™ Spinal System are provided in sterile form and are made using commercially pure titanium. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used in the instruments cleared under the primary predicate. The materials used in the subject FUSE™ Spinal System implants and instruments have a long clinical

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history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required.

Mechanical Testing

The predicate Fuse Cage K121288 are 24.5mm in length whereas the subject FUSE™ Spinal System implants are 28mm and 31.5mm in length maintaining the same width and height as the predicate. The ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices," defines a worst case intervertebral body fusion device with the smallest footprint and tallest height. Since we are not reducing the footprint it does not introduce a worst case. The mechanical strength and the expulsion resistance have been documented in a confirmatory engineering rationale.

Medtronic believes that the subject implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.

Non-Pyrogenicity Endotoxin Testing

The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests.

VII. Conclusion:

An engineering rationale and risk analysis has been completed for the change. Based on the engineering rationale, risk analysis and additional supporting documentation provided in this premarket notification, Medtronic believes the subject system demonstrates substantial equivalence to listed 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.